Ethical concerns about testing on vulnerable groups may be unnecessary and may be depriving trials of key critical data, a panel of experts says, urging the FDA to reconsider rigid rules excluding certain groups from clinical trials—or at least make decisions on a case-by-case basis. Read More
Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse — and patients and researchers should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance. Read More
NIH has delayed a controversial new policy that would have required basic brain and behavioral researchers to treat their work as clinical trials. Read More
Expansion cohorts can help bring life-saving drugs to market quickly, but sponsors should be sure to update informed consent for patients and convene expert safety panels that meet regularly, the FDA says in new draft guidance. Read More
The FDA has asked Congress for $100 million to help build an advanced analytics system the agency says will help it, at long last, master real-world evidence. Read More
Sponsors may not have to prove a proposed therapy helps addicts totally kick opioids to win FDA approval. But they will have to show it significantly cuts dependence on the potent pain meds, the agency says in new draft guidance. Read More
European regulators have stopped accepting and publishing clinical trials data, blaming the uncertainty of Brexit for staff cutbacks that the agency claims has disrupted its ability to function properly. Read More
Researchers, buoyed by a spike in promising clinical trials and tools, believe they may be close to unraveling new ways to treat some of the most insidious yet elusive effects of schizophrenia. Read More
Clinical trials of biosimilars should focus on how they differ from the drugs they copy rather than on creating a whole new safety or efficacy study, the World Health Organization says. Read More
The FDA has published the first-ever list of surrogate endpoints, giving sponsors the first concrete suggestions for the kinds of laboratory measures or physical signs that might help develop drugs even when clinically meaningful data proves elusive. Read More