Featured Clinical Leader Editorial

  1. Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act 5/23/2023

    The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.

  2. Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do 4/14/2023

    The number of systems used to support the conduct of clinical trials has increased and the amount of data used to monitor our portfolio, studies, and processes has soared. While there is still value in using traditional dashboards and reports, the use of advanced analytics and RWD/E is enabling us to ask more sophisticated questions to be more predictive — what will happen — and prescriptive — how to make it happen.

  3. How BMS Uses AI To Improve Study Design And Reduce Costs 1/19/2023

    In 2022, Bristol Myers Squibb (BMS) announced plans to work with AI developer Owkin to design and optimize cardiovascular drug trials. The partnership will allow BMS to use machine learning to enhance clinical trial design and execution.

  4. The Long-Term Impact Of COVID-19 On Clinical Trials: Part 2 1/16/2023

    The COVID-19 pandemic is helping create a “new normal” for the life sciences industry regarding the policies, procedures, and processes of clinical trials. In Part 1, we discussed five factors that more directly impact the clinical trial process and patients. In Part 2, we will discuss six factors that focus on organizational structure and the broader industry. 

  5. The Long-Term Impact Of COVID-19 On Clinical Trials: Part 1 1/11/2023

    Pandemics provide a massive pressure-test of healthcare systems, allowing us to isolate what works well and what merits improvement. The COVID-19 pandemic is going to create a “new normal” regarding resetting the equilibrium in a variety of policies, procedures, and processes. In Part 1, we examine five factors that more directly impact the clinical trial process and patients.

  6. The Future Of TransCelerate: Clinical Trial Modernization 12/19/2022

    In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate. Chang has been involved with TransCelerate since it was just a concept, and notes the time spent in the group since its launch has been an amazing journey.

  7. What Astellas Has Learned About Decentralized Trials 11/28/2022

    When the COVID pandemic hit in the spring of 2020, many companies were unprepared for the changes that were about to impact their studies. Astellas is one company that was better prepared than most. The company had initiated a formalized, internal project on decentralized clinical trial (DCT) technologies and their use in clinical trials about nine months prior to the pandemic.

  8. Key Learnings To Optimize Clinical Trials During COVID-19 11/4/2022

    Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes. 

  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.