Standardized eCOA questionnaire library will speed study start up: Medidata

16-Sep-2019 - Last updated on 17-Sep-2019 at 14:11 GMT

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Medidata is building a global library of pre-configured, pre-approved eCOA questionnaires to accelerate study start-up in collaboration with Icon's Mapi Research Trust – “a win-win-win” for all involved.

As part of the collaboration, Medidata will standardize Mapi Research Trust’s (MRT) library of eCOA (clinical outcomes assessment) questionnaires in the Medidata Rave eCOA.

The non-profit arm of Mapi Group, acquired by Icon in 2017, MRT provides patient-reported outcomes (PRO) data and has assembled a library of more than 470 eCOA forms and 7,000 translations representing 190 instrument developers.

“The ePRO industry is large,” said Anthony Costello, vice president of Mobile Health at Medidata, “There are thousands of ePRO components on clinical trials every year all around the world and it’s been a challenge for a long time to get these studies up and running quickly, because most of the technology providers are custom-building forms over and over on each study and redoing translations for those forms.”

To address this challenge, Medidata has over the last year aspired to collate a ‘true global library,’ building these forms once and translating them into as many languages as possible, Costello told us. Author agreements also will be pre-approved so that sponsors don’t have to seek approval for each individual study.

“On the sponsor side, the pharma companies want to see faster study starts,” said Costello. “Having this library in place allows them to grab prebuilt, pre-translated forms out of the library instead of having to wait for someone to build it.”

The value of MRT joining this effort is that the company is responsible for hundreds of different forms and interacts with thousands – representing authors as a sort of ‘clearing house,’ he explained.

“For [MRT], they get Medidata platform technology that’s capable of housing a library like this in ways that most of our competitors just are not capable of doing,” added Costello.

While MRT is the largest provider involved in the project, Medidata is working with other authors and instrument owners who have agreed to help build the global library.

Katrin Conway, managing director of Mapi Research Trust, said in a statement that the library aims to cut timelines by as much as 50-60%

“[Sponsors] get the speed, the authors get the consistency, and Medidata hosts the library,” said Costello, calling the project “a win-win-win for all the different groups that work together on these kinds of trials.”