Taking Steps to Address Cancer: Clinical Research

Last year, MD Anderson President John Mendelsohn, M.D., proposed 10 steps that can be taken to ensure cancer deaths decrease more rapidly, the ranks of survivors swell, and an even greater number of cancers are prevented in the first place.

This is the sixth in a series of posts on key actions outlined by Mendelsohn:

6. Accelerate the pace and improve the efficacy of clinical research.

Clinical trials are the essential step in moving research discoveries from the laboratory to patients with cancer. Clinical trials are complicated, lengthy and expensive, and they often require large numbers of patients.

Further steps must be taken to ensure that clinical trials are designed to measure the effects of new agents on the intended genetic and molecular targets, in addition to outcomes and toxicities. Innovative therapies that have great promise should move forward more rapidly from the laboratory into clinical trials. Innovative designs for clinical trials can speed up comparisons between multiple new agents, as well as studies of a number of agents in combination.

These improvements will require the collaboration and cooperation of clinical researchers, government agencies, pharmaceutical and biotech companies, government and non-government payors, and patients. The timeline for moving new drugs through clinical trials to regulatory approval can be reduced by 50%.

The numerous federal agencies that regulate, guide and fund clinical research, primarily within the Department of Health and Human Services, should streamline and harmonize rules and guidelines for trials of new therapies.

We must educate the public about the value of clinical trials, which in many cases may provide them with access to the best care available. Greater participation in trials will speed up drug development, in addition to providing patients with the best options if standard treatments fail.

The potential risks and benefits of clinical trials must be fully disclosed to the patients involved, and the trials must be carefully monitored -- as is the case today.

Next: 7. Increase funding for research.