A new, faster route for pediatric clinical trials
July 13, 2010
Researchers hoping to test promising cancer therapies for children have traditionally had to find they way through a forest of funding applications, regulatory rules, hiring procedures, review boards, statistical services, and other logistical requirements. To smooth the process, Dana-Farber Cancer Institute and Children's Hospital Boston are building an easy-access "on-ramp" to the clinical trial arena.
Late last year, these two partnering institutions launched the Clinical and Translational Investigation Program (CTIP) to make that ramp a reality. Allotted $5 million for a five-year period, the program will create an administrative and scientific infrastructure for moving clinical trials from the idea stage to the point where patients are enrolled, data is collected and analyzed, and results are published.
"Conducting clinical trials for children with cancer is particularly complex because of the relatively small number of patients with any one type or subtype of cancer," says Lisa Diller, MD, chief medical officer of Dana-Farber/Children's Hospital Cancer Center (DF/CHCC). "Here, the challenge has been magnified by the involvement of two institutions and the lack of a joint infrastructure for designing and organizing trials. CTIP enables us to take advantage of the expertise at Dana-Farber and Children's and build a system that is especially geared to pediatric trials."
To lead the program, DF/CHCC recruited Carlos Rodriguez-Galindo, MD, who specializes in treating children with sarcomas and certain rare cancers, as director of CTIP, and Wendy London, PhD, a biostatistician, as co-director. Since starting here about six months ago, the two have begun assembling the basic components of a new clinical research infrastructure.
Their to-do list includes recruiting people skilled in areas that support clinical investigations such as clinical research coordinators, research nurses, information technology professionals, and biostatistical experts.
"For years, researchers with an idea for a clinical trial had to put the whole project together from scratch—applying for grant money, hiring an administrator, finding a biostatistician to collaborate with, wading through regulatory requirements, getting approval from institutional review boards at Dana-Farber and Children's, etc.," says Diller, who also serves as clinical director of Pediatric Oncology for both institutions. "With CTIP, we'll have a core group of people who can provide those services and a ready-made system for getting trials under way."
London and Rodriguez-Galindo are also recruiting statisticians to help investigators design trials and analyze data, and who will specialize in specific disease areas and develop long-term collaborations with researchers. "We're also going to create a CTIP webpage that provides step-by-step guidance for investigators to conduct a trial," London comments. "There has been an incredible willingness by staff at DFCI and Children's to make this project happen."
Says Rodriguez-Galindo, "The scope and scale of basic laboratory science in Pediatric Oncology here is remarkable, among the best in the world. With CTIP, we're hoping to create a better "transmission system" for moving scientific advances from the lab to the clinic, where they can benefit patients."