Overcoming Challenges in Obesity Clinical Trials: A Patient-Centric Approach
5 Minute Read
Obesity is a growing global health issue, with its prevalence reaching epidemic proportions. Affecting more than one billion people worldwide, obesity is a complex, multifactorial condition that requires multifaceted treatment strategies.1 As the need for effective obesity interventions increases, so does the importance of well-executed clinical trials with well-chosen clinical trial sites. However, obesity studies present unique challenges, ranging from trial design to selection of sites that can effectively recruit and retain the right participants.
This blog explores seven challenges of designing and conducting obesity trials and offers strategies to overcome them, ensuring the successful development of new treatments.
Patient Recruitment and Retention
Recruiting and retaining participants in obesity trials is notoriously difficult. Patients may be hesitant to join due to the stigma associated with obesity, fear of judgment, or previous negative experiences with weight-loss programs. In addition, compared to other medical conditions, obesity has fewer patient organizations to turn to as a resource for patient recruitment. The long-term nature of these trials can also deter participation, leading to high dropout rates.
For specialty pharmaceutical and small biotech companies, the inherent challenges of recruitment are exacerbated by increasing congestion in the space. With the boom in obesity therapeutic development, sponsors face competition not only from other early-phase studies, but also programs that extend past Phase 3 trials to evaluate other indications such as diabetes or cardiovascular diseases.
The first step in effective recruitment and retention is selection of clinical trial sites that have the database, reach, and capability to quickly identify and contact appropriate study candidates. At Alliance Clinical Network, we have a proprietary database of more than 250,000 prescreened participants across our network of seven fully integrated sites. Effective communication and education are key to successful recruitment and retention. Emphasizing the importance of the trial and its potential health benefits and providing a supportive and non-judgmental environment can encourage participation. Offering flexible scheduling and compensation for time and travel can also improve recruitment and retention.
Heterogeneity of the Population
Obesity is not a homogenous condition. It varies widely across individuals in terms of severity, underlying causes, and comorbidities. This variability makes it challenging to design trials that are both inclusive and able to produce statistically significant results. To further complicate matters, 50 percent of current obesity studies include multi-indication components.
Increasingly, sponsors are turning to innovative approaches such as master protocols, which allow for testing of multiple hypotheses and may include parallel studies for evaluating different subgroups or multi-indications. 2 Stratified trial designs that account for different subgroups, such as body mass index (BMI), metabolic health, or genetic factors, can help address this challenge. Adaptive trial designs, where interventions can be modified based on ongoing results, are also effective in managing heterogeneity.
Patient Diversity and Data Generalizability
Regulators have emphasized that participants in clinical trials should be representative of the patients who will use the medical products. In June 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance on the Diversity Action Plans required to support most clinical studies. Despite similar prevalence of obesity across gender, the vast majority of participants in obesity studies are women. Racial and ethnic minorities are also underrepresented in these clinical trials.
Meeting potential study participants where they already are can help to improve inclusivity, diversity, and data generalizability. At Alliance, more than 85 percent of the consented patients in our database are from underrepresented populations. Targeted messaging that includes demographic-specific language and imagery can also be useful for improving diverse recruitment.
Complexity of Intervention
Obesity interventions often require a combination of lifestyle modification, pharmacotherapy, and sometimes surgical procedures. The complexity of these interventions can make it difficult to isolate the effects of a single treatment and may complicate adherence to the trial protocol.
Clear and standardized protocols, combined with robust monitoring systems, can help manage the complexity of interventions. At Alliance, centralized management harmonizes processes and systems across our sites to deliver consistent study execution, even in the most complex trials. Using digital tools to track participants’ adherence and provide real-time feedback can also enhance compliance and data accuracy.
Measurement of Outcomes
Determining appropriate and meaningful endpoints in obesity trials is challenging. While weight loss is a common measure, it may not fully capture the health benefits of an intervention, such as improvements in metabolic health or quality of life.
Utilizing a combination of primary and secondary endpoints can provide a more comprehensive assessment of the intervention’s impact. For example, alongside weight loss, consider including measures of blood glucose levels, cholesterol, and patient-reported outcomes.
Need for Long-Term Follow-Up
Obesity is a chronic condition, and long-term follow-up is necessary for assessing safety, the durability of weight loss, and the effects on comorbidities or clinical events associated with obesity. As the number of approved obesity drugs increases, this data will be critical for competing against marketed products with indications for event reduction.2 However, maintaining contact with participants over an extended period can be difficult, leading to loss of data and reduced study power. Long-term studies are also costly, highlighting the needs to create efficiencies in clinical trial conduct.
Patient-centric trial designs that include remote study visits or other decentralized elements help to ease patient burden. Implementing digital health platforms for remote monitoring can facilitate long-term follow-up. Regular check-ins, even if virtual, can help keep participants engaged. In addition, simplifying data collection methods through wearables and ensuring these devices fit seamlessly into participants’ daily routines can reduce dropout rates. Tokenization is an emerging strategy for collecting participant data on an ongoing basis through secondary sources such as electronic health records to further minimize study burden, with the added benefit of linking real-world data.
Ethical Considerations
The ethical aspects of obesity trials are complex, particularly in relation to the risks of intervention, the potential for bias, and the need to avoid exacerbating weight stigma.
Ensuring that trials are designed with patient-centric approaches is essential. This includes obtaining informed consent that is truly informed, providing appropriate counseling and support services, and designing trials that are sensitive to the potential for bias and stigma.
Conclusion
With an estimated value of over $37 billion by 2031, the obesity market is significant, and the number of clinical trials is on the rise.3 Thoughtful trial design, innovative approaches, and a patient-centered focus are critical to the success of these studies. By addressing challenges head on and partnering with purpose-built sites, researchers can accelerate the development of effective interventions that will change the landscape of obesity treatment by providing patients with alternative options and greater flexibility.
To learn more about how Alliance Clinical can accelerate your obesity program, contact us today.
1 World Health Organization. World Obesity Day 2022 – Accelerating action to stop obesity. Available at https://www.who.int/news/item/04-03-2022-world-obesity-day-2022-accelerating-action-to-stop-obesity.
2 Clinical Trial Vanguard. Taking Stock of Obesity Drug Development: Trends and Challenges Facing Today’s Researchers. Available at https://www.clinicaltrialvanguard.com/article/taking-stock-of-obesity-drug-development-trends-and-challenges-facing-todays-researchers/.
3 Clinical Trials Arena. Obesity: Six trials to watch over the next 12 months. Available at https://www.clinicaltrialsarena.com/features/obesity-trials-to-watch/.
