The contract research organization (CRO) launched the Catalyst Program in February 2016 and has since added networks to support oncology, vaccine, and most recently, psychiatry clinical research.
The Psychiatry Catalyst Site Network, participation in which is by invitation only, is made up of 32 sites across the US.
Membership is reviewed regularly and provides sites with access to an increased volume of psychiatric-related trials, and support from dedicated relationship managers.
“Psychiatry clinical research has become increasingly complex,” Tracey Gashi, PhD, executive director, Site and Patient Access at INC Research told Outsourcing-Pharma.com.
Some of the unique challenges facing these clinical trials include high placebo effect rates, delays in site initiation, high-screen failure and drug withdrawal rates, as well as the stigma to participate in novel mechanisms for trial participants that have had numerous treatment failures, she explained.
“Through close collaboration and discussion with the Catalyst Site Network, INC Research aims to develop best practices wherever possible to address these challenges,” said Gashi.
Additionally, INC will leverage its active psychiatry Site Advocacy Group (SAG) to review protocols and provide early identification of operational challenges the study will face during implementation at clinical research sites.
Gashi said, “This combined offering ensures our sponsors are able to mitigate against potential risks to the project and place the right protocol at the right sites.”
The catalyst ecosystem
As INC further develops "the optimal Catalyst ecosystem" for delivering psychiatry trials to its clients, the requirements for additional investment will become clearer, said Gashi.
"This ecosystem involves multiple components of the clinical trial delivery chain and involves partnerships with IRBs, various vendors in addition to the Catalyst sites to deliver a differentiating end-to-end process to maximize predictable delivery," she added.
Additionally, on the expansion of the overall program, Gashi said the Catalyst Site Networks will continue to expand over time into additional indications and geographies “as driven by business need.”
The Catalyst program also extends beyond the Catalyst Site Networks and includes the broader INC Catalyst Site Community, which is open to all sites.