Clinical Guest Contributors

  1. FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program 2/10/2025

    The FDA released final guidance on the Advanced Manufacturing Technologies Designation Program at the end of December. This article shares a summary, analysis, and how it compares to the 2023 draft.

  2. Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars 2/10/2025

    With an projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.

  3. Input Needed On Using AI To Create Lay Summaries Of Trial Results 2/7/2025

    CISCRP is soliciting feedback from research professionals, patients, and advocacy groups on its "Considerations for Using AI to Create Lay Summaries of Trial Results" until Feb. 18.

  4. Annual SCOPE Summit Serves Up A Similar But Satisfying Menu 2/7/2025

    Executive editor Abby Proch sums up her second SCOPE Summit experience.

  5. How "Atomic Habits" Can Help Optimize Patient Recruitment 1/31/2025

    With the third article in his series “Inspired Patient Recruitment — Taking Inspiration from Business Advice Bestsellers," Ross Jackson applies theories from "Atomic Habits" by James Clear to clinical trial patient recruitment.

  6. A Tool To Tackle The Risk Of Uninformative Trials 1/31/2025

    Uninformative trials hinder progress in clinical practice, policy decisions, and further research. Fast Data Science developed a free risk tool to help pharma companies avoid them.

  7. In Clinical Research, Every Day Is Groundhog Day 1/30/2025

    Rather than proffer some New Year's predictions, Paul Ivsin looks at clinical research through the lens of Groundhog Day and the tradition of reinventing the same thing over and over again.

  8. FDA Issues Draft Guidance: Study Of Sex Differences In The Clinical Evaluation Of Medical Products 1/29/2025

    The U.S. FDA's recent draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products deduces that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials. The public comment period ends April 7 (in theory), though it should be noted that the guidance was removed from the FDA website shortly after the new administration took office.

  9. Biopharma R&D Faces Productivity And Attrition Challenges In 2025 1/29/2025

    Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

  10. Tech Vendors Are Today's Don Quixotes 1/28/2025

    Don Quixote is known for tilting at windmills, believing them to be enemies. Today, it seems, emerging tech solution developers are embodying the spirit of the quixotic knight centuries later.