Stethoscope and Model House on Gradated Background with Selective Focus.In our disruptor profile of goBalto, we introduced an alternative approach to effective study start-up. The next biggest concern for clinical trials managers revolves around patient recruitment and retention. The general trend has been towards patient enablement, which leads to a very different strategy than includes marketing, advertising and social media. It also means physicians need to be brought onside so that when patients are personally persuaded, their professional advisors are in a position to support them.

Introduced as the “Patient- Centric Service Model”, it includes protocol visits at the patient’s home or alternate location rather than at the investigator site. For the research team, this is a significant shift in the levers of influence and control. Whilst this is more comfortable for patients and results in better recruitment , compliance and retention, it does pose serious back-office processing challenges and puts pressure on budgets. Most research professionals are accustomed to the tacit support network available as part of the investigation site, and losing creates fresh challenges.

But perhaps more significantly, for the purposes of this study, we see a significant shift in IT requirements. Our survey respondents had already highlighted the importance of mobility, so they can provide updates on-the-go. Implementation of a patient centric model will go further, with patient records needing to be more accessible to patients, more education and greater emphasis on the research team’s ability to empathise with patients and address their questions. The other complication we foresee is that a patient centric model is unlikely to replace investigation sites overnight. Co-existence is likely to be the long term picture, and this is an additional burden on information systems.

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