ROI Revealed: Quantifying the Impact of Investing in the Patient Experience on Your Trials

Investing in patient experience is known to be important, but the impact of doing so is often not quantified. This makes prioritising these investments difficult as the discussions are not data driven. Now that the appetite for investing in the patient experience has increased, so has the will to quantify its impact.

Where you can see the impact of patient experience improvements

At Stitch, we have worked with our early design partners to develop an ROI model for investing in participant experience. The outputs vary by a range of factors, such as therapeutic area, however the areas of benefit are remarkably consistent between studies.

There are a number of benefits that we don’t attempt to quantify, however those that can be more directly influenced include: Recruitment costs, study timeline, cost of protocol amendments, cost of missed and incomplete visits, and site admin time.

Let’s dive into each metric to understand how improvements to the patient experience will impact them:

1. Recruitment costs

With 92% of potential participants not making it through the screening process, there are a wealth of opportunities for improvement, including:

• Asking people to confirm their attendance at upcoming visits, which has been proven by a site network to reduce no shows for screening visits by 36%.
• Understanding why people choose not to consent, and using that information to adjust the consent process and content.

2. Study timeline

We can reduce the risk of a number of factors that often cause study delays, including:

• If your recruitment process is more efficient, then you can close recruitment earlier.
• Improving retention on your study will lead to your data reaching power earlier.

3. Cost of missed and incomplete visits

While the rate of missed visits, or incomplete visits (i.e. those where the participant attended, but not all procedures could be completed) vary by therapeutic area, there is often significant room for improvement. This can be driven by:

• Reminding participants about upcoming visits
• Improved protocol compliance through sharing requirements about visits that need patient actions, for example, fasting before a visit

4. Cost of protocol amendments

With data from Tufts suggesting that 45% of protocol amendments were avoidable, and that amendments for a phase 3 study cost $535k on average (source), there is a huge opportunity to improve your study. $240k on a typical phase 3, to be precise.

Getting feedback from your participants gives you the information you need to make changes earlier, leading to a reduced need for protocol amendments later in the study process. This can also help with study timelines, as study improvements are made earlier.

5. Site admin time

Sites spend a significant amount of time sharing information about the trial with participants. From the obvious things such as visit time and location, to the more detailed things such as reminding participants of visit requirements. This information is consistent across all sites, and yet the communication of it is duplicated for each patient. Sites can save a lot of time on your studies if you give them capabilities such as:

• Automated visit reminders sent at the right time, before every visit
• Participant access to study info, in context to where they are in the study, reducing the volume of patient questions
• Confirmation of attendance (reducing no shows, and freeing up site time)
• Visit windows that can be seen for each patient’s visit, rather than needing to be calculated each time
• One way messaging, allowing site users to add key info to a visit, and have this shared with the participant at the right time

How to approach ROI calculations

As many of these capabilities are new for sponsors, there is limited data to draw from to determine how these capabilities will impact specific trials, as the impact varies significantly due to differences in therapeutic areas, etc. As such, we suggest to all sponsors that we work with that they approach this with a high level of conservatism.

But despite this conservatism, we’re yet to see a study where investing in the patient experience does not lead to an ROI - and typically a significant one, often in the 5-10x range.

How much will this help you

Quantified benefits give you the data you need to invest in making your trials more patient centric, however we know that every trial is different. Contact the Stitch team to get a personalised ROI model, and find out how much your trials could benefit from investing in your patient experience.