After 25 years of serving the professional development needs of clinical researchers, Research Practitioner presents its final issue. On behalf of myself and the editorial and production teams, I would like to thank you for your support and readership. We are grateful for the opportunity to have served you. – Leslie Ramsey, Editorial DirectorRead More
Rare disease advocacy groups often use the phrase “rare is not rare” to drive home the point that although individual diseases and conditions might affect only a small number of people, together they constitute a large patient population. Another way of putting it, according to a 2023 paper published by researchers at the Mayo Clinic: “Rare diseases are individually rare but collectively common.”
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While often touted as a way to improve clinical trial recruitment and retention, including patient-centric features before and during the design phase of a study has many more benefits. Among them: better protocol adherence, data that reflects real impact on patients’ lives and greater likelihood of a new product being approved for marketing.
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The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans.
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The FDA has released two draft guidances on how sponsors can prepare for Bioresearch Monitoring program (BIMO) inspections in both their marketing applications as well as prior to and during the BIMO inspections themselves.
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The FDA has moved forward with its guidance on developing drugs for treating diabetic foot infections, finalizing it with no revisions despite a number of notable comments from stakeholders.
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The FDA has finalized its guidance on crafting phase 3 clinical trials for devices designed to treat opioid use disorder (OUD), providing sponsors with direction on defining patient populations, recording medication use, monitoring drug use and other elements.
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