A concerted effort has been launched in the US to boost recruitment for clinical trials of new therapies for cystic fibrosis (CF). The Cystic Fibrosis Foundation wants to double the number of people with CF participating in clinical studies over the next two years.
Working in partnership with pharmaceutical companies and academia, the Foundation has built up a virtual drug development ‘pipeline’ of nearly 30 potential treatments for cystic fibrosis. The US organisation has a non-profit drug discovery and development affiliate, Cystic Fibrosis Foundation Therapeutics, Inc (CFFT), that offers matching research awards through its Therapeutics Development Program as well as access to a specialised network of CF clinical research centres.
There are several Phase III trials now recruiting large numbers of volunteers to test new CF therapies, the Foundation pointed out. More than 1,000 people with cystic fibrosis are needed to ensure the successful completion of these studies alone. “Without patient volunteers, research and progress are not possible,” said Dr Robert Beall, president and chief executive officer of the Cystic Fibrosis Foundation.
The Foundation will work with its nationwide network of 115 care centres to deliver a “call for action” encouraging people with CF to learn about – and consider participating in – the clinical trials currently underway. To this end, the organisation has produced educational materials for people with CF and their families, launched a toll-free clinical trials hotline and created a new section of its website (www.cff.org/clinicaltrials) to heighten awareness of where trials are taking place and how people can get involved.
A study commissioned by the Foundation showed that most people with CF did not know about the “critical need” to volunteer for clinical studies, it noted. Asked why they had not taken part in a trial, the majority of respondents said no-one had asked them to.
The Foundation is also making efforts to expand the number of care centres available in the US to conduct high-quality studies of CF therapies. This year it has awarded more than $3 million to 45 centres nationwide so that they can further develop their clinical trial capabilities. The number of clinical research sites run by the Foundation has grown from eight initially to 63 today.
Some 30,000 adults and children in the United States are affected by cystic fibrosis, a genetic disease that causes life-threatening lung infections and serious digestive complications. According to the Foundation, more than 10 million Americans are symptomless carriers of the CF gene.