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Joanna Pulawska, Ph.D., Therapeutic Area Head, CNS & CVRM
Nicole Zandy, Senior Director, Clinical Project Management, Cardiovascular, Renal & Metabolic
Obesity is a rising global health issue affecting over one billion people worldwide1. In the United States alone, the Centers for Disease Control and Prevention (CDC) estimates that obesity costs exceed USD 173 billion annually2. Among the Organisation for Economic Co-operation Development (OECD) member countries, the economic burden is similarly alarming, up to 8% of annual health budgets are projected to be spent on treating obesity-related health complications, totaling approximately EUR 390 billion each year, according to the European Union Parliament3. As the prevalence of studies on weight-related health conditions continues to increase, the need for effective interventions becomes increasingly urgent. Clinical research for patients with obesity presents unique operational challenges, particularly in patient recruitment and retention.
Operational Challenges in Obesity Clinical Research
Recruiting participants for weight-related clinical research can be difficult due to multiple factors, like internal negative feelings associated with the condition, fear of judgment by others and previous unsuccessful experiences with health programs. These types of trials often stimulate negative emotions in participants whose weight and food intake are key data points that are being collected and present a substantial burden of participation for patients who may otherwise be reluctant to leave their homes. The stigma associated with weight management trials can deter individuals from participating, while the perceived burden of frequent visits and assessments can be overwhelming. Furthermore, patients on the placebo arm may drop out if they do not see the expected result, further complicating retention efforts. These challenges are compounded by the ever-increasing usage of marketed GLP-1s, particularly within the United States.
Enhancing Patient Comfort
Ensuring participants feel comfortable throughout the trial experience is essential. This may include providing larger blood pressure cuffs, chairs without arms, scales with handrails and appropriately sized gowns for trial visits. Providing cultural-competency training for site staff to respect diverse dietary habits and reduce stigma is also an important factor.
Addressing the emotional component of living with weight-related health issues by using supportive language and creating a positive environment can significantly impact patient retention.
Reducing Burden
Many participants prefer not to leave their homes due to discomfort, fear of negative social interactions or logistical challenges. Decentralizing clinical trials by bringing the trial to patients homes can significantly reduce this burden, but it requires careful planning to ensure the individual feels comfortable with the process1. What logistical support and decentralized aspects can we provide when patients need to visit the site? Providing appropriately sized vehicles for transport to and from onsite visits, ensuring convenience and exploring remote monitoring and virtual consultations can further alleviate the burden on patients.
Language and Communication
Using respectful language, such as “participant of a metabolic health study” instead of "obese patient," is crucial to avoid reinforcing negative stigma. Providing study participants with supportive language to use with friends and family can help build a positive support system and encourage participation in the trial. Patients may find it easier to tell friends they are participating in a “trial on weight-related health” rather than “an obesity trial.” Training site staff to mirror this language, to maintain a neutral tone when speaking with patients about study assessments with a potential to trigger negative emotions and to watch for signs of distress can protect study subjects from a bad experience during a study-related visit.
Focus on Patient Retention
Retention is a critical aspect of clinical trials, especially in weight-related clinical research. High dropout rates can significantly impact the validity of trial results. Therefore, focusing on patient retention through continuous education and engagement is essential. Health coaching interventions in weight loss trials have demonstrated significant improvements in retention and adherence. One study reported that participants receiving structured coaching were more likely to complete the trial and adhere to protocols4. This includes educating participants about the broader health benefits of weight loss, such as reduced cardiovascular risk, improved metabolic health and decreased joint stress.
Compliance and Retention Strategies
Retention and compliance go hand-in-hand. When patients feel comfortable and supported throughout the trial, they are more likely to adhere to the study protocols. Sites have reported that providing coaching along the way, nutrition counseling and regular check-ins from the site can significantly improve compliance. Making patients feel like the trial is their own, rather than something they are merely participating in, can foster a sense of ownership and commitment. Providing psychological support, external educational tools and educating patients about the benefits they are getting from the trial are also effective strategies.
Rapid Data Entry and Cleaning
Sponsors must be equipped to manage the rapid surge of data and ensure that clinical sites are prepared to process it effectively. On the CRO side, it's essential to design user-friendly systems that cater to all stakeholders. One such solution is One Home for Sites - a unique platform that acts as a neutral hub, seamlessly integrating and coordinating the essential systems and tasks required by sites across multiple clinical trials. Managing this data influx demands significant resources, including operational support, medical and endpoint expertise, onboarding facilitation, training and robust tracking tools for effective data oversight.
Conclusion
While obesity clinical research presents significant operational challenges, biotech and emerging biopharma companies are leading innovation and driving advancements in promising therapies. By adopting patient-centric approaches and innovative trial designs, biotech sponsors can improve recruitment and retention, ultimately driving the development of effective healthcare treatments.
Cardiovascular, Renal and Metabolic (CVRM) health represents the fastest expanding disease spectrum globally, linking cardiovascular diseases with related comorbidities, such as obesity, diabetes and chronic kidney disease. Learn more about how IQVIA Biotech is driving clinical development for holistic CVRM therapies.
Sources
[1] https://www.who.int/news/item/01-03-2024-one-in-eight-people-are-now-living-with-obesity
[2] https://www.cdc.gov/obesity/adult-obesity-facts/index.html
[3] https://op.europa.eu/en/publication-detail/-/publication/b0cbcb22-8523-11ef-a67d-01aa75ed71a1/
[4] https://link.springer.com/article/10.1007/s10880-023-10000-6