Types of Clinical Trials
The two types of studies currently underway for PKD patients include observational and interventional trials.
- Observational Studies monitor and record various clinical and/or subjective factors over a period of time, like blood pressure or quality of life, in order to better understand the course of the disease. No drugs are given or other types of interventions are made during the time of the study. The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) was an observational study.
- Interventional Studies also monitor and record various clinical and/or subjective factors over a period of time while testing experimental treatments, devices or combinations of drugs to see if the disease outcome is altered.
Phases of a Clinical Trial
A new drug to treat PKD must move through each stage before it can be reviewed for approval by the FDA.
- Phase I – The new drug is tested for safety, dosage range and side effects in a small number of healthy volunteers.
- Phase II – The new drug is tested for safety and effectiveness in a small number of volunteers with the PKD.
- Phase III – The new drug is tested in a large number of volunteers with PKD to confirm effectiveness, monitor side effects and compare results with current treatments.
- The data collected during the clinical trial is analyzed and then submitted to the FDA for regulatory review, which can take 1-3 years. Once it is approved, the new drug can be prescribed by physicians to treat PKD.
- Phase IV – These studies are done after the drug has been approved and is in use. Additional information about risks, benefits and optimal use is collected and analyzed.
Clinical Trials Awareness Program (CTAP)
Perhaps the single greatest impediment to clinical trial patient participation/ recruitment begins with awareness. We believe it is our goal to address this challenge and launched the Clinical Trials Awareness Program to:
- Alert patients and families about clinical trial opportunities
- Educate people about the clinical trials process
- Provide information so patients can discuss ongoing clinical trials with their medical providers
- Provice services to patients to qualify for ongoing trials
- Engage industry sponsors to accelerate clinical trial recruitment
Learn more about the Clinical Trials Awareness Program
Participate in a Clinical Trial
To participate in a clinical trial, you will need to have a formal diagnosis of PKD made by a physician. Learn more about the implications of a PKD diagnosis for yourself or your children.
By participating in a clinical trial, you can:
- Play a more active role in your own health care.
- Have access to new treatments before they are available to the public.
- Contribute to the development of treatments for PKD.
- Make things better for the next generation of those with PKD.