Clinical trials in Peru
Maritza Reategui Valdiviezo
Rodrigo, Elias & Medrano Abogados, Lima
Cecilia Alarcon
Rodrigo, Elias & Medrano Abogados, Lima
Clinical trials in Peru are governed by the National Institute of Health (INS). The INS serves as the chief authority in this field, playing a crucial role in the oversight and regulation of these processes. Within this institution lies the direct and specific authority to grant the necessary permission to conduct clinical investigations, a responsibility held by the General Office of Research and Technology Transfer (OGITT).
In parallel, the General Directorate of Medicines, Supplies, and Drugs (DIGEMID), as a unit within the Ministry of Health (MINSA) is responsible for regulating medicines, medical devices, and healthcare products at a national level, plays an important role in the approval process of clinical trials. Their task involves a meticulous evaluation of the safety profile of the investigational product intended for use in the clinical trial. The outcome of this evaluation establishes a binding opinion for the OGITT.
The regulatory framework that sets out guidelines for conducting clinical trials in Peru is outlined in the Regulation of Clinical Trials, ratified through Supreme Decree No 021-2017-SA.
Individuals and entities involved in clinical trials
Article 67 of this regulation outlines the essential requirements for obtaining approval for clinical trials involving the following individuals and entities, which are defined below.
Sponsor
The sponsor is the individual person, group of individuals, company, institution, or organisation, including academic ones, with legal representation in the country duly registered in the corresponding public records, who assumes responsibility for the initiation, maintenance, conclusion, and financing of a clinical trial. The sponsor must be registered in the Peruvian Registry of Clinical Trials (REPEC) managed by the INS prior to the application for clinical trial authorisation.
Contract Research Organisation (CRO)
A public or private organisation, national or foreign, to which the sponsor transfers some of its tasks and obligations through a contract. CROs must have legal recognition in Peru and engage in activities within the healthcare sector. Universities may assume the responsibilities of a sponsor or a CRO.
Monitor
An individual chosen by the sponsor or CRO who is responsible for direct oversight of the trial’s conduct. They serve as a link between the sponsor and the principal investigator when these roles are not held by the same person.
Principal investigator
The natural person, medical professional, or dentist responsible for conducting the clinical trial at a research centre, affiliated with the research institution, and leading the research team.
Research centres
Physical units within the research institution where one or more clinical trials are conducted.
Research institutions
Research institutions refer to duly authorised and categorised public or private healthcare establishments by the corresponding health authority, or its equivalent, such as hospitals, clinics, specialised health institutes, where research centres conducting clinical trials operate.
Institutional Review Board (IRB)
A non-profit body within a research institution, public research institute, or Peruvian university, consisting of professionals from various disciplines and community members willing to participate. It is responsible for safeguarding the rights, safety, and wellbeing of research subjects through, among other things, the review and approval/favourable opinion of the study protocol, the competence of investigators, and the adequacy of facilities, methods, and materials used when obtaining and documenting informed consent from research subjects.
Research product
It is also important to note that the research product is a pharmaceutical or medical device that is investigated or used as a comparator in a clinical trial. This might include products with sanitary registration when used in a trial. It may also be combined, in formulation or packaging, differently from what is authorised, or used to obtain more information about its authorised use.
It should be emphasised that clinical trial authorisation can only be requested when the research products used meet any of the following conditions:
- they have an authorisation for investigation on human beings issued by the corresponding pharmaceutical authorities from leading health surveillance countries;
- they are manufactured in Peru, have undergone preclinical investigation and are in accordance with the investigation policies or priorities determined by the Ministry of Health;
- they are used to establish therapeutic equivalence of pharmaceutical products or similar biological products;
- they are considered a priority for Peru public health or part of the investigation policies or priorities determined by the Ministry of Health; or
- they require clinical trials, according to the Ministry of Health, to support their efficacy and safety in order to grant marketing authorisation.
Post-study access
Within the framework of clinical trial regulations, it is relevant to highlight the concept of compassionate use, referred to as ‘Post-Study Access’.
Article 115 of the regulation states the following:
- Post-study access entails the free availability, for the research subject, of the investigational product that was studied in a clinical trial after the completion of the study or on the conclusion of their participation. This is even if it possesses sanitary registration in the country.
- Before the study’s initiation, post-study access must be anticipated, and this information should be provided during the informed consent process.
- To enforce this provision, the severity of the medical condition in question will be considered, alongside the anticipated impact of stopping or modifying treatment (if treatment cessation could adversely affect their health or wellbeing), the absence of satisfactory therapeutic alternatives in the country for the research subject’s medical condition, the presence of sufficient efficacy and safety information, and a positive benefit-risk balance for the intervention.
- For an investigational product to be used under the conditions of post-study access, it must be demonstrated to have benefited the research subject, at the discretion of the principal investigator, and its use will be maintained as long as there is such a benefit.