Find Your SMART: A blueprint for patient engagement

The drug development process has historically siloed pharmaceutical companies and patients until the time comes for clinical trials. Drug development is a complex, expensive process that requires a lot of expertise. But patients are experts on their own experience of illness and their insights should be more integral to drug development.

The pharmaceutical industry is already on the path towards integrating the patient experience early and often in the drug development process, partly because of the 21st Century Cures Act, which was made law in 2016 [my colleague Jeff Terkowitz had previously discussed it here].

Some companies are already on board with a stronger patient voice, but barriers within pharmaceutical companies slow down the progress of integrating patient engagement.

What is needed is a framework for engagement and guidance to navigate barriers. A series of presentations at the Second Annual Patient-centric Clinical Research: Engagement and Innovation Conference in conducted in March 2017 in Springfield Virginia offered an outline to embedding the patient voice more firmly in R & D, including execution and metrics that help demonstrate the value of incorporating the patient voice in the drug development process. These concepts are summarized into 5 key areas below:

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1) Start Small:  First implementation of patient inclusion should be on a small project.  One area to begin including patients in research and development is in trial optimization since obtaining and retaining patients is a problem in clinical trials.

Patients can offer guidance about barriers they face for staying in clinical trials or what kinds of incentives would encourage them to continue, for example.  Once patient involvement is part of trial optimization and successes are built, subsequent projects can involve patients in earlier stages of the development process.

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2)  Methodology:  Often there is concern among life science industry professionals that  patient participants will not be representative of the total population of patients with the target condition. Creating a “prototype description” of an ideal patient or group of patients using epidemiological data can help.

Matching patient characteristics to the project needs and expectations is important.  A combative personality may not be effective in a focus group requiring substantive participation, but neither is a reticent one.

Read more and access the entire blueprint by downloading the eBook below.

See our eBook “Find Your SMART: A blueprint for patient engagement”

Download eBook
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