Just a year or two ago most people didn’t even know what the term “wearable” meant. Today, they are one of the largest growing technology segments, and are predicted to continue growing exponentially. As this technology continues to improve, more uses are being invented and implemented, including in the realm of health care and clinical trial research. Read more
This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market. Read more
On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them. Read more
This week’s Research Ethics Roundup examines new findings on who benefits from genome-wide association studies, India’s new informed consent provisions, the European Union’s new clinical study report policy, and British researchers’ arguments for non-human primate research. Read more
