Latest FDA guidance has implications for EDC and EHR clinical study eSource capabilities
The U.S. FDA has just issued procedural guidance regarding the Use of Electronic Health Record Data in Clinical Investigations. While the guidance is non-binding, it is a clear signal for EDC providers who want to reap the benefits for their customers implementing full eSource capabilities, stating “[t]his guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations… FDA encourages sponsors and health care organizations to work with EHR and EDC system vendors to further advance the interoperability and integration of these systems.”
This is not the first time the FDA has provided guidance related to electronic source data or eSource, having done so in 2013 with their guidance for industry Electronic Source Data in Clinical Investigations. What is different however, is the clear signal that eClinical vendors providing EDC, whether directly to sponsors or through a CRO partnership must move to implement full eSource capabilities that will speed the clinical trial process, reduce costs, and bring greater efficiencies to bringing new drugs and therapies to market.
eSource and No Source studies are best achieved through a combination of FSPs: one or more for clinical tasks, and an eSource-No Source eClinical data management specialist. This development flow brings delays down to the barest minimum and escalates accountability to the maximum. It reduces “scope creep” nearly to zero, unless the “owner” of the protocol makes changes or amendments. Absorbing and executing systems changes is far faster and more efficient with FSP due to contract labor and unit rates pinpointing all costs. With full-service CROs, changes absorbed by various “departments” often total to astronomical sums making it difficult for the sponsor to force an accurate, coherent defense of scope changes.
The industry discusses eSource regularly, especially since the 2013 guidance, but adoption has been slow at best as EHR systems have matured. eSource has created great marketing fodder, but how much has really been completed over past 10 years? Before answering that question, we at DSG are pleased to see FDA move in this direction because as the guidance suggests “manual transcription procedures may introduce risks of data entry errors unless effective quality control systems are in place.” We couldn’t agree more.
So what has been done? Well DSG provided the first full eSource clinical study PRIOR to the guidance coming out in 2013. And the results were extraordinary with DSG pioneering eSource studies as far back as 2007.
During 2007, Sirion Therapeutics (now part of Alcon Labs, a Novartis Company) launched its first two pivotal Phase III studies using entirely eSource data collection. These trials were focused on the safety and efficacy of Difluprednate for the management of inflammation following ocular surgery. According to the VP of clinical operations at the time, “Electronic source made the most practical and economic sense; however in researching the topic, we discovered a lack of FDA guidance, an absence of industry case studies, and not subject matter expertise such as consultants with experience in submitting a 100 percent electronic source study to the Agency” (see Applied Clinical Trials, May 4, 2015).
Sirion enrolled 120 subjects into each study quickly, and from start to finish – complete the development, preparation, execution, enrollment, analyses and reporting of the studies in less than six months and within a tight budget. Centers were ophthalmic surgical suites with varying degrees of clinical trial experience. The need for a mobile data collection process was imperative to the success of the study as data collection would come from originating sources to include the surgical investigators, study coordinators and EMRs.
Simply put Sirion needed an intuitive, all encompassing, reasonably priced data collection system to obtain reliable data in real time while managing study related costs. Also, a mobile data collection process was extremely critical due to the various sources and the need for investigators to remain in motion.
DSG as Sirion’s trusted eClinical solution provider, designed, programmed, validated and launched a single, seamless solution. Sirion experienced fewer anomalous data points and the data was cleaner upon data entry due to the proprietary nature of the DSG eCaseLink™ EDC system, which used a higher quantity of complex edit check protocol validations than what would be considered industry standard.
For the sites, Sirion provided each with a wireless tablet and equipment required for wireless access to the EDC system, which allowed them to enter patient data directly into the EDC system – with no intervening paper step. Electronic source and the use of WiFi internet-enabled tablets gave surgeons and study coordinators the mobility they coveted while completely eliminating paper source documentation. This removed the need for source data verification, and dramatically decreased monitoring time and costs for Sirion.
Company executives were kept current on the progress of the study via reports generated within the eCaseLink system. Due to the efficiencies of eSource, the time to database lock following last subject-last visit was significantly shorter, allowing Sirion to proceed to conducting the analysis and to receive study results expeditiously.
When the FDA conducted in-house and site audits as part of the NDA process, Sirion and DSG worked together to support the use of eSource captured directly into eCaseLink EDC with IRT (randomization with trial supply management). The FDA auditor assigned to Sirion was unaccustomed to these methods of data collection and drug tracking, however, could easily understand the validations and documentation. The auditor thoroughly investigated the database design and validation; data collection process at the sites; drug accountability and tracking; and remote monitoring procedures. He closed the audit with a positive review, ultimately leading to FDA approval of Difluprednate on June 24, 2008.
Do you or one of your sponsors want to take advantage of full eSource capabilities? DSG can show you how, and reduce study costs and bring true speed-to-market.