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Kenneth Rockwell Jr, Pharm.D., MS
Clinical Research / Investigational Drugs
Role
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:
- 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.
- 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.
- 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.”
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