Study Highlights Value of EHRs in Trials

A new cost-benefit study found electronic health records curbed sponsor time and expenses, underscoring the potential that the technology could have for drug development efficiency.

The analysis from the European Electronic Health Records for Clinical Research project evaluated the price tag of three key steps — protocol feasibility assessments, patient identification or recruitment, and actual trial execution — in a theoretical Phase 2 or 3 cancer trial, weighing improved time-to-market. Trial performance was compared between the electronic-record standards and current clinical practice.

The EHR4CR is a four-year program co-funded by the European Commission and European Federation of Pharmaceutical Industries and Associations under the Innovative Medicines Initiative. Its platform draws on reusing data from hospital EHR systems and trial centers throughout the continent, allowing sponsors to more accurately plan for trial populations and best recruitment locations with the patient information.

Published in the Contemporary Clinical Trials journal, cost-benefit analysis results showed that if speed improved with this EHR platform, oncology drugmakers could reap gains of around $177 million in the protocol process, $50 million in patient enrollment and $2 billion in clinical trials.

The report says these improvements would address serious barriers industry is currently facing in clinical research that sees fewer innovative drugs approved. That’s because trials are becoming more complicated and convoluted with stricter patient enrollment standards, draining more resources and costs from drugmakers.

For example, almost 60 percent of early trial protocols have to be changed at a cost of around $450,000 on average – one-third of them needlessly, the study cites. Just 7 percent of trials in the U.S. and 18 percent in Europe finish enrollment on time, and more than 70 percent of data are doubled between EHR systems and trial systems. Instead, with these standards, time and costs could be cut by 50 percent.

“As the EHR4CR platform will enable refining inclusion/exclusion criteria (within hours versus weeks), reduce the time to study opening and potentially the number of protocol amendments downstream, accelerate patient identification for recruitment, and optimize clinical trial execution through seamless data exchange, it is also expected to reduce the average clinical research cycle time,” the analysis says.

On the whole, the study concluded that using electronic records would add “substantial” value to the global pharmaceutical industry.

“These findings suggest that leveraging EHR data for clinical research provides global pharmaceutical industry with a game-changing opportunity, and new value-added solutions to enhance existing processes, reduce delays and costs, and deliver innovative medicines to patients faster,” said Mats Sundgren, an EFPIA project coordinator and a scientist at AstraZeneca, in a statement.

Data Mining, a Swiss research agency, says many European drug industry leaders are planning to sign on early, and results of its use will be presented at the European Institute for Innovation through Health Data conference next March in Paris.

Across the ocean, the FDA announced this summer that it would assess the value and challenges of electronic source data like this in clinical trials (CTA, July 15).

The agency said it had hoped more firms would draw on them in regulatory filings after it issued guidance in 2013, but had seen few. Access the study at www.contemporaryclinicaltrials.com/article/S1551-7144(15)30122-1/abstract.— Victoria Pelham

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