Focus on Patients

1. 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.

2. 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. 

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. The BRAAVE 2020 Study: Engaging Black American Communities In HIV Clinical Research 10/28/2021

   Black Americans are disproportionately impacted by HIV and have the highest rates of new HIV infections every year compared to other racial groups in the U.S. This article shares Gilead Sciences' methodology for a Phase 3 clinical trial for engaging patients living with HIV who self-identified as Black, African American, or mixed race.

9. Co-Creating With Patients: The New Guide To Expanded Access 10/12/2021

   Recently, Janssen Pharmaceutical Companies had the privilege of working with patients and advocacy groups to co-create a resource about expanded access for patients and caregivers. This article shares that story and describes how patients will benefit from the resource.

10. What Can Clinical Leaders Do To Tackle The Global Women’s Health Gap? 9/9/2021

    Nearly 300,000 women die every year from preventable causes related to pregnancy and childbirth. Postpartum hemorrhage is the leading cause of maternal death globally — and in the US, it's on the rise. Uterine fibroids disproportionately impact Black women and are a leading cause of hysterectomies. We must drive a concerted, ecosystem-wide effort that scales up clinical research for women.