Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, together with Radiant Research/Clinical Research Advantage (Radiant/CRA), a clinical trial site management company, has announced that they will start a phase III clinical trial of HEPLISAV-B™, an experimental adult hepatitis B vaccine. Radiant/CRA will be responsible for 100% of the study, a major challenge for any clinical trial site management company, since this wide-ranging study is the first of its kind to be launched. The company finished enrolling 8,250 adults three months before the deadline without outsourcing, which included enrolling more than 1,100 diabetic subjects. 40 of the company’s testing sites will be conducting the trial.
Radiant/CRA was founded in 1992 and maintains 75 testing sites, enabling them to conduct large sized clinical trials such as the clinical trial for HEPLISAV-B, collaborate with pharmaceutical companies, and hire research organizations to perform clinical trials for pharmaceuticals, vaccines, and medical devices. Radiant/CRA has successfully completed more than 12,000 clinical trials, and enables trial sponsors to commercialize medical innovations very rapidly and efficiently. For more information, visit www.crastudies.com and www.radiantresearch.com.
“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,” added Hanley. “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. This type of collaboration between Radiant/CRA and Dynavax is a novel way of performing clinical trials, offering many operational advantages. “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.
Dynavax’s HEPLISAV is the company’s investigational hepatitis B vaccine for adults, which utilizes its first generation 1018 immunostimulatory sequence (1018 ISS) and hepatitis B surface antigen (HBsAg). In Phase 3 trials thus far, HEPLISAV has demonstrated earlier, increased protection from the virus with fewer doses than currently licensed vaccines.