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Patients Needed for Clinical Trials and Research

Dec 14 2018

Posted In:

20/20 Blog

Palo Alto, CA —

Why volunteer for a clinical trial?

The rigorous process of turning a new therapy into the standard of care depends on patient volunteers. 

Ophthalmology clinical trials make it possible for new therapies for currently untreatable eye diseases to leave the laboratory for the clinic.

The best candidates to participate in clinical trials are patients who have an eye disease that isn’t responding to current treatments or is untreatable and those who have a family history of eye disease.

New advances in molecular surgery and protein analysis are opening up the possibility to treat rare diseases with existing medicines.  

How can your participation in a clinical trial benefit you and others?

Clinical trial volunteers have access to cutting edge treatments that are not widely available. They are also monitored by a team of expert physicians who are dedicated to bringing patients new therapies that could improve their vision and quality of life. 

While advancing their own care, clinical trial participants are advancing the field of ophthalmology so that successful therapies can reach the largest number of people. 

Groundbreaking medical advances are dependent on the generosity of clinical trial participants of all ages regardless if they have a disease or not.

How can you be matched with a clinical trial?

The Byers Eye Institute administers a number of clinical trials for eye disease. Visit their website to find a match.

Clinical Research Coordinators help educate patients on clinical trials and determine if they are good candidates based on a number of factors like age, stage of disease, gender, genetic profile, family history, health conditions, and medications.

What is Clinical Research?

Clinical trials designed to evaluate medications and devices fall under the umbrella of clinical research. Patients do not have to participate in clinical trials, or treatment research, in order to contribute to scientific discoveries that lead to new therapies. One important way they can participate in clinical research is by sharing their clinical data and tissues that would otherwise be thrown out after surgery.Clinical research includes areas such as prevention, diagnostics, and screening. 

Over 2000 patients have participated in research performed by the Mahajan Lab, some by simply providing blood for DNA and cell studies.

For clinical research and trials with surgeon scientist Vinit Mahajan M.D., Ph.D., please reach out to Teja Chemudupati, a Clinical Research Coordinator. A major focus of the Mahajan team is providing genetic testing for inherited eye disease and to create a biorepository of eye fluid.

Teja said, “I make sure that patients who choose to enroll in our clinical research understand the purpose, procedures, possible risks and benefits , as well as the time commitment involved throughout their participation with us.” 

How can you educate yourself to get the most out of a clinical trial?

The National Institute of Health has compiled a list of potential clinical trial patient questions that cover important discussion topics including cost, scheduling, treatment plans, physician care, hospitalization, medications, and post study follow-ups. 

A Volunteer’s Bill of Rights can also guide patients in their communications with physicians, researchers, and staff. 

How are clinical trials structured?

Trials are run by a principal investigator based on a study protocol. Approved trials go through a 4-phase process.

Phase I trials test a new treatment on a small number of patients to determine safety, dosage and side effects.

Phase II trials expand the number of patients enrolled to gather more information about efficacy, dosage, and side effects.

Phase III and IV trials include larger numbers of patients from across the country and compare the new treatment with old treatments to see if the new treatment is more effective.

Patients are randomly placed in a treatment group that receives the new treatment or in a control group that receives an old treatment, no treatment, or a placebo that allows researchers to monitor the positive and negative effects of the new treatment. 

In ophthalmology trials, it is possible for patients to have one eye in one group and the other eye in another group. The eye that will be treated is usually randomly assigned.

In a non-masked trial, the patient and doctor know the group selection, in a masked trial the patient does not know the group selection, and in a double masked trial neither the doctor nor the patient knows the group selection.

Who oversees the safety of a clinical trial?

The Institutional Review Board approves clinical trials based on scientific accuracy and patient safety. 

The Data and Safety Monitoring Committee carefully monitors every National Eye Institute supported trial. If a trial is seen as dangerous in any way, or if the risks outweigh the benefits, a trial will be closed. The committee can also speed up the process of getting a successful therapy to patients.