In order for any drug or other medical treatment to receive approval by the United States Food and Drug Administration so that it is legally available for patient use, it must undergo a lengthy process to establish that it is safe and effective. A key stage in this process is clinical research trials, where the experimental treatment is administered to some patients and not others, and the results are compared.
Dr. Benson and the Be Well Medical Center have participated in over a hundred such clinical research studies over the years for HIV prevention and treatment.
Dr. Benson oversees these trials as the Principal Investigator, with physician assistant Mark Rosen serving as Sub-Investigator, and Amber Hooper, Lina Kakouz, and Gloria Karungi assisting as Clinical Research Studies Coordinators.
The studies can last up to two to three years. They are double-blinded (meaning that they are set up in such a way that neither the patient participants nor the researchers administering the treatment know which patients are receiving the experimental treatment and which are not). At any given time, Be Well may be participating in a dozen or more studies.
Are Clinical Trials Right for You?
As a patient, participation in one of Be Well’s clinical research trials is strictly voluntary. You will have the process thoroughly explained to you, and then it is your choice whether to give your informed consent. Furthermore, even if you consent you may change your mind and withdraw from the study at any time. You are not committed.
There are a number of reasons that some patients choose to participate in clinical research trials:
Participants receive their treatment for free.
Throughout the trial, participants’ health is monitored very closely, with even more frequent office visits, blood draws, tests, etc. than a conventional patient typically receives, and this also is all free.
If you are one of the participants that receives the experimental treatment, then you will be receiving a treatment that the evidence strongly indicates is as good as or better than the treatments available to patients not participating in the trial.
Participants are helping medical science; they are playing an essential role in a process that may result in improved treatments becoming available to people in need around the world.
The main drawback it is important to be aware of is that while the evidence is in favor of the experimental treatment being as good as or better than the existing treatments, that has not yet been established for certain. After all, that’s why the clinical trials are being done, to test whether a promising treatment really is safe and effective. So there’s some non-zero chance that you’ll be receiving an inferior treatment to what you would receive if you were not participating in the clinical trial.
Some patients also express concern that they might end up in the subset of participants (the “control”) who do not receive the experimental treatment but receive a placebo instead.
But this cannot happen. The standard for FDA testing is now to not use placebos such as sugar pills to compare with a new treatment. And even before that became the FDA standard, Dr. Benson as a matter of principle chose not to participate in any clinical trials where any of his patients who needed treatment might instead receive a sugar pill or other inert substance.
Instead, the control group of patients in a clinical trial receives an already approved treatment. So the comparison is not, “How do patients receiving the experimental treatment fare compared to patients receiving no treatment other than a placebo?” but rather “How do patients receiving the experimental treatment fare compared to patients receiving the standard treatment that has already been established as safe and effective?”
Often the studies don’t even involve two different drugs—one established and one experimental—but simply different dosages of the same drug. Current practice may be to prescribe a certain medication as a 500 mg pill. Researchers may believe that a 5,000 mg pill of the same medication would be equally or more safe and effective, but they won’t know that for sure until experiments are conducted. So half the participants in the clinical trial receive the 500 mg pills and half receive the 5,000 mg pills.
Please note that participation in an investigational clinical trial and the office visits associated with it are not a substitute for primary care and management of your disease. We generally provide this care and management for the participants in our studies, but you do have the option of participating in one of our studies even if you receive your health care from another practice. We also are happy to work with you and provide your primary care if you are participating in a study at another institution, and in fact have encouraged patients to participate in such a study when we believe it to be in their best interest.
If you would like to know more about clinical trials, or would like to volunteer to participate in one of our clinical trials, your provider will be happy to discuss your options with you.