Featured Articles

  1. A Promising Rebound in Clinical Trials 10/23/2024

    This report explores how clinical trials bounced back in 2023 from their decline a year earlier despite continued geopolitical, regulatory, and pricing pressures.

  2. The Importance Of A Maturity Model For Clinical Trial Transparency 10/23/2024

    A comprehensive maturity model for clinical trial disclosure and transparency offers companies a strategic tool to assess and enhance their practices in an increasingly complex regulatory environment.

  3. A Guide To Patient Engagement And Recruitment Solutions 10/7/2024

    In this text we explore strategic solutions to patient recruitment and engagement challenges, emphasizing the importance of comprehensive patient engagement and recruitment strategies.

  4. Synthetic Data's Value In Clinical Research 9/16/2024

    Synthetic data is a form of generative artificial intelligence (AI) that, in the life sciences, is especially valuable for enhancing datasets and increasing diversity in clinical trials.

  5. Diversity At The Start: Best Practices For Clinical Trial Planning 9/9/2024

    Claire Riches, Citeline's VP of Clinical Solutions, emphasizes that clinical trial diversity must start with a fit-for-purpose protocol, incorporating the patient voice early on to ensure success in reaching diverse populations.

  6. Clinical Trial Diversity From A Disclosure Perspective 9/9/2024

    Although the FDA mandate on diversity action plans won’t come until 2025, sponsors should start planning how to be inclusive, increasing the representation of underrepresented groups in clinical trials and reporting that data.

  7. 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.

  8. 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.

  9. 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.

  10. 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.