Professor Paula Williamson of the COMET Initiative (Core Outcome Measures in Effectiveness Trials), told Outsourcing-Pharma.com clinical trials measure results using different yardsticks, meaning data cannot be compared between them.
Introducing a core outcome sets for clinical researchers designing their studies will standardise findings and allow trial data to be synthesised into larger sets, she said.
She told us COMET was inspired when she led a UK study on children with asthma at the same time as separate trials by the American Thoracic Society and the European Respiratory Society, all done without the other’s knowledge.
The groups’ methods varied. The UK researchers elicited data from doctors who treat children with asthma as well as the parents of patients, whereas the professional societies asked only doctors.
By chance, the groups had two out of three core outcome sets in common. “But if COMET had existed, the three groups could have got in contact, and followed similar methods, so [all] their findings could ultimately be merged.”
The regulators’ response to COMET’s guidelines – known as SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) – has been warm, Williamson told us.
“We have a member of the EMA on our international advisory group, Irmgard Eichler; and we have a discussion next week with the FDA on how we relate to their acceptable endpoints programme. So the regulators are interested, therefore pharma should be interested.”
The UK’s already uses the COMET database when developing its clinical guidelines, she added.
The CRO’s view
Gary Coward, Head of Global Late Phase Trials at Parexel, told us the contract research organisation tentatively believes the COMET principles are a good idea, but are not ready for compulsory application.
“COMET aligns with initiatives already in progress among regulators, such as specific therapeutic drug development guidelines published by the FDA and EMEA, as well as the recent commitment in PDUFA V to Patient-Focused Drug Development.
“However, COMET does not appear to recognize that evidence from clinical trials is also used by sponsors to support dialogue with other stakeholders. As the SPIRIT guidelines seek to address current gaps and shortfalls in existing protocol guidance, SPIRIT could also prove useful in improving the quality of clinical trial protocols.”
The guidelines should not yet be made mandatory, he said, “due to the dynamic nature of outcome assessment and the ongoing dialogue between regulators and HTA agencies” about how to identify endpoints relevant to both groups.
Coward told us it is not clear if there will be any direct cost implications of the COMET guidelines for CROs. “There may be cost increases for sponsors as a result of a greater number of data points (‘the what’) or having to develop and validate new outcome measures (‘the how’).” Additional outcome assessments could also increase the burden on patients, leading to recruitment and compliance problems, he said, making CROs’ jobs more difficult.
Williamson told us the Initiative’s aim is not to stifle innovation or create more waste. “The core outcome set is a minimum set of standardised outcomes. We fully expect researchers to measure other things as well.”