It’s common knowledge that many people enroll in clinical trials to be part of an effort that furthers medical innovation and ultimately helps others. And yet, after a trial wraps up, the vast majority of participants never learn the results, or whether their participation resulted in approval of a new drug.
Thomas Littlejohn—president and executive medical director of investigative-site group PMG Research—says this leaves a huge void that can make the trial participation experience less than satisfying and the participant less apt to return for a second trial.
Now PMG, based in Winston-Salem, N.C., has come up with a way to fill that void. For each volunteer who enrolls in a trial at one of PMG’s 11 sites, a pentavalent vaccine is
donated to a child in a third-world country. PMG launched the nonprofit Greater Gift Initiative (GGI) at the end of January, through which it has retroactively donated 6,700 vaccines, one for every person who enrolled in one of its trials in 2010. Now PMG, through GGI, is making donations quarterly.
To let participants know that enrolling in a trial resulted in a vaccine donation, GGI sends each trial enrollee a certificate proclaiming that he or she helped a child in need. This is key, said Littlejohn.
“It’s a tangible thing that says: I might not know what the results of this trial are but I know I did something good for someone else,” he said.
“It provides immediate positive reinforcement,” said Jennifer Byrne, PMG’s chief executive, who came up with the idea to donate vaccines after learning of Tom Shoes, which donates a pair of shoes to a person in need for every pair purchased.
Donating 6,700 vaccines on behalf of its 2010 trial participants cost PMG about $20,000, said Littlejohn, but it’s been well worth it, as the response has been phenomenal. After receiving their certificates, many of last year’s trial subjects have asked if they are eligible for other trials, said Byrne. And one principal investigator said he’d donate vaccines on behalf of each participant in his trials specifically.
Also, said Byrne, other investigative sites around the country have expressed interest in participating, and Byrne and Littlejohn are talking to sponsors about getting on board.
For now, GGI is working with Global Alliance for Vaccines and Immunization (GAVI) to distribute the pentavalent vaccine (Diphtheria, Tetanus, HiB, Pertussis, and Hepatitis B) in about 80 countries where it’s needed. GAVI is funded in large part by the Gates Foundation. Byrne said GGI may choose different groups to work with as the nonprofit grows.
Byrne said she hopes this type of effort could be the genesis of the image remake the industry needs. “There’s no reason our industry can’t give back in this way and at the same time turn around the public perception about clinical trials.”
-- Suz Redfearn