ICON launches multi-indication trial design service for obesity drugs

Clinical trial designs for obesity treatments should accommodate candidate drugs that have the potential to treat multiple conditions, or developers risk missing opportunities, according to Irish CRO ICON.

The company quizzed 155 biotech and pharma industry professionals and found that, while most see the potential benefits of multi-indication studies, the complex nature of such research is viewed as a challenge.

Simon Bruce, vice president of drug development solutions, internal medicine at ICON, said, “In the last few years, obesity-related drugs such as GLP-1s have surged in popularity, as has interest in their applicability for other health conditions and related commercial prospects.

“This survey has shown us that respondents realize that trial design is of paramount importance in devising a multi-indication approach, but don’t necessarily know the best way to go about it.”

For example, 90% of respondents said they are not using master protocols, despite the fact such designs allow the enrolment of patients with different conditions into the same trial.

The survey also suggests data, which could help sponsors make informed decisions about multi-indication development, are not being routinely collected. For example, only 14% of respondents said they are pursuing multi-indications based on longitudinal data, and only 19% said they are following patients for more than three years.

Longitudinal data

The failure to collect longitudinal data through extended follow-up assessment reflects a lack of experience, according to Rose Kidd, president, global operations delivery at ICON.

“The considerable logistical and statistical expertise needed to collect longitudinal data and generate RWE may help explain why sponsors report lower rates of adopting such tactics,” she said.

Based on the findings, ICON has launched what it calls a “center for obesity” designed to help sponsors create studies that can test candidate products for multiple related indications more efficiently.

The center will combine an infrastructure of 100 sites and an in-development database of 10,000 pre-screened patients across the breadth of comorbidities related to obesity.

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