news roundup

Sponsors Struggle with Trial Disclosure, Patient Privacy Requirements

An upcoming public workshop, sponsored by the National Academies of Sciences, Engineering, and Medicine, plans to take a broad look at the successes and failures in data sharing and reuse by public and private researchers, as well as perspectives of trial participants, patient organizations, and sponsors.

Clinerion Partners with PPC

PPC will use Clinerion’s Patient Network Explorer platform for clinical trials at hospitals in Korea, China and Taiwan.

ClinOne’s eConsent with Video Capabilities Launched at Boston Children’s Hospital

Boston Children’s Hospital launched ClinOne’s eConsent with Video eConsent technology within its Pulmonary Research Team, as its first rollout. ClinOne’s Video Consent allows all parties in the informed consent process to participate from anywhere, with the goal of reducing the barriers of on-site consenting, or delays between updated consent documents and the need for re-consent.

News Notes

Quick hit list of news from wire reports including Parexel and SCRS, DCRI’s statin study award, the finalization of Medidata’s acquisition by Dassault systems, and more.

Articles

New FDA Model Aims to Speed More Rare Disease Treatments to Patients

FDA has launched the Rare Disease Cures Accelerator (RDCA) initiative within CDER to provide the infrastructure for a cooperative approach to designing and conducting clinical trials in rare diseases to improve testing, protocols, and patient enrollment in clinical trials. FDA is collaborating with the Critical Path Institute, NORD, patient groups, industry and other stakeholders on a framework for conducting more standardized rare disease natural history studies to help target treatment and design appropriate clinical trials.

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Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com