CROs + Patient Insights = A Required Differentiation in Clinical Trial Design Offerings for Sponsors
Over the last eight (8) years gathering direct patient insights from the actual voice of more than 22,000 real-world participants, biopharmaceutical sponsors have led the way.
Over the last eight (8) years gathering direct patient insights from the actual voice of more than 22,000 real-world participants, biopharmaceutical sponsors have led the way. These clinical market research projects have provided critical patient insights that have changed numerous clinical trial;
- protocol designs
- schedule of events
- decentralized research approaches
- eCOA instruments selection
- informed consent language
- recruitment advertisements
- retention strategies.
Biopharma is moving this patient co-creation innovation forward and is closer to making it the standard design approach for their clinical trials. In parallel to biopharma’s push to standardize rapidly, only a few CROs are now starting to offer these solutions as a part of their design solutions. As patient listening and co-creation of clinical research designs have begun to become mainstream, we are beginning to receive and answer daily questions from CRO teams working to add this feature to their suite of solutions.
If you are a CRO looking to incorporate this solution into your standard clinical trial design offerings for biopharma sponsors, below are the four (4) key questions and responses we recommend for your consideration.
Do biopharma sponsors require patient co-creation and insights?
Many CRO team members have told us they believe biopharma sponsors don’t require these insights. Our short response to pivot this inaccurate thinking is to focus on a few critical objectives that every Phase Ib – IV clinical trial and registry should consider.
- Patient insights are no longer optional as they are a regulatory expectation.The FDA's 21st Century Cures Act explicitly recommends incorporating the patient voice into clinical development, including how patient experience data is collected, analyzed, and addressed in regulatory submission. Providing this documented feedback from a group of real-world representative participants with how it was incorporated is now a well-known request from regulators.
- Sponsors, and the CROs that support them, are expected to demonstrate not just that they checked the box, but that they obtained a clear understanding of patient burden, unmet needs, and lived experience throughout this specific clinical trial’s lifecycle. Many biopharma sponsors now have these requirements in their internal protocol development approach and clinical trial design processes.
- CROs are tasked with supporting better clinical trial design. They are contracted to achieve recruitment timelines on schedule, decrease protocol amendments with expertise and enable better than retention to capture the data needed to significantly power the study analysis. These objectives require patients (and caregivers when applicable) to be included, supported and engaged. Would you design a product for a user and never ask the user how they could be best included, supported and engaged with it?
What do these patient insights offer that we don’t already know in our clinical trial experience with this participant population?
“Assumptions are made, and most assumptions are wrong.” – Albert Einstein.
We have heard from several CROs who strongly believe they already understand all the patients’ needs in a specific study because they are experienced in supporting biopharma sponsors to run clinical trials in this patient populations they have supported previously. They will often recall a meeting they attended where a patient advocate spoke about what mattered in research study design or how a previous studies’ retention rates were as expected, so the patient’s needs were understood and addressed (i.e. their design was sufficient).
Co-creating with representative patients will re-enforce previous experience and lessons learned to be introduced in this next study. It will also surface new insights specific to a study that general feedback could not offer. When done right and without assuming we know the response already, patient insights will uncover a host of friction points and offer ideas on how to overcome them in each specific study. It may validate already made decisions but most often contributes to changes needed as it acts as an early warning system in study design.
This feedback often identifies friction points in protocol design, site workflows, visit schedules, assessments, and communications that create unnecessary burden and poor retention. Uncovering these friction points early and before a study design is locked, confirms what might not work from the patient’s perspective before an issue contributes to a costly amendment, delay, or failure.
How do patient insights contribute to better study recruitment and retention?
Listening enables CROs to design patient centric recruitment and retention strategies from day one, rather than reacting once enrollment is having challenges or delays. By understanding patient motivations, barriers, and real‑world constraints early, CROs can help sponsors optimize study design, messaging, and support services.CROs are not only evaluated solely on operational execution. CROs differentiate themselves by helping their sponsors’ studies to be differentiated. This starts with the recruitment and retention materials that are provided to patients throughout the life of a clinical trial. In a clinical trial world full of repeated strategies, study designs and general messaging campaigns, you can create recruitment and retention solutions that are fresh, user-generated and standout.
We utilize a range of methods, interview strategies and question types to obtain insights for study recruitment and retention assets. To remain brief and offer an example, if you are creating patient recruitment advertisements, educational materials, training videos, retention swag, or engagement messages, representative real-world participants that could meet your clinical trial inclusion/exclusion criteria will offer their direct feedback on your drafts.
Conducting patient insights with a combination of visual A/B/C testing, open-ended questions and Likert scales can provide a robust series of responses to enhance these assets. This may re-enforce decisions already made on the strategies, highlight missing key messages and/or confirm that you need to start over again. This is a common occurrence in our experience seeing this feedback from patients on a weekly basis. You will want this feedback to contribute to better recruitment and retention strategies that patients actually want to support them.
What is the best place to start utilizing patient insights with minimal investment and proven return?
Consider starting with a five (5) patient insights project. In only days with minimal budget, you can offer patient feedback that may increase your proposal win rate.
CROs that offer this solution to their customers typically engage us as early in the protocol design process as possible. The opportunity to change specific operations in the protocol or study materials before RA/IBR/EC submission, enables listening to be truly considered in the design process. This thinking can also begin during the CRO proposal process in which you can offer patient voices and insights in your proposal materials and/or bid defense meeting.
Imagine you are presenting your protocol and study operational considerations when you click in your slide deck for a representative patient to begin speaking to the group re-enforcing the point you just contributed. Imagine you are giving difficult feedback on a specific study requirement and then click in your slide deck for a representative patient to say with directness in their own words that they would never participant in a clinical trial because of it.
The ability to start with patient co-creation in your study design thinking can differentiate your offering, how you design studies and show (not just tell) that you are pro-actively engaging with patients to deliver this study better and with more insights than your competitors.
If you are a CRO, we strongly recommend you offering patient co-creation and listening a key feature within your design features. THREAD provides a proven technology solution and industry-leading expertise to add it to your offerings. If you want to learn more about how you could incorporate patient co-creating and listening in your customer solutions, please check out or send us an email to sales@threadresearch.com.