2023-06-18 06:00:00
“Everything for the people, but without the people”. This is the phrase that the oncologist Santiago Viteri used on Friday to state that the treatment that patients receive in clinical trials can be improved, beginning with their participation in decisions relevant to the design and/or methodology. He explained it at the II Barcelona Clinical Trials Congress (CECOB’23), organized by The Ricky Rubio Foundation (TRRF). That phrase is nothing less than the motto of enlightened despotism, characterized by paternalism, of the eighteenth century; and represents just the opposite of what the French philosophers called encyclopedists: more leadership and intervention of the people in politics. Historically, it has been used to criticize authoritarian governments.
The melon reopened this week at that congress has been open for a few years now, in line with the discredit that paternalism lives in medicine and health and with current legislation on patient rights.
The Platform of Patient Organizations (POP) has denounced in some forums that patients, in general, are passive subjects in clinical trials despite being a fundamental collective (without them, there is no rehearsal). They are not usually counted on in the design, protocols and documentation (technical language), and it is also not clear that the information they receive to obtain their voluntary participation is 100% optimal or that they have all the support they need (for doubts, fears,…) throughout the study.
Spain is a power in clinical trials, so all this would have to be perfectly resolved. reviewing the Instruction document of the Spanish Agency for Medicines and Health Products (AEMPS) for conducting clinical trials in Spain (version 17, of November 18, 2022), prepared in accordance with Royal Decree 1090/2015, which regulates clinical drug trials, drug research ethics committees (CEIm) and the Spanish Registry of Clinical Studies, you realize that Participating in all of this is difficult, if not impossible.without a high degree of training and information in this respect.
Includes the participation of patients (at least one representative) in the composition of the CEIm together with: physicians, including a clinical pharmacologist; hospital or primary care pharmacist; Diploma or Graduate in Nursing; member of the healthcare ethics committee and the research commission; at least two members from outside the health professions, one of them with a law degree or graduate degree, and one member with accredited training in bioethics.
¿Who can sit there representing the patients and how is it selected? Can only those who have the disease condition do so or are former patients, relatives of patients (for example, parents of children with rare diseases) and citizens in general valid? Does it have to be a very experienced patient or one recently diagnosed with a serious and/or chronic illness who, right then and there, is banging their heads to understand the system and figure out how to navigate it with some ease?
Ideally a patient who knew very well at least the problems and needs of those affected by all kinds of diseases, but the usual thing is to know only those of one’s own. Nor does it seem that there are queues of patients willing to participate in these multidisciplinary teams, beyond those who are already representatives of associations and organizations of patients, in which case they have at least one handicap: if they receive aid from the pharmaceutical industry they may have conflicts of interest.
In a democratic society, with citizens who are perhaps the best educated in history, we must aspire to end paternalism in all areas, including the toilet, but there are areas where it is not so easy; that of clinical trials is one.
To conclude: “When you can’t do what you want, you have to want what you can” (Terence, 185-159 BC; author of comedies during the Roman Republic).
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