Applied Clinical Trials

High costs and recruitment issues drive the globalization of clinical trials

Monday, August 21, 2017

The pursuit of global trials is increasing. A report by SCORR Marketing and Applied Clinical Trials examined the reasons why companies are pursuing global clinical trials and the challenges they face in conducting them. The top two reasons cited in the survey for trials exiting the U.S. and Western Europe and moving to other regions were high costs and  patient recruitment difficulty.

[Read More]

Bridging Clinical Research and Clinical Health Care Collaborative to launch

Wednesday, June 14, 2017

In 2018, the Bridging Clinical Research and Clinical Health Care Collaborative will bring together industry leaders from pharma, biotech, CROs, healthcare organizations, advocacy groups and the FDA to advance the participation of patients and physicians in the conduct of clinical trials. The conference will be April 4–5, 2018, at the Gaylord National Resort and Conference Center in National Harbor, Maryland.

[Read More]

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including human drug and biological products, medical devices, and combinations thereof.”1 This guidance finalizes the draft guidance Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers that was issued in March 2015.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

[Read More]