For more information or to sign up for a trial
please contact our Clinical Trials Team:
(909) 478-7973
About Clinical Trials
What are clinical trials and why are they important?
Clinical trials are research studies that involve people and make up an important part of advancing cancer treatments. Through clinical trials, new medications are tested in order to determine whether new drugs or treatments are both safe and effective. These trials enable doctors to find new ways to improve treatments as well as quality of life.
Clinical trials serve as the foundation for evidence-based medicine by addressing specific clinical questions that may lead to improvements in current clinical practice. Some trials are “interventional” meaning they offer a specific treatment. Other clinical trials are “observational”, which monitor patient symptoms or quality of life while the trial participant receives standard of care treatment.
Clinical trials participants are volunteers and can withdraw from actively participating in a clinical trial at any time.
Trial Phases
Phase 1
Initial trial of a drug in humans for dosing, safety and early efficacy information. The safety of the treatment is tested with up to 100 volunteers.
Phase 2
Subsequent trial of a drug’s safety and efficacy in a particular disease setting. These trials include treatments that are tested on 100 – 300 patients to understand how well they treat the cancer they are targeted to and to gain a better understanding of possible side effects.
Phase 3
Larger trials that are tested on 1000 – 3000 patients comparing a drug with best available therapy to confirm efficacy and safety. Successful phase 3 trials often lead to FDA approval.
Phase 4
These studies are performed following FDA approval in order to collect additional data on effectiveness and to gain information about newly identified risks and benefits.
Eligibility
How do I know if I qualify to volunteer in a clinical trial?
In order to qualify as a participant in a clinical trial, each patient volunteer must meet all inclusion criteria and none of the exclusion criteria. Inclusion/Exclusion criteria are used to identify appropriate trial participants in order to keep them safe, and to help ensure that researchers can gather the information needed to document the safety and efficacy of the new treatment.
Timeline
REFERRAL
If an individual is interested in volunteering for a clinical trial, they must have a referral in order to be evaluated at the clinic. Patients may self-refer by contacting the clinical trials office at (909) 478-7973. The clinic staff can help you determine if there are any restrictions or additional requirements in order to schedule an evaluation.
The patient’s medical history is reviewed to see if he or she is a potential candidate for a specific clinical trial.
MEDICAL HISTORY
If the patient is considered appropriate for the trial, he or she will receive an informed consent form. This informed consent form (ICF) describes the details of the clinical trial in clear, plain language. After carefully reviewing the ICF, the patient will review it again with the research nurse and ask any questions they might have. If they continue to be interested in participating in the trial, they will then sign the ICF.
ICF
SCREENING PERIOD
Once the ICF is signed, the patient enters into the screening period, in which further tests are run and records are reviewed, to make sure he or she is truly a good fit for the clinical trial. The screening period for the trial could range from a few days to up to 4 weeks.
BEGIN TRIAL
Once the screening evaluation is complete and the patient meets all of the requirements for the clinical trial, he or she is able to start on the trial. During the trial, the patient follows precise treatment and testing procedures primarily to oversee their treatment, to ensure their safety and to promptly manage any side effects. The patient is able to stop the trial at any point throughout the process.
Patient Volunteer Responsibilities
As a subject in a clinical trial, you have certain responsibilities to help ensure your safety.
You must:
Complete all required visits to the study center.
Take the study drug as instructed by your study doctor.
Report all side effects or problems promptly to the study staff.
Inform the doctor and study staff if you no longer wish to participate in the study.
Benefits and Risks
Participants in a clinical trial help develop new therapies that may offer better treatments and even cures for life-threatening and chronic diseases such as cancer. There are risks and benefits for participation. You should weigh the risks and benefits before volunteering to participate in a clinical trial. It is important that you discuss the trial with trusted health care providers and/or family members. You should ensure that all of your questions are answered to your satisfaction before you sign the informed consent form.
Possible benefits for volunteers:
Gain access to innovative treatments before they are widely available.
Patient in a clinical trial receive additional close monitoring during their treatments over and above what is standard.
Help future patients by contributing to medical research.
Possible risks for volunteers:
There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
The experimental treatment may not be effective.
The protocol may require more time and attention than the standard treatment, including trips to the study site, blood draws and tests in addition to administering the treatment.
Cost
Who pays for the treatment and is there any cost incurred by the patient?
Standard parts of testing and treatment considered as “standard care” are typically billed to your insurance. Additional tests and treatments required by the trial are typically covered by the trial. Some trials compensate patients for extra trips necessary to the clinic. If so that would be stated in the ICF.
Institutional Review Boards
What oversight is available to protect research subjects?
Participants are under the care of a physician (Principal investigator or sub-investigator) and are monitored by a research nurse. Investigators are bound by strict standards to protect patients’ rights. Clinical trials are reviewed and approved by Institutional Review Boards or IRBs. These are independent entities made up of many professionals, scientists, patient representatives and legal members that operate on both the national or local level to ensure the scientific soundness of the research and protect patients rights and safety on an ongoing basis.
Other Options
Are there other options for treatment other than to participate in a clinical trial?
Your participation in a clinical trial is voluntary. You can choose not to participate in the clinical trial or withdraw your consent at any time. Your choice not to participate will not influence your present or future care. If you choose not to participate, you would be able to receive standard approved treatments or seek other trials. Clinical trials available for patients can be searched at clinicaltrials.gov.