The new regulations “Regulation (EU) no 536/2014 of the European Parliament on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC” were published in April of this year. The preamble states that “The interests of the subjects should always take priority over all other interests.” We take issue with this premise and would argue that studies conducted by reputable academic consortia are most certainly in the interests of the subjects involved as they are conducted to answer questions about the etiology, epidemiology, prognosis, diagnosis and treatment of the subjects’ own illness.
Under the combined leadership of EORTC President Dr. Roger Stupp and ESMO President Dr. Rolf A. Stahel, leading European oncologists have set their sights on addressing several issues affecting cancer clinical research. EORTC and ESMO hosted the European Cancer Clinical Research Forum on Monday, 27 October 2014 in Brussels to discuss issues related to conducting cancer clinical research in Europe. The forum was a step in the right direction towards identifying common issues, airing shared ambitions, and drawing up a plan of action to address the issues.
The ultimate goal of this forum was, together with national and European collaborative research organizations, to identify specific topics for joint action which will help safeguard the future of independent, academic cancer clinical research within Europe. This forum aims to reach out to other stakeholders (such as patient organizations, industrial partners, payers etc…). However, it was agreed it needs to achieve consensus first and start acting before getting involved with other stakeholders.
The European Cancer Clinical Research Forum was well attended by 65 participants representing European and International groups (EORTC, CECOG, IBCSG, SPCG), umbrella organizations (ENGOT, ETOP), societies (ESMO, SIOP), national groups (ABCSG, AGO-Austria, SAKK, AGO, AIO, GEICAM, TTD, ARCAGY-GYNECO, FFCD, GSF, LYSA, ICORG, GORIC, ISG, DCCG), numerous cancer centers, and non-European guests JCOG, LACOG, and SLACOM.
No one doubts that there have been and likely always will be flagrant examples of studies that were clearly in everyone’s interests except the subject’s. But we would contend that, nowadays, every investigator is fully aware of his or her obligations and should have demonstrated a sound understanding of the ethics around clinical trials be they of an intervention or observation. We would go one step further and maintain that the investigator’s interests and those of the subject are usually aligned when they are about the curing his or her disease, halting its progress or at least ameliorating its symptoms. If this is so, then it follows that the injunctions soon to become law will make it nigh impossible to conduct the wide range of clinical studies necessary to advance our understanding of any given illness. Moreover, even auditing of performance will become impossible. And why? Simply because subjects will have to give consent for each and every great and small study using information, test results or biological material gathered at the time of their illness which many may not care to be reminded of anyhow.
Academic cancer clinical research in Europe faces multiple barriers New European regulations such as the Clinical Trial, In Vitro Diagnostics, and Data Protection regulations as well as requirements for performing cross border clinical trials, present substantial challenges for academic clinical researchers. Academic research, however, is invaluable, because it provides deliverables that cannot be accomplished otherwise. Long term follow up of patients, testing combinations of drugs, and designing multimodal treatment regimens do not fit industrial business models. This European Cancer Clinical Research Forum allowed academic organizations to discuss the issues affecting their research programs in detail, outline their joint ambitions, and draft a plan of action for the benefit of patients.
We are constantly being asked to produce results to support our activities and assure the quality of our services but how are we to achieve this if subjects are either unable or unwilling to consent? Who is to facilitate the obtaining of such consent and maintain the inevitable audit trail? The administrative burden alone will far outstrip the capacity of all but the best-resourced institutes. Inquisitive young scientists will not understand the need to meet the requirements of data protection and consent when all he or she wants to do is use material or even pathogens isolated during the illness to address a new or interesting question. The effort might prove so burdensome and the bureaucracy so complex that it disheartens the aspiring scientist who then abandons the whole idea.
The regulations are clearly slanted in favour of protecting the subject against interests that he or she does not necessarily share. Yet the whole notion of consenting to a trial or study is that the patient, on balance, agrees to be a subject knowing the benefits and risks and at the same time agrees to allow personal data to be included albeit in an anonymised from to protect his or her identity. Is this really the culmination of 25 years of good clinical practice, a body of regulations that achieve the opposite by destroying the very thing they were designed to regulate?
One aim is to bring to life a European Cancer Clinical Research Forum that is positioned as a pan European Initiative. Other deliverables include mapping the gaps between European countries with respect to clinical trial regulation and conduct, but this would also include identification of the successes. It could define what is considered to be an Academic Clinical Trial, because this varies from place to place. Regarding regulatory issues, the forum could determine what could be done at a European level and what could be accomplished at the national level. They could investigate alternative ways of financing academic infrastructures, and for all of this, the need to effectively communicate the efforts of the forum was recognized.
Before these regulations are implemented there should be a proactive public consultation with subjects – past, present and future being asked whether the regulations will achieve what they set out to do. There is some time left. We urge the EU to do so now at a European level and also at national level before we end up altogether throwing the baby out with the bathwater.
A first action was to form working groups to investigate how best to improve interactions among the cooperative groups, mapping the regulatory issues across Europe, looking into how to present a uniform message concerning academic trials to insurers, and developing a communication strategy.
The European Cancer Clinical Research Forum will meet again in Spring 2015.
John Bean, PhD
EORTC, Medical Science Writer