News from working groups: Clinical Trials Group

Nuria Homedes 

We have been working hard. Two years ago, we divided Bulletin Farmacos in four bulletins. Due to the large amount of information that is emerging and the interests of our Spanish readership, one of the bulletins has been dedicated to Ethics and Clinical trials. The other bulletins are devoted to Pharmacovigilance and Appropriate use, Access and Economics, Regulatory Agencies and Policies. Consequently, we have increased the number of translations into Spanish from English and French sources.

We are presently conducting a study on the role of research ethics committees (RECs) in eight Latin-American countries (Argentina, Brazil, Chile, Colombia, Dominican Republic, Mexico, Panama and Peru). This effort began almost two years ago. Salud y Farmacos developed a proposal aimed at uncovering strategies to strengthen the capacity of Latin American to protect clinical trial participants and the integrity of data collected during the trials. There is ample evidence that RECs are unable to protect research participants in clinical trials sponsored by industry. In fact, the RECs do not verify if the subjects have understood the consent form. Also, RECs are told that they cannot even modify the consent form when they complain about translation errors or when the form is too lengthy or too complicated for the research participants to understand. If RECs can’t modify the wording in an informed consent, they have even a harder time questioning the design of the trial, the treatment for the comparator group or the sample size. Under current conditions, well-intentioned and capable RECs have very little decision-making space, they either approve the clinical trial as presented or they reject it. If they reject it, the sponsors have identified commercial RECs that would approve them in a few days, a practice known in Colombia as ‘carrusel’ (merry-go-round).

The number of clinical trials rejected by Latin American RECs is minimal, and in most countries, research sponsors engage in REC-shopping until they obtain the required seal of approval. In fact, increasingly research sponsors are avoiding RECs that use strict approval criteria and flock towards commercial RECs. The only Latin American country that has outlawed commercial RECs is Brazil. In sum, although RECs have responsibility for protecting the dignity and safety of clinical research subjects, under current circumstances, they are unable to fulfill their mission.

Our study consists of: (1) indepth interviews with current or previous REC members with experience reviewing protocols financed by the pharmaceutical industry; (2) a self-evaluation tool to be completed by REC members; and (3) focus groups with REC members. The research proposal and research instruments were presented and discussed in November 2016 in Bogota, Colombia, during a meeting with all researchers involved in this project. We are not aiming at evaluating the performance of the RECs, but at finding strategies to strengthen the ethical review of research proposals sponsored by industry. Therefore, we are only involving respondents that are known for being inquisitive thinkers who take to heart their responsibilities as members or ex-members of the RECs. While we were aiming at 10 in-depth interviews and self-evaluation forms, and one or two focus group per country, it appears that some countries, like Brazil and Colombia, might quadruple that number. In small countries, the number of interviews will be less (4 to 8). In terms of financing, the Universidad del Bosque Colombia secured funding for the fieldwork that is being conducted in four cities (Bogota, Bucaramanga, Cali and Medellin) and for all coordination meetings. Salud y Farmacos is sponsoring the operational costs in the other countries. All researchers are donating their time.

The project is advancing in all countries but had a slower start than we had anticipated. Unexpectedly, the RECs of some countries questioned the project and delayed for several months its approval. Currently, two countries have completed the first round of in-depth interviews, and all but two are well advanced in the data collection process. We held our first meeting to discuss interim results last May. We expect to be done with all the fieldwork by the end of this year.

Last year, the Journal of Empirical Research on Human Research Ethics published the results of our study in Peru (DOI: 10.1177/1556264617720756). Thirteen clinical trial participants were interviewed to assess if they understood the informed consent, and the rights and obligations that ensue from participating in clinical trials. About half of the respondents signed the consent form without reading it, and most of them did not understand basic concepts included in the informed consent. There was evidence of undue inducement by recruiters, and patients engaged in behaviors that would not only threaten their well-being but also jeopardize the quality of the data collected. For instance, they self-medicated, did not take their medications as directed, and did not inform other physicians they consulted that they were participating in a clinical trial.