Clinical evaluation, drugs physicians

Most physicians in the pharmaceutical industry work in one of three main areas, which correspond to the well-defined phases through which a drug passes in its clinical evaluation, namely ... 

Medical/clinical reviewers, often called medical officers, are almost exclusively physicians. In rare instances, nonphysicians are used as medical officers to evaluate drug data. Medical reviewers are responsible for evaluating the clinical sections of submissions, such as the safety of the clinical protocols in an IND or the results of this testing as submitted in the NDA. Within most divisions, clinical reviewers take the lead role in the IND or NDA review and are responsible for synthesizing the results of the animal toxicology, human pharmacology, and clinical reviews to formulate the overall basis for a recommended agency action on the application. 

Assessing the effectiveness of a new drug candidate can be complex and often difficult. This is because some diseases or symptoms do not follow a predictable path. For example, acute conditions such as influenza or insomnia may resolve without intervention, while chronic conditions such as multiple sclerosis or arthritis follow a varying course of progression. Depending on age, treatment, and other risk factors, heart attacks and strokes may produce variable mortality rates. Additional difficulty is introduced by subjective evaluation, which can be influenced by the expectations of patients and physicians. Some of these issues can be addressed in controlled clinical trials. 

Physicians evaluate the results of clinical tests—including adverse and therapeutic effects, and whether the proposed labeling accurately reflects the effects of the drug. 

A 59-year-old woman presents to an urgent care clinic with a 4-day history of frequent and painful urination. She has had fevers, chills, and flank pain for the last 2 days. Her physician advised her to immediately come to the clinic for evaluation. In the clinic she is febrile (38.5°C [101.3°F]) but otherwise stable and states she is not experiencing any nausea or vomiting. Her urine dipstick test is positive for leukocyte esterase. Urinalysis and urine culture are also ordered. Her past medical history is significant for three urinary tract infections in the past year. Each of these episodes was uncomplicated, treated with trimethoprim-sulfamethoxazole, and promptly resolved. She also has osteoporosis for which she takes a daily calcium supplement. The decision is made to treat her with oral antibiotics for a complicated urinary tract infection with close follow-up. Given her history what would be a reasonable empiric antibiotic choice Depending on the antibiotic choice are there potential drug interactions she should be counseled on ... 

Once a patient with a clinical problem has been evaluated and a diagnosis has been reached, the practitioner can often select from a variety of therapeutic approaches. Medication, surgery, psychiatric treatment, radiation, physical therapy, health education, counseling, further consultation, and no therapy are some of the options available. Of these options, drug therapy is by far the one most frequently chosen. In most cases, this requires the writing of a prescription. A written prescription is the prescriber s order to prepare or dispense a specific treatment—usually medication—for a specific patient. When a patient comes for an office visit, the physician or other authorized health professional prescribes medications 67% of the time, and an average of one prescription per office visit is written because more than one prescription may be written at a single visit. 

Premature ventricular contractions (PVCs) are commonly recorded in patients convalescing from myocardial infarction. Since such arrhythmias have been associated with an increased risk of sudden cardiac death, it had been the empiric practice of many physicians to treat PVCs, even if asymp-tomatic, in such patients. In CAST (Cardiac Arrhythmia Suppression Trial [CAST], Echt et al, 1991), an attempt was made to document the efficacy of such therapy in a controlled clinical trial. The effects of several antiarrhythmic drugs on arrhythmia frequency were first evaluated in an open-label fashion. Then, patients in whom antiarrhythmic therapy suppressed PVCs were randomly assigned, in a double-blind fashion, to continue that therapy or its corresponding placebo. 

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