Protocol Design Featured Articles
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Clinical Failures Persist Because They're Structural, Not Random
4/29/2026
Clinical failures are no longer contained within a single program but happen across portfolios, companies, and therapeutic areas. Advisor Mikail Evteev suggests the reason is a failure to learn from past mistakes.
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Breaking Barriers In Rare Disease Clinical Trials
4/27/2026
Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.
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Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials
4/23/2026
Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
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Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D
4/23/2026
City of Hope’s Alberto Pugliese, MD, discusses how philanthropic gifts helped launch a landmark multi-center trial to test a combination therapy using repurposed drugs for the treatment of Type 1 Diabetes.
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The Patient-Centered Trial Paradigm For Knee Osteoarthritis
4/22/2026
Although PROs can complicate a trial design, they're essential to reflecting a patient’s true knee OA experience and producing meaningful evidence, explains Katie Mowry, Ph.D., VP of R&D at Organogensis.
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A New Biomarker Risk Score May Improve Prognosis And Trials In Idiopathic Pulmonary Fibrosis
4/21/2026
A new biomarker risk score developed by the Pulmonary Fibrosis Foundation's PROLIFIC consortium could serve as the latest prognostic or predictive tool in clinical trials and care. for those diagnosed with idiopathic pulmonary fibrosis (IPF).
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Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center
4/20/2026
For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
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What Sites, Sponsors, Vendors, And CROs Can All Agree On
4/17/2026
Experts representing sponsors, sites, vendors, and CROS discussed at Life Sciences Future SW the pain points and the opportunities that lie ahead in clinical research.
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Is It Time To Replace RECIST — Or Just Add AI?
4/16/2026
Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.
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What Really Moves The Needle In Primary Immunodeficiency Research And Treatment
4/14/2026
Kedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.