ecent technological advances have expanded accessibility of clinical studies to larger and more diverse populations. However, technology alone will not ensure successful completion of research studies. The human element—how sites, sponsors, and patients use technology within applicable regulatory guidelines—is still the key to maintaining compliance, minimizing risks, and ensuring patient safety.

The FDA draft guidance provides a good collection of evolving Decentralized Clinical Trial (DCT) best practices. Newcomers to the space will benefit from reviewing the details included therein. There are also key sections regarding site and sponsor responsibilities that are crucial to ensuring compliant trial completion.

he future of clinical trials relies on addressing ways in which we can put diverse patients at the center of the medical product development process. Specifically, we need to listen to the voices of those historically misled and underrepresented in research and demonstrate how clinical trials may be a viable care option. These efforts could directly address the access and diversity issues impacting representativeness in research.

he burden of prostate cancer is considerable and growing. In 2020, 1.4 million incident prostate cancers were diagnosed and 375,000 prostate cancer deaths occurred globally. By 2040, the numbers will grow to 2.4 million incident prostate cancers and an almost doubling of prostate cancer deaths per year.

igital innovation is playing an increasingly important role in the regulatory process. As such, it should be an integral part of the outsourcing relationship. Digital technologies are increasingly being integrated into many regulated processes in the pharmaceutical industry. Technology solutions such as artificial intelligence, automation, and natural language processing can now support the pharmaceutical compliance journey.

eciding to join a company like Virpax Pharmaceuticals is both exciting and daunting. The authors have both worked for other small biopharmaceutical companies in the past, but with just six full-time employees, Virpax is decidedly one of the smallest companies either author has worked for.

espite the stated intent to adopt digital technologies in the clinical development area of R&D, uptake has been relatively slow. There are various reasons for this, not the least of which is how we think about documenting critical regulatory required information. Despite significant technical advances in our ability to document (the verb) this information, we are stuck with documents (the noun) in a way that locks important data in paper or electronic forms of paper (docx, PDF, etc.), often camouflaged in unstructured blocks of text.

nyone involved in obtaining approval to conduct clinical trials in the EU who has had to navigate the disparate and complicated systems in place since the Clinical Trials Directive was implemented in 2001 has long dreamt about change. Having a harmonized clinical trial approval system that would relieve the administrative burden and misalignment between countries in the EU so that the region would become the place to conduct clinical research in the future was and remains the goal.

rom 22-24 March, key stakeholders in global health gathered in Basel for DIA Europe 2023. Under the theme “Advancing Health Priorities,” this conference aimed to Drive Insights to Action by connecting key policy discussions to real-world knowledge and accelerate growth and performance in the drug development ecosystem.

linical trials in Latin America still face many challenges: Unstable regulations, bureaucratic complications, lack of adequate infrastructure, and an unending need to train researchers, physicians, and related research personnel show how much work remains to be done. Although quality levels and standards have noticeably improved, Latin America produces only about 3% of the world’s research, far behind Europe and Asia, which account for 25% and 29%, respectively. There is vast room for improvement.

espite broad awareness and acknowledgement about the lack of diversity in clinical trials, challenges remain. In their 2020 Drug Trials Snapshots Summary report, FDA provided average percent participation in clinical trials by subpopulation for new molecular entities and therapeutic biologics approved in 2020 and the results were stark, with disproportionately high rates of white participants (75% white) and low percentages in other groups (11% Hispanic, 8% Black or African American, and 6% Asian). These disparities were more apparent compared to the US population composition (61.6% white, 18.7% Hispanic, 12.6% Black or African American, and 6% Asian).

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