Although there are standards crisscrossing clinical studies from how data are collected to how they are to be reported to FDA for drug approvals, there is still a lot left to the discretion of study sponsors and the clinical research organizations (CROs) they hire. Streamlining parts of those processes is the goal of a new effort, sponsored by (but independent of) Veeva Systems, the CRM IT vendor. Align Clinical CRO has united, so far, six of the leading CRO vendors: ICON plc, Medpace, Syneos Health, PRA Health Sciences, PPD, and UBC. Eventually the pharma companies who are study sponsors will be invited in, but, as Henry Levy, chief strategy officer at Veeva (and a former chief commercial officer at PPD), puts it, CROs getting their own house in order by presenting a uniform approach is a desired first step.
The effort is modeled after an earlier industry-standardization effort, Align Biopharma, which Veeva also sponsored but does not direct, to standardize data exchange between healthcare providers and pharma marketers. At last report, that effort has brought together 23 pharma companies and a variety of IT providers and systems integrators.
Align Clinical CRO’s first goal is to develop a common taxonomy and vocabulary for describing a study’s parameters and data elements. “After a CRO has been chosen by a sponsor, the two spend many hours negotiating and agreeing on the fields or data that the pharma company expects from the CRO for program oversight,” such as how acceptance of trial sites is recorded, or the schedule for data delivery, says Levy. These are “pre-competitive” issues, he stresses, not involving actual study results. The eventual standard can be built into the clinical trial management systems (CTMS) and similar IT systems used in clinical research, resulting in a time and cost savings for both CROs and sponsors. (Veeva itself provides a variety of software tools for clinical researchers.)
“CROs manage roughly 50% of the sponsored clinical trials going on in industry,” notes Brett Huselton, SVP of commercial strategy at UBC. “We can’t expect the industry to adapt to our effort until we CROs can demonstrate value.” He also notes that the issues the group will attack are ones that do not drive revenue or the strategic direction of CROs, but ones that will reduce waste across the overall clinical research process.
Other goals that Align Clinical might go after involve mobile health (mHealth) technologies such as wearables that are increasingly showing up in trial designs, or how study sites are engaged. Coordination with other clinical research standardization efforts, such as the TransCelerate group, the Assn. of Clinical Research Professionals, or the Metrics Champions Consortium is also a possibility.