Standard of Care Plus

For many, the term “clinical trial” is synonymous with “experiment.” Allyson Ocean, M.D., would prefer “experiment” be replaced with “opportunity.”

The medical oncologist from Weill Cornell Medicine in New York City advocates that her patients be given every opportunity to partake in therapies based on the latest scientifically sound research. In many cases, this involves participating in a clinical trial. And contrary to some fears, it does not mean patients have to sacrifice what is currently considered the best treatment.  “I like to think of it as standard of care plus,” Ocean says.

Even those in the placebo, or control, group in clinical trials are getting the current available standard treatment. In the treatment group, they’re getting something that science has suggested might make that even better.

“I want to make sure my patients have access to every option. New drugs usually take at least five years to make it to market. If you take part in a trial, you could have the opportunity to benefit a lot sooner,” Ocean adds.

What Makes Clinical Trials Special?

Clinical trials are medical research studies that explore new treatments, new strategies for treatment, or new devices, to see if they are safe and effective for patients. By the time the trials have reached the stage where they are enrolling patients, they have undergone extensive pre-testing in the lab, and have been reviewed under stringent guidelines by scientific and regulatory boards.

These boards continue to monitor the trial as it is underway. If there are any adverse effects that are higher than the standard treatment, they can act swiftly to close the trial and warn other patients.

This heightened attention not only keeps trial participants safe, it can provide other benefits. There have been some studies  showing that patients in a clinical trial—regardless of which arm they are enrolled in—might have better outcomes than might be expected for patients not enrolled on a clinical trial, possibly because they are being managed and monitored that much more closely.

Will It Work?

When pitching a potential trial to patients, Ocean is careful to address concerns. Many have to do with potential side effects. Others include: Will this treatment work for me? Will I have to come to the clinic very often and have extra tests? How will this impact me financially?

“I’m honest with them. Because it’s a trial, we don’t know if the drug will ultimately be helpful. But, unfortunately, there’s no guarantee with any treatment you get that it will be successful, whether you are on a trial or not,” Ocean explains.

In terms of cost, doctors can get insurance approval before starting a clinical trial so that the patient’s insurance will cover all standard of care costs related to the tests that are being done. Some trials can also cover travel to clinical trial site.

Others are concerned about the influence of pharmaceutical companies in the process. There are a number of rules and regulations in place to prevent conflicts of interest between doctors and pharmaceutical companies, Ocean says.

Last Resort or Early Advantage?

People often think of clinical trials as a last resort, after patients have exhausted all their standard treatment options. But there are often trials at other stages of treatment.

Those considering clinical trials should ask their doctors if there are any trials that they are aware of, Ocean notes. They should go online to sites like the Pancreatic Cancer Action Network or to support groups. They should talk to their peers, and other doctors, perhaps getting second or third opinions from other physicians who might be aware of clinical trials.

“We know that some of the standard treatments that we are currently using work on only a subset of patients. Some have unfavorable side effects. We have made important strides, but we want to do better. The best way to do that is to test new treatments in a scientifically rigorous fashion,” Ocean says.

Benefits can extend beyond the personal, she adds. “Patients often participate with the understanding that it might not only help them, but that it might also help patients in the future,” says Ocean. “I appreciate their bravery, altruism and trust, and I’m proud of the role patients have played in advancing research, expanding treatment outcomes and improving outcomes.”