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Research & Clinical Trials

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About ECHO Clinical Trials

ResearchIn the last few decades, important progress has been made in cancer diagnosis and treatment modalities, with improvement in the overall survival and quality of life of patients with cancer. However, sometimes the best available treatments may be less than satisfactory in most of the malignancies. Identifying new, effective treatments can be done only through clinical research. It is through this science that exciting new ways to treat cancer are being discovered, providing a better quality of life for our patients.

There are thousands of people who have benefited from clinical trials. Over the years many of the drugs that were tested are now considered standard treatment for cancer patients all over the world.

Research treatments offered by ECHO are reviewed at a number of levels nationally and/or locally, to ensure both the protection of patients’ rights and the scientific merit of the research. The Institutional Review Board (IRB) is an independent body constituted of medical, scientific and non-scientific members, whose responsibility it is to ensure the protection of the patients rights and safety. The IRB assures the well-being of patients involved in every new trial by reviewing, approving and providing continuing review of trials, protocols and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial participants. The review process assures the trial is safe and beneficial to its participants and the medical community.

The staff at ECHO Associates is very committed to being forerunners in research and clinical trials for Oncology and Hematology related conditions. ECHO Associates offers patients the possibility to participate in clinical trials, an option sometimes available only in academic centers. The staff at ECHO Associates has shown their commitment to being in the forefront by participating in many clinical trials, as a part of large cooperative oncology groups (ECOG, NSABP and ACORN) or industry sponsored trials.


What is a Clinical Trial?

A clinical trial involves taking a new drug or therapy from the laboratory, testing its efficiency and safety prior to it being approved by the Food and Drug Administration (FDA). Clinical trials help ascertain if new treatments are a safe and effective way to treat patients. During trials, important information is gathered about the new treatment, the risks and how effective the drug may be.

Before a drug is approved for use, it goes through various stages:

A cancer drug is initially discovered in the laboratory. It is then tested on laboratory animals and specific cancer cell lines. Once it appears that a particular drug may be effective in inhibiting growth, then it enters the clinical phase of development.

A Phase I clinical trial is the first step in determining if a newly discovered drug is safe for patient use. It is during this phase that it is determined how the drug would be best administered, if there are any harmful side effects and what would be the safest dose to use.

During Phase II trials, doctors test to find the effectiveness of the new drug on specific cancers with the goal that the new drug would improve on the present available treatments.
By the time it reaches a Phase III clinical trial, the effectiveness and safety of the new drug has already been tested. In this phase, doctors compare the new treatment to the standard treatment. This is accomplished through a randomized study. A study includes two separate groups:

- The Intervention Group- those who are given the new treatment
- The Control Group - this group receive either the standard treatment or a placebo (a treatment that contains no active ingredient).

Phase IV, is the post marketing phase of a trial. After the drug is approved by the FDA and is available on the market, it can be further studied for better ways of administrating it.
Other clinical research studies address the management of chemotherapy-induced side effects and cancer symptoms that continue to be inadequately treated in cancer patients, with significant impact on their quality of life.

Clinical trials are required to follow very strict guidelines. Each clinical trial is overseen by a chief investigator, usually a doctor, who develops a protocol for the new medicine. Each protocol has specific criteria for who may participate, how many patients will participate in the study, how the drug will be administered and how the information regarding the results will be gathered. Every center participating in a trial follows the same protocol, insuring that all the information gathered will be true and accurate.

At Eastern Connecticut Hematology and Oncology patients are offered participation in Phase II, Phase III and Phase IV clinical studies. Other trials run at ECHO include quality of life and prevention trials that study ways of reducing the risk of getting cancer, particularly in persons at high risk. These trials imply either taking a certain medication, (such as hormonal medication or vitamins) or by modifying their lifestyle (for example: smoking cessation).

ECHO Associates is a part of an unique quality improvement program (AIM higher Initiative) launched in 15 community oncology practices in the US. It uses a pen-based computer technology designed to facilitate assessment of symptoms and provides access to scientific and clinical information regarding symptoms.

While some people have very positive results, there are risks and side effects that need to be taken into consideration. Only you, along with your doctor and family, can decide if you should participate. If you are interested in exploring the possibilities of a clinical trial, please make an appointment with one of the ECHO Associates Oncologists. They will be happy to answer any questions you may have regarding current or upcoming trials.

 

 

 

 

 

 

 

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