Veeva Systems and six large contract research organizations formed a new technology standards group focused on improving trial collaboration with sponsors. The group — dubbed Align Clinical CRO — includes ICON, Medpace, Pharmaceutical Product Development, PRA Health Sciences, Syneos Health and UBC. “There is tremendous potential to enhance clinical trial execution with common technology standards that benefit the entire industry,” said Henry Levy, president of Align Clinical CRO, which aims to reduce operational costs and run trials faster. “By creating a vehicle for CROs to collaborate and share actionable insight with sponsors, we can improve operational delivery and streamline the increasingly complex trial process,” said Syneos Health CIO Rachel Stahler. The group expects to first deliver a pre-competitive operational data exchange standard, to facilitate information sharing between sponsors and CROs, including definitions related to trial operations, key metrics and milestones. The standard will be posted for public review and input before adoption, the group said. “This is the first time CROs are coming together to make this commitment to transform clinical trials across our industry, and we are excited to be part of this effort,” said Michael Brooks, executive vice president of product registration at PRA Health Sciences. “This shows our mutual commitment to make the drug development process more efficient and to help bring needed therapies to market more quickly.”
The FDA finalized guidance for sponsors and researchers on how to efficiently use the St. George’s Respiratory Questionnaire, a self-administered patient-reported outcome tool, in clinical trials of treatments for chronic obstructive pulmonary disease. If the questionnaire is to be used for trial population stratification or enrichment purposes, it should be discussed with the FDA review division early in the protocol development phase, the agency said. The SGRQ can also be used to assess efficacy in IND, NDA and BLA submissions as a co-primary or secondary endpoint. The scoring uses three elements: the frequency and severity of symptoms, the effect of the disease on common daily physical activities and the psychosocial impact. Sponsors should only use the total score to measure improvement, with the minimum clinically important difference being least four units on the SGRQ scale. The agency said there is no evidence to support the use of other values. Responder analyses can be presented as the responder rate for each arm and the difference in rates, or as an odds ratio. Other analyses may be suitable and should be discussed with the review division. The agency said it considers SGRQ information to have clinical importance, and recommended sponsors report data regardless of the results. The full guidance is available here: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071575.pdf.
WCG Clinical Services Division acquired ACI Clinical, a provider of endpoint adjudication and data safety monitoring committees. ACI will continue to operate as an independent service organization within the clinical services division, with capital, regulatory and corporate support from WCG. Financial details about the transaction were not disclosed. ACI’s global network of more than 500 medical, statistical and safety experts can now serve as committee members and advisors to WCG clients, said WCG Chairman and CEO Donald Deieso. ACI plans to work with clinical trial sponsors, academic experts and regulatory agencies to enhance trial integrity, reduce variation in important clinical trial events and enhance patient safety, said Jonathan Seltzer, president and CEO of ACI.
The Clinical Data Interchange Standards Consortium, or CDISC, received a $1 million grant from the Leona M. and Harry B. Helmsley Charitable Trust to develop new data standards for clinical trials in type 1 diabetes. “Tools that facilitate standardized clinical trials and studies are enabling crucial data sharing and are essential to achieving our goal,” said Gina Agiostratidou, director of Helmsley’s type 1 diabetes program. The new standards plan to offer machine-readable metadata in pediatrics, devices, prevention and exercise. CDISC will work with the Critical Path Institute to pilot the use of large datasets in the development process. CDISC standards, developed for more than 30 disease areas, have been adopted in over 90 countries, and are required in submissions to U.S. and Japanese regulatory authorities. The standards will be freely available on the CDISC website.