Considering a urology clinical trial? Here’s what you need to know

Progress in health care is made through research. Discovering and collecting crucial data for developing new drugs, devices, and treatments heavily depend on clinical trials.  That’s why patients with certain medical conditions, such as prostate cancer, may be asked by their physician to consider participating in a clinical trial or research study to evaluate a new treatment. If you have been asked or maybe you have thought about doing so on your own, this article provides basic information helping you decide if cooperating in a clinical trial is right for you.

Keep in mind, there is no obligation for any patient to join a research study.  But they are worth your consideration.  Individuals who participate will be advancing scientific knowledge that can help future patients. Consider, that without clinical trials, many of today’s therapies would not exist. All of us have already benefitted from countless individuals who have joined past clinical trials that have helped advance the practice of medicine improving and saving thousands of lives.

What is a clinical trial?

Clinical trials allow researchers and doctors to test advances in medicine to see if they are improvements over current practices. It is not unusual for a clinical trial to test to see if a new treatment or technique is superior to standard care already in place. Clinical trials study the following:

• Prevention such as how to reduce the risk of disease
• Screening on how to find diseases at earlier stages to begin treatment
• Diagnostics or improving testing for a disease
• Treatment on how to provide care or cure a disease
• Quality of life or how to offer comfort for people with long-term issues

If I am accepted for a clinical trial, what can I expect?

Even if you want to and are willing to participate in a clinical trial, you must first meet certain criteria the researchers have set up on what participants they are looking for.  Once you have been accepted, you can expect a thorough discussion and personal evaluation prior to the clinical trial which will include:

• Being closely monitored – Clinical trials have to meet specific criteria for patient safety, informed consent, ethical conduct and other aspects of research and must be approved by an institutional review board.
• Sponsors of the studies usually cover the costs associated with participation – The pharmaceutical or biotechnology companies that sponsor clinical research generally assume program costs such as blood work, imaging and consultations. However, patients should confirm with the study coordinator prior to enrolling, as insurance coverage and study details can differ.
• Patient confidentially – In accordance with the Health Insurance Portability and Accountability Act (HIPAA), the patient’s informed consent agreement ensures not only confidentiality of individual’s health records but information such as name, medical record numbers, and zip codes. The informed consent agreement will detail the specific data that will be shared from the study.
• Clinical trials will vary by size, structure, and objectives – Patients may have different experiences with different trials, based on the needs of the research. For example, small scale studies may involve just a few patients and measure optimal dosage. Larger studies may examine a drug’s effectiveness compared to current standard approved treatments.
• Participation is voluntary and patients can withdraw at any time –If you are interested in participating in a clinical trial for prostate cancer, discuss this with your urologist. They can help you find a clinical trial in prostate cancer appropriate for what that research is looking for.  By your willingness to participate in current or future trials, this helps ensure that in the future, more effective therapies will be on the horizon ready to enhance care for patients in years ahead.