Duke University

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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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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Tracking adoption of risk assessment and RBM

Sunday, October 1, 2017

For all the talk about how risk-based monitoring (RBM) can improve efficiencies in clinical trial processes, the actual level of execution varies widely among sponsor companies, the industry lacks a uniform approach to the methodology and some organizations have not yet pursued alternatives to traditional monitoring strategies.

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FDA increases enforcement, policy steps against unproven stem cell therapies

Friday, September 1, 2017

Scott Gottlieb, M.D., the Commissioner of the FDA, has stated that the agency is beginning to enforce stricter and more aggressive tactics against stem cell clinics who are marketing and administrating unproven therapies to patients. The administration will work toward cracking down on companies who claim to have cures or treatments for diseases that have no conclusive clinical efficacy.

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Revisiting patient diversity in clinical trials… again

Saturday, July 1, 2017

Minority groups have historically been excluded from clinical research, an inequity that has led to well-documented public health problems in which therapies tested primarily in Caucasian patients do not work as well in other ethnic and racial groups. This problem is famously exemplified by Sanofi’s blood thinner Plavix, which was approved in 1997 but slapped with a boxed warning in 2010 after researchers realized up to half of Asian and Pacific Islander populations cannot process the drug.

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bluebird bio, Duke collaborate on value-based payment framework for gene therapy

Tuesday, May 23, 2017

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, announced that it will participate in a consortium led by Duke University’s Robert J. Margolis, M.D., Center for Health Policy to develop a broadly-supported path for value-based payment reform models for gene therapies and other innovative treatments.

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Envisioning the site of the future

Monday, May 1, 2017

The drug development world has been notoriously slow to adopt change, but industry leaders and visionaries expect the clinical research enterprise to change dramatically.
Integration of healthcare data, the power of data and analytics, a rapid move toward more targeted therapies and customized treatments, along with the desire for a lower cost R&D model are among the forces driving transformation in the way the research environment will function in the future.

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