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April 11, 2017updated 18 Sep 2018 10:41am

Industry Viewpoints: Demystifying Preconceptions of the Patient

CTA’s Henry Kerali speaks to David Collier, QMUL, who seeks to debunk some of the common myths about clinical trial patients

By Staff Writer

For clinical trial professionals who attend numerous conferences across the world, at some point during these events, conversation will invariably switch to the role of the patient. Patient centricity, ever the buzzword, will always be the focus for professionals as the industry seeks to create the ultimate patient-centric trial.

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While industry-wide efforts are made to put the patient front and center of a study, sponsor companies must always attend to their needs at each step of the way. With all that goes on during a trial, it might be easy for industry professionals to lose sight of the ultimate goal.

In the next Industry Viewpoint, CTA’s Henry Kerali discussed all things surrounding the patient with David Collier, Joint Clinical Director at the William Harvey Clinical Research Centre. In this compelling interview, Collier shines a light on patient centricity while shredding some of the common myths about clinical trial patients.

Henry Kerali: I recently attended a talk that you gave where you sought to demystify preconceptions of patients in the clinical trial setting. Can you explain your reasoning behind the angle you took?

David Collier: My goal was to make sure people understood that the patients who take part in clinical trials are usually fully competent adults who, in their daily lives, take far more complicated and difficult decisions than taking part in a trial. It is that realization that can help with trying to get a perspective on the trial’s process. We’re in danger of making trials clumsy, complicated, slow and over officious, partly by treating people as if they’re not competent adults unable to make a reasonable decision for themselves.

I argue, especially in a UK setting, where patients always have an alternative form of care, that taking part in a clinical trial should be a safe place. If we can concentrate on getting a clear message about what the study is for, why it’s being done, who’s sponsoring it, and what we’re hoping to achieve then that’s the most important thing.

The way in which trials are often operated can slightly miss the point. An example of that could be endless re-consent for clinical trials where patients are asked to sign new information sheets that are just as long as the first one, but contain very few changes. While those changes may not directly affect the patient at all, the price of those documentary changes is an erosion of trust in the clinical team.

HK: An erosion of trust – in what way?

DC: More often than not, patients are signing these re-consent forms based on trust because, let’s face it, no one wants to read through a 25-page document that’s almost identical to the one they’ve previously signed.

The balancing thing is at the end of studies the most persuasive people are currently are rather voiceless, namely, the patients themselves.

HK: With the drive that’s been made toward building more patient centric trials, do you feel as though there has been significant progress?

DC: There’s a drive, but there’s an awful lot of talk about patient centricity although not a lot has been done. The patients are more grown up than they’re treated and they put a lot of trust in the sponsor, but it’s very important that things are clear and don’t for reasons that are well disclosed. If that’s done then patients become more active in studies and it’s their insights that we learn from. After all we use drugs that our patients liked as well as the ones that gave us statistically significant results. The drugs that have made the most impact are the ones improved the health of patients. It’s the drugs that are popular with the patients and the clinicians that make the big difference.

HK: Patient centricity – all talk and not enough action?

DC: There’s definitely been a lot of high level talk, but the experience of commercial decision making and how it effects patients, we sometimes find ourselves arguing for drugs which companies have made very clear commercial decisions on. We’re trying to defend compounds against the company or to advocate drugs that have genuine use and in the long run profitable. However, sometimes there is a legitimate reason why a commercial decision has been made that we’re not aware of, or sometimes the champion of the drug may have left the company, and so on.

HK: As far as patient centricity is concerned, do you feel things will change for the better?

DC: Things will have to change – the old model has become terribly expensive and cumbersome. The lack of regulation is tying us all down in knots and not always focusing on the important things of the trial. We may get criticized about the tiny things in a study and huge decisions that are highly debatable, and we may have no influence or say in it.

We strongly believe that the most impact we’ve had in trials is where, as a site, we are intellectually engaged, have strong opinion leaders involved in the study, and we recruit well. This is essential so that by the end of the study, we can be involved in making sure the write-up story is strong, and that’s magnified if we have patients who can help to explain how it’s affected them after the study. If you can do all of those things it can be transformational for a company or a compound, or a device.

 

*David Collier is the Joint Clinical Director at the William Harvey Clinical Research Centre (QMUL)

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