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Nextrials CEO James Rogers believes with renewed focus on eSource driven by the FDA and industry standards groups like CDISC, sponsor companies and sites will take advantage of EHR systems to streamline clinical research.
Electronic Health Records Will Have a Dramatic Impact on Clinical Research Next Year
Nextrials revealed its 2016 predictions related to electronic health records (EHR) for the clinical trials community. With EHR's widespread adoption over the last few years, the company predicts these systems will now change how life science companies and medical facilities conduct clinical research.
Nextrials' 2016 predictions include:
1. Multiple projects implementing EHR integration will be launched next year with the support of the FDA: the FDA's solicitation of eSource proposals resulted in over 40 responses of interest including submissions by leading CROs and pharmaceutical companies. This official proclamation of support has signaled to the life sciences industry that the FDA encourages, even expects, that this paradigm will be implemented.
2. Research-friendly EHR software and practices will become part of the site selection process: to take advantage of the efficiencies offered by EHR systems, sponsors will need to place their studies at sites that have EHR systems and processes that easily allow access to the data for research purposes. The EHR system used at a site will be one of the factors evaluated when selecting sites for a clinical trial.
3. The flip side to #2 is that sites will position their EHR capabilities as a competitive advantage for attracting clinical trials: having a principal investigator who is a key opinion leader in his or her field will always be a big draw for sponsor companies, but having a robust EHR system will allow sites to reliably demonstrate that they have sufficient patients that meet the study criteria. And owning an EHR system capable of auto-populating the study database would also be a valuable asset.
4. Sites with EHR research offerings will collaborate and form site networks: a network of sites offering study-specific patient identification and selection, combined with the validated transfer of trial data directly from the EHR, multiplies the efficiencies seen with individual sites. This would be a compelling business case that enables site networks to flourish where previous attempts at Site Management Organizations (SMOs) have failed in the past.
5. Sponsor companies will finally recognize significant cost savings with remote monitoring: using EHRs for clinical research has a number of advantages. The most significant for sponsor companies is the potential to reduce monitoring costs by utilizing remote access to patient records for data monitoring. This practice will expand significantly in 2016 as sites adopt the necessary infrastructure and policies, and sponsors begin to wean monitors from expensive site visits.