Understanding Patient Willingness
to Participate (WTP) in Type 2
diabetes clinical trials
Why understanding the patient perspective is crucial for type 2 diabetes patient recruitment
These insights are built on an in-depth interview with a type-2 diabetes patient, click here to get the full interview.
A lack of understanding of the patient perspective is among the top reasons cited by sponsors, CROs and sites alike in our survey with 812 sponsors, CROs, and trial sites, on the persistent challenges in recruiting and retaining participants in clinical trials. For type 2 diabetes trials, this lack of understanding of patients willingness to participate is even a larger problem, as recent studies and our blog on the top 5 challenges for type 2 diabetes patient recruitment, recently highlighted.
In this blog, we take a in-depth look at patients reasons to participate in type 2 diabetes trials and measures that sponsors and trial organizers can take to improve their understanding of the patient perspective.
This blog looks at:
- The importance of the patient perspective in type 2 diabetes patient recruitment
- Methods to understand the patient perspective
- How understanding the patient perspective can improve recruitment and retention in type 2 diabetes trials
- Clariness’ approach to incorporating the in recruitment, screening, treatment and follow-up phase
This blog is based on multiple surveys and interviews we have conducted with diabetes patients about their reasons to participate in a clinical trial. Interested in reading the interview with a German type 2 diabetes patient on his reasons for participation? Download it here.
The importance of understanding the patient perspective in type 2 diabetes patient recruitment
As of July 2022, there were 819 studies for type 2 diabetes live and recruiting patients. Many of these studies are in the recruitment phase longer than initially anticipated, on hold, or even canceled before starting, highlighting the challenges that organizers face in enrolling the required number of patients for type 2 diabetes trials.
As our recent whitepaper Enhancing Clinical Trials, highlighted, sponsors, CRO’s and sites alike (27% across responders) view understanding the patient perspective as one of the biggest reasons for this failure to recruit and retain study participants.
The fact that sponsors and sites’ lack an understanding of diabetes patient populations is also signaled by various diabetes patient organizations, as Mathias Briel et al highlight in their recent quantitative survey on diabetes patient recruitment in Germany, Switzerland and Canada.
“I believe it is a lack of trust between [study] doctor and patient, bad doctor patient relationship, a lack of trust into the system, language barriers, patients not trusting the protocol or not understanding why joining the study should be beneficial for them”. – Patient organization representative interviewed by Briel et al (2021)
As an interviewed Principle Investigator notes, study organizers often fail to understand what exactly makes type 2 diabetes trials intensive for patients:
Another important reason is that the protocol – it was a randomized controlled treatment trial in diabetes – the protocol was quite intensive for patients. And a major reason why patients participate or do not participate is whether it brings them something new which they do not receive by conventional, usual daily care. So it was not very attractive.” Briel et al (2021)
While largescale surveys by for example Geppert et al (2014) confirm that the Willingness to Participate in Type 2 diabetes clinical trials is influenced heavily by the perceived intensity of participation in relation to the perceived personal benefits, this is not the whole story.
Firstly, while over 75% of the type 2 diabetes patients cite access to alternative, new or specialized treatment as their primary reason to participate in a study, over 63% see altruistic reasons as the second most important factor.
Secondly, what organizers often ignore is that these are perceived factors rather then absolute, unchangeable, reasons and that outreach campaigns and patient-centric, lay-friendly, study materials can improve understanding and thereby Willingness to Participate. More so, retention which is a often cited problem in type 2 diabetes studies, can be improved by activities that explain why a study procedure is the way it is and the wider importance of the individual study for research on diabetes in general.
Ultimately, this lack of in-depth understanding of the patient perspective results in an inadequate patient recruitment campaign or retention materials and measures.
For example, most clinical trial organizers work with study materials that are, at best, a lay-friendly summary of the study protocol, rather than informational materials that address the specific concerns of the local diabetes patient population. At Clariness, our Retention Team therefore works closely with the Patient Insight Team to produce study materials that improve recruitment and retention rates.
How to get a better understanding of patient’s Willingness to Participate in type 2 diabetes trials
Qualitative research on patient perspectives has become increasingly useful in recent years to identify and address problems in patient recruitment and retention. A qualitative understanding of the local type 2 diabetes population focuses on answering questions such as: Why do some diabetes patients choose to participate in clinical trials while the majority of patients do not? What factors influence the Willingness to Participate for type 2 diabetes patients from various backgrounds? What would improve Patient Willingness to Participate and what are the most effective outreach channels?
Three ways to improve the understanding of diabetes patient population patient perspective:
- Largescale local and international digital surveys with thousands of patients from different backgrounds
- In-depth interviews with individual patients with type 2 diabetes
- Partnerships with type 2 diabetes patient organizations
“Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions” – Penny Wright et al (2017) “Maximising Recruitment to Randomized Controlled Trials: The Role of Qualitative Research to Inform Recruitment Challenges”
At Clariness, we have conducted several largescale Type 2 diabetes surveys in the past years, regularly interview patients about their experiences and motivations to participate and work closely with a variety of patient organizations. To find out more, contact us here.
How understanding the patient perspective can improve patient-centricity, patient recruitment and retention in type 2 diabetes trials
Understanding the patient perspective is the first step to a successful patient recruitment campaign and retention of participants.
1. Using the patient perspective to create more patient-centric type 2 diabetes study designs
A 2009 review study by Robiner et al identified the most commonly cited reasons for refusal to participate in a diabetes clinical trials. Examples are not being able to work, frequency and number of appointments, study length, access to study locations, and physical discomfort associated with procedures as major barriers to participation. Introducing remote visits, making it possible to do video consults and improved compensation are ways to incorporate the patient perspective and improve retention.
2. Adjusting outreach materials and advertisements to patient perspective
A common, and understandable, assumption is that Willingness to Participate in clinical trials for a large part is related to fear for complications and side-effects due to the study medication. For type 2 diabetes clinical trials it is important to recognize that various groups can perceive the barriers to study participation differently. For example, Dutch researchers as Eline M Bunnik et al (2009) highlighted that genetical research and predictive testing in diabetes trials, might not be a reason to decide against participation for white or highly educated patients, but is for minority populations and people from lower social-economic status. This because minority populations more often fear stigmatization or do not understand why these tests are required.
Referring to data protection laws that ensure anonymous participation, ensuring that advertisements are diverse and representative of different patient groups, and highlighting the importance of the research to the respective community can help to alleviate these fears and increase participation rates.
As diabetes patients often are willing to participate in future studies, it is crucial that throughout the study as well as in the follow-up they are involved in the research progress. This is also highlighted by Stephanie Estcourt et al (2016):
“The lack of information or feedback about the research itself was extremely frustrating for several participants. There was a general sense of disappointment about the lack of information at the end of the study and no sense that feedback about results had been received.”
3. Leveraging patient motivation and perspectives
Using testimonials and experiences by other patients is a great way to improve participation rates and remove fears. Some testimonials examples from Estcourt’s study and our interview include:
‘You give something back and if it helps find a cure in the future, it might not find a cure for me, which I don’t think it will, but in the future it might help further down the line and that was my reason for doing it.’ – Patient 1
“I think that participating gives me the opportunity to be examined and accompanied by a study doctor much more extensively than otherwise with normal doctors and this was really important for me after I was just diagnosed.” – Patient 2
Clariness’ approach to incorporating the patient perspective in recruitment, screening, treatment and follow-up phase
As we recently highlighted in our whitepaper “Enhance Your Clinical Trials in 2022”, partnering with a third-party provider is one way organizers can profit from the expertise in understanding the patient perspective and boost their recruitment and retention rates.
Leveraging a third-party provider as Clariness, that based on its 17+ years of experience has a qualitative and quantitative understanding of the local and international diabetes patient populations can solve specific barriers in either the study protocol and planned study procedure, or boost patient willingness to participate and stay in the study.
Services that Clariness offers to improve the understanding of the patient perspective:
With more than 17+ years of experience of quantitative recruitment data and qualitative understanding of patients’ needs through local and international surveys and patient interviews, Clariness has a proven expertise in patient recruitment for type 2 diabetes clinical trials. This is testified by the fact that we have successfully conducted digital patient recruitment campaigns for over 75 diabetes clinical trials.
- Local and international questionnaires with a large group of diverse patients
- Individual interviews with subscribers to the ClinLife® database
- Technology and data-driven analysis. For example, analysis of answers to pre-screening questions, the most frequently accessed questions on the FAQ page, and constant analysis of advertising and the success of the channels
Want help with getting closer to patients? Contact us
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