What Are Clinical Trials?

Clinical trials are studies that evaluate the effectiveness of new drugs or treatment strategies. The development of more effective cancer treatments requires that new and innovative therapies be evaluated with cancer patients. Each clinical trial is designed to find new or better ways to treat cancer patients. Our goal is to provide patients with forms of investigational and approved therapies including national research trials and drugs, without the need to travel to other parts of the country.

Why Clinical Trials Are Important

Advances in medicine and science come from new ideas and approaches developed through research. New medical treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available. Through clinical trials, researchers learn which approaches are more effective than others. A number of treatments that are now standard were first shown to be effective in clinical trials.

Goals of Clinical Trials

Most cancer clinical trials are treatment studies that involve people who have cancer. These trials test new treatments or new ways of using existing treatments, such as new drugs, vaccines, approaches to surgery or radiation therapy, or combinations of treatments. Some treatment trials involve testing cancer cells for the presence of specific molecular markers. These markers can include changes in certain genes or proteins. These changes may help to further classify cancers and certain treatments may even target them. It is therefore important to know whether or not they are present. Treatment trials are designed to answers questions such as:

  • What new treatment methods can help people who have cancer?
  • What is the most effective treatment for people who have cancer?
  • Does the new treatment work as well as the old treatment?
  • What are the new treatment’s side effects?

Benefits to You

Involvement in a clinical trial is strictly voluntary, but people who participate can experience multiple benefits. Here are some of the benefits you could receive as a clinical trial subject:

  • Access to promising drugs, medical devices, or treatment approaches before the general public
  • A more active role in your own health care
  • Expert medical care at a leading health care facility
  • Close monitoring of your health care and side effects
  • If you decide to participate in a clinical trial at the Woodlands, you’ll play in important role in advancing scientific knowledge and helping future patients.

Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, continual information is gained about an experimental treatment, such as its risks and its effectiveness.

Who can participate in a clinical trial for cancer?

To qualify for a particular study, participants must meet a carefully defined set of criteria. These usually relate to age and gender, cancer type and stage, and the types of treatments they have already received.

How will I know if I am eligible for a Clinical Trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial,

How do drugs and procedures qualify for clinical trials?

Patients who participate in a clinical trial receive drugs or procedures that have already been researched in successful laboratory and/or animal studies. Most clinical trials study new drugs or procedures, but some study drugs or procedures that have already received approval by the U.S. Food and Drug Administration.

What happens during a clinical trial?

The doctors and nurses of the Research Department check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. The clinical trial process depends on the kind of trial being conducted and the guidelines that have been spelled out for that particular trial. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

How are patients protected?

Before any clinical trial begins, it must be approved by its host institution’s Institutional Review Board (IRB), which includes researchers and physicians. The IRB considers whether proposed studies are safe and well planned and whether they will ultimately advance patient care. It also

reviews studies to ensure patients are adequately informed about the risks of participating in clinical research. In all studies, the health of each patient is closely monitored during the course of the trial.

If you are interested in learning about Woodlands Medical Specialists Clinical Trials, please call 850-696-4000 or ask your physician.