Improving patient perceptions of clinical studies

Written by Rosie Pigott

This is the third in a series of patient centricity blog posts. You may also be interested in the first and second articles in the series – How digital is giving patients control of managing their care and Adapt or die: The risks of not being patient centric.

Participating in a clinical trial can be a challenging experience for patients, particularly if they are not properly engaged throughout the process. Though significant progress has been made (e.g. through collaborations such as CTTI, CISCRP, TransCelerate and the European Patients’ Forum), there is still more that the industry could do to enhance patient experience. This will be a particularly important differentiator as both the number and complexity of clinical trials increases, while the patient pool remains limited.

That’s why leading companies are engaging patients from trial design to beyond study close-out to create a holistic framework for improving patient experience.

Design for success

To enable the best chance of successfully developing a trial that will be both scientifically robust and patient-friendly, patients must be involved at the design phase. Traditionally, patients, advocacy groups and related stakeholders are engaged through interviews or advisory boards. Pharma companies are increasingly conducting protocol simulations to recreate the proposed trial situation and gain realistic feedback from patients, sites and study teams. Eli Lilly for example launched their CoLAB simulation initiative to do exactly this.

Eli Lilly simulation of a study site.
Image source

Simulations can result in critical patient insights. For example, a pharma client described their standard approach using white male doctors and monitors ahead of a proposed US Lupus study. During the simulation, the predominantly African American female patients expressed discomfort in discussing their disease with these doctors – a finding that could have negatively impacted patient experience, which may not have otherwise been highlighted.

Patients should also have a say in the way that clinical trial results are measured and reported through ‘Patient Important Outcomes’. Outcomes classically used in research may not always be pertinent to patients. For instance, Noble and Marson (2016) discovered additional outcomes of importance to epilepsy patients including depression, anxiety and independence. By building the collection and reporting of these outcomes into study design it resonates with patients both during the trial and when digesting the results.

Enhance the user experience

Digitisation is revolutionising the way patients engage with their healthcare and each other during clinical trials (see previous blog post). Patients can now monitor their progress and engage with their healthcare providers through smart devices, and many companies are developing innovative adherence technologies which could be utilised during clinical trials (see Merck’s digital behavioural change programme).

Improving patient experience is not just about supporting them in staying on track with their medications: it’s also about keeping them actively informed about the latest trial developments. The Mayo Clinic post videos for patients taking part in their trials, such as this recent update on current clinical trials with stem cells for the treatment of Amyotrophic Lateral Sclerosis (ALS). Open communications shouldn’t end when the trial finishes either; organisations like ViiV were early adopters of sharing anonymised patient-level data from its clinical trials. The European Medicines Agency’s (EMA’s) 2019 Clinical Trial Regulation will necessitate companies to publish lay summaries of all trials conducted in the EU but research suggests that ~90% of patients want to actively receive the results after completion, rather than just uploaded onto a repository (Shalowitz & Miller, 2008).

Pharma has the opportunity to facilitate digital patient communities by proactively establishing forums for those taking part in their clinical trials or, perhaps to greater impact, collaborating with existing, trusted networks to do so e.g. PatientsLikeMe. This can then serve as a platform for sponsors to share important information with participants, as well as assisting patients in forming important connections with those going through a similar experience.

PatientsLikeMe’s clinical trial tool.
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Demonstrate the impact and improve

There is still no common method to measure patient experience in clinical trials, which will be key to evaluating whether these approaches are having a measured effect, further improving them, and positively impacting recruitment and retention in turn. This is one of the key Transcelerate initiatives, which is working to develop a shared framework for measuring and enhancing the patient experience across all clinical trials.

In order to improve patient perceptions of clinical trials, Pharma first has to understand their perspective. If you want to find out more about what patients really think about clinical trials, this video from the Patient Empowerment Network is a good place to start:

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