Discussions about the development of a Covid-19 vaccine contributed to increased public interest in clinical trials for drugs or medical devices. It can be challenging to understand the requirements and phases involved in studying potential treatments for different diseases. Here are some questions to get started in learning more about clinical trials.
Why are clinical trials important?
They are a critical step in the drug approval process. Before a treatment such as a drug or medical device can be approved for commercialization and distribution, there are regulations set in place in order to protect patients. Clinical trials are research studies done to evaluate the efficacy and safety of a treatment in humans. Data is collected and analyzed from these studies, which provides scientific evidence that a treatment will be effective for a particular disease.
Where are clinical trials conducted?
The location is selected by the study sponsors. Clinical trials can be conducted at a hospital, university, doctor’s office, community clinic, and private clinical research facility. An example of a private facility is Altus Research in Lake Worth, Florida. The facility is run by a Medical Director, Samuel Lederman MD, FACOG and a team of nurses and research coordinators.
Who are clinical study sponsors?
A pharmaceutical company, government agency, academic institution, or private organization are examples of sponsors. They are responsible for the initiation, management, and financing of a clinical trial.
Who is the clinical study principal investigator?
This is the physician who is responsible for all activities at the study location. He/she ensures that regulatory agency requirements and Good Clinical Practices are followed. This is important to protect trial participants and the accuracy of the study results.
How many phases does a clinical trial have?
Human clinical trials have four phases.
Phase 1
Study participants consist of 20 to 100 healthy volunteers or people with the disease being treated. The purpose of the study is to determine safety and dosage. The study can take several months.
Phase 2
Study participants include up to several hundred people with the disease. The purpose of the study is to determine efficacy and side effects. The study can take several months to two years.
Phase 3
Study participants consist of 300 to 3000 volunteers who have the disease. The purpose of the study is to determine efficacy and to monitor adverse reactions. The study can take one to four years.
Phase 4
Study participants include several thousand volunteers who have the disease. The purpose of the study is to determine long-term safety and effectiveness of a treatment.
What questions should volunteers ask when deciding to enter a clinical study?
Examples of questions to start with are reasons and objectives of the study, advantages and risks to volunteers, number of volunteers or groups, length of the study, location, expenses covered, protection of medical records and privacy, tests required to participate, possible side effects, and possible restrictions on daily activities.
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