Clinical Guest Contributors

11. Online Resource Launched To Ease Clinical Trial Participation Fears 7/22/2022

    Studies have shown that patients are eager to participate in clinical trials, but they lack the resources to address their fears. Fear remains the main barrier to patient participation. Earlier this year, an independent start-up launched an online resource for patients to access information they need to ease their fears.

12. Clinical Research Sites Share Cash & Workforce Shortage Concerns 7/21/2022

    As the industry faces unprecedented macroeconomic issues, including substantial staffing challenges and inflationary pressures, resources are desperately needed to support clinical research sites and studies. As a sponsor company, consider ways to help sites right now: Can existing budgets be adjusted? If not, what other solutions may be available? 

13. 3 Strategies For Optimal Oversight Of Your Outsourcing Partner 7/20/2022

    Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

14. Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites 7/18/2022

    Sponsors can influence site choices and work better with them by creating a positive sponsor-site relationship from the onset, which includes making design decisions that consider the patient perspective and making execution decisions that alleviate common operational challenges and reduce burden on sites. Here's how.

15. Designing A Phase 3 Clinical Trial In Rare Dermatology: Lessons Learned 7/15/2022

    Rare dermatologic disease R&D is growing at a much faster rate than other fields in dermatology. Even before the data readout from our Phase 2b study, we began formulating several possible Phase 3 trial designs and asked scientific, operational, and regulatory questions. Here are our lessons learned.

16. FDA Seeks Comment On Fit-For-Purpose COAs Guidance 7/14/2022

    On June 29, the FDA released the new guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. This article sums up the guidance and explains the four types of COAs that the FDA prefers (PROs, ObsROs, ClinROs, and PerfOs). Submit comments to the FDA by September 28, 2022.

17. Decentralized Clinical Trials: Are We Using The Best Terminology For Patients? 7/12/2022

    There is a need within the clinical trials community for a broad term to describe clinical trials that make use of digital health tech and other methods for better accessibility to participants. However, is a single term as helpful for patients as it is for clinical trial professionals?

18. The Case For Implementing TransCelerate’s Modernization Of Statistical Analysis Framework 7/11/2022

    It is crucial that statistical analytics of clinical trial data steps into the modern era. Last year, TransCelerate launched the Modernization of Statistical Analysis Framework as a model methodology for demonstrating to health authorities that regulatory submissions generated with any analytical software, including nontraditional analytical tools, provide the necessary reliability.

19. Patient Diversity In Clinical Trials: How To Meet The Need 7/7/2022

    The study participants in clinical trials are often homogenous. Although 39% of the U.S. population is composed of people of color, they account for less than 16% of those in clinical trials. Black patients account for only 5% of clinical trial participants in the U.S. This article dives into the topic and shares seven action items for improving diversity.

20. Latin America’s Landscape For Medtech Clinical Trials 7/5/2022

    This article examines the need to conduct medtech clinical trials outside the U.S. and explores the growth of these trials in Latin America, particularly in Colombia and Paraguay. It also addresses critical success factors and provides recommendations to ensure cost-effective, ethical, and quality EFS and FIH medtech clinical trials in the region.