Frequently Asked Questions
What is a clinical trial?
A clinical trial (or clinical research project) is a research study used to test new medical treatments and therapies such as a drug or device. Clinical trials are an important part of the development of future medical treatments. They are done in stages or phases. In Phases I through III, clinical test volunteers are under the supervision of a physician and other research professionals. Phase IV occurs after a drug or treatment is launched and has been on the market. AccumetRx clinical studies’ primary focus is usually during the Clinical Phases II, III and IV.
What part does a medical practice play in a clinical trial?
Our practice is frequently invited to participate in urologic-related research. Most of the studies are developed by pharmaceutical and biotechnology companies (sponsors), who select qualified physicians (investigators) such as the AccumetRx Division of Urology Group of New Mexico to help. Each proposed study which AccumetRx considers for participation has met FDA protocols, and has been approved and is under the supervision of an Institutional Review Board (IRB).
How does a clinical trial work?
A clinical trial is led by a principal investigator, most often a doctor. Your Urology Group of New Mexico physician will often be one of the principal investigators of an AccumetRx clinical trial. The principal investigator and members of the research team regularly monitor each volunteer’s health to determine the study’s safety and effectiveness.
Volunteers who participate in a clinical trial are normally assigned to a specific study group. Typically, clinical trials compare a new product or therapy with another that already exists to determine if the new one is as successful as, or better than, the existing one. In some studies, participants may be assigned to receive a placebo (an inactive product that resembles the test product, but without its treatment value).
Often, the fastest and most reliable way to demonstrate the new product’s therapeutic effectiveness is to compare it with a placebo. Placebos are not used if a patient would be put at risk, particularly in the study of treatments for serious illnesses by not having effective therapy.
Potential participants are told if placebos will be used in the study before they enter a trial. However, once they enter the trial, participants are not told if they are in the “placebo” group. Important details of each trial are reviewed with each volunteer during the Informed Consent process.
What is Informed Consent?
Informed Consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. Informed Consent is an on-going process, and continues throughout the study.
The Informed Consent document includes details about the study, such as its purpose, duration, required procedures, and whom to contact for further information. The Informed Consent document also explains risks and potential benefits. A participant can then make an informed decision about whether to sign the document.
Please keep in mind that Informed Consent is not a contract. Volunteers are free to withdraw from the study completely, or to refuse particular treatments or tests at any time. However, this will sometimes make them ineligible to continue the study.
Does my information remain confidential and private?
AccumetRx has controls in place so that no volunteer’s personal information is ever released outside our system. Information linking your name to your medical information is replaced by other identifiers, such as numbers. Your information remains completely confidential and private.
Who can participate in a trial, and what is a protocol?
Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the volunteers’ health as well as to answer specific research questions. A protocol describes the following:
- Who is eligible to participate in the trial. This is also referred to as “inclusion and exclusion criteria.”
- Details about tests, procedures, medications, and dosages.
- The length of the study and what information will be gathered.
What if I qualify for a clinical trial?
With advice from their physician, patients who qualify for a clinical trial will decide whether to participate in the study. How a treatment will work for a patient in a trial cannot be known ahead of time. Therefore, the patient should be aware of both the risks and benefits of clinical trials before making a decision. If you qualify, we encourage you to discuss participation not only with your physician, but your family as well.
What happens after the trial?
After a clinical trial is completed, researchers carefully examine the information collected during the study before making decisions about the meaning of the findings or further testing. Study results can become important building blocks to new and better treatments, further research and other types of medical advances.
Are you interested in volunteering for a clinical trial?
If you are interested in joining a clinical trial, then please contact you’re the Urology Group of New Mexico at 505-872-4091 ext. 118 or ext. 117. We can also be emailed at firstname.lastname@example.org or email@example.com.
Where can I learn more?
Please visit the Clinical Trials Available page of our website for more helpful links in learning about clinical trials.