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A phase 3 clinical trial is currently ongoing in the US, Canada, Europe, and parts of Asia. This trial is being conducted at multiple locations across the US to further understand the effect of the study medication on HCM without obstruction.
Participating in clinical trials can help advance therapies for HCM. Please read below about what clinical trials (also called research studies) are and about the phases of clinical trials.
First, what are clinical trials and how do they work1?
Clinical trials are research studies that include human participants and explore how an investigational drug might act in the body and affect a disease. An “investigational drug” is a drug that is being researched. It is not yet approved by health authorities for doctors to prescribe to the general public.
What are the phases of a clinical trial?
Clinical trials are carried out in a series of steps, known as phases, to study whether the investigational drug is safe and effective for people to use.
A typical series of steps starts from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.
Phase 1
During Phase 1, usually the shortest phase, researchers test an investigational drug for the first time in humans by giving it to a small number (20-80) of healthy volunteers to evaluate how the drug works in humans and identify side effects. The information from Phase 1 studies is important to the design of Phase 2 studies. In general, approximately 70% of drugs move to the next phase.
Phase 2
During Phase 2, the investigational drug is given to a larger number of people (100-300) who have a particular disease or condition to further evaluate the side effects and whether the drug works as treatment for a specific disease.
Phase 3
During Phase 3, the investigational drug undergoes additional testing in people with the disease or condition to further evaluate the side effects, how well the drug works, how much of the drug people should take and how the drug compares to current standard treatments. Sometimes known as pivotal studies, these studies involve hundreds to thousands of participants. Phase 3 studies provide most of the safety data and usually take the most time to complete.
After Phase 3, health authorities, for example, the FDA in the US, thoroughly examine all submitted data on the investigational drug and decide to approve it or not to approve it.
As you can see, there are many required steps for a new drug to be developed and approved. This process takes 10-15 years on average.
Phase 4
After an investigational drug is approved and available by prescription, phase 4 clinical trials are sometimes conducted. In this phase, researchers are looking to understand the best way to use this drug as a treatment and whether there are any other risks or benefits associated with using this drug.
Please click here, to visit BMS Study Connect to learn more about this study and take a simple 8-question pre-screener to see if you may pre-qualify for this study or other HCM research studies.
For more information, please call 855-907-3286 or email [email protected].
Reference:
1. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
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