Regulatory Affairs Professionals Society

Experts outline considerations for pivotal trial designs for new CGTs

As cell and gene therapies (CGTs) continue to advance, they have unique developmental features that may require innovation in ...
The American Journal of Managed Care

Myeloma Experience Paves the Way for MRD in Trial Design and Regulatory Approval

Obsolescence of control arms at data maturation impedes comparative effectiveness and ICER estimation, potentially contributing to prolonged delays between registration and real-world availability.

Shorter clinical trials of medication for alcohol use disorder can be as useful or more useful than longer trials

Randomized control trials that are shorter than 12 weeks show similar results to longer trials when assessing a new ...
The New England Journal of Medicine

Ivermectin to Control Malaria — A Cluster-Randomized Trial

Malaria control and elimination is threatened by the spread of insecticide resistance and behavioral adaptation of vectors. Whether mass administration of ivermectin, a broad-spectrum antiparasitic ...
News Medical

Randomized clinical food trials: Best clinical practice, quality management & data processing

Thought LeadersAoife Hayes, Kevin O'Regan & Julie ScanlonClinical Trials Assitant, Operations Manager & Quality Assurance ManagerAtlantia Clinical Trials Food clinical trials may not be as familiar to ...