Mr Solkalski,

Every medication and nutritional supplement must be listed in your source documents.   For clinical trials, you do have the option  of excluding participants who take medication/substances that would confound your outcomes; however,  this must be in you inclusion /exclusion criteria.  If you're measuring biological outcomes, medications & supplements may adversely affect the results.  You are not reporting every medication in your findings.   Design your protocol so that you are only measuring your desired variables and not outside influences. 

Gerry

Dear Vladislavs,

Even in clinical trials involving surgery, physical examination, diet etc., the information on concomitant drug usage is very valuable. They may affect your outcome and may be related to adverse events and SUSAR's. We are mainly doing clinical trials on Stem Cell Transplantation and such patients receive more than 20 drugs per day and we have to report all of them including start day/stop day/, dose, mode of administration and frequency. I think the most important thing to do is to structure your CRF's. The mode of administration should be standard like SC, IV, TD, IT etc..., and the intervals like QD, QID, BID etc..   

YES !

AVOID THE ISMP abbreviations (see link below and go to tools !!!

http://www.ismp.org/

Dear Vladislavs Sokalsky

I think your question lacks some clarity. If you refer to is a clinical trial and seeks to investigate the effect of medicines, then you are looking for, what is your goal?

• A clinical trial is privileged and ethical way to conduct experiments in humans. The phases of drug research; I, II, III and IV aim to investigate together Efficacy and Safety of Medicines.
• The designs in clinical trials, involving intervention and should describe all the features of the products used; active ingredient, dosage form (capsule, tablet, injection, cream, ointment, spray), total daily dose administration (g, mg, mcg), frequency of administration in the day (once, twice, three times, etc. ), route of administration (intramuscular, intravenous, subcutaneous, intradermal, intranasal, oral / buccal, etc ...).
• Statistical factorial designs are recommended, crossed double-blind, comparative (drug vs. drug, drug vs placebo), which you certainly already know, to be their field of expertise and professional skills.
• All this must be considered and describe in your research protocol, although his speech does not involve the efficacy and safety of drugs,
• If the intervention is for example a biological treatment, as would be the application of stem cells in any way to consider all the characteristics described above for the medicines they use research subjects. It does not fall into methodological errors and their experiment would not have validity.
• Moreover, I could not explain whether the variables studied and compared with statistically significant difference (compliance alternative hypothesis "H1"), or the same or similar (compliance null hypothesis "H0") effects.
• On the other hand, it should be descriptive and not interpretive interventions and do not use abbreviations not previously been clarified in the text of the publication or research protocol.

By the time these dimensions, hoping to enrich the discussion on the problem.

Sincerely

Dr. Jose Luis Garcia Vigil

I agree with Dr Jose.  A clinical study is aimed at testing the validity of a particular hypothesis, which means one needs to be rather specific. Secondly, please remember that one study can answer only one or two specific questions. It cannot answer multiple questions; then the trial would lose its focus. Therefore, it all depends on the objective of the study which in turn will decide the study design.

The expectation of the monitors for FDA phase 2 and 3 trials , as well as the FDA governmental 1572 form and the GCP guidelines, is that all medications and dosages must be record with not only start dates but also stop dates.

In the real world , however, in the absence of centralized claims made on pharma data, the patients are often guessing.  Also, filling a prescription does not mean they are compliant with it. Typically, only the study medication is counted as a method of measuring "objectively" compliance. Who is to say a patient never dumped some of their pills that they "forgot to take" or "avoided taking".

Such are the challenges of real world practice and even the best efforts to enroll responsible patients who are willing to play by the rules.

There is a wonderful article in the BMJ circa 2002  about self reported daily diaries that demonstrate patients' poor compliance deceiving their docs with back-filling, but surprisingly forward filling as well.  I highly recommend it for your enlightenment and enjoyment. It should be used as evidence in med mal cases in favor of the defense, especially if it comes to "he said, she said".

Full free text article via PubMed Central.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC111114/