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Clinical Research |
| PAA's Clinical Research Center is primarily focused on conducting FDA approved Phase I-IV trials of new pharmaceutical treatments. Over the past several years, we have participated in over 50 clinical trials for asthma, allergy, COPD, etc. Our highly experienced staff includes four clinical research coordinators certified in pulmonary and laboratory procedures. Additionally, PAA's physicians have extensive experience in clinical research and are available for consultation on the design and implementation of clinical studies. Participation in clinical trials offers the physicians at PAA an opportunity to keep on the forefront of new developments in the treatment of respiratory diseases. Furthermore, it offers you an opportunity to experience new medications and devices before they are available to the public. |
| REMEMBER - TODAY'S CLINICAL TRIALS ARE TOMORROW'S MEDICAL BREAKTHROUGH |
| ABOUT CLINICAL TRIALS |
| A Clinical Trial is the process by which new medications and medical devices are tested by Pharamaceutical or Bio Tech Companies. Before they can initiate testing in subjects, they must conduct extensive preclinical and lab research. This involves years of experiments done on the cellular levels and animals, if this stage is successful they provide this data to the FDA (Food and Drug Administration), requesting approval to begin testing in humans. |
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The clinical testing of experimental drugs is normally done in three phases: Phase I - concerned with assessing what happens with the safety of the drug in the human body. This usually occurs in a small group of health volunteers (20-100). Phase I trials investigate side effects that occur as the dosage levels are increased. This process can take several months and only about 70% of these drugs pass the initial phase of testing. |
| Phase II - concerned with the safety and efficacy of the experimental drug. This phase may last from several months to two years and involves several hundred patients. Many of these trials are randomized where one group receives experimental drug and the other group gets standard therapy or placebo. Often these trials are "blinded" - meaning neither the patient nor the researchers know who is getting which therapy. This provides the pharmaceutical company and FDA comparative information about the relative safety and efficacy of the new drug. Only about 1/3 of experimental drugs successfully complete both Phase I and II studies. |
| Phase III - concerned with a more thorough understanding of the drug's effectiveness, benefits and range of possible adverse reaction. These trials usually have several thousand patients. Most of these trials are randomized and blinded. Phase II studies typically last several years and 70-90% of the drugs that enter this phase successfully complete testing. Once completed, the pharmaceutical company can request FDA approval for marketing the drug. |
| Post Marketing - Late Phase III/IV - There may be several reasons to conduct these trials: compare a drug with other drugs already on the market; monitor a drug's long-term effectiveness and impact on quality of life; and determine the cost-effectiveness of a therapy relative to other therapies. |
| Funding for clinical trials comes from both private industry (pharmaceutical and biotech companies) and federal (NIH). Sponsors hire physicians to conduct the trials and they are typically paid on a per-patient basis. Medical care and testing related to the trials is often free and patients may also be paid to participate. |
| Patient's rights and safety are protected in two important ways. First, any doctor conducting a clinical trial by a pharmaceutical company or NIH must obtain approval from and Institutional Review Board. The review board, composed of doctors and lay people, examines the study's protocol to ensure the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States must sign an "informed consent". This consent details the nature of the study, risks involved, and outline of study visits. The informed consent tells patients that they have a right to leave the study at any time. |
| Patients should talk with their doctors and any family member when considering participation. We want you to feel comfortable about your decision and feel free to ask any questions. |
| We invite you to call and set up a visit at our facility to discuss current clinical trials. |
CURRENT TRIALS
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 Pulmonary and Allergy Associates, P.A. 1 Springfield Ave, Summit, NJ 07901, 908-934-0555, 908-934-0556(fax) 8 Saddle Road, Cedar Knolls, NJ 07927, 973-267-9393, 973-540-0472(fax) Email: information@paamds.com Copyright ©2005-2006 Pulmonary and Allergy Associates, P.A. |
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