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    These are the Types of Medical Research Allowed on Human Beings in Costa Rica

    Country hosts nearly 600 different medical investigations protected by law

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    Medical research in Costa Rica ranges from learning how a disease behaves, to determining the safety and effectiveness of drugs, devices, or medical and surgical procedures. In Costa Rica, additional administrative structure is still required for the initial human testing (Phase I) and bioequivalence studies (those that test whether a generic drug has the same therapeutic efficacy as the original), but all others have developing examples.

    In May 2022, the Chamber of Health reported that the private sector maintained 212 studies in the country, the Costa Rican Social Security Fund (CCSS) another 187 investigations and to these must be added those applied by the Ministry of Health as part of their competences and those that arise in research units of the University of Costa Rica (UCR), 216 more at the time of this publication.

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    Catalina Ulloa, director of the Metropolitan Research Institute (MRI), of the Metropolitan Hospital, explained that for the development of new and better treatments, the road is long and must go through different stages.

    “The first of these is, in short, basic research, which is that which is carried out in laboratories in in vitro models and where the different molecules that may have a therapeutic benefit are studied. Subsequently, there is what is known as translational research, which precisely aims to transfer the knowledge generated in basic research into results that have a positive impact on health and can be applied in the clinic”, commented Ulloa.

    In general, the projects that are developed in the country are divided into observational or interventional. The UCR concentrates its activities in the first category, with observational clinical research and basic science studies, which aim to increase the knowledge. These can be descriptive or analytical. The CCSS also investigates in these fields.

    Interventional studies are those that require testing in humans and can be exploratory (phases I and II) or confirmatory (phases III and IV). These are the ones that have private sector sponsors as protagonists.

    The Biomedical Research Regulatory Law (9234) includes the phases for vaccines and medicines, and the companies are advocating that the corresponding ones be incorporated for tests with medical procedures and devices. Another level of statistical investigation, known as meta-analysis, does not appear in the standard.

    On average and depending on their complexity, studies are usually carried out in periods of between three and five years, although recent cases have yielded results after nine years of investigation (since the approval of Law 9234). Given the impossibility of developing Phase I and bioequivalence studies in Costa Rica, the sponsors bring Phase II, III or IV research.

    Massimo Manzi, executive director of the Costa Rican Chamber of Health, pointed out the need to work on pending regulatory aspects and speed up the implementation of studies within the public sector, since alliances with the CCSS open the possibility for large-scale research and this it would attract more major players, both from the pharmaceutical and medical device sectors.

    “These opportunities, added to others such as medical tourism, global medical education, health business process outsourcing (for example, in areas such as image reading, insurance claims), as well as the export of professional health services that can make Costa Rica a Global Health Hub”, said Manzi.

    Allowed by law

    Law 9234 specifies that the studies must be free and voluntary: the only possible remuneration for the participants is the amount for the expenses they incur for their participation. In addition, in its article 28, the law includes a right to enjoy the benefits that result from the investigation:

    “Participants in a clinical investigation will have the right to enjoy free of charge, as long as they require it, the preventive, therapeutic and diagnostic treatments generated by the study, if it has been shown that these are beneficial for health, as long as the prescription of these methods or treatments is endorsed by the professionals responsible for the treatment and follow-up of the patient, and in accordance with what is expressed in this law”.

    Some patients participate in this type of research because there are no treatments available for them or because other treatments have not worked for them. Everyone must do so voluntarily and after signing an informed consent, whose characteristics are defined by law, with international scientific and ethical standards. The body responsible for the approval and supervision of these processes and their researchers is the National Council for Health Research (Conis).

    Vaccine development phases:

    Phase I: refers to the first introduction of a trial vaccine in a human population to initially determine its safety and biological effects. This phase may include dose and route of administration studies.

    Phase II: refers to the initial trials to determine the effectiveness of the vaccine in a limited number of volunteers; this phase focuses on immunogenicity.

    Phase III: aims to more fully evaluate the safety and effectiveness in disease prevention, involving a larger number of volunteers in a generally adequately controlled multicenter study.

    Opportunities

    Social area: The UCR and the CCSS study conditions that are not very attractive to the private sector, for example, deafness; the characteristics of a specific population, such as blood donors at the San Vicente de Paul Hospital or specific cases such as antimicrobial multiresistance at Hospital México during the period 2007-2015. These are all real ongoing investigations.

    Commercial area: The companies in the Life Sciences hub promote studies in their areas of specialization, which tend to target a mass audience, thus generating advances with a global reach. Bayer, for example, in Costa Rica investigates cancer, multiple sclerosis, and infectious diseases. Other firms, such as Roche, focus on oncology, and Pfizer targets rare diseases, inflammation and immunology, and vaccines in general. The CCSS also does research in these areas.

    Drug development phases:

    Phase I: introduction of a drug in humans for the first time. Healthy volunteer subjects participate to assess at what levels of drug use toxicity is observed. Dose-response studies in patients are continuing to determine drug safety and, in some cases, early indications of effectiveness. These studies are intended to establish a preliminary safety assessment.

    Bioequivalence studies also belong to this phase (demonstrate that a generic drug has the same therapeutic efficacy as the reference innovative drug). Both are permitted by law but blocked in practice, since they must be authorized by a Central Scientific Ethics Committee that the Ministry of Health has not yet created.

    Phase II: controlled clinical trials, designed to demonstrate effectiveness and relative safety. It is usually performed on a limited number of closely supervised patients.

    Phase III: it is carried out after establishing a reasonable probability of the drug’s effectiveness and its objective is to obtain additional information on its effectiveness for specific indications and a more precise definition of the adverse effects associated with the drug. This phase includes controlled and uncontrolled studies.

    Phase IV: controls and studies applied after the distribution or commercialization has been approved. These trials may include research designed to explore a specific pharmacological effect, establish the frequency of adverse reactions, or determine the effects of long-term administration of a drug. Phase IV can be extended indefinitely throughout the life cycle of the product.

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