Focus on Patients

  1. How To Implement Patient-Focused COAs 11/1/2022

    Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

  2. How To Optimize Returns On Plain Language Summaries 10/31/2022

    The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

  3. 5 Ways To Expand Racial & Ethnic Diversity In Clinical Trials 10/13/2022

    Between 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.

  4. 2 Strategies For Rare Disease Clinical Research Patient Centricity 10/11/2022

    We all know it is important in rare disease clinical research to seek out the knowledge of clinical and academic experts who can inform study design. But we need to better prioritize the patient's voice. By prioritizing patient involvement throughout the process – listening to their insights and understanding their needs – we can achieve even greater progress.

  5. 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.

  6. 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.

  7. 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?

  8. 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.

  9. 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. 

  10. 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.