Table 3.

Role and influence of stakeholders in advancing the use of electronic health records in clinical research

Stakeholder	Contribution
Professional societies	Training and education Global platform for education at annual meetings or congresses Leverage industry support Public education to foster public support Transform EORP into a prospective trial instrument; generate support from industry who may use this resource for future trials Develop data standards (CARDS-revisited) Organize working groups charged with generating common EHR templates or data sets, or achieving agreement on minimum standards Lobby regulatory agencies and industry sponsors
Clinical trialists and industry	Engage other collaborators (e.g., ethicists, CROs, academic CROs, information governance, registries, IT providers, EHR companies, patient advocacy groups, data protection/security experts, legislators/agencies, public funders, legal experts, treating physicians, hospital administrators) Pilot the evaluation of EHR versus conventional non-EHR trials Pilot trials to compare event collection using EHRs versus usual eCRF Conduct actual EHR trials, initially in smaller countries, adapting the approach based on lessons learned, then applying to larger settings Adopt EHRs on an experimental basis for feasibility assessments and patient recruitment Lobby other stakeholders to collaborate towards developing robust methodology to incorporate EHRs in clinical trials Educate professionals and the public about potential value of EHRs
Regulatory	Work with industry to identify appropriate ways to incorporate EHR data prospectively into study designs
EHR vendors	Invest in building research capabilities on EHR platforms

CARDS cardiology audit and registration data standards, CRO contract research organization, eCRF electronic case report form, IT information technology, EHR electronic health record, EORP European Observational Research Program