Industry Advances Research Streamlining Initiatives

A consortium of leading biopharmaceutical companies is moving forward with several projects to make clinical trials more efficient and less costly. The latest undertaking by TransCelerate BioPharma is a program to share comparator compounds needed for comparative clinical trials:  members of the consortium are forming a network for direct shipment of each other’s compounds using master service agreements. A side benefit is to prevent inadvertent use of counterfeit or substandard products in clinical testing, which has become more of a threat as sourcing involves extended drug supply chains.

TransCelerate CEO Dalvir Gill described this new initiative at a conference on biomedical innovation sponsored by the Brookings Institution last week. Gill also noted progress in testing new risk-based site monitoring methods, collaborating on clinical site qualification and training activities and establishing a shared industry site portal that will allow sponsors to transmit information to sites confidentially and more efficiently.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), similarly described efforts to promote a “more robust infrastructure” for clinical trials, noting the need for standardized data and methodologies so that new compounds can be evaluated rapidly. Programs to establish standing trials that can rapidly screen candidate compounds to identify signs of effectiveness would greatly compress the research process, she noted, and avoid “reinventing the wheel” with every trial.

TransCelerate now has 17 members, up from ten original founders in September 2012, and Gill expects the organization to grow to more than 25 companies by year-end as more, smaller research-oriented firms sign up. The group also aims to establish efficacy data standards for more than 50 therapeutic areas in five years, starting with pilots on standards for asthma and diabetes launched in collaboration with CDISC and FDA. Future projects may be more far-reaching, said Gill, noting that forming a pediatric clinical trial network “is very high on our list.”