Bill aims to boost recruitment for rare disease clinical trials

By Nick Taylor

- Last updated on GMT

Related tags: Clinical trials, Clinical trial, Orphan drug

Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.

Currently legislation categorises compensation from clinical trials as income and this could increase a patient’s earnings above the SSI eligibility threshold. This leads to patients being unwilling to enter clinical trials because of the financial impact.

A bill introduced into the US Congress by Representative Edward Markey, and co-sponsored by 62 people, would allow patients with rare diseases to disregard up to $2,000 (€1,355) of compensation received for participating in clinical trials.

This should have minimal impact on the federal budget and could boost recruitment rates in trials of orphan drugs, which are classed as treatments for diseases affecting fewer than 200,000 people.

The small number of potential patients makes recruiting for trials of orphan drugs particularly problematic. Furthermore, the bill should also allow more patients to receive experimental therapies and quicken the clinical trial process.

In a press statement by the Cystic Fibrosis Foundation Senator Richard Shelby said he is confident the “legislation will open a pathway for more patients to receive life-saving treatments​”.

Increasing orphan drug recruitment rates

The bill could help raise recruitment rates in the US but CROs have been looking further afield to help ensure they have enough participants. In particular Averion published an update last year on its attempts to recruit patients for a Phase III oncology drug with orphan status.

Averion claims that it completed patient enrolment six months ahead of the other CRO that was recruiting for the trial and attributed this to its operations in Central and Eastern Europe (CEE).

The 54 sites in the CEE accounted for 71 per cent of patient recruitment, enrolling almost three times as many patients as the 35 clinics in Western Europe.

Related news

Show more

Related products

show more

QPS: Global Custom-Built Research Services

QPS: Global Custom-Built Research Services

QPS | 16-Dec-2019 | Product Brochure

Performing complex studies in special populations with remarkable agility. Clinical research just got better with QPS’ Custom-Built Research Services....

Validating The Simoa Technology

Validating The Simoa Technology

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

Related suppliers

Follow us


View more