How to connect the common goals of varying clinical trial stakeholders

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/Rawpixel)
(Image: Getty/Rawpixel)

Related tags PCT Europe Clinical trials Drug development

All clinical research stakeholders are looking to deliver better patient outcomes faster, though silos across the industry are creating a disconnect.

Nicholas Brooke is the founder and executive director of PFMD (Patient Focused Medicines Development) and The Synergist, Belgium.

Next week during PCT Europe, Brooke will address how to manage the different goals of sponsors, contract research organizations (CROs), patients, regulators, and investigators.

Ahead of the conference, we caught up with Brooke to further discuss how the industry can find balance among all of these goals.

Why did you found PFMD? And what is the goal?

Patient engagement was and is still high on the agenda, but this is far from being the norm. Within a stakeholder group, in a given country, in one phase of medicine development or within one department, there are bubbles of patient engagement in various qualities and delivering outcomes perceived as positive but difficult to measure. This fragmentation prevents systematically engaging patients as partners in the process of drug development and delivery.

PFMD founding members, representing patients and industry, agreed to support a pre-competitive not for profit platform to help identify good practices and existing frameworks, and co-create a working plan with all stakeholders.

It also worked to materialize a patient engagement meta-framework aimed at all stakeholders around the globe, and finally, operationalize patient involvement by providing a support kit including tools, methodologies, and services.

The vision is a streamlined, coherent, and integrated meta-framework for patient engagement that would meet expectations and operational needs of all stakeholders and would allow customization to a single organization or stakeholder group.

More recently, PFMD added a fifth objective of building the demand and creating the conditions to make patient engagement happen.

What are some of the different goals of sponsors, CROs, patients, regulators, and investigators?

All stakeholders share the same objective of delivering better patient outcomes faster. Very often, patient engagement is perceived as a new objective coming with new tasks and extra burden.

Each stakeholder group or team is then looking at it in a silo, disconnected from previous and next stakeholders in the chain and creating distortion, duplication, conflicting activities, and extra burden. This is where we believe we have different goals.

However, I believe we don't have different goals and the primary goal remains. On the contrary, patient engagement is a means to achieve the shared goal and improve respective existing performance indicators.

Patient engagement is a way to reduce the number of protocol amendments, increase recruitment and retention performance over the cycle of clinical trials, increase the net present value, and ultimately deliver better performing drugs for the benefit of the patients together with the manufacturer and the entire health system.

How do these goals need to be balanced? And what are the challenges to achieving this balance?

We need a paradigm shift towards a streamlined patient engagement process to improve current drug development practices and specific performances measured by all stakeholders at different phases.

The patient is at the same time the source and the end receiver of everything that will happen during medicine development and delivery, and staying close to them all along the process just seems the best way to reduce the burden and deliver better outcomes

How can those outside the industry help?

Industry is only one of the stakeholders involved and facing the cultural shift and operational challenge patient engagement represents.

I have seen early adopters, people in between, and others lagging in all stakeholder groups. I think early adopters from all groups have to join the collective platforms and pre-competitive communities to share their positive experience and help accelerate the adoption rate towards patient involvement.

The status quo is a very heavy weight to push away.

What do you expect from the next five, ten years?

The combination of several trends in health, including real-world evidence, patient engagement, and behavioral science will converge to both patient centricity and patient empowerment, turning patients into one of the most influential stakeholders at the table. This empowerment will accelerate as the patient community develops skills and capabilities.

To date, the above trends progressed in a linear curve, but together with the converging trends and the FDA’s current focus on patient engagement, we are preparing for a tipping point.

Benefits-risks, patient experience of the burden of the disease and the burden of the treatment, and now clinical outcomes assessment designed with patients in mind, are all becoming a reality one after the other in a very short period of time.

It will set patient engagement expectations not only in the US but with ripple effects globally. No stakeholder is ready to face the consequences of reaching the tipping point and it might create temporarily not only positive disruption.

For industry thought, lack of readiness might simply mean being out of the competition because of the lack of competitive advantage in terms of patient engagement.

As it pertains to the industry, what keeps you up at night?

We are now shifting from contemplating the risk of doing patient engagement to the urging need to face the risk of not doing patient engagement.

Those who miss that paradigm shift might very well fail to stay in business.

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