Contents
- Cover Story
Forging a Path From Laboratory to Clinic
Critical Resources
Forging a Path From Laboratory to Clinic
For the most part, the current generation of clinical researchers could only draw on the resources of their own departments to carry out their work. “But as science has advanced, we need a set of tools and knowledge that transcends the structures of a typical clinical department,” says Robert Califf, vice chancellor for clinical and translational research at Duke University Medical Center. “That is why NIH Director Elias Zerhouni decided we needed to provide a home for this kind of research.” Califf, along with Lars Berglund, associate dean for clinical and translational research at the University of California, Davis, cochairs the CTSA consortium oversight committee.
The CTSA consortium, initiated in 2006 with 12 “homes” for clinical and translational research, is enhancing the nation’s clinical research enterprise by encouraging and enabling transdisciplinary collaborations within and across research institutions, providing researchers with access to sophisticated technologies and expertise, offering assistance with regulatory and administrative tasks, and training the next generation of clinical and translational scientists.
Although the first 12 CTSAs are just starting to make the necessary facilities and programs available at their own institutions, many researchers are already realizing the impact that the new infrastructure will have on their current and future work.
Speeding the Development of New Therapies
Through its CTSA, the University of Pennsylvania provided invaluable assistance to Grupp in negotiating an agreement to work on his neuroblastoma trial with colleagues at Dana-Farber Cancer Institute, considerably speeding up patient recruitment. “The collaboration will cut the length of the trial from eight to four months,” explains Grupp.
Getting another entity involved in the trial was far from easy. “This is an Investigational New Drug (IND) study, and Penn holds the IND,” says Grupp. “So we had to develop procedures for Dana-Farber to participate. We had to write new standard operating procedures that could be exported to a different site.” The payoff is that when the trial is completed in fall 2007, Grupp will have a chance to move forward with testing his new cancer vaccine. And if he and investigators at Dana-Farber decide to collaborate to test the new therapy, the groundwork has already been laid. “We now have a clinical trial agreement between the two institutions,” he says.
Researchers are often not trained in complying with all the regulations set in place to ensure patient safety, and even if they have the necessary know-how, they cannot afford the time and effort to get through all the associated paperwork. CTSAs focus on freeing up the intellectual and creative talents of clinical and translational researchers by providing regulatory support, clinical research coordinators, technology transfer assistance, and project management. “The CTSAs help researchers deal with the complexities of human studies,” says Berglund. “At our university, we have individuals who are trained to take care of regulations. With increased use, their experience increases, and they become better and faster at the task.”
