Patient Perspectives

Patient Engagement from the Inside Out

Richard Stephens
Former Chair, NCRI Consumer Forum
Joint Editor-in-Chief, Journal of Research Involvement and Engagement

Lode Dewulf

Chief Patient Officer

or industry, regulators, and prescribers, a drug is essentially built on data. Those data used to come only from clinical trials, in which participants were often seen as little more than data sources. Study participants were “subjects” (a term which sadly still survives in much clinical trial-related guidance and nomenclature). Yet, these people put the most skin in the drug development game–quite literally, as they contribute their tissue samples, their blood, and their data. It is encouraging to see that patients are increasingly being seen as THE MOST IMPORTANT stakeholder in clinical research. The need by and motivation for the sponsor and study staff to engage with patients is clear. But what is the motivation for study participants?

Every research study participant, healthy or not, is a volunteer. What motivates them? It is clearly not money, because they don’t receive any for participating. Nor is it science, which they very often do not fully understand. For certain trials, personal therapeutic gain—even if its chances are reduced by randomization—may be an important motivation, but this does not apply to many studies. It is time we ask this question routinely, so that we can learn and appreciate why so many of our fellow citizens are willing to put up with the complexity and burden of clinical studies. Motivations will differ, but we will begin to understand them only if we ask.

So I asked someone, and here is what he wrote:

When I was a university student—way back in the 1980s—I had a summer vacation job in a local charity shop. It was a simple operation. People donated unwanted items; we sold them and the charity kept the money, minus our wages, shop rent, bills, overheads etc.

It was a great little place, full of jigsaw puzzles and kids’ toys, loads of books, paintings, and ornaments, plenty of clothes on racks and hooks and anywhere else we could stick them, trays, tea sets, and cake tins—and sometimes cakes and homemade jams too—and the occasional piece of furniture, and random pieces of cloth, that my Manageress, Mrs P., would knowledgeably pronounce as “Aha, art deco table napkins” or “Late Edwardian antimacassar!” It was an Aladdin’s cave of genteel English bric-a-brac and unwanted Christmas presents.

And dead people’s clothes. It always surprised me just how much of the shop’s contents came from dead people, especially the clothes. Living people, too, often getting rid of clothes they hadn’t worn for a decade or two, or possibly ever. But whatever the source, we had a strict routine for such things. We accepted everything, then at quiet times during the day we’d check for wear and tear, make sure all the pockets were emptied, remove all name tags, and then, if she felt the clothes were good enough to sell, Mrs P. would take them to the launderette at the end of the row of shops. When they came back, we’d put them on display with everything else.

We had similar routines with other items. We’d count all the pieces in the jigsaws, for example, and on really quiet days we’d have a go at assembling them. We didn’t accept any electrically powered goods, but anything requiring batteries was tested to see if it worked.

And the customers kept coming. Every day we sold as many things as we took in; I was (and still am) surprised at how well balanced it all was and how many people came in. Sometimes people donating things also bought something. There were people who came in every day for a browse—and often a chat too, I think. And sometimes people came in to ask if their donation had been sold. Mrs P. said it gave people comfort to know that their gift had helped someone else, and that the charity had benefitted too.

“People trust us,” she said. “We must never forget that. Everything they bring us has been important to them in some way, even if they didn’t want it, and they want us to make sure it is useful to someone else.”

Many years later I was asked to speak to the European Parliamentary working group looking at the then proposed GDPR, and it struck me that data for medical research work on the same broad principles as the old clothes given to the charity shop. We patients donate it so it will be useful to others. It may need a bit of cleaning up, and it certainly needs our names taken off it, and we trust the data handlers to keep it safe and to let researchers use it to help other patients.

It isn’t a perfect analogy of course. But it’s not a bad way of thinking about it. And as Mrs P said, it’s all about trust, really.