Bringing the Voice of the Patient to Clinical Research

Bringing the Voice of the Patient to Clinical Research

Clinical trials are designed to prove the efficacy and safety of treatments and are fundamentally, therefore, data gathering exercises. Study participants are data sources and to preserve the quality/integrity of the data and the statistical power of the study, it makes sense to ensure the participation experience is as positive as possible. Participants who enjoy their involvement are more likely to remain with the study for the full course of the trial and comply with the treatment regimen, and possibly participate in further trials.

In general patients have little interaction with trials outside of site visits. Current methods of collecting patient-reported outcomes in the form of questionnaires and diaries may feel like homework, so compliance can be a challenge. Entries may not be completed until the last minute (e.g., in the car park lot just before the next visit), resulting in low quality data. One way to motivate patient-mediated data reporting is to facilitate is with devices which form part of their day to day lives such as mobile phones and tablets.

Medidata is a company that aims to provide CROs (clinical research organizations) with the most advanced tools for planning and managing their clinical trials. Using the Medidata Patient Cloud™, patients can use their own mobile devices which already fit into their lifestyle to fulfil their roles as trial participants both off and onsite. While it may not seem like a significant step on its own, the shift to a patient-centric device provides the foundation for more and better communication with patients, both patient-to-trial and trial-to-patient, and may just be the between achieiving mediocre or good quality trial outcomes.

The Medidata Patient Cloud™ and similar technological innovations enable patient-centric data capture and management. It provides electronic patient questionnaire and diary functionality in a model that simplifies the building and deploying process, freeing research organizations from the burdens of custom software and proprietary devices. By streamlining the trial process, the Patient Cloud helps get data to clinical researchers more efficiently, eliminating integration steps and minimizing cost, time and risk. For the same reasons it helps maximise the authenticity of the patient reported trial data, thereby enhancing the voice of the patient in the clinical trial process.


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