The hidden value of
patient engagement in
pharmaceutical development

By Su Smith

In the past decade, there has been a noteworthy shift towards actively involving patients in the pharmaceutical research and development process. This transformation has seen patients transition from passive recipients of healthcare to become integral partners in various stages of drug development. Regulators, government and health technology assessment (HTA) bodies now require the involvement of patients at all stages of the drug life cycle, from clinical development through to market access into commercialisation. Furthermore, regulators and HTA bodies now place great value on patient experience and real-world evidence data, requiring it to be submitted alongside clinical data.

However, despite the compelling ethical and practical reasons for embracing this patient-centric approach, some pharmaceutical organisations remain hesitant to break away from tradition. A tradition that sees doctors and researchers dictating all healthcare decisions while the patient’s voice remains unheard. But what is the reason for this resistance?

Abraham Maslow is quoted as saying: ‘In any given moment, we have two options: to step forward into growth or to step back into safety.’

A significant stumbling block may be the lack of awareness of the financial value of patient engagement, but there is good evidence to suggest that consulting patients can yield substantial cost savings during clinical trial planning.

Research has indicated that drugs developed using patient-centric designs are 20% more likely to be successfully launched than drugs developed without patient engagement.  Additionally, it tends to take less time to recruit 100 participants in patient-centric trials, taking just four months compared with the seven months required in non-patient-centric trials.

Protocol amendments are notorious for their high costs and are usually made to modify eligibility criteria, either due to changes in strategy or because of recruitment challenges.  Research suggests that a single amendment adds approximately 90 days to the development timeline and increases direct costs by an average of $535,000 in phase 3 trials. Indirect costs, primarily related to staff workload, are estimated to be even higher.

Conducting protocol reviews with patient groups can improve communication with prospective trial participants. This can help tailor trials to be more patient-friendly by revising eligibility criteria in the design phase, which helps to improve enrolment rates and reduce the time to trial launch. Simplifying informed consent procedures, making trials less demanding and providing in-trial feedback can also boost protocol adherence and reduce patient dropout rates.

John F. Kennedy is quoted as saying: ‘Change is the law of life, and those who look only to the past or present are certain to miss the future.’

Demonstrating the financial benefits of involving patients in the drug development process could provide the necessary impetus for pharmaceutical organisations to fully embrace this approach. It is not only a matter of ethics; it is also about making astute business decisions that can lead to more efficient development of treatments and, ultimately, more comfortable and more satisfied patients.

The pharmaceutical industry is at a crossroads, where some organisations have fully embraced the value of the patient voice, while others lag behind. Clear evidence exists to show that involving patients in drug development can yield significant financial benefits, from cost savings to faster trial launches and improved success rates. To ensure increased patient satisfaction, and ethical responsibility, it is imperative that more pharmaceutical organisations recognise and harness the power of the patient voice in shaping the future of healthcare.

Origins is a patient-focused specialist agency; our world revolves around patients and helping our clients to connect with patients in a meaningful and mutually beneficial manner.

Our award-winning programmes have been recognised as the gold standard in patient focus.

To find out more about the benefits of the patient voice, please contact Su on contact@origins-patients.com

References are available on request.