Research Practitioner

Decreasing adverse events in a clinical research unit: A quality improvement project

Wednesday, June 1, 2016

Clinical research units provide a safe environment to conduct clinical trials that lead to new advancements in healthcare modalities for patients. Many regulations govern the conduct of clinical trials with human subjects, and with regulations come many ways in which research units have to report any event that is potentially related to the intervention being tested. These reports are classified as either adverse events or serious adverse event reports. An adverse event is a side effect that may be harmful and/or caused by the intervention.1

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Lack of clinical data overshadows opioid prescribing guidelines

Sunday, May 1, 2016

On March 18, 2016, the Centers for Disease Control (CDC) in Atlanta released its guidelines for prescribing opioids for chronic pain in outpatient settings outside of active cancer treatment, palliative care, and end-of-life care. The results were instantly controversial. While no one argues that opioid addiction has become a health crisis, critics claim that a scarcity of clinical trial data undermine the guidelines and could even lead to patients being harmed.

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Trial volunteer death throws spotlight on disclosure

Friday, April 1, 2016

On Jan. 1, 2016, clinical researchers heard news that they dread: Healthy volunteers in a drug trial experienced serious side effects. One volunteer in the French trial died and five others were hospitalized with neurological symptoms. Questions now remain as to how this happened and how the tragedy will affect clinical trials in Europe and in the United States.

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Common Rule changes are first in 25-year history of human research protection

Saturday, March 19, 2016

The war in Iraq, officially called Operation Desert Storm, began under President George H. W. Bush. First-class postage increased from 25 cents to 29 cents. Silence of the Lambs was released in movie theatres. The Dow Jones Industrial Average closed at 3000 for the first time in its history. Mikael Gorbachev resigned as president of the Union of Soviet Socialist Republics and member states declared their independence. Clinical trials of statin drugs for treating high-cholesterol were being studied with mixed results. Looking back, research professionals undoubtedly would say that these major events occurred a long time ago.

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FDA gives guidance to sponsor-investigators

Friday, January 15, 2016

Last May FDA released a draft guidance designed to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).1 “Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process,” the draft guidance says. This guidance is not an exhaustive step-by-step instruction manual but rather a document that “highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND.” The guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.

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FDA IRB inspections: What, why, and how

Friday, January 1, 2016

Has your institutional review board (IRB) been inspected by the FDA for compliance with IRB regulations? These inspections focus on IRB operations and responsibilities. If your IRB reviews and approves FDA-regulated clinical trials, this article will provide you a guide for what to expect during an IRB inspection.

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