Is it Time to Move on From the Nüremberg Syndrome?

February 27, 2019
Peter O'Donnell
Peter O'Donnell

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Applied Clinical Trials

Reflections explored during the mid-February EFGCP conference in Brussels on making clinical research an element of better healthcare.

The conscious divide between medical care and medical research-the consequence of the post-WWII determination to protect patients-may now be operating against the interests of the patients it was designed to protect. That is one of the reflections explored during the mid-February conference in Brussels on making clinical research an element of better healthcare (Trial Participants: The Unsung Heroes of Clinical Research).

This is not to minimize the horrors of Nazi doctors’ experimentation on concentration camp internees-experimentation designed not to improve the lot of the patient, but in search of knowledge that might protect German soldiers. But the rigid distinction between treatment and research could be due for a re-think in the context of rapidly-changing science and technology. The underlying question posed was whether it still makes sense to maintain that rigid separation between treatment and learning more about treatment.

Hans-Georg Eichler of the European Medicines Agency triggered the discussion with a thought-provoking parallel. Aircraft manufacturers receive full data-feedback on every aspect of the flights of their products, irrespective of the airline operator or geography, he pointed out. Detailed and comprehensive information on the performance of high-technology agriculture products and process is similarly routinely communicated to the developers, whichever farmer or processor is using them.

This wealth of data operates in the interests of users by feeding into product and process improvements-or alerting to potential hazards and prompting adjustments. But the firewall between medical research and medical practice can impede the completion of a similar virtuous circle.

Extending this concept to the development of medical technology prompts consideration of two possible advantages.

One is that wider access to real-world data on the use of technology throughout its life-cycle-from the time of study through to beyond its authorized release-should play into speeding and improving understanding of a technology's scope and limitations.

The other is a re-evaluation of the importance of the patients who are participating in trials-the hundreds of thousands of patients around the world who have agreed to accept some risk in return for improving their chances of benefit. They merit attention not just as trial subjects, as elements in medical research, but also as patients. And that has implications for everyone involved-treating physicians, researchers, academics, regulators, payers, and industry, and, of course, patients themselves.

The EFGCP meeting also ventured into other equally sensitive territory: whether patients should be paid for their engagement in trials. Regulators have traditionally been-and seem to remain-firmly against the idea. But among patients and their advocates, the feeling is mounting that their contributions in providing advice to industry, regulators, HTA organizations and ethics committees deserves some return. Their argument is that they give consultation based on their unique expertise and their advice will help industry to develop their drugs faster and more efficiently, leading to higher company revenues. Patient representatives find it, therefore, only fair to be appropriately reimbursed for their advice, in the same way as other consultants that are hired in drug development programs. Industry has hesitations, because of concerns that this could lead to suspicions of undue influence, even to accusations of bribery. Authorities have similar concerns since they use patient representatives increasingly in their own processes. Discussion at the meeting even turned to exploring some of the possible mechanisms-perhaps through involvement of the patient community in whole as an organized player in a wider restructuring of the European approach to the development of medical care and technology.

Ingrid Klingmann, the chair of EFGCP, told Applied Clinical Trials after the meeting that the wide-ranging discussion did not produce solutions to the numerous questions raised-which also touched on how to better integrate clinical research into intensive care, how to adapt clinical trial design so as to align more closely with trial patients' own evolution, how far involving patients in trial design improves the chances of successful outcomes, or how strong the link is between trial participation and health outcomes. But, she observed, the questions are being voiced more strongly and articulated more precisely, through bringing together the distinct players in care and cure. The next stage, for EFGCP, will be to produce a roadmap of identified areas for action by each of the players, to move towards a more clearly defined partnership approach that could bring greater benefits to patients, trials, and everyone involved in healthcare.

 

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium

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