Inclusion of pregnant women in COVID-19 treatment trials: a review and global call to action.

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely – and at times uniquely – affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy – in consultation with a variety of external experts and stakeholders.

Scarce research with pregnant women has led to a dearth of evidence to guide medical decisions about safe and effective treatment and preventive interventions for pregnant women and their potential offspring. In this paper, we highlight three aspects of the landscape in which pregnant women are included or, more frequently, excluded from research: international ethics guidance, regional and national regulatory frameworks, and prevailing practices. Our paper suggests that, in some cases, regulatory frameworks can be more restrictive than international ethics guidance, and that even when regulations permit research with pregnant women, practical challenges—as well as the prevailing practices of stakeholders, such as ethics review committees and investigators—may lead to the generalized exclusion of pregnant women from research.

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Ethics, regulation, and beyond : the landscape of research with pregnant women

COVID-19 represents a global crisis. Rapidly conducting a clinical trial with the rigor necessary to obtain reliable results requires the collaboration of various participants involved in the development, evaluation and authorization of clinical trials (CT) such as the trial sponsor, researchers, regulatory authority and the ethics committee (EC). Carrying out these studies is not only scientifically appropriate, but an ethical and moral obligation to guarantee our patients effective treatment. SOLIDARITY is a mega clinical trial that recruited thousands of subjects with moderate to severe disease, who were randomly assigned to one of the treatment groups under evaluation, including hydroxychloroquine, lopinavir/ritonavir associated or not with interferon; or remdesivir compared to standard therapy. Peru has joined the list of countries where the trial will be reproduced, through which it will be possible to quickly identify if any of these drugs offers a real benefit to patients.

/pdf/respuestas-rapidas-a-la-pandemia-de-covid-19-a-traves-de-la-2ccb9pcm42.pdf

Respuestas rápidas a la pandemia de COVID-19 a través de la ciencia y la colaboración global: el ensayo clínico Solidaridad.

/pdf/un-llamado-etico-a-la-inclusion-de-mujeres-embarazadas-en-56ir3q02t6.pdf

Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación

This article describes the concept of global health security and its development over time. It emphasizes the need to control challenges against global health such as those produced by biologic agents both natural and intentional. It presents world initiatives that have developed during the last two decades and the contribution of Peru to the Global Health Security Agenda (GHSA) and the Monitoring and Evaluation Framework. In order to accelerate the implementation of the International Health Regulations Peru has played an important role to accelerate the implementation of International Health Regulations (IHR), participating with a group of countries, World Health Organization (WHO), and GHSA in the creation of the Joint External Evaluation Tool (JEE).

/pdf/contribucion-del-peru-en-las-iniciativas-para-promover-la-45rmz4ut95.pdf

Contribución del Perú en las iniciativas para promover la seguridad sanitaria mundial

Conflictos de interés: MP es investigador principal en estudios clínicos auspiciados por MSD, Sanofi-Aventis, AstraZeneca, Novartis Biosciences, Roche y Phenomix Corporation; miembro del Advisory Board de Sanofi-Aventis del Perú; conferenciante para Sanofi-Aventis del Perú, Novartis Biosciences y BristolMyers Squibb; ha recibido auspicio para asistir a eventos científicos por Sanofi-Aventis del Perú y MSD.

/pdf/regulation-of-clinical-trials-and-authorization-for-1kvgzeapuf.pdf

Regulation of clinical trials and authorization for commercialisation of drugs

Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category.

/pdf/eficacia-y-seguridad-en-la-nueva-regulacion-de-productos-2mwdlaz7w1.pdf

Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú

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Un llamado ético a la inclusión de mujeres embarazadas en investigación: Reflexiones del Foro Global de Bioética en Investigación

Contribución del Perú en las iniciativas para promover la seguridad sanitaria mundial

Regulation of clinical trials and authorization for commercialisation of drugs

Eficacia y seguridad en la nueva regulación de productos farmacéuticos en el Perú