News & Event
Watertown, MA, January 23, 2017
The FDA reported 14 Phase 3 trials in which the investigational medicinal product (IMP) failed to demonstrate efficacy, 1 Phase 3 trial failed to demonstrate safety, and 7 Phase 3 trials failed to demonstrate both.
This report highlights to the CRO industry that, although we made rapid and positive advances in improving the clinical trial processes (such as combining phases of trials and finding alternatives to traditional large scale Phase 3 trials), we should not be lulled into a false sense of security.
Alternatives to pivotal Phase 3 trials may not always be appropriate, as demonstrated by cases where inaccurate prediction of safety and/or efficacy for an IMP can have negative public health impact.
That’s where NERI’s teams excel – from our scientists to project managers, statisticians, data managers, clinical research associates, and support staff. Each job function realizes the importance of their contributions in designing and executing clinical trials. We understand that even if an IMP has a positive target product profile (TPP) there are still possibilities that the IMP could fail in later phase studies for effectiveness, safety, or both. We realize our jobs are critical to the process to ensure scientific integrity including data quality at all stages of collection, analysis, and reporting.
That is why our motto is: our people are our greatest assets.
Our staff understand their important role as it pertains to the report’s conclusion: “As we continue to explore alternatives to requiring phase 3 testing, it is important to keep in mind the benefits they provide to both patients and to the medical research enterprise.”
No Research Without Therapeutic or Policy Benefit.
Thoughtful Science. Tailored Solutions.
Indianapolis and Ridgefield, Conn. – The first patients have now enrolled in AIRWISE, the world’s largest ever pragmatic clinical trial in chronic obstructive pulmonary disease (COPD) to study how commonly prescribed medicines may reduce the occurrence of exacerbations of COPD.
This landmark research is a collaboration between Anthem, Inc., its outcomes research subsidiary, HealthCore, Inc. and Boehringer Ingelheim, a pharmaceutical company with a long history of leadership in respiratory research worldwide.
View the full press release [PDF]