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Considering Clinical Trials

Posted 2/20/2015

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  Clinical trials are the bedrock of evidence-based medicine. Everything we know about treatments that work, and those that don't, came from patients who were willing to participate in trials. To begin this conversation, here is a short fact sheet that I developed for our medical center:

Clinical Trials at Beth Israel Medical Center

BIDMC is an academic medical center and a founding member of the Dana Farber Harvard Cancer Center. This means that our commitment is both to excellence in patient care and participation in research to better understand and treat cancer.
If you are interested in learning more about cancer clinical trials, the National Cancer Institute has an excellent website:
As you and your doctors begin to consider the best treatment for you, here are some things to remember about clinical trials:
** Clinical trials are conducted in every Department throughout the Medical Center.
** Clinical trials are designed to help patients with all kinds of diseases and problems. They are not only for very ill people who have no other options.
** Everything we know about good treatment for cancer is because people have agreed to participate in trials in the past. Everything we are learning for the future is because people are now willing to consider being part of an appropriate trial.
** If you would like to know more, talk with your doctors.

  This pretty much covers the basics, but leaves out the critical question of whether considering participation in a trial is right for you. Let's begin by remembering that this is not, for many people, a one time opportunity or question. If you have an early stage cancer and will be undergoing adjuvant treatment that is aimed at cure, there may be a trial to consider that will indeed be a solo experience. If you are living with recurrent or metastatic or advanced cancer, this question may well come up each time a treatment change is in order.

  Here is one of the dilemmas: Most trials limit the number of previous treatments that a participant has undergone. The reason for this is that cancer cells are clever and find a way to mutate and become resistant to any one drug. In testing new drugs, it is important to find out if they are effective on purer (for lack of a better word) cancer cells. Having already been through half a dozen treatments likely has changed the biology enough to make the trial not useful for a particular individual. So, this opens the dilemma of whether to participate in a trial earlier (when there are known drugs that will help, and when no one really knows if the trial drug will be useful--that, after all, is the point) or whether to wait and use the known-to-be-helpful drugs and then maybe not be eligible for later trials.

  Here is another dilemma: Drugs are in trials because we are trying to learn the safe dose, the best dose, and whether they are more effective than other treatments. Most trials drugs, and this means those being evaluated for all kinds of illnesses, turn out not to be valuable and are never approved by the FDA. Occasionally a trial drug is a spectacular success (consider herceptin for her2 positive breast cancer or Gleevac for CLL), and early participants were richly rewarded. Study after study has found, not surprisingly, that individuals agree to a trial because they were hopeful it will be individually helpful. They understand that they are contributing to an important body of knowledge and furthering research, but it is the personal motivation that drives them.  There is nothing wrong with this, but people do need to understand the unliklihood of a trial drug being a game-changer.

  There is now an on-line decision tool called PRE-ACT that is designed to help people make this important choice. Here is a short article about this from Cancer Net and a link directly to the tool:

Link to PRE-ACT:

Dr. Neal Meropol is chief of the division of hematology and oncology at University Hospitals
Case Medical Center and Case Western Reserve University in Cleveland, Ohio. He is also the
Associate Director for Clinical Programs at University Hospitals Seidman Cancer Center

As a practicing oncologist in an academic medical center, I am always looking for new ways to
improve care for my patients. The best way we have to test new therapies against cancer is
through clinical trials. Unfortunately, although clinical trials are critical for advancing cancer
treatment and ultimately serve as the basis for new standards of care, very few patients
In my own research, I’ve tried to understand the barriers that exist for patients in considering
clinical trials as a treatment option. In addition to not being able to access research studies, we
have identified a variety of knowledge gaps and attitudes that might interfere with a person’s
willingness to participate in a clinical trial. Some people have never heard of clinical trials, and
others are worried about the side effects that they may experience on a clinical trial or the
possibility of receiving a placebo.
It occurred to me and my colleagues that we could help people make better decisions about their treatment options if they were more prepared to learn about all of the possible choices—both standard therapies and treatments given as part of a clinical trial. We thus developed an online program called PRE-ACT, Preparatory Education About Clinical Trials.
The basic idea behind PRE-ACT is that we can help patients make treatment choices that are best for them by addressing their knowledge gaps and attitudes about clinical trials before they meet with their oncologist for the first time. To do this,
the PRE-ACT program asks patients a series of questions to identify their knowledge and attitudes about clinical trials. Based on their responses, PRE-ACT delivers a series of videos to address their specific concerns.


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