provide the greatest precision in diagnosis. Typi-
cally if an adjudication committee is established to
evaluate safety outcomes, detailed information
concerning the adverse event of interest is
requested of the clinical investigator shortly after
the event occurs to assure that necessary and most
accurate, complete clinical information is avail-
able for each event, which allows the committee
to assess and categorize adverse events. Pooled
analyses of data that are adjudicated across a
large clinical program can provide the most robust
assessment of drug safety. The strength of the
approach lies in increasing the sample size avail-
able for the analysis, which increases substantially
the ability to make more definitive statistical infer-
ences. Because the sample size and, hence, power
of the analysis is substantially greater, this
approach can replace large clinical trials that
would be very costly and time consuming. If the
analysis is performed according to rigorous statis-
tical methodology, the results can sometimes serve
as a substitute for specific phase IV commitments.
37.5 Practitioner and
investigator interactionMedical Information
and communications unit
Another major function of the Medical Affairs
department is that of providing information about
a company’s products. Their customers range from
fellow healthcare professionals to the public and
internal company clients. The frontline is usually
comprised of nurses and registered pharmacists
who respond to telephone and written requests
for medical information about products, spanning
clinical safety and efficacy questions. Companies
often offer this service as needed and most can
respond to clinical questions within 24 h of a
request with specific and detailed information. A
frequently asked question document is prepared
to enhance rapidity of response. If this document
does not provide the needed information, further
research by Medical Information specialist, often
in collaboration with internal clinical staff, is
pursued to yield the necessary response. Callers
are frequently retail pharmacists and physicians
asking about potential drug–drug interactions and
unsolicited requests for information on ‘off label’
use, which may have been described in a medical
journal or at a medical meeting. The staff often
provide articles that describe results from clinical
trials, or information from studies conducted to
assess ‘off label’ use that is clearly marked so
that the clinician does not confuse this with
approved use of the drug.Medical writing unit
The Medical Information department may have its
own medical writers dedicated to phase IV (post-
approval) publications, booklets and pamphlets.
Many large companies have a specific Medical
Writing department usually reporting into the
Research department, who will assist in writing
clinical reports, publications and help prepare the
clinical investigational brochure or NDA annual
safety reports. These associates usually have
science degrees and have been trained in technical
and medical writing.Drug safety and epidemiology unit
In many companies, even medium-sized compa-
nies, this unit reports into Medical Affairs. This is
because it is responsible for tracking the safety
record of the drug and because the largest use of
a new drug or device will be after postmarketing.
Rare serious adverse events occurring at the inci-
dence of one in 10 000 patients will not be found in
the average NDA database of 2000–3000 patients.
A clear ‘signal’ may not emerge until many thou-
sands of patients have been exposures which would
allow discrimination from ‘background’ incidence
of rare clinical adverse events. The mechanism of
safety monitoring usually takes the form of adju-
dication of adverse events that occur in the setting
of ongoing clinical trials by a blinded (usually
external) committee and compilation of adverse
events from pooled databases or by analysis of
MedWatch reports provided via the Adverse524 CH37 MEDICAL AFFAIRS