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.