Lab to Pharmacy Part: 2, 3, 4

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   If you were a participant in one of these studies, you would be given a complete physical examination by a physician. In addition, the results of a chest x-ray, an electrocardiogram, and blood and serum laboratory studies would be determined. Only after the results of these examinations were known and your physical state qualified you for the study would you be allowed to enter into a research program. You would be fully informed about any study in which you might participate and would be asked to sign an informed consent statement.

  Studies are conducted on either an in-patient basis in a hospital or an out-patient basis at the DRAC facility or in a physician's office. There are strict controls on your medication and possibly also on your diet. You would be observed by physicians, pharmacist, and nurses - people trained to recognize drug effects. Because you might miss some time from work and have transportation expenses due to the frequent visits to the study physician that are required by the protocol, you would be paid for your participation.

  Most of the studies conducted by DRAC are controlled studies in which a portion of the patients get a new drug, and a portion get either a positive control drug (one previously shown to be effective and already approved by the FDA) or a placebo (an identically-appearing pill that has all the formulation of the test drug except the actual drug itself.) Placebo therapy plays a very important role in drug research. If a drug company cannot show that their new drug for a particular condition is more effective than a placebo then that drug has very little chance of reaching your pharmacy.

  A code to determine whether a patient is taking a new drug, a positive control drug or a placebo is used when double-blind studies are conducted. In these studies neither the patient, DRAC, nor the physician conducting the study knows what medication the patient is receiving. That information is available, however, in sealed envelopes should the need for that knowledge arise. This situation is necessary for the unbiased evaluation of a new drug.

  One would expect that those patients who get a satisfactory response are the ones who receive the
actual test drug and those who get no relief receive the placebo, but that isn't always the case. When the code is broken at the end of a study, sometimes a person with a positive response is found actually to have received the placebo.

  After a new drug is shown to be more effective than a placebo, it is then studied along with a drug that is already on the market to see if the new drug is as good as, or better than, a marketed drug, A new drug does not always have to be better than an existing marketed drug to be approved by the FDA. The basic charge to the FDA by Congress is that a new drug must be shown to be safe and effective for a particular condition. The law does not require that a new drug be better than one which is already available.

  There are numerous complaints about the length of time it takes the FDA to approve new drugs. The sooner testing can be completed, the sooner a new drug may be placed on the market. Part of DRAC's service lies in the fact that a large number of patients with a particular condition can be entered rapidly into a research study. If a drug company wants 40 patients to be treated with a new drug for high blood pressure, arthritis, or some other condition DRAC can enter those 40 patients into a study within a matter of days or weeks by advertising for patients with certain medical problems. (Next)

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