Improving Clinical Trials: "Yes We Can"

by Kristin Schneeman, Program Director, FasterCures

Probably one of the most persistent problems slowing medical research that we hear about at FasterCures is that the cost in time and dollars of clinical trials is crushing the discovery enterprise. Professionals from all corners of the clinical research enterprise express frustration with the complex web of problems and the long-term gridlock they perceive. They are weary of devoting time and energy to any effort – whether a one-time conference, an ongoing process, a consortium or alliance – that will revisit the “same old issues” surrounding clinical trials.

In the spirit of the New Year, we’d like to highlight some heartening efforts from a variety of quarters to stop griping and try to solve some of these thorny problems. They’re all very different, yet what links them is their optimism that change is possible.

The National Cancer Institute and the CEO Roundtable on Cancer are engaged in an ongoing effort to develop "model language" for use in the contract agreements that govern clinical trials. The model language covers seven areas in which negotiations regularly stall, including intellectual property, study data, indemnification, subject injury, confidentiality, publication rights, and biological samples.

Duke University is hosting an effort springing from FDA’s Critical Path effort, the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia. Its more than 50 members will work together to develop new standards and identify new methods and technologies that improve safety, boost the quality of information derived from clinical trials, and make the research process more efficient. This is not another exercise in analysis paralysis; it is meant to be a practical effort to generate data and test solutions.

And finally, the Dr. Susan Love Research Foundation and the Avon Foundation have recently joined forces to launch the Army of Women Web site. This is a new and different way to engage people in clinical research – not a walk or a telethon, but an opportunity to directly contribute to research. Army of Women seeks to recruit one million healthy women of every age and ethnicity, including breast cancer survivors and women at high-risk for the disease, to partner with breast cancer researchers and directly participate in research; and to challenge the scientific community to expand its current focus to include breast cancer prevention research conducted on healthy women. Women can register to be notified of opportunities to participate in research projects (by mailing in blood, saliva, even breast milk samples, filling out questionnaires, etc.).

Within each patient is a Rosetta Stone of information that could unlock the potential to cure disease. It’s nice to know not everyone has stopped trying to solve the puzzle.