Normally, I don’t think much about research and development. I usually leave that subject to our sister magazine, Applied Clinical Trials. I do think about patient safety, though, and today an announcement on the website of the US Department of Health and Human Services (DHHS) got my attention.DHHS’s Office for Human Research Protections (OHRP) is soliciting public comment about a proposal to issue guidance recommending training for personnel who conduct, review, or oversee human clinical trials. I was surprised that such training was not already formalized.When I read a little more, I was even more surprised.According to an article in Outsourcing Pharma, DHHS’s inspector general found that the US Food and Drug Administration’s oversight of clinical trials was marked by great lapses. The inspector general’s report said FDA did not know how many clinical trials were being conducted in human subjects. This shocks me. If FDA doesn’t have even this basic information, how can it ensure that trials are being conducted safely?Perhaps not surprising, but no less troubling, is the revelation that FDA inspected less than 1% of the estimated number of clinical-trial sites. When inspectors did examine sites, they turned their attention to data quality and ignored patient protection.In this light, OHRP’s proposal to recommend training for personnel who conduct or oversee clinical trials sounds like it addresses an urgent need. I think regulators should be trained to ensure that human subjects’ safety and rights are secured. This is just as important a concern during clinical trials as it is after a drug is marketed.Somehow we must also ensure that FDA receives updated information about all trials being conducted in humans. When it has accurate information, the agency should be expected to inspect a greater proportion of trial sites. I guess it’d be impractical to expect FDA to inspect every site, but we should expect the agency to oversee a big enough sample to ensure that trials are being conducted properly, without endangering the subjects’ health.