Bridging The Gap In The Clinical Development Business Model With Patient Involvement

By Abbe Steel, founder and CEO, HealthiVibe

In March of this year, Sanofi appointed Anne Beal, M.D., MPH to the position of chief patient officer (CPO). It marked a first for a top 10 biopharmaceutical company and is a sign that patient engagement may finally be coming, albeit slowly, to the one area within pharma where it’s been most lacking: clinical development.

Recruitment and retention problems have long plagued clinical trials and frustrated top-level executives. The bottom-line impact has been enormous (e.g., trial cost overruns, protocol amendment delays, postmarket difficulties that highlight a widening gap between trial design and patient needs). The problems are well-documented. Solutions have remained elusive, in part, because of a prevailing culture within pharma that still emphasizes providers and regulators over patients. It’s an antiquated and inefficient model that needs to change.

There are obvious reasons for the current model. Investigator initiation is necessary to get a trial moving, and regulators hold the ultimate authority. Patients, meanwhile, have historically been kept at arm’s length, due in part to privacy concerns. Patients have been kept at a distance for so long that they’re not even recognized as a true core constituency, which undermines the principles of sound study design and makes the root problem that much harder to identify. And it leaves those same toplevel executives scratching their heads over how to find a solution.

The Missing Link
Every clinical-trial patient faces challenges. By necessity those challenges are unique to the trial, to the patient’s underlying conditions and comorbidities, and to the logistical considerations imposed by the study design — considerations that are only revealed to be daunting when considered in context. The missing link in study design has been grasping that context.

Pharma clinical development teams will point to increased engagement with advocacy groups, online communities, and low-risk patient-centric innovation pilots as evidence of a shift toward patient engagement across the product life cycle. But within clinical development specifically, the benefits are marginal because the engagement isn’t study-specific, or else it comes too late to impact protocol design. The patient is still at arm’s length throughout protocol design and often throughout the study itself. Trial patients are rarely asked for feedback about the studies in which they’ve just participated. Detailed patient feedback is absent or lacking in specificity, exactly when it’s most critical and when clear market research is most beneficial.

An interesting angle here is that patients, more than ever, want and are able to share their insights. They seek out engagement. The last 10 years have seen an explosion in mobile device technology and social networking use, and the two factors together have directly led to patients taking a more active role in their healthcare decisions. Elsewhere in the healthcare space, even within pharma, this is well-recognized and even starting to be embraced. Only in clinical development has it been largely ignored.

For all the talk about advocacy groups, patient workshops, and the changing culture of pharma, little has changed in how trials are designed and conducted, and the improvement on cost and time to market has been minimal. It’s emblematic of a pharma culture that pays lip service to the ideals of patient-centricity, but remains content with half measures.

Shifting the Culture
If there’s a gap in pharma’s understanding of patient needs, it can be addressed with effort. The more critical problem is the lack of a true corporate emphasis on shrinking that gap.

A solution requires nothing less than a culture shift, so that the business model tilts for the first time to include the patient.

As the Sanofi announcement demonstrates, such a shift has to originate from the top. It requires a dedicated budget item for patient engagement. It requires the creation of a C-suite position with true ROI accountability. It requires the same allocation of resources and commitment that any other business-critical initiative demands. And it requires, finally, an acknowledgement that patient involvement is a core component of the business and a corresponding mandate that no study can move forward without it.