Clinical Guest Contributors
-
Reducing The Number Of Clinical Holds On Cell And Gene Therapies: Approaches For Sponsors And The FDA
3/25/2024
There is a large proportion of clinical trials for cell and gene therapies that the FDA places on clinical hold. Why is this, and what can sponsor companies and the FDA do differently?
-
The Rise, Fall, And Eventual Rebound Of DCTs
3/25/2024
First there was skepticism, then enthusiasm, and then disillusionment. DCTs have had their ups and downs. Here, we're looking ahead to the future of DCTs.
-
Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
-
AI Technologies Drive Drug Development And Enhance Patient Experience In Neurology & Rare Diseases
3/21/2024
Digital healthcare and AI technologies play a crucial role in exploring and treating a range of rare diseases as we welcome a new era of personalized care and potentially better patient outcomes.
-
No CRO? No Problem As Curadev Tackles Site Selection For Its First Clinical Trial
3/21/2024
Curadev COO and CFO Manish Tandon discusses the company's first foray into site selection (all without a CRO), covering a site’s influence on patient recruitment and centricity.
-
Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement
3/20/2024
Results from the latest CISCRP “Perceptions & Insights” study reveal five opportunities to improve clinical trial recruitment and participation, especially among ethnic and racial minority groups.
-
Why Small Clinical-Stage Companies Need Developmental Risk Management Plans
3/19/2024
For small clinical-stage companies, developmental risk management plans are not a regulatory requirement but a strategic imperative to proactively manage risks.
-
Why The ‘Illusion’ Of Speed In Clinical Trials Unravels As Contracting Demands Scale
3/19/2024
Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.
-
Informed Consent In Clinical Trials: Understanding The FDA’s And OHRP’s Joint Draft Guidance
3/18/2024
The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants.
-
What’s Needed To Keep Tinnitus Research From Going Quiet
3/18/2024
Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.