Focus on Patients

31. 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?

32. 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.

33. 4 Tips To Optimize Engagement With Patient Organizations For Rare Disease Clinical Trials 2/8/2022

    For rare disease clinical trials, communications are enabled by working closely and effectively with patient advocacy organizations. In this article, a director of scientific and patient affairs shares 4 tips on what has helped their company overcome some of the barriers.

34. Gilead Sciences’ Innovative Approach To An HIV Clinical Trial 12/16/2021

    When Gilead launched its Phase 3 study of investigational lenacapavir for PrEP, the team recognized that any clinical pathways intent on introducing new PrEP options must commit to addressing and effectively bridging existing gaps if we strive to drive real change in HIV prevention. This is the story of how Gilead approached trial design in an innovative manner.

35. Diversity In Clinical Trials: Recent Efforts From The MedTech Color Collaborative 12/7/2021

    Earlier this year, the MedTech Color Collaborative was created with a goal of convening a diverse cross-section of industry stakeholders to work together to identify issues and opportunities for improvement in this critical space. The group shares and curates existing knowledge and strives to develop evidence-based solutions and best practices to address the health inequities facing minorities. 

36. The Clinical Trials Transformation Initiative: Shaping The Future Of Clinical Research 12/3/2021

    The Clinical Trials Transformation Initiative (CTTI), co-founded by Duke University and the FDA, consists of a group of individuals and organizations working to improve the quality and efficiency of clinical trials. This article shares CTTI's goals to improve clinical trials and modernize research, as well as how you can get involved.

37. How To Overcome The 3 Major Challenges In Conducting Rare Disease Clinical Trials 11/30/2021

    Designing and conducting clinical trials for rare diseases often requires drug developers to plan for and address many challenges that are often not associated with or are less severe in larger trials for more common diseases and conditions. If they are not adequately addressed, these challenges can result in trial delays or discontinuations. This article shares Cyclo Therapeutics' 3 lessons learned.

38. Decentralized Clinical Trials: Data Considerations & Value-Added Taxes 11/23/2021

    The rapidly changing regulatory, tax, and global business landscape, driven in part by COVID-19 and ongoing economic and political shifts, means that biopharma executives must keep careful watch over how they implement and monitor decentralized clinical trials (DCTs). This article examines key considerations for biopharma executives in overseeing hybrid or fully decentralized clinical trials.

39. Your Workbook To Create A Rare Disease Clinical Trial Strategy 11/9/2021

    In the rare disease space, planning and creating a robust patient recruitment plan is essential. This will lay the foundation for the budget, tactics, and expectations that are needed. In this article, the author shares her three-step process that she implemented in her career and it can set you on a path toward success for clinical trial recruitment in rare disease.

40. Rare Disease Clinical Trials: 3 Areas We Could Improve On 11/4/2021

    Rare disease clinical trials pose unique and complex challenges. Small and geographically dispersed locations of treatment centers, disease heterogeneity, and incomplete disease natural history can complicate the process. However, there are actionable and tangible steps we can take to improve the process and enable development of innovative and meaningful therapies.