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Clinical investigators considering taking on sponsor responsibilities in investigator-initiated clinical trials (IITs) will need to boost their knowledge of both investigator and sponsor FDA regulations, or they could find themselves in a tangled web of compliance trouble, an FDA official said.
Some of the pharmaceutical industry’s largest players are continuing to hide key information about clinical trials despite the fact that drugmakers are doing a better job making trial data public, according to a new study.
The National Cancer Research Network (NCRN) in the UK has quadrupled its clinical trials enrollment as a result of implementing an electronic data capture (EDC) system for conducting its oncology studies, says an expert.
Drugmakers will likely have to be the main investors in merging the parallel universes of electronic health information on the healthcare side and electronic data capture on the clinical research side to achieve interoperability, according to experts.
Medical journal editors are cracking down on authors who fail to disclose ties to drug or device companies, following several journal disclosures that peer-reviewed articles were written by freelance writers hired by drug companies.