EMA Releases Guideline on Covariates in Clinical Trials
Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments.
Often, these covariates are measures taken early in a trial, such as a baseline measurement, that would prompt sponsors to stratify patients into different treatment arms, according to guidance released last week.
- Clinical Trials Group Backs Mobile Tech to Develop Patient-Centric Novel Endpoints July 11, 2017Clinical researchers can use mobile technologies to improve the trial process if they focus on patient-centric measures and engagement with regulators, according to the Clinical Trials Transformation Initiative (CTTI).
- FDA Pediatric Cancer Panel: Increase International Collaboration July 11, 2017In a June meeting, the FDA’s pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials.
- FDA Pediatric Cancer Panel: Move Away from Single-Agent Studies July 11, 2017In developing future clinical trials, sponsors should consider whether the drug will be intended for use as a single agent or as part of a combination therapy, said members of the Oncologic Drug Advisory Committee’s pediatric subcommittee, in a meeting last month.
- LOGFILE No. 28/2017 – Checklist Performance Qualification July 18, 2017Checklist Performance Qualification An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification by Hans H. Schicht, PhDmehr
- Joint pharma venture planned between India and Russia July 13, 2017According to pharmabiz.com, India is planning to set up a joint pharmaceutical venture in the region of Chelyabinsk in Russia and is now seeking views and suggestions from its pharmaceutical industry. On July 17, a interactive meeting with government senior officials and industry leaders will take place.mehr
- LOGFILE No. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona July 11, 2017Future Trends of Pharmaceutical Manufacturing revealed in Barcelona A report on the ISPE 2017 Europe Annual Conference 6 minutes reading time by Sabine Paris, PhDmehr