The
loss of clinical data collected during clinical trials and clinical data
insecurity has continued to be experienced in spite of contemporary global
trends in many world cultures and the different ways in which clinical
institutions try to protect their patients’ data. A clinical institution may be
very prominent, good and reliable with effective and sincere staff but may also
experience the loss of data and data insecurity due to a malfunctioning CDM
system or a non-experienced staff. This paper presents a framework that
outlines the uses of not just CDM but a good and effective CDM, what can be
done to surmount the problem of data loss and data insecurity. Also the method
the CDM system should be designed and implemented. It also outlines the different
types of CDM software available and the different services that each of them
provides.
INTRODUCTION
CDM is
consistently being recognized as a primary part of clinical development team. Clinical
research has become impossible without the use of Clinical Data Management (CDM) systems to handle the increasing amount of data that must be collected,
processed and analyzed for clinical trials. To reduce the possibility of
errors, a CDM system employs means to verify the correctness and plausibility
of entered data. CDMS codes data or generates reports. CDM is important because
clinical
data has been recognized key corporate assets in today’s biopharmaceutical
industry, and that turning data into meaningful information is a critical core
function for sponsor firms to make faster and more flexible assessments of
compounds in development, design better clinical protocols when tailoring the
appropriate target population with a specific indication, and enable innovative
study initiatives and new clinical programs to ensure a robust clinical product
pipeline.
HISTORICAL BACKGROUND OF CDM
As its
importance has grown, Clinical Data
Management (CDM) has changed from an essentially clerical task in the late
1970s and 1980s to the highly computerized specialty it is today. In the mid to late 80’s, a tool called remote data entry
(RDE) was available which replaced double key data entry and paper CRF’s. Bayer
Corporation was one of the very few companies to implement such a system. When
RDE was used in a clinical trial, a company would provide a portable computer
to the investigational site. The coordinator would collect study-related
patient data, and then enter the data directly into the computer via specially
designed data entry screens. The electronic data would then be monitored, and
after data cleanup, a floppy disk would be sent to the sponsor via an overnight
courier service. These tasks would occur periodically during the course of the
clinical trial.
CDM system, when properly implemented, can streamline the RDE
processes, as well as streamline all other aspects of data and project
management. Also, when managed properly, there are significant time and
cost-savings by eliminating double key data entry, by automating the query
system, by reducing the time the monitor has to spend at the study site and
interact with the site coordinator, and by reducing the time from
last-patient-last-visit to database lock. CDMs systems are here to stay and
eventually, all companies will abandon paper CRFs and move into the electronic
world.
CDM
has evolved from a data entry process into a diverse process to provide clean
data in a useable format in a timely manner and also to provide a database fit for
use. CDMS ensures that data are clean and database is ready to lock. Presently,
CDM manages
- entry of CRF data
- merging of non-CRF data
- systems and processes designed to identify bad data
- generate, track CRFs and queries
- determine protocol violators
- interact with site personnel to resolve data issues.
