2017

The Pulse on Technology

FDA proposes collaborative approach for pediatric rare disease research

December 18, 2017

For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multiarm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies.

The proposed, double-blind design would minimize the number of patients receiving a placebo, using a single control group for multiple investigational drugs. In addition, a single treatment arm could be stopped early following clinical decline.

The Pulse on Study Startup

Despite years of valiant efforts, study execution remains far from optimal

December 11, 2017

The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal. For study startup, the data are dismal: Contract cycle times have doubled from an industry median of 1.5 months in 2009–2011 to more than three months in 2014–2015.

Nearly 50% of clinical trials are behind schedule, with slow patient enrollment cited as the top reason. Research also suggests a lengthy 16.7 months is typically required to initiate all approved sites for phase II–III trials.

Three Questions

Three Questions for Thomas Wicks, CSO at TrialScope

December 11, 2017

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Thomas Wicks, chief strategy officer at TrialScope. Wicks is responsible for leading TrialScope’s response to emerging trends and regulatory mandates, and championing the company’s strategic vision, which focuses on clinical transparency management.

Q: It’s been nearly a year since the final rule of FDAAA 801 (42 CFR Part 11) went into effect, expanding requirements for submitting clinical trial registration and results informa- tion to the FDA. Has this had an impact on the industry yet?

Features

Clinical research in the cloud, with help from Microsoft

October 30, 2017

Clinical research technology is expanding, and there is now infrastructure to back it. Last week, Parexel, a global clinical research organization, announced a new partnership with Microsoft to develop innovative cloud-based services for their clients. The collaboration will bring Parexel’s current tech offerings to the Microsoft Azure cloud platform and catalyze new developments aimed at enhancing participant engagement in clinical trials, and streamlining drug development.