Research Practitioner

Changes in oncology treatments may lead to changes in clinical trial design: An overview of a basket trial in progress

Thursday, June 1, 2017

As technology and science have evolved over the last several years, new treatment modalities for cancer have emerged. These new treatment options have presented a challenge for researchers. How do we translate new scientific advancements to patient populations rapidly and effectively, especially in oncology? Arguments that the drug development process is “broken” have stimulated improvements in clinical trial designs.1 One category of clinical trial design that has emerged as a result is a master protocol. Several designs fall under the master protocol category.

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Disclosures bring continued focus to Bial trial

Thursday, June 1, 2017

Last year, two issues of Research Practitioner included a discussion about a French trial in which one healthy volunteer died and five others were hospitalized. Researchers and pharmacologists are becoming more critical of the trial as new information become available. Were the researchers negligent? Why was this compound chosen over other similar ones for the study?

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OHRP/FDA offer final guidance on electronic informed consent

Saturday, April 1, 2017

On December 15, 2016, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS) and the FDA published final guidance aimed at providing answers to commonly asked questions about using electronic informed consent (eConsent)in clinical investigations. The guidance applies to “electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.

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Meet the newest ethical and legal challenge of obtaining and using data via the internet: The dark web

Wednesday, March 1, 2017

Are you afraid of the dark? What thoughts come to mind when you hear the word “dark”? Scary? Hidden? Sinister? Mysterious? Shadowy? The opposite of dark, of course, is “light” — and this signifies transparency, full disclosure, openness, and clarity. It is in this context that research professionals increasingly are using what is called the “dark web” to collect and use data for studies that are looking at activities that are often, but not always, illegal. What makes the dark web both intriguing and worrisome for researchers is not the kind of information it includes but rather the methods used to obtain the data (neither the usual search engines nor by hacking passwords).

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Lies and the career research subject

Wednesday, February 1, 2017

Patients can also lie about their health to be accepted into a trial. Some even make their “living” going from one trial to another. The problem will continue, some observers say, until a national registry is put into place to catch these kinds of problems.

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HHS/NIH finalize requirements for clinical trial reporting

Sunday, January 1, 2017

Faced with noncompliance of required reporting of clinical trial information, the U.S. Department of Health and Human Services (HSS) issued a final rule last September that gave more specifics about registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule also expanded the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological, and device products. National Institutes of Health (NIH)-funded trials fell under reporting requirements, as well, as the NIH issued a complementary policy at the same time. NIH-funded trials must register and submit summary results information to ClinicalTrials.gov even if the trials are not subject to the final rule. Although the enhancements add measures to improve the amount of clinical trial information on ClinicalTrials.gov, some researchers in favor of total transparency say that enforcement action and penalties still fall short.

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Study shows that almost half of pediatric trials are not finished or published

Tuesday, November 1, 2016

As Research Practitioner highlighted earlier this year, clinical research results have been disclosed late or not at all at least 95% of the time since reporting of results from human studies to the federal government’s ClinicalTrials.gov database became mandatory in 2008.1  Most of these trials, however, use adult subjects. Researchers at Boston’s Children Hospital in Massachusetts decided to examine the reporting of pediatric study results and found that almost half of the studies had been discontinued or not published.

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New NIH policy ties funding approval to single IRB review

Saturday, October 1, 2016

The wait is over. For the past few years researchers and their respective research institutions have faced the distinct probability that the regulations to protect individuals who agree to volunteer in a research study will be significantly changed. After much discussion on proposed changes to the Common Rule in the Notice of Proposed Rulemaking (NPRM), the Department of Health and Human Services (HHS) is poised to publish a Final Rule. “We expect to publish the Final Rule before the end of the year,” according to an HHS spokesperson.

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Advancing patient protection through proposed Common Rule changes for informed consent

Thursday, September 1, 2016

Research practitioners eagerly anticipate finalization and publication of the revised U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule, which is scheduled to be released in September 2016. Many experts speculate that the revised policy may not be published as expected, yet there appears to be consensus that change in the rules governing human subjects is inevitable; the question remains as to what will be the final rulemaking and the impact on research practice. More than five years have passed since the impending change was announced in an Advance Notice of Proposed Rulemaking (ANPRM) on July 26, 2011 [FR 2011; 76(143): 44512-44531]. After consideration of substantive public debate, the U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies published a Notice of Proposed Rulemaking (NPRM) with prospective revisions to the Common Rule on September 8, 2015 [FR 2015; 80(173): 53933-54060]. Stakeholders have carefully reviewed the proposed revision, provided essential feedback during an extended open comment period, and continued to consider the implications of potential new requirements as they await publication of a final rulemaking.1,2

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