Manish Gupta has over 15 years of experience in developing and executing global clinical trials in cardiac and neurological devices (including those developed to manage essential tremor). He shares how clinical trials work and how the IETF partners with Cala Health to recruit participants.
By Manish Gupta
Vice President of Clinical Affairs
Cala Health, Inc.
Clinical trials are research studies that explore whether a medical device, drug or treatment is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses, diseases, disorders or groups of patients. Clinical trials produce the most reliable data available for health care decision making. They follow strict scientific standards to protect patients and help produce dependable study results.
Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory, where scientists/technologists first develop and test new ideas. If an approach seems promising, the next step for higher risk devices may involve animal testing. This shows how the approach affects a living body and assesses its safety. However, an approach that works well in the lab or animals may not always work well in people. Thus, research in humans is needed.
For safety purposes, clinical trials start with small groups of patients to find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about the new approach’s risks and benefits in larger groups of patients.
A clinical trial may find that a new device, drug or treatment
1) improves patient outcomes; or
2) offers no benefit; or
3) causes unexpected harm
All of these results are important because they advance medical knowledge and help improve patient care.
Patients participating in research are generally referred to as “subjects.” During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of the subject’s treatment team. They will monitor the subject’s health very closely, conducting more tests and medical exams than standard care.
Taking part in a clinical trial can have many benefits. If a new treatment is proven to work, subjects are among the first to benefit. Even if subjects don’t directly benefit from the clinical trial, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many subjects volunteer because they also want to help others.
Many government agencies, companies, patient advocacy groups and other organizations sponsor clinical trials. Collaboration between two or more of such groups/organizations is common in clinical research to create patient awareness about the clinical research and the disease. Cala Health’s collaboration with International Essential Tremor Foundation (IETF) is one great example of a partnership that creates patient awareness throughout the United States about essential tremor (ET) clinical trials. Cala Health, Inc. is actively conducting ET clinical trials of its wrist-worn therapy at leading centers in the US.
IETF is an essential partner to Cala Health informing the ET community of the clinical research opportunities to advance medical knowledge and patient care.
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About Cala Health, Inc.
Cala Health is a medical technology company pioneering a new class of electrical medicine. The company is merging innovations in neuroscience and electronics to deliver individualized, prescription neuromodulation therapies. These therapies treat chronic disease non-invasively by stimulating peripheral nerves with body-worn electronics. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology, including Johnson & Johnson Innovation – JJDC, Inc., Corp, Lux Capital, Lightstone Ventures, GV, dRx Capital and Action Potential Venture Capital.
The IETF funds research grants, advocates for more research on essential tremor, and works with companies like Cala Health to recruit participants for research studies. Your donations to research are the reason the IETF is able to carry out these initiatives and work toward improving the quality of life for every generation living with essential tremor. Help us keep hope alive.