Featured Clinical Leader Editorial

71. Becoming A PI: The Power of Physician-To-Physician Recruitment 5/25/2023

    Principal investigators (PI) can be in short supply. So, what's the best way to encourage more physicians to become PIs? By enlisting the help of other physicians. Here, Dr. Katie Smentek shares her experience of becoming her clinic's first PI and how she encourages fellow doctors to become investigators in clinical trials.

72. 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.

73. A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms 5/16/2023

    The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.

74. Phase 1 Strategies To Optimize Orphan Drug Development 5/12/2023

    While evidence of clinical activity is often sought and collected during Phase 1 trials, it is not typically the primary trial endpoint. But in later-stage trials such as a Phase 1b dose expansion study, there are opportunities to collect additional critical data that will help to guide further development. This includes clinical activity, biomarker and genetic mutation assessments, and preliminary impact in combination therapy. 

75. Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials 5/10/2023

    The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.

76. Advancing Innovative Therapies For Mild-To-Moderate Psoriasis With Novel PASI-HD Assessment 5/8/2023

    The Psoriasis Area and Severity Index, or PASI, was developed in the 1970s as a tool for assessing the severity of psoriatic lesions for the purpose of assessing outcomes in a psoriasis clinical development program. But it falls short in assessing the severity of the disease in those wild mild to moderate psoriasis. Enter PASI-HD.

77. New Advancement Toward The First Primary Endpoint Qualification Of A Digital Endpoint For Duchenne 4/27/2023

    Current methods for assessing ambulatory function in patients with Duchenne muscular dystrophy do not fully reflect how they experience DMD in their daily lives. Now, researchers have developed a new endpoint measured by a wearable device that records a patient's fastest spontaneous strides outside the clinic. What's more, it could become the first-ever digital primary endpoint approved by regulators.

78. Need To Clean Up Your Clinical Trials Budgeting And Forecasting Process? Try MOP-FACE 4/17/2023

    Like the CTM who drinks CDER at the SPA without getting anyone SAD or MAD, our industry enjoys a good acronym. As such, here is the acronym to remember that will lead you to budgeting enlightenment: MOP-FACE.

79. 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.

80. What Core Outcome Sets Can Do — If We All Adopt Them 3/22/2023

    A single trial provides just a snapshot of evidence. Many trials provide a summative account of how effective an intervention can be. But when the selected outcomes are different from trial to trial, it becomes much more challenging to reach a conclusion. Stuart Nicholls of the Ottawa Hospital Research Institute advocates core outcome sets as the remedy.