Sponsors need to do a better job of understanding disease and disability conditions and aligning that knowledge with measures for patient-reported outcomes. Read More

Access to a forthcoming clinical trials portal and database would be limited to authorized users and “super users,” under draft specifications released by the European Medicines Agency. Read More

An HHS watchdog will audit how the FDA inspects generics manufacturing facilities, oversees postmarketing studies and ensures compliance with clinical trial reporting requirements, as well as how the drug industry is implementing the track-and-trace law. Read More

The World Health Organization is seeking public comment on its long-held position that clinical trial sponsors should share their study data in a timely manner, pointing to recent research that finds many results are never published. Read More

Drug sponsors conducting a clinical trial should take efforts to better understand the effects of a particular disease on patients when designing ways to measure patient-reported outcomes, says an FDA clinical trials official. Read More

Regulators in Europe have proposed restricting access to certain information in a forthcoming clinical trials portal and database, but industry wants assurances that the system will be able to differentiate security access for different types of documents. Read More

Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More

Starting Jan. 1, drugmakers that sell products in the EU will have to make publicly available clinical trial data used to support marketing authorization. Read More

Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency. Read More

Local and regional medicines authorities need to have mechanisms in place to ensure that clinical trial data quality is preserved in secondary studies, a Washington, D.C.-based think tank says. Read More

Montana clinical investigator John Wise received a warning letter for failing to maintain records of clinical trial protocols. Read More

Testing an experimental Ebola drug during an outbreak such as the one currently going strong in West Africa poses a number of ethical issues, clinical trials experts say. Read More