Kenneth Rockwell Jr, Pharm.D., MS

Clinical Research/Investigational Drugs

Clinical research involving medications is necessary for developing new drug products. Pharmacists involved in this field will see new drugs years before they come to market, as well as many more drugs that never make it that far. In several respects, medications used in clinical research are handled differently than commercially-available or even compounded medications. Preparation and dispensing of research medications must be carried out according to research protocols, assuring that patients receive the correct medications in the correct doses. This is especially important with investigational drugs, since therapeutic doses may be unknown and the safety of the medication is not yet fully understood.

In the past, a vast majority of investigational drug research took place in large academic health centers. Today, however, drug research can take place in ambulatory clinics, private practices, community hospitals, or stand-alone research facilities.

The pharmacist's role in this field of practice is threefold:

1. To prepare and dispense investigational medications and assure, not only that patients receive proper doses at proper times as defined by the research protocols, but that the proper drug is administered as well. In order to maintain the integrity of the study and prevent bias, the pharmacist is often the only person involved in the study who is unblinded and therefore knows whether the patient is receiving the study drug, an alternative drug, or placebo. The pharmacist must assure that the physician, the nurse, the patient and others involved, cannot discern which medication or which dose the patient has received.
2. To maintain and update the records involved with dispensing an investigational drug. These records must account for every dose of medication missing from the pharmacy and are necessary to determine if a patient was properly treated.
3. To educate patients, physicians, and members of the study team about the medication and its proper use.

Dr. Rockwell has made his institution’s Investigational Drug Service (IDS) a hub for clinic-based research. His team now plays a part in every drug research project at one of the most research-intensive medical schools in the nation.

How They Got There

As a pharmacy clerkship student at St. Louis College of Pharmacy, Dr. Rockwell participated in a clinical rotation that introduced him to investigational drug trials. During his residency at a community hospital, he helped to develop policies related to investigational drug use. Two years later, in an administrative pharmacy residency at a large university hospital, Dr. Rockwell spent two months working in an investigational drug service. He presented a poster on that work at an ASHP meeting, where he was recruited for his current position.

Other Professional Activities

Through his close work with physician-investigators in developing and conducting research trials, Dr. Rockwell has had the opportunity to author and co-author several major papers related to the drugs his staff dispenses. In addition, he is a regular contributor to Evaluations of Drug Interactions, precepts students, and presents lectures to medical students and fellows.

Advanced Training

To become a clinical research/investigational pharmacist, a Doctor of Pharmacy degree is recommended. In addition, attention to detail and creativity are critical traits for anyone considering a career in clinical research. Training courses in medical ethics, patient safety, and good clinical practice are very important. Many larger universities are now conducting mandatory training courses in these areas for personnel involved in clinical research.

Advice

“Keep an open mind. With experience you'll learn to balance the integrity of the research trial with the need for patient safety. Not every drug we study is safe and not every drug will be effective. Properly conducted and properly designed trials will be able to distinguish which drugs are safe and which are effective. Poorly designed or poorly conducted trials will put more patients at risk, lead to higher costs, and can sometimes result in the premature halt of a program involving a promising drug. As research pharmacists we must be vigilant in promoting good science while protecting patients.”