Over 850 Active Clinical Trials Provide Access to the Latest Treatments and Technologies
Our world-renowned physician scientists continually advance our understanding of health and disease, innovating new pathways of care.
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What is a Clinical Trial?
For centuries, medical advancements have improved quality of life, enabling longer and healthier lifespans. These strides have changed the course of human history, and the cutting-edge medical research happening today promises to create an even brighter future. Clinical trials are at the forefront of this progress, serving as the rigorous testing ground for new drugs, diagnostic tests and therapeutic treatments. Medical investigators tirelessly work to discover new ways to prevent, detect and treat various diseases, reinforcing the crucial role of research in driving medical innovation.
Clinical trials go through multiple phases to assess the safety, effectiveness and potential side effects of new treatments, heavily relying on the participation of qualified volunteers. The data collected from these participants is invaluable, offering insights into a wide array of medical conditions and potential cures. From cancer treatments and substance abuse recovery programs to advancements in prosthetics and immunizations, clinical trials have been pivotal in various medical breakthroughs. Participating in a clinical trial not only helps advance the field but can also lead to significant discoveries that have the potential to improve health and save lives.
Participating in a Clinical Trial
Trial Process
General Questions
Privacy
Federal regulations provide privacy protections for participants in some clinical trials. We follow these and other strict guidelines to safeguard volunteers’ private health information.
Protecting your privacy, including the confidentiality of your medical records, is something we take very seriously. We take special precautions to safeguard your medical information, including any data that identifies you, when you take part in a clinical trial. For example, whenever possible, researchers use a code instead of your name to associate blood or tissue samples with your medical records.
We work to ensure that your health information and personal identity stay securely within Montefiore Einstein. When we occasionally work with outside researchers, we will only provide your materials anonymously or with a code that only our investigators can access.
The Four Clinical
Trial Phases
Phase I
In Phase I, the new drug or treatment is tested on a small group of people, typically ranging from 20 to 80 volunteers. The main goals are to:
- Evaluate the treatment's safety
- Determine an appropriate dosage range
- Identify any potential side effects
Phase II
Phase II involves a larger group of participants, often numbering in the hundreds. In this phase, researchers aim to:
- Measure the treatment's effectiveness for a specific condition
- Continue evaluating its safety
Phase III
Phase III trials involve an even larger and more diverse group of participants, often including several hundred to several thousand individuals. The primary objectives are to:
- Confirm the treatment's effectiveness
- Monitor for side effects
- Compare the new treatment to existing, FDA-approved treatments
- Validate that the treatment is safe for a broad range of patients
Phase IV
Phase IV trials happen after the drug or treatment has been approved for public use. Although less common, these trials sometimes are required by the FDA and aim to:
- Gather information on long-term effects
- Assess the treatment's efficacy and risks in various patient populations
These trials can help researchers understand how the drug or treatment performs in real-world conditions, beyond the controlled environments of earlier-phase trials.
Office of Clinical Trials
The Office of Clinical Trials (OCT) serves as the key administrative hub for privately funded research at Montefiore Einstein. It offers comprehensive support, from pre-award to post-award management, including education, training, contract negotiation, budget planning, financial management and administration of various research technology tools.