How Medidata Rave EDC Improves Clinical Trial Site User Experience
Clinical trial data management is difficult even in the most well-designed and executed trials. Common issues, such as redundant clinical trial data entry, lack of integration between systems, and inconsistencies in trial design, plague most data collection methods.
Your Electronic Data Capture (EDC) system providers should always be improving your EDC system so that all site users—clinical research coordinators and principal investigators—have the most streamlined experience possible. In addition, EDC system providers should regularly consult with site users to identify pain points and then work to update their existing offering or create new capabilities to meet these needs. If contract research organizations (CROs) and clinical trial sponsors listen to feedback from their sites in this manner, they can prevent problems before they develop and accelerate clinical trial results.
Continuously Improving Electronic Data Capture (EDC) Experience through Internal and External Insights
The improvement process starts with the people who use the EDC system directly. Your EDC provider should use multiple techniques for this purpose, such as capturing customer feedback in surveys, participating in one-on-one discussions or small user focus groups, and using unsolicited enhancement requests.
A holistic view of the challenges for all site users—from clinical staff to patients—can be used to improve and add functionality to the EDC that supports all stakeholders. The biggest barriers to site user success are inefficient steps in the clinical trial process, such as redundant or difficult data entry and unique forms or documentation for each trial. A high-quality EDC system helps customers overcome these common clinical data challenges—especially those that cost the valuable time of clinical health staff. Some clinicians report having to spend more time on data entry after a patient visit than they spend with the patient during the visit.
How Can Sponsors and Clinical Research Organizations (CROs) Support Better EDC System Implementation?
Some of the challenges EDC users continue to encounter require support from sponsors and CROs. Many site users are the unfortunate finders of flaws in either the clinical trial or electronic case report form (eCRF) designs that cause issues throughout the trial, often at the cost of large amounts of time, as duplicate manual data entry or other painstaking processes are required to fix these errors. Medidata Rave EDC readily and quickly adapts to mid-study changes, unlike many alternatives. But a better solution would be to prevent such problems from arising in the first place.
CROs and sponsors could give the industry a time-saving boost by conducting trial test runs. Performing a test trial before enrolling patients would help identify problems early and correct potential errors before enrollment. The sponsor could then provide early feedback to the EDC provider. This would benefit both the sponsors and EDC providers—accelerating trial timelines and preventing potentially expensive issues before starting the trial. The sponsor would also have an early preview of the EDC system’s capabilities in a real-world environment, eliminating any chance of an unexpected issue.
So far, however, CROs and sponsors have been resistant to this approach as it is prohibitively expensive and would delay trial startups. A more viable approach would be to standardize portions of clinical trial design and eCRFs. A more standardized set of forms and processes throughout the industry could unlock greater efficiencies by eliminating clinical research data entry steps and more easily reconciling data between different systems. But a strong EDC system is capable of adapting to changes and integrating with other systems to maximize performance within the current environment.
Rave EDC Is Designed for Clinical Site Users to Succeed
To date, Rave EDC has had over 262,000 certified site users, providing a veritable treasure trove of user-generated critiques and solutions. Medidata also runs a site advisory group with a dozen representatives from clinical research sites worldwide, in partnership with the Society for Clinical Research Sites (SCRS). We meet with this group quarterly to gather both feedback and suggestions.
But our dedication to improvement doesn’t stop with the customer and clinical trial staff. Rave EDC has been used to collect the data of more than 7 million patients so far. Indeed, expanding ease of use to the patient experience has become a priority as the industry shifts to decentralized trials and self-report systems. Medidata’s Patient Insights team includes patient advocates who have previously participated in clinical trials, so the patient’s perspective is always represented. Similarly, we collect impressions, feedback, and suggestions from patients using all our digital systems, including patient registries, eConsent, eCOA/ePRO, and video visits.
We designed and continually update Rave EDC to help customers overcome common clinical trial data management challenges. A major obstacle in clinical trial data entry is the time it takes—especially for clinical health staff. Rave EDC and Medidata’s augmenting systems are designed for quick data entry to alleviate this problem. For example, Medidata Rave Coder supports fast, accurate coding of verbatim terms, including medications and symptoms, with regularly updated dictionaries and a unified workflow with Rave EDC. In addition, Rave EDC’s query management is designed to quickly and efficiently resolve queries so that clinical staff spend more time with patients and less time performing administrative work.
To facilitate ease of use, we created Rave EDC with the capability to integrate with pre-existing clinical trial site infrastructure to let site staff use mostly familiar technology instead of spending valuable time training on entirely new systems. Rave EDC’s training is attached to the user so that clinical trial staff can be trained on the system once instead of once per study. To enhance ease of use, each user has a single username and password for all systems across a study instead of a group of disconnected accounts.
Each improvement in ease of use and speed aggregates to a significant time-saving effect. In fact, in a CRO-validated comparison of 20 studies, Rave EDC had a 60% faster median patient data capture cycle time.
The key to Rave EDC’s industry-leading performance has been a forward-looking and iterative process for identifying sponsor, CRO, and site user needs, deploying potential solutions, and then validating this approach in a virtuous cycle. The result is an accelerated clinical trial for sponsors and CROs, which lets healthcare professionals spend more time with patients and less time in clinical trial systems.