Clinical Guest Contributors

  1. Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19 6/4/2020

    Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

  2. Inside Novo Nordisk’s Patient Advisory Board Meetings 6/2/2020

    Novo Nordisk's first DEEP (Disease Experience Expert People) Advisory Board meeting brought together leaders of patient organizations, patient advocates, and patients from five countries to participate in a dialogue with the company's Global Patient Relations team, project vice presidents, medical specialists, and trial managers.

  3. What Patients Are Telling Sites About Trial Participation During COVID-19 5/28/2020

    LMC Manna conducted interviews with patients who are currently enrolled in a Phase 3 clinical trial at one of their sites, with questions focusing on the impact of COVID-19 during their trial participation. Here's what they had to say.

  4. Post-COVID-19 Clinical Trials: Finally Understanding The Meaning Of Patient-Centricity 5/27/2020

    Despite being instrumental to our mission of making lifesaving therapies accessible to all, patient perspectives are far too often lost in the wake of “flashier” news about COVID-19 therapy approvals, supply chains, and scientific breakthroughs.

  5. An Update On Regulatory Guidance For U.S. Clinical Trials During COVID-19 5/21/2020

    To preserve integrity in clinical trials and mitigate the need to place clinical trials on hold indefinitely, the FDA has issued updated guidance to support important research and exploration of new treatments. Additionally, the U.S. Department of Health and Human Services’ Office of Human Research Protection issued guidance to assist researchers in applying human subject protection regulations.

  6. Diverse Enrollment In Clinical Trials: What Do Successful Research Sites Have In Common? 5/19/2020

    Diverse enrollment in clinical research studies is a complex issue that has multifaceted implications for clinical research sites. An understanding of the research site community’s perceived awareness and current ability to enroll these populations is lacking in the clinical trials landscape.

  7. Moving Virtual Trials From Aspiration To Reality In Today’s Environment 5/14/2020

    With the COVID-19 pandemic upon us, we are at a place where the business case is clear, the barriers to adoption are largely removed, and sites and participants alike have begun accepting virtual trials as not just an option but a must.

  8. COVID-19 & Clinical Trials: Understanding The Long-Term Impact 5/12/2020

    While most regulatory agencies have stated an intention to be flexible during these unprecedented times, it is critical that drug developers continue to monitor their risk diligently and develop contingency plans to adapt and respond to factors that affect their clinical development programs.

  9. eConsent In Clinical Trials: Insights For Implementation During COVID-19 And Beyond 5/7/2020

    The world has changed in the wake of COVID-19. To adjust, clinical trial sponsors must adapt their protocols, and many are urgently doing so, to provide virtual tools for clinical trial use. One example of an important tool in this space is electronic consent, or eConsent.

  10. How Do Underserved Communities Prefer To Learn About Clinical Research? 5/5/2020

    It is important to look at the big picture and better understand core participation motivators and barriers from the underrepresented patient’s perspective in order to better enable access to and increase their participation in clinical trials.