Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More

Clinical research staff working on corrective and preventive action reports should think seriously about the root causes of good clinical practice violations identified at their sites and how to prevent those errors from recurring. Read More

Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More

Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More

The goal of recruiting sufficient numbers of minority patients at U.S. clinical trial sites is hardly ever reached, rather than hard to reach, a trials expert says. Read More

Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More

Not all clinical trials need to be registered on clinicaltrials.gov, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says. Read More

The European Medicines Agency’s management board has delayed formal adoption of a controversial clinical trial transparency policy, pending further clarifications on final wording and practical considerations at its Oct. 2 meeting. Read More

The European Medicines Agency is pushing back against critics who accuse it of softening its commitment to clinical trials data transparency, saying there has been “absolutely no change in direction” in the agency’s efforts to make trial data more publicly available. Read More

Bayer HealthCare, Boehringer Ingelheim and Eli Lilly are the latest drugmakers to make more clinical trial data available — in line with a recent push for transparency on the part of European regulators. Read More

Drug companies that redact commercially confidential information from clinical study reports in Europe will have to justify their actions, a spokesman for the European Medicines Agency says. Read More

Eli Lilly said it will begin sharing clinical trial data used in support of regulatory filings in the U.S. and Europe with qualified researchers, becoming the latest drugmaker to join the growing clinical trial data transparency movement. Read More