Principles and Practice of Pharmaceutical Medicine

interpretation of efficacy findings;

ability to ensure that the conclusions are sup-
ported by the data;

ability to ensure that reports satisfy regulatory
requirements;

developing clear, simple graphs, tables, figures
to illustrate and support findings;

ability to write a clear, concise report that accu-
rately summarizes and interprets the results.

Preparing annual safety reports

Sponsors are required to submit annually to regu-
latory authorities a summary of safety findings of
investigational products. This involves verification
of AE tabulations against computer data listings
and the preparation of safety tables. The current
findings are reviewed and compared with AE data
from the past reporting period.
The sponsor’s representatives must be able to
clarify any outstanding issues regarding safety
interpretation and presentation of the data. As
this information is of critical importance to the
regulatory authorities, the annual report must be
written in a clear, concise manner that accurately
summarizes and interprets the safety results. The
annual report should provide clear, simple graphs,
tables and figures to illustrate and support safety
findings.
Following the submission of the annual report,
safety findings are usually integrated into an
updated version of the IB.
To be able to prepare annual reports, the spon-
sor’s representative should know how the reports
satisfy regulatory authority requirements. The clin-
ical representative should be able to interpret clin-
ical safety and laboratory findings. The ability to
understand computer-generated clinical output and
the organization and structure of the NDA/BLA/
MAA safety database is important.
The annual report and NDA/BLA/MAA safety
update review and approval procedures must be

understood, as well as the procedures for the pre-

paration of the IB.

Preparing clinical sections of NDA/BLA/MAA

The knowledge and skill needed to prepare an

NDA/BLA/MAA include the ability to

verify individual study tabulations against over-

all summary computer listings;

prepare brief descriptions of the studies;

interpret critical clinical safety and efficacy

results;

interpret laboratory findings;

develop clear tables, figures to illustrate and

support clinical findings;

summarize, interpret and integrate the overall

safety and efficacy results;

prepare NDA/BLA/MAA clinical study summa-

ries, benefit/risk summary, expert reports and

Package Insert.

In addition, an understanding of electronic NDA/

BLA/MAAs and regulatory authority data presen-

tation requirements are useful.

The expert report usually generates considerable

discussion within a project. The sponsor often pre-

pares this document under the guidance of an exter-

nal expert. Although internal experts are acceptable,

it should be remembered that the regulatory autho-

rities are looking for an individual who knows the

drug thoroughly and can express an unbiased opi-

nion of its medical importance. The expert report is

not just a summary but also a critical assessment of

the clinical evaluation of the drug. The expert

report provides an independent assessment of the

risk-to-benefit ratio of the drug and its use. The text

is limited to 25 pages, but may include an ‘unlim-

ited’ number of attachments. Many companies have

been creative in font size and two-sided preparation

of the document.

38 CH3 CLINICAL RESEARCH EDUCATION AND TRAINING FOR BIOPHARMACEUTICAL STAFF