Most of the big companies sponsor clinical trials for their product. But usually trials are directed and inclusion/exclusion criteria will look perfect when reality we can see different results.
The way most big companies advertize their products by highly exaggerating facts, and by making false claims, will lead to similar conclusions about pharmaceutical companies as well. In their scramble for more profit, one can expect all kinds of falsehood from them. There is a need for effectively regulating their activities so as to save the innocent public from being deceived.
Such sponsorship certainly has the potential to raise serious concerns over the validity of the results. I don’t necessarily think it is an issue for companies to sponsor trials, however, efforts to improve transparency need to ensure that the results from all trials are made available to the public for scrutiny. Btw, for anyone interested in this topic, the book ‘Bad Pharma’ does a good job of covering this (and related issues) with respect to pharmaceutical companies.
Thank you Elliroma for your valuable comments and as you said transparency is needed
Having worked both in academic and pharma industrthe believe more in the pharma sponsored trial results than academic trials.The most important reason being that pharma sponsored trials are rigorously conducted and monitored. The regulatory bodies oversea these trials and can audit them as and when required. Pharma companies risk loosing more by publishing bias results. Most of the major pharma companies nowadays make their trial results available in public domain.
Academic or pharmaceutical research.. which is more reliable ? It depends on many things. Conflict of interest can be easily expected for the pharma sponsor trial results, but even, academic studies can be argued for disclosure reasons (scientific reputation, research career plans, etc.). I think, that transparency and standardized procedures may afford more confidence in trial results.
Most of pharmaceutical do that and there is inevitably some bias in the study. However, medical research is money first of all, idea and perseverence follow. So, some bias is unavoidable but making use of their funds is also unavoidable to have big trials done. the ideal setup of course would be that of the a non-profit scientific body. There few in the world of the kind, the NIH is one of them
nothing absolute
Put regulation
effective M&E
and review well
Conflict of interest is always present even after consent, But how to overcome that that is the point..
I feel, there is no clear-cut answer to this question. Pharma sponsored projects can be two ways. One where the pharma sponsored trials are rigorously conducted and monitored as rigtly said by Rahul Dimber. On other hand, some pharma companies would just sponsor for the material cost involved, or give some newly launched drug for free trial to academic post graduates to study. In later senario there is some moral pressure on the researcher and hence have high chances of conflict of interest.
Projects which are funded by third party (NGO/Govt/institute/etc) regardless of the materials used, could have better transparency and might be more reliable.
We should be aware also, that reliability of trial results doesn't depend only on whom is performing them. As said by AMIT AGRAWAL, there is no clear-cut answer to the question. But, I think that repetition of the trial can help to confirm conclusions. So, it's only question of time, and global research efforts
Thank you all for answering this hot practical topics and for giving valuable feedback
As mr. Razgallah puts it, there may be bias on both - and may I add any - sort of publication, even without the researchers' intention.
As the (in)famous case of dr. Benveniste's "proving" of homeopathy, the original research and even further experimentation had provided apparently solid results, but more rigorous trials (specially Maddox et al) showed that there were (probably) unconscious biases towards those results as they were proven to be false.
So as many others have suggested above, reproducibility is a crucial aspect of the scientific endeavour, only possible by complete transparency of research methodology. True science should not be affected by whoever's making it.
Dear @Mohamed, The companies are usually searching for research and results that can be used to promote their products. So, they have annual budget for research; part of this research is used to improve the products and the other part is used to promote the company and its products.
Dear Mohamed
The clinical research sponsored by the pharmaceutical industry is a major problem faced by the researchers. The relationship researcher and pharmaceutical industry presents valid concerns and interaction that normally promote mutual benefits, however conflicts of interest are inevitable. The industry keeps for profit and its commitment and responsibility is to the shareholders while the commitment of the physician should be the patient's interest is first. When the pursuit of profit is given priority over the well being of the patient, is characterized that the validity of the research is unduly influenced by a secondary interest
I think the clinical trials must have a sponsorship , no problem if the companies support the trials, but this must not affect the decision about exclusion or inclusion.
Thanks
Not necessarily!
The motives of the sponsorship may be established to avoid and/or evade any unethical conduct!
Period!
You may be right, Tobias,
but sponsoring may be very compelling for the sponsored ones.
Dear @Tobias and @Hanno, This might be the case in few cases, but the most cases might have conflict of interest as @Abdalla said.
Nice question. Why would a business firm be interested in anything which draws no money or non-financial gains again helping some how in commerce. yes if clinicians are blinded and are unaware of funding party, these trials will be fine. Health and related research should not be commerce driven but should be guided by the spirit to allay the pain of suffering humanity.
Dear Mohamed
This is an Interesting question. I think, it is difficult to say conclusively on the basis of one's own experience. But I definitely do not have excessive faith in the company-sponsored clinical trials.
I have experienced that they are largely biased and the results are exaggerated towards promoting the products of the company concerned.
Early launching and Promotion of products is the prime aim, every thing else revolves around that !
I think if you find a method to avoid bias it will be great to do like these experiments.
Thanks
Sara
I am pleased to draw your attention to the results of a study published in the German Medical Journal, the abstracts of which you find downmentioned:
The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences: Part 1. A Qualitative, Systematic Review of the Literature on Possible Influences on the Findings, Protocols, and Quality of Drug Trials
Dtsch Arztebl Int 2010; 107(16): 279-85; DOI: 10.3238/arztebl.2010.0279
Schott, Gisela; Pachl, Henry; Limbach, Ulrich; Gundert-Remy, Ursula; Ludwig, Wolf-Dieter; Lieb, Klaus
Part 1
Summary
The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences: Part 1. A Qualitative, Systematic Review of the Literature on Possible Influences on the Findings, Protocols, and Quality of Drug Trials
Background: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This paper provides an overview of the findings of current, systematic studies on this topic.
Methods: Publications retrieved from a systematic Medline search on this topic from 1 November 2002 to 16 December 2009 were independently evaluated and selected by two of the authors. These publications were supplemented by further ones found in their references sections.
Results: 57 publications were included for evaluation in Parts 1 and 2 of this article. Published drug trials that were financed by pharmaceutical companies, or whose authors declared a financial conflict of interest, were found to yield favorable results for the drug manufacturer more frequently than independently financed trials whose authors had no such conflicts. The results were also interpreted favorably more often than in independently financed trials. Furthermore, there was evidence that pharmaceutical companies influenced study protocols in a way that was favorable to themselves. The methodological quality of trials financed by pharmaceutical companies was not found to be any worse than that of trials financed in other ways.
Conclusion: Published drug trials that are financed by pharmaceutical companies may present a distorted picture. This cannot be explained by any difference in methodological quality between such trials and trials financed in other ways.
Part 2
SUMMARY
The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences: Part 2. A Qualitative, Systematic Review of the Literature on Possible Influences on Authorship, Access to Trial Data, and Trial Registration and Publication
Background: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This overview of current, systematic studies on this topic is intended to identify and characterize the particular aspects of the performance of a drug trial that can be affected by financial support from a pharmaceutical company.
Methods: Publications retrieved from a systematic Medline search on this topic from 1 November 2002 to 16 December 2009 were independently evaluated and selected by two of the authors. These publications were supplemented by further ones found in their references sections.
Results: 57 publications were included for evaluation in Parts 1 and 2 of this article. A number of studies revealed that many trials financed by pharmaceutical companies—in some cases, as many as half of all such trials—are never published. Moreover, multiple publications of the same findings were found, and some reports were found to include selectively published data. Further studies revealed evidence of other problems including incomplete trial registration, constraints on publishing rights, withheld knowledge of adverse drug reactions, and the use of ghostwriters who were supplied by the pharmaceutical companies.
Conclusion: Financial support from a pharmaceutical company influences multiple aspects of the performance of drug trials and often leads to a favorable result for the corporate sponsor of the trial. Public access to trial protocols and results must be ensured. Moreover, more effort should be made to carry out drug trials independently, without the financial support of pharmaceutical companies.
And now Part 2 again:
Part 2
SUMMARY
The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences: Part 2. A Qualitative, Systematic Review of the Literature on Possible Influences on Authorship, Access to Trial Data, and Trial Registration and Publication
Background: In recent years, a number of studies have shown that clinical drug trials financed by pharmaceutical companies yield favorable results for company products more often than independent trials do. Moreover, pharmaceutical companies have been found to influence drug trials in various ways. This overview of current, systematic studies on this topic is intended to identify and characterize the particular aspects of the performance of a drug trial that can be affected by financial support from a pharmaceutical company.
Methods: Publications retrieved from a systematic Medline search on this topic from 1 November 2002 to 16 December 2009 were independently evaluated and selected by two of the authors. These publications were supplemented by further ones found in their references sections.
Results: 57 publications were included for evaluation in Parts 1 and 2 of this article. A number of studies revealed that many trials financed by pharmaceutical companies—in some cases, as many as half of all such trials—are never published. Moreover, multiple publications of the same findings were found, and some reports were found to include selectively published data. Further studies revealed evidence of other problems including incomplete trial registration, constraints on publishing rights, withheld knowledge of adverse drug reactions, and the use of ghostwriters who were supplied by the pharmaceutical companies.
Conclusion: Financial support from a pharmaceutical company influences multiple aspects of the performance of drug trials and often leads to a favorable result for the corporate sponsor of the trial. Public access to trial protocols and results must be ensured. Moreover, more effort should be made to carry out drug trials independently, without the financial support of pharmaceutical companies.
India’s top drug regulator has proposed to change clinical trial requirements, by delineating more clearly the responsibilities for reporting cases of clinical trial-related injuries. This decision, which would amend some clinical research-related clauses in India’s Drug & Cosmetics Rules 1945, follows a Supreme Court inquiry into the actual number of deaths and severe adverse effects (SAEs) caused to people during clinical studies.
http://www.contractpharma.com/issues/2014-06-01/view_india-report/india-tightens-clinical-trial-requirements/
There may be biasness to protect their product. Law should interfere for verification of results.
Dear Mohamad, it is likely that the result may bias as per the requirement and pressure created by sponser companies. Specially in drug related research result need to be handle very sensitively without biasing it...
Sponsored Clinical trials should not be biased as it is against the principles of professional ethics....After clinical trials the product moves the value chain towards Commercialisation process.... then to ensure relaibility, stringent validation and transparent process of verfication is required...
Though I mentioned the multifaceted bias of industrial led research projects I wish to point out the research laboratories of the pharmaceutical industry which are usually extremely well equipped with opulent research facilities and most often research personnel as well. Rational and realtime decision making is another feature. In contrast state university departments often suffer from never-ending financial restrictions and endless discussions. Therefore researchers understandably either try to receive third-party funds by industrial cooperation to keep alive with research activities or relocate to research institutions outside of the university (like Max Planck Society, Helmholtz-Institutes etc. with a reputation in the world of science), institutions which are supported by public funds as well. The more third-party funds become a pillar of research in university departments the less financial support from the public will occur or intentionally will even be induced because of successfully recruiting third-party funds. This may become a maelstrom destroying independent research as a pillar of universitarial research which must be detained.
The following ideas may be of some help to counter such a process:
1. Research projects with third-party funds only should not be allowed.
2. University should distribute financial involvement compulsory.
3. University should be obliged to increase its original university - bound personnel by the proportion 1:3 if financial benefits come in from third-party funds.
4. University secures a professional decision making within 6 weeks after presentation of a qualified decision memo.
5. University secures a professional project and quality management together with the third-party fund.
6. Universitarial researchers may only acquire third-party funds if they continue in the position of the steering committee with the right to a veto-vote.
7. Third-party members (as well as universitarial members of course) should be obliged to
a. publish the hypotheses underlying their project
b. publish methods used, protocols and results achieved irrespective of the results
c. provide the public presentation with all their original data underlying published papers on the website of the university institute as well as on the website of the third-party company
The clinical research funded by pharmaceuticals can be biased some times and presents a major problem for researchers. Some times researchers can be pressurised not to declare complete information that conflicts industrial claim. Often researchers have less to say on the claims. However on the brighter side clinical research and trials are crucial for development and release of any new drugs into market.
Hi,
It is normal for such trial to be biased as these companies want to increase the credibility of their products.Despite these bias ,science had benefit .So I guess that making regulation to decrease bias could
The way most big companies advertize their products by highly exaggerating facts, and by making false claims, will lead to similar conclusions about pharmaceutical companies as well. In their scramble for more profit, one can expect all kinds of falsehood from them. There is a need for effectively regulating their activities so as to save the innocent public from being deceived.
There is a related big problem with Psychotropic Drugging. You should at least watch one of the following documentaries:
https://www.youtube.com/watch?v=UDlH9sV0lHU
https://www.youtube.com/watch?v=IgCpa1RlSdQ
Furthermore I attached a list of psychiaters that are getting a lot of money from pharmaceutical companies. It looks that banks and pharmaceutical companies are of the biggest enemies to people.
Hi all,
though I can very well understand the reservation or even dislike or malaise to cooperate with private companies in research we should not throw out the baby with the bath water. We must consider the fact that many if not most of relevant inventions were done by individual persons working in private companies or founding them later. Therefore I am convinced that research in private companies is one agent to assure the survival of our culture in a free market economy. Instead we must think about using this potential to the benefit of all and avoid collateral damage at the same time. Therefore I recommend to look for methods to attain a “win / win - situation”:
· Welcoming a favourable social and political climate of structured, transparent cooperations with a clear allocation of benefit and for whom
· Setup of an registration office for all cooperations with internet access for all
· Introducing high ethical standards at the beginning at school, continuing at university and applying for all occupations and professionals
· Publicizing all cooperations compulsary to establish transparency
· Protecting key persons eg. in politics from direct or hidden influences
· Prosecuting noncompliance of individual persons or institutions
· Marginilisation of non compliant people socially irrespective of their status or position
· Severe penalization to fight corruption
What are your opinions about clinical trials sponsored by companies, do you think results are biased?
The clinical trials sponsored by companies means there will eventually be approval for these trial drugs to be used on patients.
The results are always biased in favour of the companies because they will publish only results that they will benefit from patients trialling the drug and the results of the trials are never fully disclosed.
"(This many) people have used this drug to date. Why don't you also join the trial if eligible?"
The results of the trials including newly discovered side effects and deaths are minimally mentioned in the excitement regarding the new trial drug.
In the forgone hysteria, there is little mention of patients who have trialled the drug/medication and continue to suffer from the 'choice' to join the trial of the drug.
Between the company and the patient, the company profits from the clinical trials.
I think it is a mater that depends on the researcher's ethics and morals, where they ought not accept any funds unless they make sure that there are no pressures to get results and evidences supporting what ever a product and after acceptance they are to be ethical enough to publish their results even in cases where certain company products are challenged by these results.
Today in India, many Pharmaceutical companies outsource this activity of Clinical trials to Start up Biotech companies.
The ulterior requirement is not on the reality of test but on the documentation that needs to carried out for validation and clearances.
To the major problem seem to be that on one hand we have the allegiance problem and on the other hand there is the problem that without private funding research in many areas is impossible. Additionally research can not be understood and realized without respecting cultural context. Currently most of the above criticized research depends on the context of being proceeded in liberal societies, where a central control mechanism is hard to achieve. An other aspect we should not forget is that solutions can change to problems over time. If for example implemented control mechanisms themselves need to be controlled. Then as for example in many areas of evidence-based medicine a strict and rigid hierarchy can be the consequence ...
Therefor an ideal solution seem to be impossible to me. Because all real research has advantages and disadvantages for all involved parties and questions, values and interests change over time. It probably is the best to follow a falsificationistic idea to identify the most relevant problems and try out better solutions. This can probably be realized in an open society. Best to me seems that there are critical parties in dense interaction with different interests and values that interact with each other (e.g. patient organizations, stake holders, universities, ethical boards, experts, press).
Thomas
Clinical trials are fundamental to the science itself as well as for the companies to develop new treatment and testing them. Usually there should be obvious contract that they should not interfere with any step in the research and they should accept the results whatever and even negative ones
We have to remeber some facts
most of the major clinical trials which change the treatment decissions are company sponsored and when you come to the effects of these medications they never looks like what is described in clinical trials
The conduct of clinical trials involving human participants, has highlighted a number of ethical issues, especially in those situations in which researchers or research sponsors from one country wish to conduct research in another country.
The studies in question might simply be one way of helping the host country address a public health problem, or they might reflect a research sponsor´s assessment that the foreign location is a more convenient, efficient, or less trouble-some site for conducting a particular clinical trial. They might also represent a joint effort to address an important health concern faced by both parties. As the pace and scope of international collaborative biomedical research have increased during the past decade, long-standing questions about the ethics of designing, conducting, and following up on international clinical trials have re-emerged.
Some of these issues have begun to take center stage because of the concern that research conducted by scientists from more prosperous countries in poorer nations that are more heavily burdened by disease may, at times, be seen as imposing ethically inappropriate burdens on the host country and on those who participate in the research trials.
Clinical trials conducted by pharmaceutical, biotechnology, and medical device companies.
The changing landscape of international research becoming more involved as collaborators in research, as many of the countries from which these investigators come have developed their capacity for technical contributions to research projects and for appropriate ethical review of research protocols.
Some market forces have pressured private companies to become more efficient in the conduct of research, which may -- absent vigilance -- compromise the protection of research participants. Although the extent, relevance, and force of these pressures are widely debated, it is clear that such pressures can exist regardless of the funding source.
https://bioethicsarchive.georgetown.edu/nbac/clinical/execsum.html
I do not think it is a problem to conduct clinical trial funded by companies. Yet there should be a tight agreement from the start that they should not interfere with the process itself, further even negative finding should be published. Mind you there is no company to waste their money unless they know that their product is as should be. Second point is that most of the companies have their own researchers and hey developed the product after long investiagtions
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
http://www.nlm.nih.gov/medlineplus/clinicaltrials.html
I agree with you Mr. Kamal Eddin Bani-Hani. This malpractice is not good for our society.
I believe governmental bodies should shoulder or at least contribute to finding evidences by having a role in such a play by either conducting the trial itself or governing it.
I completely agree with Prof Mahfuz, however these protocols and rules should be followed strictly and honestly. Health of volunteers whether they are man or woman must be on priority. Yes if government take a lead in this area than it will definitely be more reliable. Here I would like to mention that after completion of all the clinical tests output results whether they are positive or negative must be published and known to people. Thanks
Honesty is the best policy of dedication hence, the ethical practices should be adapted as fast as possible.
Clinical trials are sponsored by government agencies, private organizations, and individual researchers who are seeking ways to improve the health of people living with chronic and life-threatening illnesses. Sponsors include:
* government agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA)
* pharmaceutical, biotechnology and medical devices companies
* individual researchers
* health care institutions such as academic medical centers and health maintenance organizations (HMOs)
Clinical trials take place in a variety of locations, including hospitals, universities, doctors' offices, or community health clinics.
http://www.nlm.nih.gov/services/ctsponsor.html
BERKELEY UNIVERSITY
A pharmaceutical company paying for a study of a new depression medication, for example, might influence the study's design or interpretation in ways that subtly favor the drug that they'd like to market. There is evidence that some biases like this do occur. Drug research sponsored by the pharmaceutical industry is more likely to end up favoring the drug under consideration than studies sponsored by government grants or charitable organizations. Similarly, nutrition research sponsored by the food industry is more likely to end up favoring the food under consideration than independently funded research. Tobacco industry's manipulation of scientific research on the Public Health
So what should we make of all this? Should we ignore any research funded by companies or special interest groups? Certainly not. These groups provide invaluable funding for scientific research. Furthermore, science has many safeguards in place to catch instances of bias that affect research outcomes. Ultimately, misleading results will be corrected as science proceeds; however, this process takes time. Meanwhile, it pays to scrutinize studies funded by industry or special interest groups with extra care. So don't, for example, brush off a study of cell phone safety just because it was funded by a cell phone manufacturer — but do ask some careful questions about the research before jumping on the bandwagon. Are the results consistent with other independently funded studies? Does the study seem fairly designed? What do other scientists have to say about this research? A little scrutiny can go a long way towards identifying bias associated with funding source.
http://undsci.berkeley.edu/article/0_0_0/who_pays
If there are companies that want to sponsor clinical trials and research, then there should be an inter-university organization that gets the money and distributes it anonymously to related researchers. The results of the research gets pattens, and any company that have sponsored the research, can get the patten with special price.
Clinical trials are done in phases. Each phase describes the general information about a new treatment that is being collected in a clinical trial, such as the dose, safety, and how well it works. The phases are called I, II, and III.
Preclinical research
Before a new treatment can be given to patients, the underlying research hypothesis (the explanation for how the new treatment works) must be proven in a laboratory. This stage is called preclinical research, and it often takes years to turn this knowledge into a new treatment.
If the laboratory research suggests that the treatment might be an effective cancer treatment, the sponsor of the clinical trial files an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) asking permission to study the treatment in people. If the IND application is approved, researchers can move on to the next step of research, which includes studies to find out more about the treatment.
Phase I clinical trials
The goal of a phase I clinical trial is to show that a new drug or treatment, which has proven to be safe for use in animals, may also be given safely to people. Doctors collect data on the dose, timing, and safety of the treatment. People who participate in phase I clinical trials are often the first to receive a new therapy or a new combination of therapies.
In phase I clinical trials, the dose of the drug being studied is gradually increased to find the dose that works best without causing severe side effects. This process is called dose escalation. The first participants are given a small dose of the drug. If there are no or few side effects, the next participants are given higher amounts of the drug until the doctors find the highest dose with the fewest side effects. Sometimes, the doctors need to find out the best way to give the new treatment, such as by mouth or through a vein. In addition, the doctors collect data on how the drug is absorbed, processed, and spread throughout the body.
Phase I clinical trials generally last several months to a year and most often involve a small number of people, usually no more than 10 to 20. People whose cancers are no longer responding to standard treatments are often offered treatment in phase I clinical trials. Although phase I clinical trials are not primarily designed to test how well a treatment or combination of treatments work, an investigational treatment in this phase may help to slow or stop the growth of a person’s cancer. All currently available treatments were first tested for use in people in phase I trials.
Phase II clinical trials
Phase II clinical trials provide more detailed information about the safety of the treatment, in addition to evaluating how well it works. These clinical trials focus on finding out whether the new treatment works for a specific cancer, which may be measured by a decrease in tumor size or through blood tests. Phase II clinical trials take about two years to complete and usually involve about 20 to 40 people. Sometimes phase II clinical trials will assign patients to several possible treatments. This is known as a randomized phase II trial and may include up to several hundred patients. The new treatment needs to show it is likely to work and is safe when compared to the standard treatment for it to be tested in phase III clinical trials.
Phase III clinical trials
The goal of phase III clinical trials is to take a new treatment that has shown promising results when used for a small number of patients with a particular disease and compare it with the current standard of care for that specific disease. In this phase, data are gathered from large numbers of patients to find out whether the new treatment is better and possibly has fewer side effects than the current standard treatment. Phase III clinical trials are usually randomized, meaning that patients receive either the investigational treatment or the standard treatment in a non-ordered way. In phase III studies at least two (and often more than two treatment options) are compared. Although phase III clinical trials focus on patients with a specific disease, they typically include patients of various ages, ethnicities, and both genders so that the results may be applicable to a large number of people. The number of people enrolled in a phase III clinical trial can range from the hundreds to the thousands, and these clinical trials take many years to complete.
Once a drug has been shown to work well to treat a specific cancer in a phase III clinical trial, the researchers can submit an application for FDA approval. If data from the clinical trials meet the FDA's standards, the treatment is approved for a specific use.
http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/phases-clinical-trials
Dear Nelson.
The relationship researcher and pharmaceutical industry presents valid concerns and interaction that normally promote mutual benefits, however conflicts of interest are inevitable. Nicely said.
An important component of the clinical trial is getting the the approval of the ethical committee . This committee which has members from different groups should sincerely scrutinize the documents & their primary aim is to protect the subject participants from serious harm . They should not be influenced by anyone & should be independent . Research is essential to bring new drugs for the treatment of various diseases & the new drugs have to be introduced with great care & it is here that ethical committee has a major role , as far as protecting the subject participants . The recent Ebola Virus Disease epidemic has highlighted the urgent need for drugs & vaccines to protect the citizens of the affected countries , but this needs proper procedures to start new therapies , in a scientific manner . This also highlights the urgency of new drugs to save lives . It is only results of clinical trials of drugs manufactured by drug companies & approved by ethical committees that can benefit patients .
Clinical trials are usually done utilizing Random controlled trials , which have strict inclusion / exclusion criteria to evaluate the benefit of the drugs . Later , prospective observational studies might give valuable data in the post marketing phase . This is to comment on Mohamed A Yassin's remarks .
It is difficult to be proved something like that, since there are protocols, procedures and other processes. But, the profit orientation of all companies has to be into account and further ways of independence guarantee have to be established. I am not a specialist, but as for a first step, the reproducibility of the results by two more independent researchers should be asked before circulation of a new pharmacy.
How are organizations are protected when clinical trials are conducted in the developing world?
The Principles affirm that clinical trials in the developing world must be conducted in accordance with ethical principles established by the Guidelines for Good Clinical Practice in addition to applicable laws and regulations and the requirements of local ethics committees. .Informed consent is a cornerstone of ethical clinical research and should be obtained in a manner that is understandable by the research participant, consistent with local requirements, regardless of the location of the clinical trial, and in writing whenever possible. Our members work with local governments, non- governmental organizations associated with the United Nations, and local institutions to ensure the appropriate selection of research participants, appropriate use of place bio-comparators, and access to post-trial treatment for research participants
http://www.phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final.pdf
The clinical trials sponsored by the pharmaceutical industry are always in news for bad. In fact, these companies are in so much haste to launch their products due to completion that generally their clinical trials do not respect even basic statistical requirements and size of sample of subjects is always in question for non-satisfactory results. They make money and patients suffer.
Corrupted system is built on kickbacks. A hand washes a hand.
I d o think that we can generate science without help of these big companies
Criticism by the European national health authorities
- inconsistent implementation of the clinical trials directive into national law by the individual EU member states,
- regulatory frameworks not always being adapted to practical requirements,
- adaptation to special characteristics of the trial populations (e.g. paediatric patients) and trial design, as well as
- ensuring compliance with Good Clinical Practices (GCP) in clinical trials performed in third countries.
- Clinical trials are conducted at multiple sites in multiple European countries, the need for local knowledge and resources is obvious.
“Qualified Person” QP must verify that the investigation medicinal products (IMP) is manufactured in compliance with GMP standards equivalent to European GMP. Usually a site audit is performed to assess the manufacturing and testing facilities.
https://www.pharmatching.com/inforena/clinical-trials-in-the-eu-challenges-for-non-eu-pharmaceutical-companies
Dear Brenda Jacono Thanks So it is an individual matter and depend on the situation
Although the pharmaceutical industry has always been a fairly well-established part of Swiss-India collaboration and trade, the emergence of India as a location for clinical trials by Swiss pharmaceutical companies is more recent. Swiss pharmaceutical giants such as Novartis and Hoffman-La Roche have established, and increased their stakes in, subsidiary companies in India to take advantage of opportunities there.
Indian patent laws have set a high threshold for the patenting of new versions of existing drugs, demanding that the modified compounds must show improved efficacy. Legal judgments in India have set a critical precedent for ensuring access to medicines for not only Indians but also for people in the developing world.
https://www.ladb.ch/fileadmin/files/documents/Klinische_Versuche/1309_INDIA_Final_Report.pdf
If research is done for scientific purpose and the pharmaceutical scientific office sponsoring for that reason its OK, but if sponsoring to prove quality of that product manufactured by that company here, yes a bias is raised
I worked 5 years, 84 to 88, in The Upjohn co Spanish subsidiary, now Pfizer, as clinical research coordinator, and I'd say that all the studies in which I participated had sound designs from an ethical point of view, however, the behavior of some investigators may have been subject of ethical discussions in issues such as economical relationships with their institutions, and informed consent process, but in dealing with adults that are supposed knowing what their duties are respect CR, you can't force them into acting in a certain way. People in pharmaceutical industry decission taking elements do not necessarily have to be more ethical or have a more fair behavior than the rest of population, so, you'll for sure meet some evildoers there.
Cases of counterfeited research, most from investigators, are not rare, and as it happens with independently sponsorized research, some times results of trials or other research are never published, it's known that there's a: 'selection bias', in that positive studies tend to be published more often than the negatives, as example, the CRFs of an study of an sleep pill in elderly dissapeared in coincidence with the sponsor deciding to withdraw form market the unit dose used in study, and switched to a dose 25% of the original hs dose in study, but this may have been pure hazard.
They say the top in the 'societies' pyramid -I'd say anyone using the word: 'social', is at least suspected of fraud, scam- tends to have a personality and a way of acting similar to that of the underground, i.e. goal-oriented behavior, that for some is considered as a marker of psychopathic, or borderline, or anti-social personality disorder, that does necessarily mean conflicts with law enforcement bodies, some that don't show a goal-oriented behavior may actually be having a behavior oriented to the goals of others.
if for some the attitutde is: 'be perfect', meaning: 'do the good, never do evil', for others it's: 'be impeccable', meaning: 'don't let them catch you', that perhaps may be considered a psychopatic behavior basic trait, Hermes, or Mercury, both patron of commerce and of thieves, may be the one invoked by those moving on this line. (The french song: 'Stances a un cambrioleur', by Georges Brassens, contains harder comments on this line)
I attach another, perhaps copyrighted image, about pharma industries, that doesn't reflect any actual person or fact I've contacted, watched or heard of, it's just a joke.
In most instances, the results are seen to be biased, erroneous and full of arbitrary data which hampers common people's life. Other companies do it sincerely. In the former case, the authority should take immediate strong step in order to curb it and to achieve higher development potential in sector of public health.
Most of all, I think individual companies should remain honest in their action, otherwise future of our society will be ruined.
There is a significant movement within the Continuing Medical Educational process to avoid any “bias information”. The recent Justice Department probe and Congressional investigations into the medical device industry has everyone (professional medical societies) running scared and overreacting. There is significant discussion of removing commercial funding from CME to eliminate any bias information. This, in my professional opinion, is an overreaction and will create more problems than it could possible solve.
Lets look at a few facts that benefit our current system of education. The health Care Industry supports educational activities to the tune of about one billion dollars ($1,000,000,000) a year within the United States (WSJ’s blog on health & the business of health 11/15/09). Our first assumption should be this is good because dollars are necessary to put effective teaching and learning tools into place. Imagine for a moment that we did not have this money available to education. How much longer would it take to train and educate our health care professionals? How many patients would suffer longer than necessary if our information on drugs, devices and techniques slowed down?
Who would pick up the financial slack, or would there just be a lag in training and education. The concern should not be that there is an industry supporting education, (thank God we have an industry that can help support educational activities) but focus should be on the process of disclosure not on elimination of funding sources.
I think we should be challenging our industries to increase their funding not looking at demonizing them because they do. We have with the Accreditation Council for Continuing Medical Education (ACCME® www.accme.org) procedures in place that are effective and do an adequate job with-regard to disclosure of commercial funding. These guidelines and standards need to be living documents that undergo their own review and modifications on an incremental schedule. Drastic or radical change is rarely beneficial.
It is time we challenged the proponents against “Bias Information” to back down and acknowledge all bias information is not bad. This is a term that is being misused and I for one look towards my selection of medical professionals to have strong biases within their practice of medicine. I just want them to disclose their biases.
The key is that bias information should be balanced with other or different perspective “Bias” information so there is a balance of information presented within the content of a given subject matter.
I suggest we all want to hear bias information because this information is often the result of training, experience and results. We don’t necessarily want to hear bias information that is based on monetary reward. However, often presentations and/or publications can have multiple biases within any given subject material. The proper way to inform individuals of “bias” information is through disclosure not by elimination. Only by disclosure can the audience determine if the quality of the information has true merit.
Just the fact of monetary interest does not suggest that the bias presentation does not have significant merit in its content, method and conclusions. The fact that there is a disclosure with regard to monetary benefit to the author should be considered and reviewed from that point of reference.
Example:
A Total Hip Arthroplasty performed with the selection of femoral component being fully porous coated like the “AML® Stem”, suggest that the use of this device demonstrates a preference towards a device with extensive porous coating over the length of a cylinder style stem. Over the years, some surgeons that have lectured on their use of this stem have disclosed the fact that they had a financial interest in the device. This disclosure in no way changed the fact of the long-term clinical results, benefits and/or potential problems related to this device.
In my 45 years in the orthopaedic health care field I have never known any surgeon that has switched his selection of product and/or technique as a result of hearing one bias talk.
I have found just the opposite. Surgeons, because of their own biases due to their training and experience, are reluctant to change. They only change as a result of significant information that addresses a problem or concern they have experienced.
I am bias towards bias information remaining as part of our educational activities and I also continue to indorse the use of commercial funding for CME activities and wish the industry would increase its budget for balanced CME activities.
This is a subject that should be important to all of us involved with research and health care.
Regards,
Tim
Dear Tim I agree with you, financial support for our clinical trials sponsored by companies or any other institutes offer a great help to all fields of science, education, training and research.
The crude truth may be that investigator sponsored clinical research may have the almost impossible hurdle to overcome, at least in some places, of having to pay for the Drugs cost and for the cost of added tests that are not part of standard care for the disease, this is a hughe amount even for pharma industry, a promising CT on Anapsos for MS fatigue was never started because it required a budget over 6 million €
In my opinion for objective results it will be only DOUBLE-BLIND RANDOMIZED TYPE of clinical trial highlighting all results, including also negative and side effects
I am sendibg to your attention the paper
Thanks Marianne Levon Shahsuvaryan
Please note that sometimes difficult to conduct DOUBLE-BLIND RANDOMIZED TYPE
Dear All,
I think one can differ clinical trials with real research objects that are designed according to the scientific rules and pseudo-scientific clinical trials serving to remunerate partisans (often leading physicians) of certain pharmaceutical companies. These partisans are supported for their marketing activity – which is masked as research - and one can easily recognise these trials as realised on 3-5 individuals.
I think that the biases introduced to promote big pharma products will never be truly eliminated. What I do take issue is at the Governing bodies in which we entrust to monitor the acceptance of such products for mass consumption. Some institutions receive part of their operating budget from the same companies which they are charged to audit. This is a huge conflict of interest and I think this is a major problem.
Whomever we entrust to validate studies should be free from any financial dependence that might bias their judgment .
Mafhuz has made an excellent description of the different phases in clinical trials... In my opinion, particularly in case of multicentric clinical trials: it's very difficult that "big pharma" makes results biased. During the last 25 years, I participated in 20 multicentric clinical trials; I consider that never their results were biased. However...are always published clinical trials with negative results ?
Dear J Perriot
I do not think there will be evidence based results without the big companies support
I would like a definition on how everyone is using the term Bias. Bias as I have pointed out in past communications can mean different things to different people. I do not believe the term bias is necessarily a negative finding. As with proper disclosure as to potential conflict of interest research disclosing bias early in the document might go a long way to extending the credibility of the paper.
Yes, there will be for sure.. otherwise we cannot expect such profits without results
When I started working at the then 6th pharma in the world, The Upjohn co, Kalamazoo, MI, the company's TOEFLer, Tony Marshall, suggested me reading a novel entitled: 'Dangerous medicine'. I'm sure this company tried doing unbiased science, even when the goals in their research were discovering active products, having it approved for market by HRAs, and physicians prescribing it, as sales was that kept the company and them alive.
They were fair enough as to call their first line employees: 'sales force', and not: 'medical representatives' , 'scientific delegates', or other fantasy names
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