Six leading CROs, along with cloud-computing vendor Veeva Systems, have banded together to form Align Clinical CRO, a new industry standards group that hopes to make it easier for CROs and sponsors to work together. At the core of Align Clinical CRO is the desire to build lasting partnerships with open and transparent communications and standards for data information sharing. Benefits that are expected to be delivered via the collaboration include shared decision making, cross-study solutions, performance assessments, and a shared risk/reward structure.
A press release from the organization notes the founding members, with input from across the industry, plan to create open technology standards intended to improve trial execution and collaboration with life science companies. The CROs coming together to develop the standards are ICON, PPD, Medpace, PRA Health Sciences, Syneos Health, and UBC. Henry Levy, president of Align Clinical CRO, notes common technology standards have a tremendous potential to enhance clinical trial execution across the entire industry and accelerate drug development timelines.
The open technology standards developed by Align Clinical CRO are intended to increase sponsor and CRO productivity, reduce operational costs, and allow trials to be completed in less time. The first standard Align Clinical CRO will tackle is an Operational Data Exchange standard, which is expected to facilitate seamless information sharing between sponsors and CROs. The standard will include the definition of a technical standard for data to be exchanged between CROs and sponsors, including key metrics and milestone information. This standard is expected to be released for public review and input later this year.
A New Approach To An Old Problem
Align Clinical CRO is not the first attempt to bring standards to the information discrepancies that arise between sponsors and CROs during clinical trials. The Metrics Champion Consortium (MCC), founded in 2006, is attempting to adopt standardized metrics and benchmarks to drive performance improvement in clinical trials. MCC is providing for the collaboration between sponsors, service providers, and sites to improve trials via MCC standardized performance metrics. That group has the support of Ken Getz, founder and chairman of CISCRP and director at Tufts, and author Dave Zuckerman, who wrote the book Pharmaceutical Metrics. Both men serve as owner and advisor at MCC.
Clinical Data Acquisition Standards Harmonization (CDASH) is another effort attempting to establish a standard way to collect and share data across studies and sponsors. CDASH is an effort headed up by CDISC (Clinical Data Interchange Standards Consortium), a nonprofit charitable organization that develops data standards to streamline clinical research. Its goal is data collection formats and structures that provide clear traceability of submission data so as to deliver more transparency to regulators and others who conduct data review.
The Data and Information Systems (DIMS) Project at the National Institute for Health Research is also attempting to develop data standards for clinical research. The industry group TransCelerate Biopharma also has an initiative devoted to clinical trial standards. It is working on this initiative in conjunction with CDISC, the Clinical Path Institute (C-Path), and others.
The issue is clearly a complicated one. It will be interesting to see if Align Clinical CRO can make progress in this space, especially if it opts to not align with any of the efforts currently underway.
Can We Get Everyone On Board?
Align Clinical CRO will certainly garner attention by having the support of several large CROs and the technical expertise of Veeva Systems. But to make an impact in the effort to drive industry standards, greater participation will likely be needed. As it stands now, CRO giants IQVIA, Lab Corp (Covance and Chiltern), and PAREXEL are not onboard with the project. These three CROs combined have a significant percentage of pharma sponsor companies as partners. Their absence from the collaboration could leave many of their sponsor company clients feeling left out of the discussion.
Standards will certainly help level the vendor playing field, therefore, helping many of the mid-size CROs as well as the large clinical service providers. The benefit to pharma is also clear, as standards will allow them to more easily combine data from multiple trials (and perhaps multiple CROs) for each asset in development.
The most interesting part of the collaboration might be the fact that it will relate to the operational execution of a trial, including key metrics and milestone information. As one industry analyst recently remarked to me, "The metrics and milestones are always the holy grail of this type of effort. The problem is that every study is different. The metrics that range from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) are very different for an oncology trial than for a rare cancer trial. This is due to many factors, mainly the large difference in the number of patients in an oncology trial versus the small number of patients in a rare cancer trial."
To succeed, Align Clinical CRO will have to show results in an area where others continue to struggle to forge a path forward. This will be a huge feat for the group to accomplish without additional industry support.