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.
International Standards to Ensure Research Excellence
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..."
- "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."
Our approach to research: maximum learning with minimum risk to patients
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 these companies have worked with us on several trials.
Investing in Research to deliver superior care to our patients.
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 centers are located at 909 8th Avenue, Fort Worth, telephone number 817-332-5599, and 911C Medical Centre Drive, Arlington, telephone number 817-461-0201. Someone can also be reached 24 hours a day at 817-223-0061 or 817-235-6296. This number is answered by one of our coordinators.