We have recently re-examined this question for Mesothelioma surgery in Thorax.
Dear Avijit,
all clinical trials of any phase do have a protocol. The protocol has to be finished and approved before the trial can start. It has to be reviewed by regulatory authorities as well as an ethics commitee. In the study protocol, the aim, the design and the end-points of the study are defined. Also, there is always a section where the inclusion criteria are mentioned. Patients have to meet all of these criteria to be included in that particular trial, eg. having a certain type of cancer, a minumum age and so on. There also always a list of exclusion criteria, eg. pregnancy or that patients can not be included that a prior therapy for their cancer. Also, there is always a point saying that if you as the investigator think that the patient should not enter the trial, he or she has to be excluded, eg. if you think that he will not be compliant. These are the major reasons for a clinician for not including somebody into a clinical trial. In my experience, patients refuse to enter a clinical trial if they think you want to make them a guinea pig. Also, they have to wait for quite a while before treatment in a trial really starts and some of them are not willing to do so.
Hope that helps,
Bastian
Dear Bastian - thank you, I take on board your finishing sentences. I guess I was looking to explore the psyche of both clinicians and patients more. There have been some large scale approved trials which have failed to recruit sufficient patients, equally there are areas of clinical practice where a trial is needed yet practice continues. See for example the recent paper by Lesley Fallowfield:
Jenkins V, Farewell V, Farewell D, Darmanin J, Wagstaff J, Langridge C, Fallowfield L; TTT Steering committee. (2013) Drivers and barriers to patient participation in RCTs. Br J Cancer. 2013 Apr 16;108(7):1402-7 and our recent Thorax paper.
Any thoughts ?
See also: Ford E, Jenkins V, Fallowfield L, Stuart N, Farewell D, Farewell V. (2011) Clinicians' attitudes towards clinical trials of cancer therapy Br J Cancer. 2011 May 10;104(10):1535-43. Physicians rather than surgeons & clinicians in specialist centres rather than district hospitals recruit to trials. Do you think this applies in Germany, Bastian ?
Dear Avijit, in my experience it is more the Clinicians' attitude than the patients' willingness preventing the inclusion into a clinical trial. This is largely based on a work overload of most clinicians and the lack of infrastructure facilitating the necessary documentation within a clinical trial. The above mentioned article is nicely reflecting this notion, i.e. in specialized centers the situation is better than in community hospitals. Moreover, not all interesting clinical trials can be offered by all center - again the advantage is at the specialized centers. Indeed, Bastian is in a very privileged situation as he is working in one of the leading centers for Dermato-Oncology in Europe.
Regards, Jürgen
Well, I think Jürgen is right in saying that specialized centers do have access to more apropriate resources to conduct clinical trials. Having specialized cencers for certain diseases is the most beneficial option for patients, especially when they suffer from rather rare types of cancer like melanoma and mesothelioma. I think there is another important aspect of clinicians attitude that is nicely discussed in the paper Avijit has provided: There are clinicians that prefer to perform medicine based on expertise and not on evidence. In my experience, that is a state of mind that is most common among surgeons. Something that might contribute to the findings of the Br J Cancer paper Avijit mentioned. I think that paper also reflects the situation in Germany very well.
As Jürgen mentioned, I'm in a privileged situation myself. We do participate in several clinical trials that are sponsored by pharmaceutic companies so that we get financial compensation. The more patients we enroll, the more money is available for hiring staff, and then we can treat more patients again. For surgical trials, funding is another major problem, and please tell me if I'm wrong: There is simply not a lot of funding for surgical trials. If there is no funding, a clinical trial becomes part of the work overload Jürgen has mentoined.
Regards,
Bastian
@kest urba - could you expand, please, on the Stanford University trial
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