Focus on Patients

1. Overcoming 4 Challenges In Orphan Disease Clinical Trials 9/22/2022

   Developing innovative treatments for patients with orphan and rare diseases offers substantial challenges. This article shares the author's tips for recruiting from small patient populations, collaborating with the FDA, choosing to work with a CRO or not, and determining a patient-centric approach.

2. Patient Insights & Current Vs. Next-Gen Patient Engagement 8/30/2022

   The FDA and the EMA have paid increasingly more attention to patient engagement in their agendas. However, current guidelines lack theoretical development and empirical guidance. The result is often that patient engagement turns into an ethical token of limited value. The article also shares how we can work on better patient engagement.

3. How Can We Improve Patient Centricity In Benefit-Risk Assessments? 8/25/2022

   The goal of patient centricity is a top priority across our entire ecosystem, but the industry approach has been fragmented. Patients may not be motivated to participate in premarket benefit-risk assessments. How can we change that?

4. 3 Strategies For Diverse, Large-Scale Clinical Studies 8/18/2022

   Chuanbo Xu of Freenome shares the three strategies that his team used to successfully enroll a diverse patient population across 200 sites for its recent clinical trial.

5. How AI/ML Is Helping Clinical Researchers Investigate Alzheimer’s 7/28/2022

   Like many cognitive conditions, Alzheimer’s disease can cause changes to a person’s speech and language. Artificial intelligence (AI) and machine learning scientists are working on automating speech assessments to detect the disease earlier and improve understanding of the efficacy of novel treatments. 

6. 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.

7. 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?

8. 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.

9. 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.

10. 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.