Contributor: Jame Abraham, MD
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Available cancer treatment options are far from perfect. Every day, more than 1,500 mothers, fathers, sisters, daughters and sons die from a cancer diagnosis in the United States alone. That is equivalent to five jets carrying 300 passengers crashing every day in our country.
Clinical trials are the cornerstone of progress in disease treatment. As a cancer doctor of more than 15 years who has taken care of thousands of patients, I believe a scientifically sound –– and ethically and expertly designed –– clinical trial is the gold standard in treatment. While clinical trials are key in cancer research, they’re also important in a range of diseases and conditions.
Selecting the right trial is not an easy process for those involved. It’s certainly not easy for the patient, who is trying to navigate the complicated decision-making process. It’s not easy for many doctors either.
Contributing to science
Every medicine available today, whether for headaches, heart attacks or cancer, was developed through a clinical trial.
Someone like you and me, after weighing the risks and benefits, signed the informed consent to take that medicine in a trial. Now, each one of us and our family members are reaping the benefits of that patient’s willingness to go the extra mile in the name of science.
A scientifically sound and ethically designed clinical trial undergoes many checks and balance to protect the patient.
Patient safety, from beginning to end, is key to the decision-making for the design of any trial. Therefore, anyone who signs up to participate in a trial can be assured that they are not considered a guinea pig, but rather, part of an exciting new treatment that could change the treatment of that condition forever.
Phases of a trial
Trials are divided into phase I, II and III. There are also phase IV (post-marketing) trials.
- Phase I trials, in general, focus on a drug’s side effects, how it is metabolized in our body and the optimal dose by itself or in combination with another drug.
- Phase II trials are designed to find the efficacy of a new drug in a particular disease — lung cancer, breast cancer or lymphoma, for example.
- Phase III trials are mature trials; by the time a drug reaches phase III, it has already passed phase I and phase II. In phase III trials, we are trying to compare the new drug, new approach or new combination to the current standard treatment. If the new drug is found to be better than the standard treatment, it’ll be filed for Food and Drug Administration approval.
The informed consent process is the most important aspect of participating in a trial, prior to you joining it.
Usually the investigator, research nurse or another member of the study team will review the consent in detail with you. You will be given ample time to review the document, ask questions and take notes.
This is the time to ask questions. All clinical trials are completely voluntary, and without your full informed consent, you will not be entered into a trial.
The thought of participating in a clinical trial can be burdensome for patients, but if they know the questions to ask and have an open mind, it will become clear whether to participate.
As an oncologist working to advance medical treatment, I encourage patients to consider them, and ultimately make a decision aligned with their situation.