Insights

Clinical Trials in Dravet Syndrome: Opportunities, Challenges, and Collaborative Solutions

Clinical ResearcherAugust 15, 2023

Trial participation for a patient with a rare disease that has significant medical needs, as in the case of Dravet syndrome, can be challenging and adds to the already overwhelming caregiver burden on parents. An organized, informed, and connected patient community can ease some of these challenges.

An Adoption and Change Management Guide for Sites Implementing New Study Technologies

Clinical ResearcherAugust 15, 2023

Identifying eligible patients, obtaining consent, executing the study, capturing data, and complying with all reporting and regulatory obligations take time and vital resources away from other important responsibilities at study sites. That’s where new clinical research technology comes in.

What the FDA’s Final Guidance on Covariates Means for Fighting the Placebo Response in RCTs

Clinical ResearcherAugust 15, 2023

The FDA has released final guidance on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” One relatively minor difference from the draft version actually represents a major step forward in statistical analyses for randomized controlled trials (RCTs).

Everything Must Change

Clinical ResearcherAugust 15, 2023

Taken as a whole, in one way or another the pieces of this issue are all about not just the need for, but the inevitability of, ongoing change in the clinical research enterprise—not just change for the sake of change, but change for the better.

Nadine H. Spring, PhD, CCRC, Director of Operations, SpringWell360 LLC

PIs Recognize Need for Greater Diversity in Trials, Feel Frustrated by Limitations

BlogAugust 9, 2023

Principal investigators interviewed for a recent academic dissertation recognized the need for greater diversity among participants in the clinical trials but are frustrated that the inclusion/exclusion criteria handed by sponsors often don’t match the real-life situations of the average patient in their practice with the condition of interest. In the forthcoming August issue of ACRP’s Clinical Researcher journal, these and other findings are detailed in a peer-reviewed article.

As the most passionate advocate for the clinical research profession, ACRP is committed to amplifying the voice of clinical research professionals. Explore community perspectives – and the latest ACRP news – below.

Clinical Trials in Dravet Syndrome: Opportunities, Challenges, and Collaborative Solutions

An Adoption and Change Management Guide for Sites Implementing New Study Technologies

What the FDA’s Final Guidance on Covariates Means for Fighting the Placebo Response in RCTs

Everything Must Change

PIs Recognize Need for Greater Diversity in Trials, Feel Frustrated by Limitations