White Paper

Virtualizing Clinical Trials

Patient with ipad

The backbone of drug and medical device development is the clinical trial process, which is regulated by regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency. This is the lengthy and rigorous process by which new therapeutics are tested to demonstrate their safety and efficacy in human patients.

Historically, clinical trials have been steeped in esoteric language and opaque to the public at large. The process is run in top-down fashion, and managed in tightly controlled clinical settings. It is highly regulated; trials are subjected to strict validation rules for data gathering and analysis. And trial data generally flow from investigators back to the drug company/sponsor — instead of to the patients who were subjects in the trials.

This last characteristic of clinical investigations is changing. A trend is emerging toward greater patient involvement in clinical trials — making them more patient-centric.

Trial sponsors and clinical investigators are exploring ways to immerse patients in trials — including their perspectives and better informing them about risks, benefits, and disease progression. There are two recurring themes in these discussions: the user/patient experience and data quality.

The objective of a typical trial is no longer to just determine whether the drug causes the intended biochemical effect. Investigational drugs must be safe, effective and produce a positive outcome. Investigators, regulators and pharmaceutical marketers are increasingly interested in outcomes as measured from the patient’s perspective. “Outcome” more broadly refers to the improvement in the patient’s wellness or quality of life, and not just reversal of disease or extension of longevity.

The patient experience is an important consideration in trial design. The organizations that sponsor and conduct trials are identifying best practices and testing methods to get the patient experience right.

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