New Requirements for Clinical Trials: What You Need to Know

Researchers and staff involved in clinical trials research should be aware of several new requirements regarding applying for funding, Good Clinical Practice training, and registering and reporting results of clinical trials on Clinicaltrials.gov.  The new expanded legal policies from the U.S. Department of Health and Human Services (HHS) and National Institutes of Health (NIH) will apply to many clinical trials that were not previously under any formal obligations.

The largest changes come from the NIH, which greatly expanded its definition of a clinical trial to include any prospective study investigating a health-related biomedical or behavioral intervention, which may include placebo or other controls. This purposefully broad definition applies to studies funded wholly or in part by the NIH and includes Phase I and feasibility trials.

Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA. doi:10.1001/jama.2016.14668

The NIH released three new requirements for studies that meet the new definition:

• Good Clinical Practice: Starting January 1, 2017, all NIH-funded investigators and staff conducting, overseeing, or managing a clinical trial must undergo Good Clinical Practice (GCP) training. This mandate aims to ensure that clinical trials are conducted with rigor and integrity, that data are reliable, and above all, that human subjects are protected. The University of Rochester Medical Center offers GCP training on the Office for Human Subjects Protection website.
• New Funding Mechanism: All applications for funding involving one or more clinical trials, even in combination with non-clinical studies, must be submitted through a new funding mechanism specifically designed for clinical trials beginning September 27, 2017. This requirement will ensure that all clinical trial applications are held to the same standard and undergo a uniform review process.
• New Registration and Reporting Guidelines: In an effort to improve accessibility of clinical trials information, all NIH-funded investigators conducting clinical trials initiated on or after January 18, 2017 must register their study and follow all guidelines on reporting study results mandated by clinicaltrials.gov. Studies must be registered within 21 days of first participant enrollment and must report results within one year of primary completion date. While ongoing clinical trials are not required to meet these standards, they are strongly encouraged to do so.

 

HHS released the Final Rule for requirements on reporting results in Clinicaltrials.gov. The rule applies to “applicable clinical trials” as defined by Clinicaltrials.gov, which differs from the NIH definition in that it includes clinical trials regardless of funding source, but excludes trials investigating behavioral interventions as well as Phase I trials and feasibility studies. However, all NIH funded studies now required to register and report in Clinicaltrials.gov according to the NIH definition of a clinical trial, must adhere to the Final Rule. Three important changes in that policy, taking effect January 18, 2017, are noted below:

• Reporting race and ethnicity of participants is now required along with gender and age.
• When reporting adverse events, investigators must indicate whether those data were collected systematically (participants reported events based on a pre-determined list of possible outcomes) or non-systematic (participants freely reported adverse experiences).
• Investigators are now required to upload study protocols and all amendments as a single document when they report study results. Principle Investigators will be responsible for saving all of these documents electronically.

Michael Hazard | 9/30/2016

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