Duke Clinical Research Institute

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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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including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015.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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DCRI, Pfizer, Premier partner on vaccination rates

Tuesday, August 30, 2016

A new quality improvement initiative that aims to create effective solutions in optimizing adult vaccination rates has been announced. The program, the Adult Immunization Project, is a collaboration among the Duke Clinical Research Institute (DCRI), Duke Primary Care, Pfizer and Premier. Researchers will jointly work to develop evidence-based interventions to support indicated adult vaccination practices among providers in the Duke Health system.

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Boehringer, Duke collaborate on IPF patient registry

Friday, August 26, 2016

Boehringer Ingelheim Pharmaceuticals and the Duke Clinical Research Institute (DCRI) have announced the expansion of the Idiopathic Pulmonary Fibrosis—PROspective Outcomes (IPF-PRO) Registry, a patient registry developed to uncover insights into IPF, a rare and serious lung disease. The expansion will increase the study enrollment from 300 patients at 18 study sites to 1,500 patients at approximately 45 sites, creating the largest registry of newly diagnosed IPF patients.

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