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Is your clinical trial method tried and tested with patients in mind?

As you may know, we talk about putting patients first, a lot. This means thinking about patients when discussing, writing and designing recruitment materials, whilst also using a multi-method approach. For example, there are huge benefits in using direct patient insights from advocacy groups, as well as conducting social listening exercises. If you utilise these approaches, you’re more likely to engage with the patient population as effectively as possible. This is what creates successful patient recruitment strategies. Makes sense, right?

Patients should be put first in clinical trials too. Producing beautiful and intuitive patient documents, digital marketing and websites certainly helps — but how do you take it to the next level? How do you ensure that your clinical trials are designed, from conception to completion, with the user experience in mind? Let’s take a closer look.

Different clinical trial methods: what does the evidence say?

Clinical trial methodology has become a hot topic in recent years. There is a growing body of research into the effectiveness of strategies used across the industry that are used to improve recruitment, retention and other indicators of trial performance. Yet when I think about it, this makes no sense to me. Let me explain why.

We work in the business of the scientific method — rigorously testing one thing against another to find evidence of superiority. However, when it comes to the methods used to attract and retain patients, to train staff involved in running the trial, and to adapt trial design to optimise benefits for patients – there has been little to no evidence about which of these methods we should be using, or which are preferred by patients. It seems that research has been mainly geared towards what might enhance clinical trial performance, rather than what’s best for the patient.

The value of adaptive trial designs

Due to the coronavirus pandemic and the paradigm shift in the industry towards decentralised trials, there is also growing evidence of the effect this has on patient recruitment, retention and satisfaction as a whole. Adaptive trial designs have also partly been born out of the results of this work. But what exactly are they?

At the most basic level, they are trials that have criteria written into the protocol from the outset that allow different treatment or doses to be added or removed, based on pre-defined interim analysis periods, and real-time decisions based on incoming data rather than waiting until the final analysis. Essentially, as data is collected throughout the trial, the protocol allows pre-defined adjustments to be made — giving greater flexibility and increasing the chance of answering the clinical question being asked in the trial.

In reality, this means that less effective treatments can be removed, and effective doses can be identified earlier. For this reason, adaptive trial designs can have many benefits, including cost savings, shorter trial duration and a greater possibility of patient receiving an active treatment that will benefit their condition, rather than the 50/50 chance on a traditional two-arm, placebo-controlled randomised clinical trial. Furthermore, combining adaptive trial design with remote visits and electronic data collection could hugely change the public perception of what is required for patients to take part.

Appealing to your most-valued stakeholder

Of course, treatment compliance, protocol adherence, and data integrity remain highly important to the value of a clinical trial. However, reducing patient burden in terms of intrusive clinical assessments, multiple study-specific hospital visits, and mind-numbing data collection can have a huge impact of the attractiveness of your trial to your most important stakeholder — you guessed it — the patient.

Utilising the combination of patient-first philosophy and forward-thinking trial design is a powerful strategy for ensuring that your clinical trial is attractive, cost-effective and deliverable.

COUCH Health are already working with clients on improving the patient experience through trial design, including projects that are part of the FDA’s Complex Innovative Trial Design (CID) Pilot Program. If you think we could help you, please get in touch…

This blog was first published here.

1st June 2021

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