Clinical Trials Are Vital to Improving Medical Care

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.

Photo of Manish Gupta with Cala HealthClinical 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.

Quote from Manish Gupta for Research Month blogA 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.

 

 

 

 

 

 

 

 

 

New Year, New Opportunities

Patrick McCartney
Executive Director

As we kick off 2018, we are excited about the New Year and the opportunities to promote our mission to provide hope to the essential tremor (ET) community worldwide through awareness, education, support, and research.

The IETF is celebrating its 30th anniversary in 2018. We will kick off the celebration in March, which also happens to be National Essential Tremor Awareness month. There are a variety of ways for you to advocate for more ET awareness and education in your community. To learn more about how you can get involved here.

When we ask ET patients what they would like to see the IETF focus its efforts on, one subject comes up consistently: research to help find a dedicated treatment(s) for ET and, hopefully, someday a cure.

With the generous support of our donors,
we have been able to fund more than
$750,000 in ET research.

 

If you would like to learn more about the studies your donations have funded and the results they have achieved, you can find more information here.

Also, there are several clinical trials currently taking place that focus on ET-specific medications and wearable devices. If you are interested in participating in one of these trials check out the list of programs on the IETF website. You can also visit www.clinicaltrials.gov for easy access to free information on clinical studies for a wide range of conditions including ET.

Another great way to get involved is through a local support group. The IETF currently has more than 60 support groups around the world. We have a listing of all the supports groups on our website here. Or take part in our online support group through Facebook.

If you can’t find a support group in your area and Facebook isn’t your thing, we encourage you to consider starting a support group. We have all the tools to get you started and help you promote the meetings.

As always, we thank you for your support of the IETF and the ET community. The IETF has so many resources to share with patients, doctors, family members, and caregivers. We hope you will spread the word and help us continue to educate people on the most common movement disorder in the world.