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Pain points: Unsolved recruitment and trial design issues in pain clinical trials

Urtė Fultinavičiūtė

Mar 18, 2023

Although pain affects millions of people worldwide, the industry is still struggling in the ongoing search for safe and effective medication.

Pain is universal, yet it is highly individual and subjective. As such, clinical trials investigating pain face multiple challenges. Even though 2023 started with a surge of pain clinical trials, these studies have some of the lowest success rates.

To shed light on this field, a non-profit organisation the US Pain Foundation has started an initiative to raise awareness about pain research in September, which is Pain Awareness Month.

Clinical Trials Arena spoke to experts about the existing challenges in pain clinical trials. They shared their opinions about recruiting patients with different pain states, what control groups and trial designs are most effective, and why developing safe and effective pain medication is challenging.

Standardised acute pain model

Patient recruitment is a persistent challenge across all therapy areas. A Clinical Trials Arena analysis showed that one of the most common reasons for early trial termination is low accrual rates, with oncology and central nervous system (CNS) leading this trend.

However, recruitment in pain clinical trials depends on the pain state that is being investigated. Dr Nathaniel Katz, president of consulting company Ein Sof Innovation, says that pain models and recruitment have been largely standardised in acute pain trials, especially third molar extraction, bunionectomy and abdominoplasty.

In so-called recruited models, the recruitment begins before the trial even starts. “People have created databases of people who would be delighted to get a high-quality surgical procedure done for free, and the only thing that they have to exchange for that is the willingness to participate in a clinical trial,” Katz says.

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