Do research with us, not on us

Much more needs to be done to ensure patient centricity is at the heart of all clinical trials.

“Do research with us, not on us,” stated Matthew Zachary, chief executive of US patient advocacy organisation StupidCancer, on the first day of Partnerships in Clinical Trials Europe.

At this point in time, he said, there is nothing ‘centric’ about patient centricity in clinical trial design or execution. “Industry uses data to find people, but patient organisations use people to find data and understand their individual journeys – and there is a vast divide between the two,” he noted.

Does industry know what matters most to patients in clinical trials? According to Zachary, their concerns are often very different to what the industry is led to believe: “It’s about their family, peers and personal relationships; it’s about their finances, their insurance, their education; and it’s about managing their fear and anxiety and dealing with issues relating to self-image.”

So how do we redesign trials so that they are in line with the terms that patients want and need? This was the central question posed during the course of the two-day event.

While patient advocates are increasingly part of the research paradigm, much more needs to be done, stressed Virgil Simons, founder and president of The Prostate Net. With many populations – such as racial and ethnic minorities – severely under-represented in trials (more than 30% of the US population but less than 17% of trial participation), we need to ask ‘who are we developing drugs for and are we really benefiting society?’

In the US alone, almost $12 billion was spent last year on disease management – costs that look set to spiral as the population ages and new diagnostic tests and therapeutic agents come on board. Key to getting on top of this is to strive for patient centricity, added Simons, as defined by the US Institute of Medicines, “Providing care that is respectful of, and responsive to, individual patient preferences, need and values and ensuring that patient values guide all clinical decisions.”

This seems simple enough. But the barriers to patient centricity are three-fold, Simons explained. First, patients need to understand the benefits to themselves as individuals, compared to broader society, and the likely outcomes versus the impact on their quality of life. Then, for providers, it means treading a fine line between optimising patient care and the financial realities of delivering that care; third, for pharma, the barriers revolve around regulatory mandates, protocol acceptance by patients and, of course, the need to maximise shareholder returns.

Ultimately, all stakeholders need to be involved if the quality and relevance of clinical research is to be improved, with patients fully integrated in planning and outcomes to make studies not only more engaging, but accessible to greater numbers of people. In one 800-person survey of women in their reproductive years – across 400 US cancer sites – 70% said they were interested in participating in a trial but could not get access, Zachary pointed out. Worryingly, just 13% of these women had been informed of the risks to their fertility from treatment.

Designing better protocols would start to drive a positive shift, noted Adama Ibrahim, senior clinical operations lead at Biogen Idec, increasing both compliance and patient satisfaction. But with no defined return on investment, it could be hard to get traction for patient engagement activities from a financial, regulatory, legal or compliance point of view. Or it might simply be deemed not profitable.

As one panel speaker noted, “Measuring hard outcomes in clinical trials may be easy and measuring important outcomes may be hard, but this is a transformation that needs to happen.”

In a cost-constrained healthcare system, pharma must be able to demonstrate the value of its products and be able to communicate its value to all sections of society. The answer is clear – it’s time to cut through the red tape and put the patient front and centre of every decision made, because believing you can’t engage with patients is probably the biggest barrier of all.

For more information on the Partnerships in Clinical Trials Europe 2016 conference, go to: 

About the author:

Claire Bowie is Head of Publishing at pharmaphorum. She has extensive experience in healthcare communications and publishing, supported by a background in biological sciences.

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