GUEST COLUMNISTS

• Clinical Trial Duration Trends & The Study Closeout Gap

  Clinical study durations are increasing. Contributing significantly is what we will refer to as a study closeout gap. Is your company positioned to reverse this trend and reduce time to market for your new drugs and therapies? This article explores study duration data as well as related labor challenges and macroeconomic trends. 

• How To Leverage RWE To Facilitate Access To Cell & Gene Therapies

  As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.

• Improving Diversity In Clinical Trials With A Community-Based Approach

  Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.

• Latin America: A Compelling Region To Conduct Your Clinical Trials

  This article examines the need to conduct clinical trials outside the U.S., addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. Colombia is highlighted as a country that stands out as ripe with opportunity.

• IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy

  European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.

• How Can We Investigate Biomarkers For Lung Cancer Patients More Effectively?

  With a 5-year mortality rate of nearly 90%, lung cancer is in dire need of targeted control interventions. There is a serious lack of sufficient predictive biomarkers, turning the lung cancer journey into one in which the patient and physician alike may as well be wearing blindfolds. This article discusses how we can start to swing the needle in the patient's favor.

• Making An Unapprovable Drug Product Approvable: Lessons Learned

  This true story explores a drug product that was in the middle of Phase 3 trials, generating the keen interest of the FDA, but which suffered a commercialization setback due to manufacturing inefficiency and safety concerns. They asked us to think about how we would transform the manufacturing process into a licensable process.

• New Clinical Studies In ALS Show Promise

  Right now, there is no cure for amyotrophic lateral sclerosis (ALS) and approved therapies only moderately slow progression of the disease. However, new clinical studies are taking new approaches to targeted therapy, including using a platform trial design, investigating secondary endpoints, and using brain-computer interfaces.