Applied Clinical Trials
Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
In accordance with recommendations from the FDA, there are four key actions that biopharmaceutical sponsors can take immediately to offset disruptions:
These are just a few questions among many that need to be sorted out. To plan for the short- and long-term scenarios, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines and budgets against the evolving global landscape.
Sponsors should note that these strategies may require amendments to study protocols, and the FDA guidelines urge sponsors to engage with institutional review boards (IRBs) as soon as possible. However, in cases where protocol changes are made to directly eliminate hazards to patients, these may be implemented6 without IRB approval. Finally, alarming projections indicate that social distancing countermeasures may need to be in place well into 20217, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
Sharma Ramanathan is a manager in ZS’s San Francisco office. Ronald Du is a manager in ZS’s Los Angeles office. Mike Martin is ZS’s global clinical lead, based out of ZS’s Princeton office. Arvind Chavali is an associate consultant in ZS’s San Francisco office.
Editor’s Note: The full version of this article will be available in our April digital edition on April 13.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.