Clinical Trials

Why Participate?

Why Participate?

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Access treatment options that may not be available outside of the research setting

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Improve personal health; if treatment works, can be among the first to benefit

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Contribute to develop the next generation of drugs for kidney cancer

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Make a difference

Understanding Clinical Trials

Clinical trials are the means to advance medical treatments. At their apex, they involve comparing a new treatment to the current treatment standard. While developed to advance treatment, new drugs or procedures are not always better and they may have more side effects. At the Kidney Cancer Program, clinical trials are carefully selected and vetted by a group of expert doctors. Only trials perceived to have a high potential to advance kidney cancer management are activated.

Inasmuch as clinical trials involve non-standard-of-care interventions and deal with patient health information, there are always risks. While efforts are made to ensure that the interventions are reasonable and clinical trials are reviewed by independent scientific (PRMC committee) and ethical (IRB committee) bodies, there is no substitute for careful review of the informed consent document and obtaining answers to any questions that may arise.

Essential for executing clinical trials ethically, informed consent is the process whereby potential participants are informed about the clinical trial, its risks and the potential benefits. Careful document review is imperative to make an informed decision. Informed consent and other clinical trial documents are approved by the IRB (Internal Review Board), a third party independent from the investigators that ensures that trials adhere to appropriate ethical standards.

Types of Trials​

Types of Trials

Oncology drug trials are typically divided into:

First time a drug is tested in a human. Typically involves testing progressively higher doses of a drug while closely monitoring for toxicity. Starting dose is determined based on studies in animals erring on the side of safety over activity. Often the main objective is the identification of the maximal tolerated dose/regimen, which will be later evaluated to ascertain activity. Typically 10 to 50 participants.

Phase 2 trials seek to determine whether the drug regimen (dose and schedule) has activity against a particular tumor type. Typically fewer than 100 participants.

These trials, which are the foundation for regulatory bodies such as the FDA to approve new treatments, compare a new drug regimen to the standard of care. Ideally, they are randomized and blinded. Randomization and blindness to the treatment allocation minimize the possibility that the results of the trial would be influenced by the physician investigators or the participants. Typically more than 500 participants.

Why Participate?

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Access treatment options that may not be available outside of the research setting

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Improve personal health; if treatment works, can be among the first to benefit

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Active roll in treatment decisions

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Help improve medical care for others and advance cancer treatments

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Make a difference

Understanding Clinical Trials

Provide high-quality care
  • Volunteers not receiving newest treatment being tested receive the best standard treatment currently available
New Treatments not always better
  • Standard care available may end up being as good or better than new treatment approach
Not everyone benefits
  • New treatment approaches that show benefits may not work for all volunteers
  • Even proven standard treatments do not help everyone
Informed Consent
  • Learning about all of the key facts of the research study, along with patients’ rights, before deciding to participate
  • Responsibility of research staff to ensure participants understand all aspects, given ample time to decide, feel comfortable
  • Additional information, visit NCI

Information coming soon

Types of Trials

  • May include:
    • medical drugs or devices
    • medical procedures
    • behavior changes or modifications (ex: diet)
  • May compare new treatment approach to:
    • one currently available
    • a placebo, OR
    • no intervention
  • May compare two or more currently available

Information coming soon

Information coming soon

Information coming soon

UTSW Clinical Trials

Leading Provider

National Kidney Cancer Clinical Trials Consortium

Along with M.D. Anderson Cancer Center (lead), Cleveland Clinic, and Beth Israel Deaconess/Harvard Cancer Center, the UT Southwestern Kidney Cancer Program is a founder member of the first National Kidney Cancer Clinical Trials Consortium, an initiative spearheaded by the Congressionally Directed Kidney Cancer Research Program under the leadership of Dr. Brugarolas during his tenure as Chair of the Integration Panel.

National Clinical Trials Network
UT Southwestern Simmons Cancer Center is one of just 30 National Clinical Trials Network Lead Academic Participating Sites.