Drugs

New NIH Policies ‘Affect Clinical Study Awardees’

Four Hogan Lovells attorneys say that new policies introduced by the National Institutes of Health (NIH) in recent months “put pressure on the research compliance infrastructure across a broad swath of NIH awardees, including universities, hospitals, and medical institutions.” The attorneys summarize three policies — ClinicalTrials.gov requirements, good clinical practice training, and the Single Institutional Review Board policy — in an online blog post.

The attorneys write that NIH expects that all institutions conducting clinical trials funded in whole or part by NIH will register their studies at ClinicalTrials.gov and submit results information to that Web site. The post says that the NIH policy goes further than a September HHS final rule that “clarifies and expands” the requirements for clinical trial registration and results submission to the Web site. “The final rule requires an unprecedented level of transparency in reporting,” they write. “It obligates awardees to submit for posting the full study protocol and statistical analysis plan (including amendments) and patient demographics including race and ethnicity of trial participants (if collected).”

The NIH policy applies to all clinical trials, regardless of whether they are covered by the HHS rule, the attorneys say. It extends to Phase 1 drug and biological product trials, feasibility studies of device products, and behavioral, surgical, and other medical interventions not regulated by FDA.

The post says that the research community was surprised by a September mandate that all NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials receive good clinical practice training, consistent with principles of the International Conference on Harmonization. This training is in addition to the human subjects research education required since 6/2000 for all NIH-funded investigators and individuals responsible for the design or conduct of research involving human subjects.

A June final policy requires a single institutional review board of record to be used in the review of NIH-funded non-exempt human subjects research protocols carried out at more than one site in the U.S. The policy applies to multi-site studies where each site will conduct the same protocol, whether supported through grants, cooperative agreements, contracts, or the NIH intramural research program.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome