Clinical Trials Advisor

Drug sponsors will continue to streamline clinical trial protocols in the near term as part of an industrywide effort to improve R&D productivity, according to a new report.

Drug sponsors could experience greater certainty during drug reviews if the agency’s upcoming pilot program to standardize the evaluation of new products is a success.

The FDA is finishing a final guidance on co-development of two or more novel drugs for use in combination and hopes to release it in the next few months, Center for Drug Evaluation and Research Director Janet Woodcock tells CTA.

PPS Clinical Research has admitted to falsifying clinical trial records and knowingly lying about the records during an FDA investigation.

Investigators’ could see their recruitment goals and the number of patients they enroll in clinical trials made public if the authors of a recent article in PLoS Medicine have their way.

A proposed Indian rule that would let ethics committees decide the cause of serious adverse events (SAEs) and the level of SAE compensation provided to trial participants could make conducting high quality, scientifically valid trials in the country impossible, the Association of Clinical Research Organizations (ACRO) says.

Merck must report annually on delayed clinical trials under terms of a settlement reached with shareholders, marking another milestone in the fallout from the ENHANCE trial of its cholesterol drug Vytorin.

The European Medicines Agency (EMA) is revising its guideline on anticancer drug development, placing additional emphasis on the use of biomarkers.

Sponsors must ensure the stability of investigational drug products before beginning clinical trials and bioequivalence studies in India, according to the Central Drugs Standard Control Organization (CDSCO).