Clinical Guest Contributors

31. Community-Driven Registries Drive Understanding Of Rare Diseases 3/8/2024

    In an effort to increase and diversify research, the Pulmonary Fibrosis Foundation (PFF) envisioned a new approach to aggregating usable medical data — asking patients directly.

32. 3 Tips For Selecting Your eTMF Platform 3/7/2024

    Each eTMF platform presents its own set of advantages and drawbacks. Be sure to incorporate these three tips when considering a new eTMF vendor and its services.

33. 2 Ways To Encourage Clinical Trial Investor Funding 3/6/2024

    Consider these two promising funding models that balance risk with reward: trial-specific fundraising and staged funding release.

34. The Key Differences Between Expanded Access Programs And Investigator Sponsored Trials 3/6/2024

    Expanded access programs (EAPs) and investigator sponsored trials (ISTs) play significant roles. While both aim to provide patients with access to investigational therapies, they operate under distinct frameworks and serve different purposes. Understanding their differences from traditional clinical trials is crucial from an investigational medicine product and supply chain perspective.

35. Best Practices For Complete Registration And Reporting Of Summary Results On ClinicalTrials.gov 3/5/2024

    The Clinical Trials Transformation Initiative (CTTI), alongside the FDA, investigated factors and barriers to registration and summary results information reporting. Here is what they found and what they suggest for ensuring complete reporting of trial results.

36. Is Ignoring Gender Non-Conformity Research Holding Us Back? 3/4/2024

    Including individuals across the gender spectrum in clinical trials isn't just the right thing to do, it's also strategic move with benefits for science, society, and business.

37. Tokenism In Clinical Trials For Rare Disease Patients 2/29/2024

    While recent efforts promote diversity in clinical trials, the lack of enforcement and tokenistic approaches risk leaving people of color behind. This article delves into the urgency of addressing this crisis and building genuine inclusivity for a healthier future for all.

38. Channel Your Inner Child To Become A Better Clinical Research Professional 2/28/2024

    Sites, CROs, and sponsors sometimes have contentious relationships. It doesn't have to be that way. Discover how to leverage The Zones of Regulation to better manage emotions and become a better partner and CRP.

39. Leveraging AI For Data Analysis In Pharmacy-Based Trials 2/28/2024

    Leveraging AI for data analysis in pharmacy-based trials holds immense potential for revolutionizing drug development and healthcare delivery.

40. FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions 2/27/2024

    On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.