The regulatory environment in Latin America
At this month’s DIA annual meeting in San Diego, I gave a talk on leveraging the digital ecosystem for patient recruitment.
From the many questions of the attendees, it’s clear there is a heightened interest in using digital and social media for patient recruitment outside of the U.S. But many people are unsure how varying regulatory environments limit their use. This column, the first in a three-part series taking a comparative look at the regulatory environments of three different regions, focuses on Latin America.
The regulatory environment in Latin America is fairly sophisticated, based on commonly accepted international ethical standards, such as full information disclosure, fair balance of risk and benefits, patient confidentiality and privacy, and freedom of the participant to withdraw consent and to stop participating in a study without prejudice.
Throughout Latin America, patient recruitment usually is reviewed in protocol approval, including the manner it will be advertised and the wording to be used, in order to ensure recruiting practices are appropriate and non-coercive.
A sample of five countries—Argentina, Brazil, Colombia, Guatemala and Mexico— shows countries in the region, with one notable exception, allow for the use of digital and social media and apply standard ethics guidelines for recruitment regardless of the channel used.
Argentina—The governing body in Argentina, ANMAT, is the most restrictive in the region when it comes to authorizing advertisements of clinical trials to the general public. ANMAT reviews and approves all promotional content and has published decisions stating that any mass media advertising for patient recruiting must be approved by the Ethics Committee and ANMAT. There must be strong justification for the need to advertise the recruitment process, such as rare/low incidence diseases about which patients would have no other easy access to information about specific clinical trials.
Specifically, in reference to social network advertising, ANMAT recently issued a press release stating recruitment via social networks would not be permissible and alerting patients of the potential risks associated with participation in trials not suggested or monitored by physicians who patients know and trust. The press release further indicates the use of social networks and web pages to participate in clinical trials should be avoided.
Brazil—In Brazil, the Ethics Committee of each hospital or research center is responsible for verifying that advertisements are consistent with the objectives of the clinical trial, the profile of the patients who need to be recruited and the study protocol as a whole.
The National Health Council has provided guidance related to equal access and compensation, to which the Ethics Committee must adhere. Notably, recruitment must be equally advertised for all groups eligible to participate in the study. This can affect how prospects are targeted. If lower socio-economic groups do not have access to social media and mobile apps, for instance, the use of social media to reach them must be balanced with other means.
Colombia—There are no specific rules related to advertisement to recruit patients into clinical trials in Colombia. The regulatory framework relies on rules for obtaining informed consent to ensure ethical conduct, including informing prospective participants of alternate procedures that may be beneficial to them.
As in Brazil, any advertisement must be evaluated and authorized by the Ethics Committee of the trial site, and any promotional activities should respect the confidentiality of the patient’s information. According to INVIMA, Colombia’s health agency, participants in Colombia have the right to be informed of the study results.
Guatemala—To carry out clinical trial recruitment in Guatemala, investigators obtain approval of the protocol from the Department of Regulation and Control of Pharmaceutical Products of the Ministry of Public Health and Social Assistance.
According to clinical trials legislation, there is no specific prohibition to advertise online to recruit patients. The Guatemalan Constitution protects the Freedom to Act, whereby any person has the right to carry out anything not forbidden by law. This means advertising for patient recruitment using social media is permissible, as long as it is carried out in good faith and based on facts.
Mexico—Mexico’s regulatory authority, the Federal Commission for the Protection Against Sanitary Risk, allows the use of digital media. However, advertising of clinical trials is restricted and must meet certain ethics criteria, most similar to those of Brazil.
The status of patient recruitment and information about the approved protocol also must be approved by the Mexican regulatory authority and registered in the National Register of Clinical Trials.
Matthew Howes is head of strategic services at inVentiv Digital + Innovation, the digital center of excellence for inVentiv Health. A leader in digital strategy, Matthew has provided the fuel for digital businesses visited by over 100 million people every month. Email firstname.lastname@example.org
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