Research Operations for Secondary Use of Clinical Sites’ EMR
Provisions of the US Food and Drug Administration’s 2016 21st Century Cures Act, and several initiatives funded by the European Medicines Agency, have greatly increased demand for real-world data (RWD) from life sciences companies. These initiatives have increased the potential for real-world evidence (RWE) derived from RWD to influence regulatory decision making, including approval of new indications for approved drugs.
Uses of RWD that get closer to the approval of new indications greatly increase regulators’ scrutiny of study design rigor, richness of clinical detail, and validation of data against primary sources. Pre-curated RWD research databases that have been used widely to influence reimbursement or post-authorization decisions have rarely passed the scrutiny demanded for such uses.
Sponsors’ pharmacovigilance and medical affairs teams frequently gather RWD directly from medical sites for chart reviews, registries, and other observational studies. These sources have also become more attractive sources for RWD to supplement new indication applications, particularly under accelerated approval schemes for breakthrough therapies and orphan indications. The increasing global adoption of electronic medical records (EMRs) at clinical sites has prompted interest in using sites’ EMRs systematically for observational studies. The hope of sponsors is that sites can spend less time performing manual abstraction and resolving queries, leading to lower costs, faster data collection, larger sample sizes, and higher quality and accuracy.
Implementing site-based EMR studies requires new collaborations and change management within clinical sites. Evidera recently released a white paper addressing four key lessons for implementing site-based, observational EMR studies.
Read white paper: http://bit.ly/EvideraDec2019
EMR Studies Operate in a Clinical Trials World
It Takes a Village to Judge a Site’s EMR Feasibility
EMR Studies Strain Ethics and Data Protection Workflows
If You’ve Seen One EMR, You Haven’t Seen Them All
Read the white paper: http://bit.ly/EvideraDec2019