Featured Articles

31. Diversity In Clinical Trials: LGBTQIA+ Community Needs Not Just Allies, But Crusaders 9/9/2024

    In an ACRP webinar on LGBTQIA+ diversity in clinical trials, industry panelists came together to discuss FDA action plans, SOGI data, advocacy efforts, challenges of transgender patients, and more.

32. Practical Approaches To Clinical Trial Diversity 9/9/2024

    Gain insights on FDA diversity action plans, and the important role that data points play in ensuring inclusion of underrepresented populations.

33. Outlook Good For 7 Drugs Up For Q3 Review 8/15/2024

    A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.

34. Crafting A Successful Clinical Trial Diversity Action Plan 8/15/2024

    Ensure your clinical trial meets FDA diversity requirements by clearly defining your enrollment goals and strategies in a comprehensive diversity action plan.

35. Cell And Gene Therapy Field Quiet In Q2 8/15/2024

    While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.

36. Deciphering The FDA's Diversity Plan Updated Guidance 7/16/2024

    Updated FDA guidance from June outlines the format and content of Diversity Action Plans, the products and studies requiring a plan, and the submission process. Learn about the changes and what to expect.

37. The Promise And Peril Of AI In Clinical Trials 7/16/2024

    In clinical research, as with many industries, AI is met with both excitement and trepidation. The impact of AI and machine learning is starting to be felt across the pharmaceutical industry.

38. Billion Dollar Blueprint: The Journey To Blockbuster Status 7/16/2024

    The allure of a blockbuster drug lies not only in its ability to generate billions in revenue but also in its potential to spur additional R&D investment.

39. 10 Ways To Set Up Your Sites For Recruitment Success 7/16/2024

    Selecting the right trial sites is key to success. Choose sites with the right experience, patient population, diversity mix, and timelines. See these nine tips to boost recruitment and retention.

40. Including Diversity At The Onset 6/13/2024

    Designing a clinical protocol that is fit for purpose can incorporate diversity into clinical trial planning early on. Explore strategies for incorporating diversity into clinical planning and study protocols.