When choosing to participate in a clinical trial it is important to understand the process and what is involved in trials. There are misconceptions surrounding trials leading to confusion and possibly fear about trials. Many times people associate clinical trials with being "guinea pigs" for the pharmaceutical companies trying to get new medications to the market. In reality, the safety of the participants of trials is of utmost importance to both the pharmaceutical companies and research sites. In order to develop new medications or medical devices there needs to be trials to determine if the product is safe for the use of humans. The FDA oversees all research trials and has guidelines in which trials are to be conducted. These guidelines keep the safety of research subjects in mind and have been developed at times out of the need for change in the way research is handled.

In the Declaration of Helsinki (1964), a document of recommendations guiding physicians in biomedical research involving human subjects, it states:

"It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission... The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease. In current medical practice most diagnostic, therapeutic, or prophylactic procedures involve hazards. This applies especially to biomedical research..."

This document is one of the guiding factors for medical professionals involved in research. In addition, clinical trials are often carried out according to the International Conference on Harmonisation (ICH)/World Health Organization (WHO) Good Clinical Practice standards. These are documents that guide clinical research and trials. In the introduction of the ICH Guideline for Good Clinical Practice is states:

"Good Clinical Practice (GCP) is an international ethical and scientific quality standard designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that clinical trials are credible."

Medical professionals involved in research are very serious about the safety of the research subjects as well as being able to conduct their trials in a manner that will provide accurate and reliable data to determine if the medication or device under investigation is safe and meets the expectations of the community.

Texas Pulmonary & Critical Care Consultants, P.A. (TPCCC) has been involved in clinical trials for more than twenty-three years. During this time, Dr. John Burk has been the primary physician involved. There have been a variety of trials conducted including device, hospital-based, and pharmaceutical. Obstructive sleep apnea, insomnia, and various pulmonary conditions have been disease processes studied.

TPCCC has worked with many different companies in trials. Boehringer Ingelheim; GlaxoSmithKline; Novartis Pharmaceuticals; SkyePharma AG; Almirall Prodesfarma, S.A.; Forest; Altana/Nycomed; Astra-Zeneca; Genentech; Eli Lilly; Miles, Inc., Pharmaceutical Division; Lorex Pharmaceuticals; Abbott Laboratories; and Glaxo Wellcome are pharmaceutical companies with whom we have partnered for trials. For device studies, we have partnered with Respironics, Inc, Xillix Technologies Corporation, and National Institutes of Health and University of Texas at Arlington. Many of the these companies have worked with us on several trials.

Recently, we have opened another research site in the Arlington area and are looking to open additional sites throughout Tarrant County. Our goal is to make research accessible for all of our patients and residents of Tarrant County. We are committed to providing quality care and to ensure the safety of all those involved in clinical trials. All of the physicians involved in clinical trials at TPCCC adhere to the guidelines of research and are dedicated to perform all of our trials within those guidelines. Clinical research is vital to those suffering with chronic disease. By offering research at different sites, we feel we are able to better serve the communities.

If you are interested or have questions related to clinical trials please contact us. We have experienced study coordinators available to answer your questions or to explain the various studies we have. Our research center is located at 909 8th Avenue, Fort Worth, telephone number 817-332-5599. Someone can also be reached twenty-four hours a day at 817-223-0061. This number is answered by one of our coordinators.