It is widely accepted among clinical trial professionals that EDC solutions deliver many benefits with respect to time, productivity,
and costs. This is especially true for the collection and cleaning of standard CRF data such as demographics, concomitant
medication, medical history, efficacy, and safety. EDC also covers the areas of patient reported outcomes, central laboratory
data, and data from other external sources. However, a very important aspect of clinical trial data management is not adequately
addressed in many EDC solutions and eCRFs: namely, the collection, processing, and reporting of Serious Adverse Events (SAE).
In many EDC trials the SAE process is still paper- and fax-based. This process is often carried out in isolation from other
data management activities and results in redundant activities such as duplicate documentation for the investigator and drug
safety unit.
Holding back progress
There are various reasons for such a lack of integration when collecting, reporting, and processing SAEs and SUSARs (suspected
unexpected serious adverse reactions) in eCRFs. First of all, one has to understand the special requirements needed when processing
SAEs and SUSARs: different as it is to nonsafety data, data from SAEs and SUSARs have to be processed and reported to regulatory
authorities at very short notice, and the required expertise differ greatly from those in the field of clinical data management.
Consequently, most medium and large pharmaceutical or biotech companies have highly specialized in-house drug safety departments,
which utilize dedicated database applications for the comprehensive management of SAEs and the reporting of SUSARs. Smaller
companies frequently outsource these tasks to CROs, which then provide the appropriate database applications and corresponding
processes.
As drug safety reporting is of ever-increasing importance throughout the drug development process, most companies are reluctant
to change their existing procedures, which are often reliable but inefficient. They feel it would be better to remain with
a flawed but familiar system rather than undergoing the upheaval associated with introducing a new one. Another reason for
the lack of integration is the historical use of existing applications, which lack the necessary interfaces to enable the
smooth exchange of data with other systems.
Importing or synchronizing SAE data from an EDC system into a drug safety application—preferably in XML format—would require
an elaborated and validated functionality, enabling users to handle and track changes, update records, manage queries, and
carry out numerous other processes. Many EDC systems do not offer such synchronization options and lack an easy-to-use and
flexible import/export functionality. But does this mean we should wait for the "perfect" solution of full SAE reporting capabilities
within EDC systems? It would perhaps be wise to consider the interim step of incorporating smart SAE forms into eCRFs. This
would allow the use of state-of-the-art EDC functionalities and the seamless transfer of SAE information to drug safety applications.
eCRF SAE forms
It should be noted that, in order to implement an efficient electronic SAE process, it is important to take care of the additional
requirements for electronic SAE pages in an EDC system. SAE data pages differ from other eCRF pages in various ways:
- Data entry and updates require immediate attention.
- Most of the data on SAE pages already exist on other pages of the eCRF.
- The query-management process differs and involves the drug safety department.
- The data is frequently incomplete and requires updating.
- Additional reporting requirements are necessary.
However, choosing the right EDC solution, designing smart eCRF pages, and making full use of its capabilities will significantly
increase data quality and the efficiency of the SAE process.
Figure 1. Linking of data already collected on other eCRF pages is simple, avoids redundancies, and improves quality of entries
in SAE forms.
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An eCRF SAE form and the backend EDC system should:
- Automatically display study information, such as demographics and standard baseline data, which has already been entered into
the eCRF.
- Allow the investigator to choose data that has been entered on other forms to be linked to the electronic SAE form. The data
only has to be entered once, thus avoiding inconsistencies. This greatly simplifies the documentation of SAEs to specify related
medical history and concomitant medication records (see Figure 1).
- Offer specific user rights for drug safety managers to perform data reviews and cleaning within the EDC system, or even enter
data into predefined fields (if required).
- Contain fields in which the investigator, CRA or drug safety manager can upload/attach certain information (e.g., hospital/discharge
letters).
- Automatically synchronize AE and SAE eCRF forms (see bullet point 1).
- Include an alert system that notifies a predefined group of recipients via email, SMS or automatically generated fax reports.
- Generate on-demand SAE reports in PDF format (full or incremental modified information).
- Offer a standardized and incremental transfer of SAE information to a dedicated drug-safety application, preferably in XML
format.
