The Importance of Clinical Trials

Clinical trials are important to everyone: patients, researchers, clinicians, and pharmaceutical companies. There are lives to be saved, understanding to be gained, and, yes, money to be made.

That said, I found an article in The New York Times about Amgen stopping its Phase III trial of a pancreatic cancer drug interesting because it sited that "weak results" were the culprit behind closing the trial down.

My first thought was at Phase III, really? By this point, companies are completing the final steps before applying for approval from the FDA. Usually, companies aren't gambling on efficacy -- they move to Phase III because it's promising, and it's usually side effects not efficacy that will shut a trial down. However, in this case, "Amgen said that no safety concerns were raised in the review of the trial -- there simply was not enough evidence that it worked."

Dr. Leonard Saltz, chief of the gastrointestinal oncology service at the Memorial Sloan-Kettering Cancer Center, told the Times he once knew of 11 companies with similar drugs in development. “They’ve all been disappointments. And so what it really turns out is that even though the science pointed very encouragingly in that direction, the clinical trials have not been successful.”

We've talked about the value of clinical trials on TheONC before. In fact, Katie Mitchell shares in her blog Tough Decisions: Choosing Treatment Options that clinical trials are recommended as treatment by the NCCN guidelines for recurrent ovarian cancer disease. In those guidelines the NCCN says, "NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged."

I want to encourage nurses to continue to help enroll their patients into trials. It is important to remember that researchers are also on our cancer care teams. Clinical trials are the only place where the science gets tested and proved. They are the key to discovering better treatments and, eventually, a cure for cancer.

To learn more about the value of clinical trials, you can read these blogs from TheONC:

• Clinical Trials as a Treatment Option
  Ann Johnson discusses the value of clinical research to cancer patients.
• Lower-Income Patients Less Likely to Participate in Cancer Clinical Trials
  Community editor Michelle Bragazzi shares a report on lower-income patients and cancer clinical trial participation.
• What Are Those Research Nurses Really Doing?
  Ann Johnston reveals the truth behind the clipboard: clinical nurses are patient advocates who are a vital part of the cancer care team.