Blog Date: December 9, 2021
Are you considering participating in a clinical trial and not sure if this is right for you? Not all clinical trials involve testing a new treatment. Some do, of course, but many are observational where doctors learn about particular disease states by monitoring a group of affected patients. Others may be testing an already approved and safe medication that is normally used for other health issues (known as repurposing an existing drug).
Of course, many trials are directed at testing new medications. Any new treatment has its risks, but keep in mind that the drug development process is heavily regulated and monitored for safety. By the time a drug is tested in humans, researchers have already had to show scientific evidence that it will likely work and is safe. In many cases, the treatment has already passed safety studies and has been shown to be potentially effective before it is tested on human study participants.
Let’s explore reasons why clinical trial participation is right for you.
1. The smartest minds in medicine designed this for you:
Trial design includes a large collection of many of the brightest minds in medicine—nationally recognized physician thought leaders, pharmaceutical industry pioneers, large collaborative international work groups, disease specific patient advocates, and experienced regulatory oversight. Trials compare head-to-head two (or more) therapy options. Those options include the current standard (which is sometimes studied by observation) vs. an experimental option we think might be better. If we didn’t think the experimental arm had a chance to improve outcomes—the trial would never happen.
2. You trust your physician
When your doctor agreed to open this trial at your facility, he/she carefully reviewed the background science in careful detail. They agreed the trial is a valid option for treatment regardless of which arm of the study you are randomized to. This background knowledge is why they are offering it to you in particular. Your physician believes the trial is a great option. As always ask questions, but have trust in their recommendation.
3. Institutional Review Boards that protect your rights
An institutional review board (IRB) is an independent body designated to evaluate and monitor all clinical research at your hospital/health system to protect the rights and welfare of human research subjects. The process is unique to trials and doesn’t exist in standard practice. There is no independent group of people reviewing your care and watching out for your best interest unless you are on a clinical trial. The review boards ensure clinical trials are conducted both ethically and safely for all participants.
4. Clinical trials staff who closely monitor you
When you are receiving care on a clinical trial, every last part of your care is monitored not only by your physician, but also by a trained set of clinical research staff members. They look at every lab test and consider every symptom or reaction, closely watching your care, and your outcome. They adhere to protocols making sure labs, imaging, and medications are all done exactly right.
5. Information is power
When you enroll in a clinical trial, you undergo “informed consent,” which means you receive a long, detailed document carefully outlining every step with information reviewed by dozens of experts, written in your language, on your reading level. Informed consents lay out your rights as a patient. If you are interested in participating in a clinical trial, read all you can and ask all your questions. The more you know about the benefits and risks, the more at-ease you will feel with your commitment.
Physicians and patient advocates alike are fighting for better access to clinical trials and more comprehensive trial options for patients. This desperation speaks to the important role clinical trials play in kidney care. Clinical trials may offer you the opportunity to receive the latest nephrology treatments, without the need to wait for them to be made available or worry about payment for them.
If you have questions about clinical trials, call NANI Research at 331-216-1115.
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