Clinical Guest Contributors
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3 Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial
9/23/2025
Discover how non-profit partnerships, adaptive trial design, and real-world evidence can all play a part in helping biotech's successfully launch their first-in-human trial.
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New FDA Program Adds Flexibility For Ultra-Rare Disease Submissions
9/23/2025
Life science legal experts Mark A. Tobolowsky and Frank J. Sasinowski discuss the FDA's new Rare Disease Evidence Principles (RDEP) initiative.
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Why Research Professionals Should Enroll In At Least One Clinical Trial
9/23/2025
Consultant and former director of the HHS Office for Human Research Protections (OHRP) Molly Klote, MD, implores clinical research professionals to enroll in a clinical trial to help them become more empathetic researchers.
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Combining RWD And Machine Learning To Determine Meaningful Patient Populations
9/22/2025
Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.
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Bridging Community And Central Hospitals With Japan's DCT Model
9/19/2025
Regulatory support and improved DCT infrastructure, as well as a uniquely Japanese approach to site relationships, are advancing the DCT landscape in Japan, explains consultant Takuma Matsunaga.
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RWD Helps Abbvie Bridge Oncology Trial Data Gaps
9/18/2025
AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.
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FDA Issues New Guidance For Clinical Trial Dosage Of Oncology Therapeutic Radiopharmaceuticals
9/17/2025
The FDA has issued a draft guidance titled Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development and is accepting public comments through October 20, 2025.
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CISCRP's Mobile Health Exhibit Brings Clinical Trial Education To Communities
9/17/2025
CISCRP shares its mobile education project brings clinical trial awareness and information directly to communities.
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RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It?
9/16/2025
The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.
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How Brazil's New Law Is Redefining The Country's Clinical Research
9/15/2025
Brazil aims to revamp its clinical research industry with the introduction of a new law intended to make trials faster, empower local ethics committees, and give patients greater post-trial access to investigational drugs.