Electronic By Default: Why Paper is No Longer the Gold Standard of Data Capture in Clinical Trials

Clinical Trials have traditionally collected data from patients by using the most ubiquitous technology of all: the pen and paper. While the use of electronic patient reported outcomes (ePROs) is becoming widespread, and ePROs are seemingly well accepted by regulators and the industry as a whole, there still seems to be an implicit sense of paper being the gold-standard when it comes to questionnaire design. Consequently questionnaires continue to be written with the unique properties, and limitations, of pen and paper in mind.

Paul O’Donohoe and Paul Margerison argue that it is time for the industry to move beyond this mind-set. Not only do the electronic media match the capabilities of paper, but there are capabilities unique to electronic media which allow data capture to be engineered in ways that are not possible using pen and paper.

Embracing the new media actually changes the type and quality of data that can be gathered, while improving the quality of data captured under existing paradigms. The new media offer a chance to think creatively. New research territory is opening up, and it falls to the disciplines of study design and instrument design to explore it. By treating electronic media as the primary platform, and looking afresh at how data capture is devised and executed, the industry will likely see trials harvesting more complex data, more reliably, and faster than was ever possible before.

Speakers

Paul O’Donohoe, Director of Health Outcomes, CRF Health

Paul O’Donohoe is Director of Health Outcomes at CRF Health and is based in their London office. He is responsible for developing the company’s internal scientific expertise and supporting the scientific consulting being offered to clients. Previously Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups.

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Paul Margerison, Lead User Experience Designer, CRF Health

Paul Margerison speaks to us from the field of product design. Paul has worked on the design of products across many sectors, from News to Retailing and Telecoms. Before joining CRF Health he was Head of Digital User Experience for the Education and Arts organization, The British Council.

Based in CRF Health’s London office, Paul champions the needs of the ‘end user’, whether that person is a patient, a caregiver or an investigator. He is there to remind us that diaries end up in the hands of ordinary people, who strongly desire them to be friendly, confidence-inspiring and easy to use.

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