Best of April: Top 5 Insights in Clinical Research

#1 - New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials

For the first time since 2006, the FDA has proclaimed its broad expectations for the scope of oversight, conduct, and practices of a data monitoring committee. In a new draft guidance, the FDA describes expectations of DMCs in clinical trials. 

#2 - Q&A with Novartis and IQVIA Study Start-Up Leaders

The industry is measuring longer cycle times between protocol approval and site activation. Experts from Novartis and IQVIA share creative solutions to combat this trend and accelerate trial timelines.

#3 - Informed Consent In Clinical Trials: Understanding The FDA’s And OHRP’s Joint Draft Guidance

The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants.

#4 - Pursuing Protocol Designs That Maximize The Value Of Hybrid Clinical Trials

Sponsors can maximize the value of hybrid clinical trials by prioritizing patient experience in trial design, balancing technologies with in-home care, site visits,and more to achieve the right design.

#5 - FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics

The FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics. Review the key takeways in this article.