Diabetes is a chronic disease characterized by elevated levels of blood sugar and it is estimated that 1.5 million people die from its consequences every year. Diabetes can cause serious damage to the heart, blood vessels, eyes, kidneys and nerves. According to the World Health Organization (WHO), there is a globally agreed target to halt the rise in diabetes and obesity by 2025.
Early diagnosis and effective treatments must be available to patients if this target is to be met. Clinical trials are an important step in the development of new drugs, medical devices and treatments for various diseases and health conditions, including diabetes. In this article, we will explore what is the role of IVD CROs in healthcare, how IVD clinical trials are involved in diabetes diagnosis, and why patient recruitment and retention is important. Finally, we will share 5 strategies to improve patient engagement, based on our experience as a leading CRO.
What is an IVD CRO?
Contract Research Organizations (CROs) provide support to medical devices and drugs manufacturers by offering research services such as biologic assay development, clinical trial management, and post-market clinical follow-ups. By outsourcing these services, medical device manufacturers and other healthcare companies can save time and money, increase product development efficiency and provide patients with effective diagnosis and treatment more quickly.
In-Vitro Diagnostics (IVD) clinical trials are conducted to test the safety and efficacy of new tests and devices which can detect a condition or an illness. “In-vitro” means that the diagnostic test is conducted primarily in laboratory equipment such as test tubes, and not directly in the patient’s body. IVD CROs offer expertise in conducting IVD clinical trials for companies that wish to market a new IVD test or device and need to comply with relevant regulations as well as ensure patient safety and satisfaction.
IVD CRO Clinical Trials in Diabetes
As with many other diseases and health conditions, early diagnosis is the starting point of an effective treatment for diabetes. The longer a patient lives with undiagnosed diabetes, the harder it is to provide them with adequate treatment and the symptoms may be worse, affecting their quality of life.
Therefore, IVD tests and devices play an important role in the global effort to stop diabetes, which affects more and more people each year. IVD clinical trials are constantly being conducted to allow market access to new diagnostic methods that can improve diabetic patients’ outcomes. Many clinical trials are also conducted to accelerate the approval of treatments to delay the progression of the disease and target specific diabetes consequences.
CROs have a team of researchers that dedicate their expertise to planning and implementing clinical trials. Regulatory affairs professionals also support manufacturers that are partnering with a CRO to ensure compliance with relevant regulations (such as FDA requirements in the US and MDR in the EU). However, clinical trials are not possible without the participation of other human subjects who agree to enroll in data collection.
If you want to learn more about clinical trials and how we plan and execute effective clinical studies under different regulations, you are welcome to explore our blog and read our articles on the subject. In this article, we will focus on the importance of efficient data collection to the success of clinical trials in diabetes.
When conducting a clinical trial, accuracy of data depends more on the quality of patient recruitment than on the quantity of information. Of course, comprehensive research is the core of medical device development, which can involve literature review and comparison with similar devices as well. However, clinical research data is not complete without the participation of a patient group that correctly represents the population that will be using the test or device. In the next section, we will explore the importance of recruiting the right patient group and keeping them involved in the study to have efficient research outcomes.
Why Patient Recruitment and Retention is Important in Clinical Trials in Diabetes
Diabetes affects people of different ages and is generally divided into type 1 and type 2 diabetes. A clinical study focused on diabetes will have to consider many aspects of patients’ demographics as well as the market which the manufacturer is aiming to access.
Knowing how to successfully recruit the patient group and keep them involved throughout the duration of the study is important because:
- If the group of participants does not reflect well the target population, quality of data will not be as high as it could be, and this will affect the analysis made by researchers.
- A successful clinical trial depends on having enough patient data, even though the necessary number of participants involved will depend on the study.
- High drop-out rates will affect the quality of data as well and may hinder the research team’s efforts.
- Difficulties in recruiting and engaging participants may delay the whole research process, disappointing funding organizations and the people who are counting on the improvements that the new device or treatment may bring to their quality of life.
Challenges to Expect
While efficient patient recruitment and retention is clearly essential for the success of a clinical trial, researchers may encounter some barriers to build effective enrollment processes and keep patients engaged. In the next section, we will share some strategies that may improve patient recruitment and engagement in IVD clinical trials in diabetes. However, knowing what challenges may be encountered is a good first step, as it allows teams to be prepared for them.
- Lack of interest: people might not feel interested in or compelled to take part in a clinical trial, often because they do not understand what it means to be a clinical research subject, or they do not have support from family and friends to enroll.
- High drop-out rates: people might quit the trial before its completion due to a variety of reasons, including complexity of data collection protocols and extended study time frame.
- Communication problems: because studies involve medical research professionals as well as people from completely different backgrounds acting as participants, communication is not always easy. It takes some effort to build trustful and clear communication using language that everybody understands and is comfortable with.
- Budget constraints: conducting clinical research without the help of a CRO can be costly. In order to reach more people and meet the desired recruitment goal, sponsors may need to invest more than expected.
5 Strategies to Improve Patient Recruitment and Retention in Clinical Trials in Diabetes
Now that you already know the role of clinical trials in diabetes diagnosis and treatment, and how important it is to have effective patient recruitment and retention, you may be interested in some tips on how to overcome challenges and improve this process. In this section, we share 5 strategies that can be employed to enhance patient recruitment as well as keep participants engaged throughout the whole study. We are focusing on clinical trials in diabetes, but most of these strategies can be applied to many other types of clinical studies.
- Adopt a patient-centric approach
ECLEVAR supports the use of a patient centered approach in all clinical trials. This can improve patient recruitment as well as retention and it essentially means planning all stages of a clinical trial having patients’ wellbeing considered first. Let people know how important their participation is. Avoid lack of interest by ensuring that participants feel that they are at the core of the process, and not just a secondary subject submitting to tests.
To improve retention rates, a patient-centric approach can be used to keep patients engaged and willing to collaborate. People are more likely to commit to regular participation and data collection if they are reminded of the importance of their collaboration. A patient-centric approach also means providing patients with friendly and quick responses to any concerns, questions or difficulties they may have at any time.
- Provide clear and accessible information
Good communication is key. To attract people’s interest, recruitment materials should explain what the study is for in a clear way and highlight its possible outcomes. Be aware of the use of jargon and complex terminology, as well as extensive blocks of text. Remember that nowadays people are used to receiving information through social media and plan to include this means of communication in the recruitment process.
Considering the needs of diverse groups of patients is also part of a communication strategy that improves recruitment and, even more, retention of participants. Get to know the group well and write explanation documents and consent forms in a language that speaks to them and that can be understood by that specific group. They may have the need for translations, for example, or for special document design.
- Make the most of technology
ECLEVAR also endorses the use of the best and newest digital tools to enhance every stage of clinical trials. Technology can facilitate participant screening, improving patient recruitment. Social media and other online tools can help researchers to reach more people and recruit patients from a wider area. Software such as eConsent tools can make the consent acquisition process more accessible and attractive to patients, increasing recruitment rates.
To improve retention, technology can be used to aid communication, which contributes to the previous strategy. Remote patient monitoring is another technology-enabled development which helps with patient retention, as it allows them to participate in the study with minimal disturbance in their regular routines.
- Offer personalized support
A patient-centric approach prioritizes the needs and preferences of patients as a group. But patient retention can be further improved by personalizing even more the communication and procedures. If the clinical trial is designed to collect data from diabetic patients, every detail should reflect the specific needs of this group of people. If participants feel they are taking part in a generic scientific study, they are more likely to underestimate the importance of their participation and be discouraged from continuing.
Personalized support also means considering each participant’s personal history when answering their questions and collecting symptoms reporting. This might not be possible in larger studies involving a great number of participants. However, it can significantly improve retention because it shapes communication in a way that highlights the patient’s role in the study.
- Minimize the burden on patients
Some of the previous strategies already contribute towards the goal of minimizing the burden on patients and improving retention. Recruitment and retention can be further improved by considering even more situations in which helping patients will encourage them to collaborate.
For some patients, this could be financial support or reimbursements. Careful site selection and meeting scheduling can make all the difference for patients with busy agendas. Comprehensive and agile feedback has the potential of reducing the stress felt by some patients who are already treating uncomfortable symptoms.
Bonus Tip: Partner With an IVD CRO to Improve Your Clinical Trial in Diabetes
In this article, we have explored the importance of clinical trials in the development of new diagnostics tests and treatments for diabetes. You have also learnt what are the challenges in recruiting and engaging patients, and some strategies that can help to build patient-centric studies and improve retention.
By partnering with an experienced CRO, your company has access to comprehensive guidance on conducting clinical trials. ECLEVAR’s team is ready to assist you in your study recruitment process, as well as designing study plans with high-quality data collection and low drop-out rates. Contact us to start discussing your project.
Summary
- Diabetes is a chronic disease characterized by elevated levels of blood sugar and leads to 1.5 million deaths every year.
- IVD CROs conduct IVD clinical trials in diabetes for companies that wish to market a new IVD test or device and need to comply with relevant regulations as well as ensure patient safety and satisfaction.
- IVD tests and devices play an important role in the global effort to stop diabetes. IVD clinical trials are constantly being conducted to allow market access to new diagnostic methods which can improve diabetic patients’ outcomes.
- Patient recruitment and retention is essential to clinical trials in diabetes, as low recruitment and high drop-out rates decrease the quality of data.
- Some strategies to improve patient recruitment and retention are adopting a patient-centric approach, providing clear information, making the most of technology, offering personalized support and minimizing the burden on patients.