Nonprofit TransCelerate BioPharma is launching three new global initiatives to further advance efficiency in clinical trials and accelerate the development of new medicines: creation of common clinical trial protocol templates, development of clinical trial networks for pediatric and minority populations and establishment of a global investigator registry.
TransCelerate also is expanding two of its original five initiatives, the Clinical Trial Comparator Network and the Site Qualification and Training project.
In addition, Cubist Pharmaceuticals has joined the organization, bringing the member total to 18. Since the September 2012 launch, eight companies have joined TransCelerate's 10 founding members.
"While TransCelerate is not the first organization or consortium the biopharmaceutical industry has formed to solve common challenges, it is one of the most ambitious and supported collaborations to date. We have not only set goals, but we have delivered on these goals in just over one year since we were incorporated," said Dalvir Gill, Ph.D., chief executive officer of TransCelerate. "Our focus in this second year will be to expand upon our principles of collaboration among the organization's member companies to address new initiatives directed at resolving common challenges impeding R&D in the industry, and expand the scope and success of our original work."
The format of clinical trial protocols varies from company to company, making interpretation difficult for sites, IRBs and regulators. These protocols have become increasingly complex, as no agreed upon standards exist, driving up cost and time. In addition, manual set-up of clinical systems based on non-standard "manual" protocols is time consuming, costly and prone to error.Working with other industry stakeholders and regulators, TransCelerate seeks to standardize the format of clinical trial protocols and develop standards for required protocol endpoints, in alignment with the ongoing TransCelerate Clinical Data Standards project. This will simplify study protocols, facilitate data interpretation and enable down-stream automation of many clinical processes, increasing productivity and reducing costs.
Qualified investigators with adequate numbers of patients in pediatric and minority populations are difficult to find, and studies in these areas typically are exceptionally costly and lengthy. Especially in pediatrics, efforts to establish a network of investigators and sites often are repeated for each clinical trial and then dispersed after a trial is completed. With this initiative, TransCelerate, working closely with existing regional networks, will lead the development of global investigator networks for these populations, to accelerate development of new drugs or indications for children, adolescents and minorities, as well as reduce clinical trial costs.
Sponsors frequently invest significant time and resources in identifying qualified investigators and establishing study sites. The inability to obtain information on site experience and qualifications often delay crucial trials. TransCelerate's Investigator Registry will create a shared repository of investigator contact details and site-related data. This initiative builds on TransCelerate's Shared Portal Project, and accelerates identification and recruitment of qualified investigators, which will avoid duplication of standard site qualification and creation of investigator documentation, thereby reducing cost and trial length.
In addition, TransCelerate will expand on two successful projects that were part of the original five initiatives, including site qualification and training and its comparator network. To build on the creation of common criteria for mutual recognition of GCP training and common forms to collect generic information about study sites, TransCelerate will provide a common framework to streamline the process for qualifying sites and standardizing non-protocol-specific forms for clinical trials. It also will establish criteria for training site personnel new to clinical trials. To enhance the value of the network, TransCelerate will expand on the current offerings to include products for clinical trial blinding: active and placebo, devices and bulk commercial products. It also will include the option of product discounts and expansion of the network in other regions of the world.