The top 5 barriers to type 2 diabetes patient recruitment, and how to overcome them
Different conditions and indications present their own distinct challenges when recruiting patients for clinical trials, and diabetes is no exception.
Clariness has supported more than 75 diabetes clinical trials, and with this, we have built an understanding of the main barriers to recruitment. Further, with 18+ years of quantitative recruitment data and qualitative understanding of patients’ needs through surveys, we know the best ways to tackle these barriers, by leveraging different resources, methods, and tailor-made services.
In this blog, we focus on the top 5 barriers to recruiting patients with type 2 diabetes, and provide our recommendations on how to overcome them, these are:
- Lower levels of patient discipline
- Lack of perceived benefits
- Compensation expectations
- Patient understanding of inclusion and exclusion criteria
- Unique needs of different patient populations
The rise of type 2 diabetes and the need for better patient recruitment
According to the World Health Organization, the number of people that suffer from diabetes has increased dramatically over the past years. Type 2 diabetes is now the most common type of diabetes, with >90% of patients with diabetes suffering from type 2 diabetes.
Despite the growing number of patients with type 2 diabetes, many clinical trial organizers don’t reach the expected/required target of patients to participate in their trials due to multiple factors. Research has shown, that in the case of diabetes, factors such as strict inclusion and exclusion criteria, diabetic patients’ needs in different regions, patients’ discipline and commitment, pose barriers to enrollment.
Barrier 1: Lower patient discipline
Patients with diabetes can very often “lack discipline”, and this with regards to trial timelines, scheduled visits, and recruitment commitments can be very challenging. This can be connected to the manifestation of type 2 diabetes and its symptoms, including for example the decrease in muscle mass, which makes regular exercise and physical activity more difficult.
How to overcome this barrier
Some useful recommendations to solve this barrier can be:
- Support the sites in terms of planning visits
- Send reminders to patients to prevent them from forgetting their appointments
- Implement visit cards with the details of the visit and the dates of their next visits
- Provide patients and their families with educational materials explaining the benefits of helping motivate patients
Barrier 2: Lack of perceived benefits
Sometimes it can be hard to explain why participating in a clinical trial can be beneficial for patients with type 2 diabetes, or there can be misconceptions about clinical trials in general.
Moreover, there are already several commonly prescribed medications for type 2 diabetes, including Insulin, Metformin, Glipizide and Glimepiride. With most patients therefore being able to manage their condition well, the perceived marginal gains for many patients don’t weigh up against the perceived risks.
How to overcome this barrier
It is vital to explain to the patients the benefits that come with participating in a clinical study, not only for them, but also for the advancement of medical research and study-related benefits for all patients with diabetes type 2.
This means that the goal of the study should be advertised in a way that makes clear the benefits to the patient participating, as well as to the patient community in general. For instance, if the study is assessing modern technologies or devices to better monitor patient’s health, present this in a way that explains the potential impact to a patient or others with the same condition, in terms of more convenience, or more frequent data and monitoring, for example.
By participating, patients have access to high quality treatments and personal care by specialist medical professionals. Explaining that these trials have the goal of supporting the patients with different conditions and improve their wellbeing can improve their willingness to participate.
Furthermore, patient testimonials from the same study, or similar ones, can be powerful tools in conveying patients’ perceived benefits, as they bring their own experience and outcomes which will better resonate with a study participant. At ClinLife®, we notice that explaining the goals and progress of clinical research in a patient-friendly way, helps with sign-up rates and improving retention rates for diabetes type 2 trials.
Barrier 3: Compensation expectations
It is very often that people expect to be remunerated for their participation time through financial compensation, especially when it comes to patients of a lower economic status. This does not depend on a specific region or country, but rather it is seen globally.
Patients with diabetes may not want to participate at the beginning, as they expect compensation, rewards, or benefits. There may be sites that don’t specify if the clinical trial offers compensation.
How to overcome this barrier
We suggest highlighting immediately whether the trial is compensated or not. It might still be better to focus on the wider benefits to either the study participant, or others with a similar condition, to bridge the shift drivers from financial gain to altruism. IF the study is not compensated, it is still recommended to bring in the wider benefits of participation to attract those that may have been initially driven by financial gain, to altruistic drivers.
At Clariness, we understand this challenge, therefore, we are committed to being transparent and providing the right information to patients, including conveying patient benefits in a patient-centric manner. Further, it is important to state from the start the estimated duration of the trial, whether in months or weeks, and if there is going to be any compensation for the time spent, or monetary aid for transport or time invested.
Barrier 4: Patient understanding of inclusion and exclusion criteria
When recruiting patients with diabetes, the study specific demands for patient enrollment can vary widely. It is crucial to highlight and explain to potential participants why stringent eligibility criteria includes more than just having the condition, but also their health status, medical history, behaviors and characteristics, among others.
Often, the eligibility criteria is presented to the patient only later in the enrollment process and using medical terminology that is not patient friendly. This creates barriers in both the initial sign-up process, and frustration for both patients and investigators if willing patients are screened at a site where they do not meet the criteria.
How to overcome this barrier
It is not just vital to state from the beginning in a clear and patient-centric way, the specific criteria that patients need to fulfil to qualify for the diabetes studies, but also help patients in finding out if they fulfill these criteria. Clariness has created indication and study-specific digital screeners in multiple languages that provide patients with eligibility criteria in a way that is easy to understand. This reduces drop-out when patients reach the study site, as they will already have been pre-screened and further qualified by Clariness’ in-house enrollment management center, which speaks directly with potential patients over the phone to walkthrough inclusion and exclusion criteria and process of participating in a clinical trial.
Clariness has introduced a powerful new tool called Clinlytics, which allows for the analyzing of thousands of protocols and patient-recorded data to better optimize study feasibility. You can learn more about Clinlytics here.
Barrier 5: Unique needs of different patient populations
Patients with diabetes across the globe have diverse cultures, languages, and sociodemographic statuses that impact enrollment. Patients living in countries in Asia or South America have unique needs from those in Europe. Patients in developing countries may not have the economic resources to access certain medicines or treatments. For instance, some medications or drugs can be particularly expensive or scarce for patients living in certain regions.
How to overcome this barrier
This barrier can be addressed in different ways:
- Having experts that understand the needs of patients depending on the region they are in, with experience in delivering patients from your study’s target regions
- Researching, in-depth, the target population and their background, culture, and lifestyle, including patient focus groups, surveys, and patient-recorded data
- Remembering to design a trial that works with patients from different regions, there is not a one size fits all trial that works globally
Clariness has the skills and knowledge to understand patients from different regions and countries on a global level, which is vital for a successful clinical recruitment campaign. We provide real-world patient population data, international patient, and site surveys, and bring with us more than 18 years of global experience in internationally recruiting patients with diabetes.
If you want to know in detail how we make this possible, feel free to contact us here.
Conclusion: Patient understanding is key to successful diabetes type 2 patient recruitment
To overcome the obstacles of diabetes type 2 patient recruitment, it is vital to understand the patients and their actual needs and concerns, educating them and their close circle about the potential benefits to their health or lifestyle. By recognizing the possible barriers that can arise when recruiting patients with this condition, you will understand the bigger picture, and how best to deal with these challenges.
Understanding your patient population on an international level can be difficult, but you can reach your target by teaming up with partners like Clariness with 18 years of experience in supporting over 75 international diabetes studies and providing relevant data. This way, you can fast track your journey to patient insights and enrollment.
If you are interested in learning more about how we can improve your diabetes study’s patient recruitment, don’t hesitate to contact us here. To learn more about our success with diabetes clinical trials, you can access our case studies here.
Want to know how we can support your diabetes patient recruitment?
Whether you’re planning, or actively recruiting, we can support your trials to ensure you meet your diabetes enrollment targets. Simply get in touch with one of our experts, and we will review your study’s requirements, and develop a strategy to enroll more patients.
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