DIA shares with all our scientific stakeholder communities (basic research, product development, medical, and regulatory) the conviction that science and scientific data are and must continue to be the fundamental basis for decisions that affect the health of individuals and of the public at large. This includes decisions on the development, regulatory approval, patient access, and continuing oversight of needed therapies, vaccines, diagnostics, and technologies.

The COVID-19 pandemic makes this unequivocal commitment to science even more crucial for the world. An unprecedented number of stakeholders across healthcare – including academia, government, industry, non-governmental organizations, medicine, patients, study volunteers and many, many more – are working around the clock and around the world to develop and deliver life-saving products to us all.

While there is an urgent need for quick access to definitive treatments, vaccines, and diagnostics, the road to truly effective and safe quality remedies can be long, winding, and difficult, despite the best efforts, creativity, commitment, and collaboration of so many.

Scientific rigor requires diligence, patience, and the ability to make informed decisions based on robust scientific data that are collected using internationally recognized practices to develop and distribute safe, efficacious, and quality products. Transparency is key – a lack of full data transparency for those in decision-making positions raises the likelihood of distrust by patients who may benefit the most from new scientific data, whether positive or negative.

DIA reaffirms its commitment and calls on decision-makers and partners around the world to recognize the importance and preeminence of both basic science and regulatory science – the discipline that positions and values science as the essential foundation of regulatory and other decisions. Now more than ever, data and decisions must be robust and transparent as we face the challenges brought on by the COVID-19 pandemic.

DIA will continue to inform, educate, inspire, convene, and support all who are engaged in our mission to create a safer, healthier world for all. Working together, and armed with an unshakeable reliance on science, our world can truly be saved.

he search for COVID-19 treatments has been filled with controversy and confusion. It is clear that the randomized clinical trial is more valuable than ever but is not being utilized as effectively as possible. In this commentary I give examples of these problems and discuss some potential improvements.

For example, publication of a small non-randomized French study, claiming effectiveness for hydroxychloroquine as treatment for COVID-19 led to a world-wide frenzy for the drug. The study incorporated data for 20 treated patients of whom six discontinued treatment early. Sixteen patients, who did not receive the drug, were used as a control group. Excluding results for the six patients who discontinued treatment, the investigators found that 70 percent of the hydroxychloroquine group had negative SARS-CoV-2 nasopharyngeal swabs at day 6 compared to 12.5 percent in the control group. The resulting rush on chloroquine led to a shortage of the drug worldwide for patients taking regular chloroquine or hydroxychloroquine for lupus or other systemic diseases.

his article is an overview of the use of real world data (RWD) and real world evidence (RWE) for regulatory decision-making in Brazil, focusing on decisions regarding the registration process and post-approval changes of drugs at the Brazilian Health Regulatory Agency (Anvisa).

Real world evidence (RWE) is clinical evidence about the use or potential risks/benefits of a drug based on the analysis of real world data.

n August 12, 2020, PLOS Medicine published a collection of five papers on the East Africa regulatory harmonization initiative. You can find these papers online. This article will provide highlights of this collection.

This collection reports the early adoption of the Common Technical Document (CTD) across the region as well as shared regulatory requirements and standards for medical products regulation; this set the stage for countries to start assessing marketing applications (MAs) jointly. The initiative also enabled, through strong advocacy, creation of new autonomous regulatory agencies in Rwanda, South Sudan, and Zanzibar.

t a recent symposium about expanding regulatory innovation, I discussed the importance of Regulatory Reliance, defined by WHO as, “The act whereby the NRA in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution, or to any other authoritative information in reaching its own decision. The relying authority remains independent, responsible, and accountable regarding the decisions taken, even when it relies on the decisions and information of others.” This approach offers a true win-win opportunity for all parties involved – notably to society and patients, who depend on timely access to high-quality, innovative, safe, and efficacious medical products.

ndia, with a large population, a variety of communicable and non-communicable diseases, and diversity of healthcare systems, provides immense opportunity for conducting studies in real world evidence (RWE). But this potential is not yet realized because of lack of demand from regulators, payers, insurance companies, and patients, and low level of interest from clinical investigators. This is a brief review of industry’s role and challenges in creating an enabling environment for RWE studies.

OVID-19 is a catalyst for transformation of clinical research. The critical need to ensure greater diversity in clinical trial participation is more evident than ever. With increased attention paid to disparities in clinical trial study access and participation in recent COVID-19 vaccine trials and the global impact of clinical trial disruption due to the pandemic, there is increased need to rethink study inclusion and diversity – to develop creative ways to engage underserved communities and accommodate geographically diverse or disadvantaged populations (e.g., through remote trial models) to increase representation in clinical trials.