Understanding Research and Clinical Trials

Phase III clinical trials are the type of research that results in real changes to treatment options offered to women who suffer from gynecological cancers. Yet, no nearly enough of these are underway. Unfortunately, they are the most expensive trials to perform often requiring millions of dollars to answer a single important question.

Many cancer foundations use donations to fund small, innovative research projects that have only a small chance to result in practical changes in the care of patients. The Up the Volume Foundation take a different approach and only supports phase III trials resulting in practical outcomes to improve the length and quality of life for women with gynecological cancers. Your tax-deductible donation will support real changes in gynecologic cancer care and ultimately change standards of care for all women with these deadly diseases.

Learn more about how research moves from the lab to the patient.

The Process

Basic Science Research (petri dishes and test tubes)

The first and often the least expensive step in medical research starts in the laboratory. In this step scientists test prospective, innovative treatments to see if they result in specific biochemical or genetic effects. Of thousands of innovative ideas that are tested a few produce an intriguing effect and are evaluated further in the next step in the research process.

Animal Research (mice, rabbits, pigs, etc.)

Often we find that innovative treatments that give a desired effect in the laboratory do not result in the expected biological effect when tested in an animal model. Of the many agents tested on animals, only a few produce the desired biological effect and move on to be studied in humans.

Human Clinical Trials

There are generally 3 phases of clinical trials when studying treatments on humans. Each phase of research is heavily monitored to ensure the safety of the patients who voluntarily enroll. With each phase, a larger number of patients must be evaluated and the expense increases.

Phases of clinical trials

Phase I: Phase I clinical trials are specifically performed to evaluate the toxicity of a potential treatment. These trials also determine the dose that is reasonably well tolerated by patients. Only treatments with an acceptable toxicity and safety profile move to the next phase of clinical evaluation.

Phase II: Phase II clinical trials are performed to ensure that the potential treatment results in a response on the cancer. In other words, does the cancer shrink after patients are treated with the investigational drug? Only treatments that result in a significant reduction in the size of the cancer being treated are further evaluated in phase III trials.

Phase III: Phase III clinical trials are large trials performed to compare an investigational treatment against the current standard-of-care treatment. Patients are randomly assigned to the experimental arm or the standard arm of the study. Results from these trials definitively determine the best treatment. In this way standard recommendations that are offered to women with gynecologic cancers can be changed for the better. Ultimately, these trials are the type of research that improves the length and quality of life for future cancer patients.

In order to achieve the mission set forth by Up the Volume Foundation we must raise large sums of money to allocate to groups of gynecologic oncology experts who can design and implement important phase III trials that will answer critical questions to improve the screening, diagnosis, and treatment of gynecologic cancers. These are the answers that will improve the length and quality of life of women affected by these diseases.