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Patient-centricity in clinical trial design

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Patient/trial collaboration could be the way forward for study design. MESM investigates the benefits and pain points using industry examples.

Collaboration has been hailed as the cornerstone of better clinical trials.[1] Patients are no longer being viewed as ‘subjects’ but as informed participants who can provide unique insights into the trial process. Patient-centricity is the ‘buzzword’ most often used when discussing collaborative drug development.

It’s useful to have a recognisable buzzword to make the subject an accessible one. However, merging the varied components of patient-centricity into one term can result in the misconception that a patient-centred trial is more complex and less cost-effective. This article will examine the benefits and the most common pain points of patient/trial collaborations. Using the Lilly CoDESIGN initiative as an exemplar, we investigate how these issues can be resolved.

Patient/trial collaboration: The benefits

Following research into patient involvement in trial design, academics at Guy’s Hospital in London concluded that “trial design should be based on the principle of joint ownership”.[2] The FDA and NIHR agree that collaborating with patients has a positive effect on the outcome of the trial.[3] Here are some of the most prominent reasons for this:

  • Recruitment and retention: Participants who are fully aware of what lays ahead in a trial may be less likely to drop-out.[4] The result will be higher retention rates and fewer costly delays. This is of huge importance considering that “recruitment and retention of patients is one of the biggest challenges of drug development”.[5]
  • A unique perspective: Patient-participants can offer a personal outlook which may not have been considered by study managers with less experience of the health condition under scrutiny.
  • Fewer delays: Engaging patients from an early stage helps to give them ownership over their role in the trial which may make them more responsive to feedback requests later on.
  • Reputation: Patient collaboration will help to raise the positive profile of a trial and position it as progressive and highly considerate.[6]

 

Pain points: What holds back effective communication between patients and clinical trials professionals?

“There isn’t time.”

  • Tight budgets and strict planning often mean that clinical trials professionals are pushed for time. A simple solution would be a pre-trial patient survey. Questions could include: ‘what would you like to get out of this trial?’ and ‘how would you like to be informed of trial progress?’. Identifying the level of involvement which participants desire will help to alleviate subsequent time pressures and set a strong precedence for patient-centricity in the rest of the trial.

“The trial is already designed. Patient input can’t change that.”

  • Initial proposals must be flexible to allow for patient feedback. Although not a viable option for all projects, Adaptive trial designs allow for modifications to be made mid-trial.[7] Learn more about the pros and cons of Adaptive trial design here.

“Funding doesn’t allow for patient collaboration.”

  • There are many low-budget ways of including patient feedback in your trial design.[8] Online forums and Facebook groups can be a great resource for opinions and open discussion. Just be sure to make transparency a priority so that patients are fully aware of how their data is being used.

 

Focus on: The Elli Lilly CoDESIGN (formally CoLAB) initiative[9]

In the early stages of trial design Elli Lilly invite key stakeholders to witness a discussion which covers the initial plans for study design. These key stakeholders include patients and caregivers along with study coordinators and managers. This ‘dress rehearsal’ allows all parties to voice their opinions and concerns before the protocol is written up so that it can be designed with the interests of all participants in mind.

 The CoDESIGN initiative is devised to reduce delays during the live trial bought about by patient drop-outs and clinical issues which could have been spotted earlier on. Elli Lilly is leading the field when it comes to patient/trial collaboration. The CoDESIGN initiative is a great example of how clinical trials professionals can collaborate with participants to bring drugs to market more quickly.

“Nothing about us without us” [10]

Participants use this term to express their desire to be involved in all stages of clinical trial design.[11] Collaboration brings advantages to all parties and should be a major consideration for study managers and coordinators.[12] Empowering patients to actively collaborate in trial design helps to increase retention rates, reduce recruitment costs, and thus keep clinical trials on-time and on-budget.

 

[1] https://www.outsourcing-pharma.com/Article/2018/12/12/Collaboration-created-the-cornerstone-of-better-clinical-trials-now-it-s-time-to-build

[2] https://onlinelibrary.wiley.com/doi/full/10.1111/j.1369-7625.2004.00232.x

[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504054/

   https://www.fda.gov/forpatients/patientengagement/ucm506248.htm

[4] http://www.evidentlycochrane.net/retention-to-clinical-trials/

[5] https://pharmaphorum.com/views-and-analysis/future-clinical-trial-collaboration-patient-centricity-2/

[6] https://www.boehringer-ingelheim.com/press-release/virtual-clinical-trial-collaboration-science-37

   https://www.lilly.co.uk/global/img/UK/Patient/Lilly-PAG-Report-FINAL-WEB-COPY.pdf

[7] https://www.bmj.com/content/360/bmj.k698

[8] https://www.bmj.com/content/353/bmj.i1922

[9] https://blog.lillytrialguide.com/codesign-clinical-trial-experience-together/

[10] https://www.bmj.com/content/354/bmj.i3883.abstract

[11] Ibid.

[12] https://onlinelibrary.wiley.com/doi/full/10.1111/j.1369-7625.2004.00232.x