Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Clinical Research: Quo Vadis?
- Arun Nanivadekar (5 July 2008)
-
We are moving in the right direction.
- Paula G. Didham (7 July 2008)
|
|
|||
|
Arun Nanivadekar, Medical Research Consultant C-2. Flushel Apts, 21 Road, Bandra (W), Mumbai 400050, India
Send response to journal:
|
Mr Firkin's article reminded me of a comment by Michael Brown[1]: "You have heard that war is too important to be left to the generals; likewise, drug development is too important to be left to the drug companies." As chairman or member of several ethics committees, I have often got a feeling that many investigators do not feel involved in clinical trials because they have not not had any opportunity to participate in its design or make any conceptual contribution to it. The sponsors seem to design them primarily to meet regulatory requirements rather than genuine needs of patients. As a result, they become monotonous, unimaginative, tedious, and dull. The urge to cross regulatory hurdles is so overpowering that any attempts to make trials simple, large enough, and focused on patients' and doctors' goals are resisted by the sponsors. As Chalmers has emphasized[2], this then paradoxically compromises the interests of the patients for whose benefit the trials are meant in the first place. I also sometimes feel that clinical drug research is unwittingly hijacked by regulators and statisticians to the detriment of patients. A recent book by Taleb[3] has made me acutely aware of re-examining our current way of thinking in probabilities, especially of rare but momentous events. I thank Mr Firkin for his essay, and hope more members of the community will voice their experiences and views on this subject, so that their collective weight may lead to some sensible regulatory reforms. Arun Nanivadekar, MD MSc 1. Brown M. The making of a physician-scientist: 2000. Grossman DC, Valtin H, ed. Great Issues for Medicine in the Twenty-first Century. Ann N Y Acad Aci 1999; 882: 247-256. 2. Chalmers I. Regulation of therapeutic research is compromising the interest of patients. Int J Pharm Med 2007; 21: 1-11. 3. Taleb NN. The Black Swan. London: Penguin Books, 2007. Competing interests: I am a medical research consultant to some hospitals and pharmaceutical companies in India. |
|||
|
|
|||
|
Paula G. Didham, Nurse Educator Western Regional School of Nursing, Corner Brook, NL, Canada, A2H 6J7
Send response to journal:
|
I understand Mr. Firkins's frustrations with the establishment of priorities for research. His experiences reflect many of the same challenges that I have witnessed as a nurse working in the health care system for the last 30 years. However, I am becoming more encouraged by what I see as a gradual shift from the historical top-down ivory tower approach to research to a much more participatory and user-friendly one. At a nursing research internship at the University of Ottawa this summer I heard representatives from the major funding agencies for health research in Canada speak out about new mandates that support initiatives focusing on public engagement throughout the research process. For example, the Canadian Institutes of Health Research knowledge translation mandate involves engaging potential knowledge users as partners in helping to define the research questions and in helping to interpret and apply the research results. So even though the wheels of change turn slowly, I believe that – particularly with the help of consumer driven calls for change like Mr. Firkins's - we will see more pervasive improvements in all areas of health research in the years that lie ahead. We are moving in the right direction. However, as practitioners in the health field, it is our duty to be forever vigilant in continuing to advocate for organizational and policy level changes that promote a more community responsive and inclusive research agenda, such as the one that Mr. Firkins is recommending. Competing interests: None declared |
|||