Clinical Trials

From the Physician’s Desk

As a physician and researcher, Charles M. Balch, professor of surgery, The University of Texas MD Anderson Cancer Center, has seen many benefits for people participating in clinical trials. Through his vast experience, he has answered varied questions and helped to reassure people that they will get the best possible care while participating in a clinical trial. He encourages people to seriously consider clinical trials, when appropriate, to gain access to the most advanced medicine available today. Dr. Balch shares his insights to help explain the purpose of clinical trials and why they are such a valuable option to consider.

Clinical trials give patients access to new therapies that aren’t yet available to the public,” Dr. Balch says. “They offer patients the possibility of new treatments that may be their best treatment option for their diagnosis and stage of cancer. Every current patient care plan is based on previous clinical trials. Through clinical trials, the medical community also can develop better standards of care for future patients. In addition, clinical trials allow us to discover the value of a potential new drug by using scientific methods. We have to have trials that use science and objectivity to determine if the drugs offer a therapeutic benefit or not.”

All treatment strategies currently available today were once a part of a clinical trial. The U.S. Food and Drug Administration requires new drugs or devices to go through trials before it will approve them. So, volunteers are needed to help bring new medical interventions to the public.

Dr. Balch urges patients to talk to their doctor about participating and to help evaluate if they are a good candidate for a clinical trial.

“I recommend that patients always ask their doctor about clinical trials in their local or regional area,” Dr. Balch says. Everyone also should research clinical trials on their own. They can search and look for trials nationwide. It’s important for potential participants and their family members to be their own advocates and do research.”

“Of course, there are always uncertainties and unknowns in clinical trials,” he says. “There will be things we [as doctors] don’t know. This can be frightening. But there’s no need to worry because national experts design these trials and have approved the methodology of the trial. Participants will get the best standard of care and be fully informed throughout the process.”

“Our job as doctors is to help people find a comfort level with participating,” he says. “If for some reason they aren’t comfortable, we also remind them that they can choose to go off the study at any time.”

If cost is a concern for participating in a clinical trial, Dr. Balch notes that insurance plans may cover part or all of the trial expense similarly to any other treatment option.

“Check with the insurance company to determine coverage for the standard of care costs involved in the trial. Patients may achieve the best outcome when they work through their doctor’s office to request insurance coverage for a trial. It’s best to work out the cost expectations prior to joining a clinical trial.”


Understanding Informed Consent

Before volunteering for a clinical trial, potential participants receive detailed information about the clinical trial in an Informed Consent form. This form details the purpose of the research, including what the participant’s role will be in the trial and how the trial will work. It also includes risks, benefits and other pertinent information to answer a potential participant’s questions. To ensure they fully understand what they are agreeing to, potential participants are required to review the form during the Informed Consent process.

The informed consent information will be explained in easy-to-understand language and will describe the study’s purpose, the length of time of the study, predictable risks, possible benefits, expectations, protocols, alternative beneficial procedures or treatments, the research subject’s rights, where more information can be found and answers to additional questions about the research. The document will include some of the following information:

  • The trial and its goals.
  • How the participant will be monitored and what side effects to expect.
  • The best standard regimen of care for their stage of disease, regardless of the doctor or institution.
  • The safeguards in place. All clinical trial participants are protected by rules that apply nationwide to all facilities.
  • How to withdraw from the trial at any time.

The Informed Consent process should give the potential participants a reasonable amount of time to review the trial’s information and ask questions before volunteering. They should use this time to check with any insurance providers to determine what procedures are covered and what they are expected or required to pay out of pocket. Although many trials cover the costs of certain treatments, other expenses may be the responsibility of the participants, which would best be discovered before starting a trial.

Potential participants need to understand their role as “subjects of research” and not as patients. Although they may receive personal treatment, they are not guaranteed to benefit from the study. They may be exposed to unknown risks, and they are entering a study that may be very different from current standard medical practices.



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