The Pulse

The Pulse on Study Conduct

Educate yourself on new therapeutic areas

January 8, 2018

Medical knowledge for the vast assimi­lation of clinical research guidelines is necessary for anyone entering the field. The diverse regulatory landscape requires us to stay abreast of changes that impact patient safety data. It is a multifaceted learning process with educational requirements that vary by role. We should never expect anyone to have every answer, or to know everything about a protocol/therapeutic area. That sets an unreal­istic standard that undermines performance.

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rare diseases, sponsors can implement controlled, multiarm, multi-company clinical trials, according to a new draft guidance that the FDA says could help eliminate the need for certain studies.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