03 July 2014

Routing Clinical Trial Data – from Data Management to Statistical Analysis Software

Introduction to Clinical Data Management (CDM):
Clinical data management is a branch of clinical research that plays an important role in the field of clinical data processing and management services. Most of the health and medical organizations feel the urge to switch to clinical data management for various electronic drug development solutions. These kinds of drug development solutions enhance the effectiveness of pharmaceutical companies in planning and implementation of clinical trials with powerful data-integration and analysis.

Clinical data management is known to be one of the key essentials to manage data that is generated in the clinical trials and it is used  to analyze the trial data to understand the critical parameters like drug’s safety, efficacy and also to know its potential economic value with in the market.

At the clinical trial site the investigator collects the required data from the subjects participating in the clinical trial, which is then entered into the Electronic Case Report Forms’s of the Clinical Data Management System, then the system employs various ways to verify the data, avoiding the possibility of errors which is more common during the entry of data manually. To manage this huge amount of data collected during a trial, the Clinical Trial Management System, which is like a tracking system is used.  This is a self contained system that is used to manage large amount of data involved with the operation of a clinical trial. A CTMS (Clinical Trail Management System) with CDM can help in the validation of the trial data.

Overview of Clinical Data Management process:

After the start of a clinical trial at different site, the subject’s data is collected at each of the sites during the various stages of the trial process. This data forms the basis of the safety and efficacy analysis of the trial drug, which will in turn drive the decision of the pharmaceutical industry on product development.

The first step in any data management is to design and develop a database according to the study protocol and this has to be done before starting of a clinical trial. Once the subject enrollment is started at the site, the subject’s data is collected by the study physician and inputted to the database. By using different data collection/management tools, data is validated, checked for consistency and ensured it is complete, since incomplete data will lead to huge deviation in the analysis.

CDM is also involved in Case Report Form designing, tracking, database design, database validation, database archiving, clinical data processing like double data entry, data comparison, query generation, query resolving, data cleaning, database locking and releasing, export of data to statistical software.

At the end of the trial, the clinical data management ensures that each and every data within the trail is collected, accounted and data management activities are up to date and complete. At this final stage they will declare that the data is locked and database freeze has been done and that the data is ready to be transferred for further statistical analysis.

What is Statistical Analysis Software (SAS)?
SAS is statistical analysis software / system, which enables programmers to write a code of programs that is used to retrieve, manage the data in the form of tables, analyze the data in different form of report files like Statistical report and visualization reports that is displayed in the form of charts or graphs.

How CDM and SAS are related?
After collection of data from the clinical trial, the data has to be analyzed to get the report of the trial; statistical analysis software through which analysis of the clinical trial data can be done, converts the data into an appropriate and sophisticated report for that particular trial. There are some competitor software’s present in the market like systat, stratica, hyperion, cognos etc that are also used for the analyses of clinical trial data. However, SAS is most widely used software because of its user friendly and easy to understand nature. SAS functions mainly on four data driven tasks like data access, data management, data analysis and data presentation.

The work flow of SAS starts from the raw data which is present in the database. It can access the data by using some of the data step statements wherein creating many data sets/structured files are within the SAS environment. By using the process step of SAS, the data is generated into different type of reports, which is presented to the steering committee, where it can be submitted to FDA / DCGI for further approval processes.

Thus clinical data management is used to manage the data to avoid loss / misusage of the data and SAS is used to analyze the data, and generate the data into a form of report that can demonstrate a clear outcome of the clinical trial. Very often CDM and SAS are linked together to get the report of the clinical trial data appropriately.

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