Clinical Trials Division
Director of Clinical Trials and Principal Investigator: Randall Berliner, M.D. F.A.H.S.
Clinical Research Coordinator: Sarah Reed, M.A.
Tele. 718-360-8738; e-mail address: sreed@regionalneurological.com
Exploring Clinical Trials: Advancing Medicine for the Future
Welcome to our Clinical Trials Division, led by Principal Investigator Dr. Randall Berliner and Research Coordinator Sarah Reed. We are at the forefront of cutting-edge research in drug development, and we invite you to join us on this exciting journey.
What is a Clinical Trial?
Clinical trials aren’t just about testing new treatments; they’re about shaping the future of healthcare. They’re about finding answers to questions that may have eluded us for years. They’re about pioneering advancements that can alleviate suffering, extend lives, and enhance our understanding of disease.
Before a medication can be released to the public, it must undergo rigorous testing to ensure its safety and effectiveness. This is typically carried out through a clinical trial. In a classic example, a double-blind placebo-controlled trial is conducted, where participants are randomly assigned to receive either the study drug or a placebo (an inactive pill). The study assesses specific endpoints to determine how well the medication manages a particular condition. The goal is to evaluate whether the study drug performs better than the placebo in treating the targeted symptoms.
Before reaching the double-blind, placebo-controlled phase, preliminary studies focus on safety and dosing. By the time the drug enters this phase, investigators have a good understanding of potential side effects and effective doses.
Why Get Involved in a Clinical Trial?
Every volunteer, every researcher, and every trial is a vital piece of this intricate puzzle. Together, we are rewriting the story of medicine, with each trial bringing us closer to finding new ways to prevent, diagnose, and treat illnesses.
Participating in a clinical trial can provide access to medications for conditions that are inadequately managed by currently available drugs. Most new drugs are developed to address unmet medical needs. However, it’s important to note that in some trials, participants may be randomly assigned to receive a placebo. To ensure the validity of the results, neither the investigator nor the participant knows whether they are receiving the study drug or a placebo.
Some studies offer the option to enroll in an open-label extension, where participants are guaranteed to receive the study drug, regardless of whether they initially received a placebo.
Understanding the Risks and Risk Mitigation
Clinical trials may involve more risks than taking a well-established medication that has been on the market for a while. These risks primarily stem from the experimental nature of the therapies.
- Placebo Assignment: Participants may receive a placebo, and this allocation remains unknown until after the trial. This is done to assess the actual effectiveness of the study drug.
- Side Effects: While researchers have a good idea of potential side effects, the medication is not as widely used as established drugs. Therefore, part of the study’s purpose is to investigate and document any emerging side effects, ensuring that we are fully aware of the drug’s effects if and when it gets approved.
Clinical trials are meticulously designed to minimize risks and prioritize participant safety. They must be approved by an Internal Review Board to ensure ethical conduct. Throughout the study, investigators closely monitor side effects and adverse events to protect participants and gather essential data about the new drug’s effects.
Participating in a clinical trial is an opportunity to contribute to medical advancements while being closely supervised and protected throughout the process. If you have any questions or are interested in participating, please feel free to contact us. Your involvement could make a significant difference in the future of medicine.
Compensation
Most clinical trials offer compensation for participants expenses in transportation. Some even offer compensation for participation. Ask the coordinator about the specific study that you are interested in.
Links for Articles and Study Results
