The efficiency and effectiveness of clinical trial procedures is central to generating accurate safety and efficacy data from those studies. Critical processes such as participant recruitment and retention can affect how well a trial operates to meet its goals.
Read More
Identifying and evaluating investigational sites is one of the most critical aspects of study startup. A clinical trial can’t commence without it. The final site list is determined by a rigorous site evaluation process to assess whether there are appropriate facilities and equipment and qualified personnel necessary to conduct a study.
Read More
Developers of graft-versus-host disease (GVHD) therapies can design trials based on a new FDA draft guidance that focuses on using biomarkers to identify individual patients’ specific immune dysfunction rather than suppressing the entire immune system.
Read More
With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining current recommendations for development programs and trial designs of moderate-to-severe cocaine use, methamphetamine use and prescription stimulant use disorder.
Read More
Sponsors of postmarket trials and certain phase 3 trials can now expect the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to process their trial applications within two weeks rather than the statutory 30 days, as long as they meet certain criteria.
Read More
The European Medicines Agency (EMA) has revised the data transparency rules for its Clinical Trials Information System (CTIS), reducing complexities and barring sponsors from deferring the publication of critical data and trial documents.
Read More
Seeking to better understand innovative clinical trial designs and approaches, the FDA’s Center for Drug Evaluation and Research (CDER) has asked stakeholders to share their thoughts on the current barriers to and enablers of innovation.
Read More
The FDA has issued a pair of final guidances meant to assist sponsors with submitting patient-reported outcome (PRO) data gathered in cancer trials and general clinical outcome assessment (COA) data, respectively, offering technical specifications.
Read More
