Radiant/CRA Enroll 8,000 for Hepatitis B Vaccine Study
Radiant Research/Clinical Research Advantage (Radiant/CRA), the country’s largest wholly owned clinical trial site management organization, has completed enrollment for the Dynavax Technologies Corporation (Dynavax) phase III clinical trial of HEPLISAV-B™, an investigational adult hepatitis B vaccine. 100 percent of the study was awarded to Radiant/CRA. Forty Radiant/CRA Sites are conducting the trial, which has randomized over 8,250 adults, including over 1,100 diabetic subjects. The sites completed the enrollment three months ahead of schedule without the use of an outside recruiting company.
Radiant/CRA is breaking ground with this study because this is the first time one clinical trial site management organization has been exclusively awarded a study that requires the enrollment of more than 8,000 patients. As the largest wholly owned clinical trial site management organization in the U.S., Radiant/CRA has 75 unique sites, which gives it the ability to conduct studies of this size. “Our company is providing study sponsors with an option they didn’t have previously,” said Mark S. Hanley, CEO of Radiant/CRA. “Because we have 75 sites around the country – and we’re continuing to grow – sponsors do not need to seek out individual clinical trial sites to conduct large-scale trials. We have everything they need within our wholly owned network.”
By working with Radiant/CRA, pharmaceutical companies and CROs can conduct studies with greater efficiency and ease while ensuring that they will receive high quality data. “When choosing our sites, study sponsors can conduct a large-scale trial using one contract, one budget and access to all of our sites and our database of more than two million patients. This helps to significantly reduce the time it takes to conduct the trial while also reducing the cost of the trial,” said David M. Bruggeman, President and COO of Radiant/CRA.
The partnership between Radiant/CRA and Dynavax has shown that this new option for conducting clinical trials offers a variety of benefits. “Utilizing a single site management organization to recruit patients and conduct the trial has made the process more efficient and more cost-effective,” said Rob Janssen, Chief Medical Officer of Dynavax.