MASH clinical trial recruitment: which specialists to target

Why is MASH recruitment so hard?

Therapeutic trials in MASH are hampered by screen failure rates of 70 to 80%, mostly because the baseline liver biopsy does not show fibrotic MASH (JHEP Reports). That is roughly double the 36.3% average across all therapeutic areas (Tufts CSDD). Despite two decades of trials, only two drugs have been approved for MASH with fibrosis (Drugs, 2026), so demand for trial patients remains high.

Which physicians should a MASH site contact?

• Hepatologists and gastroenterologists, who see patients with confirmed liver disease and fibrosis staging.
• Endocrinologists, who manage the diabetes and obesity that often accompany MASH.
• Primary care physicians, who see the largest pool of patients with metabolic risk factors.

How do referrals reduce screen failure?

By sending patients with evidence of fibrosis, not just risk factors. Researchers found that sequential combinations of noninvasive tests designed for fibrotic MASH improve identification of trial candidates (JHEP Reports). A physician summary should state exactly which tests or imaging results make a patient worth referring.

Does community outreach matter in MASH?

In an interview published by Medpace, MASH trial investigator Dr. Harrison described disease awareness as key to recruitment, including going into physician offices in person rather than relying on advertising alone (Medpace). Structured physician outreach is how that scales.

What should a MASH outreach plan include?

1. The core specialists and relevant primary care physicians within realistic driving distance of the site.
2. A one page summary with the diagnosis requirements, key exclusions, procedures, and visit schedule.
3. A named coordinator contact, and a commitment to report back on every referral.
4. Follow up by email and LinkedIn, prioritizing physicians who engaged.

See referral strategy by therapeutic area for other conditions.