TransCelerate BioPharma, the US-based non-profit organisation established by leading pharmaceutical companies to advance innovation and tackle inefficiencies in R&D, is launching three new initiatives and expanding on two existing programmes in its second year of existence.
The organisation also has a new member, Cubist Pharmaceuticals, bringing the total membership to 18 companies. Eight new companies have joined TransCelerate’s 10 founding members since the organisation was launched in September 2012.
The new TransCelerate initiatives are:
- Common Clinical-Trial Protocol Templates
As the consortium notes, the format of clinical-trial protocols varies from company to company, “making interpretation difficult for trial sites, institutional review boards and regulators”.
With no agreed common standards, protocols have also become increasingly complex, driving up trial times and costs. Moreover, manual set-up of clinical systems based on non-standard protocols is “time-consuming, costly, and prone to error”, TransCelerate points out.
Working with other industry stakeholders and regulators, the organisation is looking to standardise the format of clinical-trial protocols and to develop standards for required protocol endpoints, in line with the ongoing TransCelerate Clinical Data Standards project.
- Special Populations Clinical-Trial Networks (Paediatric and Minority)
As things stand, qualified investigators with sufficient numbers of patients in special populations are hard to find, often rendering clinical trials in these areas “exceptionally costly and lengthy”, TransCelerate says.
In close collaboration with existing regional networks, the organisation wants to spearhead development of global investigator networks for these populations, driving accelerated development of new drugs or indications for children, adolescents and minorities, as well as reduced clinical-trial costs.
- Investigator Registry
As TransCelerate explains, clinical-trial sponsors often invest significant time and resources in identifying qualified investigators and establishing study sites.
Building on the organisation’s Shared Portal Project, TransCelerate’s new Investigator Registry will create a shared repository of investigator contact details and site-related data to speed up the identification and recruitment of qualified investigators, while avoiding duplication of standard site-qualification and investigator documentation.
TransCelerate is also expanding on two projects that were part of its five original initiatives:
- Site Qualification and Training (common framework to streamline the process for qualifying investigator, standardising non-protocol specific forms for clinical trials, etc.
- Comparator Network (will now include products for clinical-trial blinding as well option for product discounts and expansion of the network globally).
Set and delivered
“We have not only set goals, but we have delivered on these goals in just over one year since we were incorporated,” commented Dalvir Gill, chief executive officer of TransCelerate BioPharma.
"Our focus in this second year will be to expand upon our principles of collaboration among the organisation’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.”