CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Helen Springford, vice president of Strategic Development for U.K.-based Illingworth Research, a traditional CRO that also offers research nurse home visits to study participants.
Q: How does patient centricity bear on operations with patients in clinical trials? Hasn’t there always been some aspect of patient centricity when a patient interacts with a nurse?
A: Yes and no. Nurses seeing patients—as I began doing 25 years ago when I became a research nurse—in the clinic is of course patient-centric just by its nature; you’re with patients. But back then, it was far more simple: people went to the hospital or primary care physician to be seen for the study. That’s just the way it was. In those days, we didn’t have the technology to conduct study visits in the home the way we do now. The whole process is now easier on patients, making them happier and retaining them in the study.
Research into orphan diseases has also played a part in changing the dynamic. The rarer the disease, the harder it is to find patients for the trials. It can be like finding a pearl in the ocean or a needle in a haystack. The value of each enrolled patient is huge, and once researchers identify a patient for a rare disease trial, they want to do everything they can to make it easy for them to participate. The idea of being patient-centric has spread and is now used in many types of trials. Sponsors and CROs are comfortable with the fact that the trial doesn’t necessarily need to take place inside a specific building. Because everything’s so mobile now, the trial can come to the patient.
Here’s a good example. We had a pediatric patient with Duchenne muscular dystrophy who used to have to go from the Isle of Man to London every week for a patient visit. He would miss a day of school and his parents had to miss work. The sponsor engaged us, and our research nurses went to see him at home for the majority of the visits. Thanks to the switch, he missed just a half day of school and didn’t have the stress of travel. Traveling is also very hard for elderly patients, patients with pain and patients with cancer. It’s rather simple. If you make life easier for patients, there’s a good chance they’ll stay in the trial.
Q: Does the investment in a truly patient-centric approach really pay dividends?
A: Yes, but not just in terms of monetary value. Satisfaction and happiness among patients and people who care for patients should never be underestimated. My background is in nursing, and no matter what I’m doing as I work on a study—recruiting, working with data—I never forget there’s a patient at the end of it.
The more patient-centric approach helps a lot with recruitment and retention. When we looked at our numbers after we began doing home visits, we saw that in a few studies where home visits were offered, we lost no patients. Not a single one was lost. If you lose a patient, you might be looking at a huge loss to the sponsor as it could delay getting to market. To not lose one patient in a study is phenomenal, especially in a rare patient population.
I don’t see this trend ending, especially now that the technology is here to support it. People are much more mobile than they used to be, and it isn’t always necessary for patients to come to the hospital to participate in a study. There’s so much you can do with them and for them in their homes, in the workplace and at school.
Q: Will the recent U.K. vote to leave the European Union spell disaster for the U.K. clinical trials arena?
A: Everyone is showing great concern about what will happen to companies and research in the U.K., but no one knows what will actually happen. It will take several years to negotiate the terms of Brexit, in any case. A few possible scenarios are: funding sources that typically come from outside the U.K. will dry up, or the political uncertainty and instability—as we’ve seen among some clients who have worked in Ukraine, Russia and Serbia in the past—may cause some degree of aftershock. But I can’t see the U.K. closing down clinical research. There is such talent here. People are worried, but things could stay largely the same. Possibly some good could even come of it. Maybe we find that we actually can trade well with other parts of the world, and we come out ahead. Or it could be that we negotiate the terms of the Brexit deal and take it to another vote and decide to stay. Who knows? I certainly have heard a lot of questions about it from clients already. But nothing is different yet, other than all the questions.
This article was reprinted from Volume 20, Issue 35, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »