Overcoming the 4 leading barriers to cardiovascular disease patient recruitment
Organizers of clinical trials for heart diseases for long have struggled finding and retaining the required number of patients to participate in their trials. Recently conducted meta-reviews suggest, that recruitment for heart trials is often more difficult then for other indications.
This is particularly concerning as heart disease is the leading cause of deaths worldwide; this represented over 30% of all global deaths.
Although the overall incidence is roughly 1% worldwide, there are big differences between different parts of the world, individual countries and population groups. With an average of over 20% of the elderly population being affected, the number of patients with heart diseases in Western nations is estimated to rise especially hard (up to 200-250% according to some studies) due demographic aging.
Leveraging our experience of supporting over 70 cardiovascular disease clinical trials across the globe, and external sources, this blog looks at the 4 main barriers that make recruitment and enrollment for cardiovascular disease so difficult, including: travel distance, time constraints, unclear relevance of study and health problems.
This blog explains how to overcome these barriers to patient recruitment for cardiovascular diseases in 3 steps:
- The need to understand the different barriers to participation for different patient populations with cardiovascular disease
- The 4 main barriers to patient recruitment as cited from recent studies
- Overcoming the barriers to cardiovascular disease patient recruitment and retention
Want to learn more about barriers to participation for certain groups of cardiac patients, how digital methods can increase the diversity of cardiovascular disease trials, and strategies to increase patient participation and retention?
Download our new Cardiovascular Disease Patient Recruitment Whitepaper.
1. The need to understand the barriers to participation for different patient populations with cardiovascular diseases
Cardiovascular disease covers a wide range of conditions from abnormal heart rhythms, angina, coronary artery disease, peripheral arterial disease, stroke and heart failure.
In order to conduct a successful and cost-effective global or local patient recruitment campaign, it is crucial to have a thorough understanding and expertise of the different local and regional patient populations, but also the different drivers and barriers faced by sub-populations (female, ethnical minority, different cultural frameworks) within a study’s target population.
Collaborations with digital patient communities are an good way to inform patients about the workings of clinical trials, safety and ethical regulations and potential benefits of participation for themselves and others.
More so, it is key to understand specific barriers of different cardiovascular diseases and incorporate that in the outreach campaign. As we for example highlight in our whitepaper, heart failure patient recruitment campaigns often fail because they take a general approach that isn’t sensitive to specific barriers and concerns. Examples that we discuss in our whitepaper are the fact that heart failure patients have a high symptom burden and severe fatigue is a reason that patients decide against participation because they fear that the travel to the study center ad necessary screening is too burdensome.
The barriers to cardiovascular clinical trial participation vary between type of cardiovascular disease but also between different patient populations. Below are some examples from a number of recent studies on Willingness to Participate (WTP) to illustrate these differences:
- Racial and ethnic minorities are less likely to express willingness to participate in cardiovascular disease trials and surveys, due to a number of historical barriers. While studies have focused primarily on ethnic minorities in the United States, it is important to note that this is also true for European minorities, for whom health literacy is lower, particularly among older patients.
- Patients with higher education levels are more willing to participate in cardiovascular disease clinical trials, and this is mostly linked to a greater health literacy and a better understanding of their condition
- Women, the elderly, and minorities are consistently under-represented in cardiovascular disease (CVD) clinical trials and often cite barriers to participation, rather than a lack of interest or drive to participate
- People with higher risk factors for cardiovascular disease, or a more severe condition, are less willing to participate in cardiovascular disease trials. Often cited risk factors that influence willingness to participate include left ventricular dysfunction, kidney disease, persistent smoking, symptoms of anxiety and depression, and strokes
This should make it clear that when targeting different patient populations, locally or globally, it’s important to understand the different needs, drivers and barriers to participation to diversify the trial population and ensure higher enrollment and retention.
At Clariness, we have supported over 70 cardiovascular clinical trials in APAC, EMEA and the Americas, and leverage performance data and our patient insight surveys to develop campaigns that overcome the barriers that most influence the patient populations of specific studies. This way, we have connected more patients to clinical trials and improved retention rates by pro-active, patient-centric, information about the study procedures. For more information on our track record, you can download our cardiovascular patient recruitment case studies here.
2. The 4 main barriers to cardiovascular disease patient recruitment and retention, as cited from recent studies
In recent years, researchers have increasingly focused on the barriers that prevent cardiac patients from participating in clinical trials, or cause them to drop out. Studies of barriers to specific cardiovascular diseases – from arrhythmias, coronary artery disease, and thrombosis to myocardial infarction and heart failure – have identified four general barriers, these are:
- Travel distance: The research center is too far away, or patients are afraid of having to bear the travel costs themselves
- Time constraints: Participation is perceived as too time burdensome, some patients feel they are too busy to participate
- Unclear relevance: Patients do not believe participation will provide significant health benefits, or they do not feel they have enough information to decide whether to participate
- Health problems: Many patients fear that participation in a study will make their health problems worse, or they fear that they will not receive quality care
Based on our experience with cardiovascular disease patient recruitment, we know that an easily accessible and understandable digital survey is an important way to gain the first level of understanding of your patient populations.
Interested in learning how we can improve your understanding of study populations? Contact our team here.
3. Overcoming the barriers to cardiovascular disease patient recruitment and retention
While recent studies and large-scale surveys have succeeded in identifying barriers to participation in cardiovascular disease trials, remarkably, little attention has been paid to transferable solutions to overcome these barriers.
Take-away 1: Financial compensation alone is not the solution for cardiovascular disease clinical trials
On platforms dedicated to clinical research, one often reads the suggestion that the introduction of compensation for all clinical trial participants would be the most important means of overcoming barriers to participation.
For example, WebMD chief medical officer Dr John Whyte argued in a recent piece in USA Today that in order to boost participation of particularly minority populations in clinical trials “everyone should get paid to participate”. Kezia Parkins, Executive Editor of the Medical Device Network and Medical Technology Magazine, also suggested that higher compensation could improve hiring rates.
Both however, admitted that financial compensation alone is not the primary driver of willingness to participate. It is important to underline that while compensation may remove some barriers, yet is not the primary method for improving recruitment or retention in cardiovascular disease trials.
Indeed, recent studies highlight that for most patients monetary compensation was “a nice feature”, for most it was not influencing their decision to participate in clinical trials.
Take-away 2: Cardiovascular disease clinical trial patients are driven by potential health benefits
In cardiovascular disease trials specifically, where relatively few studies have been conducted on factors improving willingness to participate, studies show that primary motivation for participation in the study appeared to be the desire to gain some benefit to themselves and others with the same condition. The primary sought benefits that are mentioned often include:
- Learning more about the origin and symptoms of the condition
- Learning additional ways deal with symptoms and limitations
- Reduce the limitation that symptoms pose on day-to-day activities
- Do something meaningful as contributing to scientific research, despite being limited by the symptoms of cardiovascular disease
Hence, both recent studies and our experience with recruiting for Cardiovascular Disease trials show how Willingness to Participate was mostly shaped by health literacy and trust.
Clariness’ approach to overcoming the main barriers to cardiovascular disease patient recruitment and retention
There is a great deal of dissatisfaction with many of the existing treatments for cardiovascular disease, because they are not effective or have side effects. Explaining how important clinical trials are to the development of new drugs and that trials are a potential way to gain access to the drugs of the future, increases interest and participation rates.
Our patient recruitment campaigns are build on the following three steps:
| Patient-centric information & communication | Studies show that a better understanding of the clinical trial process, safety measures, and potential benefits, are the main reasons patients decide to participate in a cardiovascular disease trials. With our ClinLife patient blog, which we have launched in both Poland and Germany, we explain the clinical trial process, safety measures and the ethics committee, and highlight current research advances in cardiovascular disease. |
| Adjust outreach to local patient populations & minorities | At Clariness, we apply great importance to the representativeness of our advertising. We include images of people from different backgrounds, and highlight for example that women have different symptoms and experiences, such as not being diagnosed, in the case of cardiovascular disease. Targeting on channels such as social media and digital patient communities allows us to place these ads to people who identify as female, and have seen greater conversion rates when comparing these tailored ads compared to general heart disease ads. |
| Resolving group-specific barriers | Group-specific barriers, from lack of trust in clinical science among minorities, to travel distance and understanding of difficulties in participating and health literacy of elderly patients, can be resolved or reduced through a targeted approach, engaging patient advocates and (online) patient communities to build trust, educating them about the benefits and importance of clinical trials, and diversifying investigators on the study team to build trust. Our Creatives & Retention team creates lay-friendly study materials in local languages and helps patients understand the specific study in the broader context of clinical research. |
Ultimately, organizers of clinical trials can look at other methods as study design, compensation for travel distances or lost working days and new options as hybrid and remote trials. As we explored in a recent blog and whitepaper on ”Achieving diversity, equity and inclusion in clinical trials”, simple changes to study design that allow for telephone counseling and video visits, or provide compensation for transportation and allowances, can already greatly increase participation and retention rates.
Want to know more?
This blog only covers the surface of patient recruitment barriers and solutions for cardiovascular disease. Interested to learn more and see the data in full detail? Read our recent whitepaper on recent academic literature on cardiovascular disease patient recruitment, which you can download for free here.
If you have a particular study or challenges with regards to cardiovascular disease, you can contact us directly here by filling out the contact form here.
Want to know how we can support your cardiovascular disease patient recruitment?
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