Clinical Trials

Research is an important aspect in the fight against cancer. Cancer hates innovation—and research IS innovation. Participation in clinical trials helps create new ideas, and it helps researchers gain new knowledge, data, and insights that can impact potential treatments and medications that could help future generations. Taking part in research can also present patients who have attempted other treatments or are looking for other options with a choice not otherwise available to the general public because the medications and therapies involved are still being evaluated.

But research at Baylor Scott & White is about more than just seeing how we can treat cancer.

We have studies that seek to find better ways to detect and prevent cancer in patients who have never had it, may have a family history of it, or are worried about their cancer coming back. We also study how cancer progresses in different individuals and under different circumstances, such as when other health conditions are involved. And we have trials that seek to find ways to improve the quality of life for people who are living with cancer or who have just completed their treatment.

Participation in research can help inform every aspect of a patient’s cancer journey.

Because clinical trials and other research studies are designed to evaluate a new treatment or therapy, factors such as safety, side effects and basic effectiveness are a natural part of the evaluation. As such, participants may experience an adverse response or run the risk of the treatment or therapy having no effect at all. These factors are all discussed with patients in advance of any involvement, and patients are closely monitored throughout the process to watch for any such signs.

Not all trials involve the use of a placebo. If the trial you are considering does involve placebos, a research team member will discuss this information and related details with you prior to as part of your initial screening.

Every research opportunity has specific inclusion and exclusion criteria that help determine if a person qualifies for the study. Research team members review these criteria with interested participants as part of an initial screening. Criteria can include general information like your age, as well as more detailed factors, such as the stage of cancer you have or other health conditions or procedures in your medical history.

Every trial is different, but generally participants do not have to pay for costs tied to the treatments or medications involved in the trial. These costs are generally covered by the trial’s sponsor(s). The patient (or the patient’s insurance provider) maintains the responsibility of covering costs related to any routine testing, procedures or medications they take as part of their existing cancer treatment.

As part of the trial, a BSWRI team member will review study consent forms with you and provide information about what payments you are and are not responsible for making.

Research participation can require more appointments, lab work, in-person visits, or even hospital stays than a participant is used to having. This is needed as part of the monitoring and study process, but may require more time investments than expected. Appointment and other study-related details will be discussed in advance with participants as part of the enrollment process.

No, you can stop participating in a clinical trial at any time and for any reason. You are not required to stay enrolled under any circumstances.

There are different types of studies and trials involved in research. Some focus on data collection and observation, or studying tissue and tumor samples. These types of studies generally require less time from the patient after samples and related information are initially captured. Others studies involve more direct patient interaction and monitoring – these are often the studies that involve evaluation of a new drug, or combination of drugs, or a new therapy or treatment approach. Below is a breakdown of these phases as explained by the U.S. Food and Drug Administration (FDA):

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including post-market requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.

Baylor Scott & White Research Institute currently supports research within each of the different phases and categories mentioned above.