Research Practitioner

The evolution of mobile technology use in clinical trials

Wednesday, October 18, 2017

William Osler, a founder of Johns Hopkins University, was a clinician ahead of his time. He was one of the first doctors to bring medical students out of the lecture hall and to the patient’s bedside — a revolutionary format change in its day. His 1892 book, The Principles and Practice of Medicine, was labeled as an “imaginative new curriculum” that prevailed for 50 years.1 Osler once said, “The good physician treats the disease; the great physician treats the patient who has the disease.”

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Conflicts of interest and the clinical investigator

Tuesday, August 1, 2017

A conflict of interest (COI) can erode the judgment of clinical research professionals, leading to questions about their professionalism and integrity. Every professional has a COI. It could be an interest in a promotion, a financial collaboration, or a need to gain more research funding or be published in a medical journal. The May 2, 2017, issue of the Journal of the American Medical Association (JAMA) looked at the issue of COI; one topic addressed biomedical researchers and the difference between financial and nonfinancial possible biases.

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The importance of disclosure for publication

Tuesday, August 1, 2017

As clinical trial researchers seek to improve human health through their biomedical discoveries, medical journals seek to provide information and data about these discoveries in an objective and credible way. Conflict of interest (COI) issues can undermine the trust of this information, JAMA authors say in the May 2, 2017, issue primarily dedicated to the issue of COI. “[I]t is more important than ever that editors and publishers of medical journals work intelligently, and together, to redefine their policies about conflict of interest issues and to reaffirm their values focused on public trust for the integrity and independence of the editorial process,” says Thomas J. Easley, senior vice president and publisher of the JAMA Network.

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Information blocking routine among vendors and health systems

Saturday, July 1, 2017

Using electronic source data in clinical trials can be difficult because of the interoperability between data capture systems and the aversion to change among sponsors and investigators who are used to doing things a certain way. But what if some vendors and health systems purposely block information from being shared? Congress has expressed concerns about this practice in the past, and a recent study says that information blocking is still considered routine among some vendors and health systems.

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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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