Investigator attrition and solving the “one and done” phenomenon

Monday, October 23, 2017

A significant number of trial investigators are abandoning the field of clinical research, sometimes after only a single study. When the Clinical Trials Transformative Initiative (CTTI) noted this high investigator turnover, they decided to issue guidance on how to tackle the issue. Established by the FDA and Duke University, CTTI is an organization dedicated to improving the clinical trial industry—the trials themselves, the safety of participants and the obligation to stakeholders. Their focus is on clinical trials performed for regulatory submission.

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CTTI takes on site investigator turnover in new recommendations

Friday, October 6, 2017

The Clinical Trials Transformation Initiative (CTTI) unveiled new recommendations aimed at reducing high rates of turnover among U.S. clinical trial site investigators at the Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on Oct. 7. CTTI’s practical solutions address the administrative, financial, and logistical burdens that are causing investigators to abandon clinical research.

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The CenterWatch Monthly Industry Close-Up, July 2017

Saturday, July 1, 2017

Healthcare stakeholders recognize that there is a clear, ethical rationale to support patient engagement in clinical trials. Setting standards that describe how patient engagement is achieved will lead to research findings that are more pertinent to patients’ concerns and dilemmas.1 However, as there are limited comparative analytic studies to recommend a particular method that improves understanding of patients’ concerns1 and enables comparisons of the methods employed, it is unclear how to best engage patients and how to measure the success of engagement.

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HHS appoints Quorum’s Dr. Stephen Rosenfeld SACHRP Chair

Wednesday, December 21, 2016

Dr. Stephen J. Rosenfeld, executive IRB chair for Quorum Review IRB, has accepted an invitation from Sylvia Burwell, the Secretary of the Department of Health and Human Services (DHHS), to chair the Secretary’s Advisory Committee for Human Research Protections (SACHRP). SACHRP comprises experts in the fields of research and ethics, and provides advice and recommendations to the Secretary of DHHS on issues pertaining to the protection of human subjects in research.

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Go directly to the source—Patients

Monday, November 14, 2016

The Pulse on Patient Recruitment by Ashley Tointon

With more companies working on patient-centric initiatives, it’s a good time to appraise what is being done to enhance the patient’s clinical trial experience. Although there is no agreed-upon definition of the term patient centricity, the premise is to put patients first.

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Three Questions: Wendy K.D. Selig, WSCollaborative

Monday, August 17, 2015

CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trials space. Wendy K.D. Selig is founder and CEO of WSCollaborative, a consulting firm that advises patient advocacy groups and other health-sector clients in defining and implementing strategies for collaborations with industry and government.

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Syndax appoints Dr. Briggs Morrison CEO, Michael Metzger president and COO

Monday, June 15, 2015

Syndax Pharmaceuticals, a privately held oncology company based in Waltham, Mass., has announced that Briggs W. Morrison, M.D., is joining the company as CEO and a member of the board of directors, and Michael A. Metzger is joining the company as president and chief operating officer. Morrison joins Syndax from AstraZeneca, where he was executive vice president, global medicines development and chief medical officer. Metzger joins from Regado Biosciences, where he was president and CEO through the company’s strategic merger with Tobira Therapeutics.

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CTTI issues new recommendations to improve quality in clinical trials

Monday, June 15, 2015

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership to identify practices to increase the quality and efficiency of clinical trials based in Durham, N.C., has issued recommendations to improve the quality and efficiency of clinical trials by helping sponsors focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not. 

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