There are 4 phases of drug development. Phase 3, the phase Morgantown Pulmonary Associates usually participates in, is the last phase before a drug is approved by the FDA to be sold to the public. Phase 4 pertains to studying a medication after it is available for patient use.
Layers of safety built into clinical trials include the Federal Drug Administration overseeing all clinical trials to assure they are done ethically and do not put patients at undue risk. Clinical trials require an IRB (institution review board) who is a group of unbiased people who are not affiliated with the drug company. Their role is to assure the clinical trials are performed safely and to track any adverse events. Finally, Dr. Abrahams, the Principal Investigator, evaluates each patient to make sure they are appropriate for the clinical trial and that they would not be put at undue risk.
Patients are not locked into a clinical trial and are free to withdraw from the study for any reason.
Clinical trials usually last 3 months to a year, depending on the study. You will be required to attend the study visits that average about once a month and participate in the free testing that could include pulmonary function testing, blood tests, EKG, chest x-ray, questionnaires, and a diary of symptoms.
Study nurses will talk to you over the phone to see if it looks like you will qualify for a study. If so, you will be invited for a Screening Visit to review past medical history and medications and to perform preliminary tests to see if you will qualify for the study. Some Clinical Trials require 3 visits before you actually are approved to receive the study medication, but you will be paid for your time and travel.