Need Better Clinical Trial Retention? Start with eConsent

Electronic ICF is cost-effective, scalable, and easy-to-use

Author: Tina Caruana, MSc, MBA, Medrio Subject Matter Expert – eClinical Solutions (Digital & Decentralized Trials)

Quantifying the Participant Retention Issue

Clinical trials are expensive. It takes an enormous investment of time and money to bring a product through research and development to the market. One of the most significant expenditures is participant enrollment, which makes up 40% of a clinical trial budget [1] – and a huge driver of that cost is participant attrition. Across all therapeutic areas, roughly 19% of participants in clinical trials drop out [2] , and the average cost to recruit a new patient if one is lost is $2,273 [3]. Together, these factors greatly increase study timelines and inflate research costs. 

And, it is only getting worse. The participant retention issue, and its corresponding cost issue, appear to be escalating. The Tufts Center for the Study of Drug Development reports that participant dropout rates increased by nearly 25% from 2012 to 2019 [3]. When participant retention is not addressed, studies need to recruit additional participants and extend trial timelines, leading ultimately to budget overruns. 

Problem Solving at Scale

Improving participant retention and mitigating high study costs can be difficult for sponsors, CROs and sites to achieve at scale. Many of the common reasons for clinical trial attrition, such as travel inconvenience, and time or cost burdens, are participant-centric and require expensive, individualized solutions. However, the informed consent process is an aspect that can be enhanced at a broader trial level – using eConsent, to ultimately retain more participants. How is this possible?

Managing Participant Expectations

A controllable, but often overlooked, reason for clinical trial attrition is that the experience was not what participants thought they signed up for. Trial participants who drop out early are twice as likely as those who complete the trial to say that the trial fell short of or did not meet their expectations [4].

Why might clinical trials not meet participant expectations?

It appears to start with informed consent. When compared to participants who completed a trial, those who dropped out [4] were:

  • More likely to report that they found the informed consent form (ICF) difficult to understand
  • Less satisfied that their questions had been answered
  • More likely to find the clinical trial visits stressful

In other words, for many clinical trial participants who drop out, the informed consent process failed. They didn’t understand the study’s purpose, procedures, risks, or benefits – all of which are necessary for fully informed consent.  

What is eConsent?

Electronic informed consent (eConsent) is a tool designed to make the consent process more accessible and inclusive for patients. Compared to paper-based consent workflows, eConsent can reduce attrition and lower study costs by tackling participant expectations. It provides the necessary information in a convenient format, affords time for participants to digest study requirements, and supports enhanced engagement with site staff – vastly improving consent form discussion and comprehension so that participants know what to expect from a clinical trial and the risks involved.

Building a Better Consent Process

Informed consent is a journey – for patients and their caregivers as well as study teams – rather than a mundane procedure of simply gathering signatures. A robust eConsent platform can be built to address participant concerns and answer questions while being extremely cost-effective. With support from a team of Subject Matter Experts, sponsors and CROs can begin to implement tools like Medrio eConsent with confidence, allowing all major trial stakeholders – participants, sites and sponsors – to experience the benefits of a more engaging, informative and modern consent process. Click here to learn more about Medrio eConsent.

References

1. Nuttall, A. (2012, March 23). Considerations for improving patient recruitment into clinical trials. RDP CLINICAL OUTSOURCING. Retrieved September 12, 2022.

2. Getz, K. A. (2020, December 19). Can recruitment and retention get any worse? Applied Clinical Trials Online. Retrieved September 12, 2022.

3. Tufts. (2020, January/February). New global recruitment performance benchmarks yield mixed results. IMPACT report, Tufts Center for the study of drug development. Retrieved September 12, 2022.

4. Advarra. (2021, March 23). Retention in clinical trials: Keeping patients on protocols. Advarra. Retrieved September 12, 2022.

5. EConsent clinical trial software. Medrio. (2022, September 5). Retrieved September 12, 2022.

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