What You Should Know about Clinical Research Studies
What Is a Clinical Research Study?2
Clinical research studies, also called clinical trials, look at an investigational drug or medical device to see if it is safe, how it works in the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who specialize in your disease and are responsible for the study participants' study-related care.
In most countries, the regulatory health authority, such as the United States Food and Drug Administration (US FDA), requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.
Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.
What Is Adjuvant Treatment?
Adjuvant treatment is additional treatment given after a primary treatment, such as surgery. Adjuvant treatment is important to maximize the effectiveness of the primary treatment.1
What Is the Investigational Drug and the Comparator?
The investigational drug, called infigratinib*, is being compared to a matching placebo to evaluate its safety and effectiveness. A placebo is a dummy pill that has no medicine. “Investigational” means the drug is being studied by QED Therapeutics and study doctors, and that regulatory authorities (e.g., the US FDA [United States Food and Drug Administration]) have not approved infigratinib for use in patients.
The PROOF 302 Trial is a blinded study, meaning that you and your study doctor will not know whether you are receiving infigratinib or the placebo.
*The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.
What Should I Expect?
Before interested individuals can take part in the PROOF 302 Trial, the study team will evaluate them to determine if they qualify.
- Prescreening: First, interested individuals will be evaluated to determine if they have FGFR3 genetic alterations. Individuals who do not have confirmed documentation of FGFR3 genetic alterations will be offered molecular testing during prescreening to determine whether their tumor contains FGFR3 genetic alterations.
- Screening: Those with FGFR3 genetic alterations who are interested in study participation will then be provided with the full informed consent form (ICF), and the study team will explain the entire study to them. Once the interested individual signs the ICF, they will enter the screening period. This period consists of additional tests and procedures, including blood draws, physical exams, questionnaires, urine sample collection, heart assessments, and an imaging assessment of the entire body – all of which are used to determine if potential participants qualify for this study. If all screening assessments demonstrate eligibility, an individual will then be enrolled in the study.
- Treatment and Follow-Up: At each study visit, participants will answer questions about their health and undergo study-related procedures, including blood draws, urine sample collection, electrocardiograms, and physical exams. They will also be evaluated for tumors throughout the treatment period and follow-up period.
Study participants will receive their assigned study treatment, as well as study-related assessments, including laboratory tests and imaging, at no cost. Participants or their health insurance company may be billed for any other healthcare costs, including those standard-of-care procedures that they receive while participating in the study.
Can I Leave the Study If I Change My Mind?
Participation in any clinical research study is completely voluntary, and participants may choose to leave the study at any time without any need to provide a reason. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely.
How Long Will Study Participation Last?
The duration of participation in this trial could last up to approximately four years. The total length of time that a patient will participate in the trial depends on how he or she responds to the assigned study treatment.
- Mayo Clinic. “Adjuvant therapy: Treatment to keep cancer from returning.” For additional information, visit https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/adjuvant-therapy/art-20046687.
- FDA. “Clinical Trials: What Patients Need to Know.” For additional information, visit https://www.fda.gov/patients/clinical-trials-what-patients-need-know.