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In the world of clinical trials, we create detailed development plans, craft thorough study designs, and manage our trials
with precision and care. However, the back side of that equation, medical writing of the final study report or clinical study
report (CSR), is often a low priority. Once top line results are announced and a summary is generated, the actual CSR can
languish for months or even years.
Often the reason these reports are relegated to the lowest priority is that explaining the nuances of the clinical trial and
the data generated is arduous and unappealing. Writing a protocol for a new study, however, is fresh and exciting.
For small companies, finding personnel with time available to comb through the tables and listings can be a challenge. For
larger companies, gathering the information needed from the various contributors (kineticists, clinical teams, statistical
teams, etc.) can be time consuming, particularly when these functions are distributed among separate business units.
And the task of writing some CSRs can be daunting, even for experienced writers. Amendments need to be explained, protocol
deviations may require discussion, and data doesn't always present a clear picture. However, the CSR documents the results
of the effort and skill of the entire team who contributes to clinical research: clinical management, statistics, data management,
pharmacovigilance, regulatory operations, and even the investigators. So no matter how daunting the task, ultimately the data is why we complete the research and the CSR is how we present that
data.
Among the worst circumstances are CSRs that are complicated by personnel or team changes, or CSRs that must be assembled with
old data or data contributed by outside partners. For these CSRs, a clear plan for explanation of the study and presentation
of the data can seem unattainable.
As illustrated with the case studies that follow, an experienced medical writer will employ certain techniques to make even
the messiest situations provide meaningful CSRs. A strategic approach to writing these documents, rescue medical writing,
is in order. Let's take a look.
Case One: Changing faces
FDA Rules on Foreign Studies
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Company A requires a CSR for a Phase I study completed two years earlier. They hired one CRO to compose the protocol and write
the initial draft of the CSR (CRO 1). A second CRO was hired to implement the study, complete the data management and statistics,
and provide the SAS output tables and listings (CRO 2).
Both CROs, however, went through multiple staff changes such that different writers and study administrators were involved
at different stages. Even at Company A, no single person participated in the implementation of the study for the duration
of its lifecycle (from protocol through CSR). To complicate matters, the company went through drastic staff changes during
this time, replacing medical directors and clinical personnel so that after its initial draft, the CSR sat unreviewed for
over a year.
After a meeting with the FDA, Company A decided that submission of a finalized CSR was needed. They hired the medical writing
company Whitsell Innovations, Inc. (WI) to review and finalize the CSR. At the time WI was hired, the study itself had been
completed for over two years and the last draft of the CSR was over a year old.
Faulty findings. The writer reviewed the study documents in their entirety, starting with the protocol and working through each data set that
would contribute to the CSR (the statistical analysis plan, SAS output tables and listings, the bioanalytical report, and
third-party medical reviews).
Upon review of the protocol in conjunction with the bioanalytical report, the WI reviewer noticed that bioanalytical samples
for a third of the subjects were not included in the final bioanalytical report. Other potentially spurious data points were
noted, such as body weights that did not have matching doses in a mg/kg dosing scenario, subjects who seemed to have been
enrolled outside the protocol-specified age ranges, and tables containing too many or too few subjects.
