Pharmacy

Over the last few years, Electronic Data Capture (EDC) has strengthened its usage and it is predicted that it will replace paper for capturing clinical trial data. Will we see a paperless world in the near future, or certain obstacles such as not realizing the true value of EDC will act as a barrier?

Clean, high-quality data is one of the most critical elements of any clinical trial and to obtain this most companies engaged in clinical research have a robust Clinical Data Management System (CDMS) in place.

CDMS is a tool used in clinical research to manage the data of a clinical trial and can be broadly divided into paper-based and EDC system, historically, the collection of clinical trial data has been a very manual, paper-based process. The clinical trial data is gathered at the investigator site in the Case Report Forms (CRFs) and sent to the company for

Which trial is being performed or to the Contract Research Organization (CRO) that is managing the trial for a company. The data on forms is transferred to the CDMS tool through data entry. This can be by single or double data entry. The most popular method is double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, the system gives an alert and verification can be done manually. The data in CDMS is then transferred for data validation to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required. Also, in these systems, during validation the data clarification from sites are done through paper forms, which are printed with the issue description and sent to the investigator site and site responds by answering on forms and mailing it back. This process is labour intensive, slow and involves extensive use of  paper forms.                          

Paradigm shift

Given the fact that the pharmaceutical industry is under extraordinary economic pressure and the demand to quickly deliver therapies to market intensifies, there is a growing need to implement technology solutions such as EDC to control operational costs and expedite time-lo-market.

Clinical trials are the most expensive and critical part of drug development and EDC has the potential to significantly decrease time to market and clinical trial costs.

In EDC, traditional data management roles have changed, as it is the site staff that enters data into the system and the programmed edit checks will trigger queries at the time of entry or immediately after submitting the data. This instant validation provides a higher level of data quality at reduced cost and without delay-

Clinical Data Management (CDM) no longer makes data changes in the system based on site query responses, but rather site staff enters the data changes, CDM can now focus attention on performing data reviews using listings and reports to fully ensure that data are complete, consistent and logical.

EDC systems also allow sponsors to gain access into study data for an insight into the conduct of studies. In turn, earlier insights enable study decisions to be made in a timely manner during the clinical development cycle.

Implementation of EDC has resulted in reduction of paper consumption and had on clinical research associates to manage large volumes of paper. It has also reduced the risk of loss/damage of CRFs during transit and also the costs associated with transferring CRFs.

Requirements of an EDC system

Today, companies that decide to go in for an EDC tool have a number of products to choose from but careful consideration has to be given to selecting the most appropriate product. Some important features to be considered are:

• Ensure compliance with 21 CFR Part 11 and consistency with the Food and Drug Administration's (FDA) guidance for industry; Computerized systems used in clinical trials

• Inbuilt feature to prevent unauthorized access to data and electronic signature

• The system should support the utilization of automated data capture, management and archiving

• It should easily integrate with other systems/ applications

• Once all important decisions have been made on which product to go ahead with, the next step is successful implementation   of the   system.

• Several factors come into play when implementing an EDC tool. The following list is not exhaustive but is a good place to start:

• Leadership:    Strong   leadership, management skills and positive open attitude are essential to a successful implementation

• Change   management:    Handle implementation   as   a   change management process, not Just a new technology. Processes and jobs must change

• Planning: The planning part of a project is often short changed because of timelines, but it is an extremely important stage. PRISM denotes a   helpful   set   of steps for

a new EDC process:

• Planning

• Resourcing with 'can do' personnel and a good leader
•  Implementing according to the plan (with contingency planning included)
• Supporting standards adequately and
•  Metrics collection  to  measure success

• Implementation partner: Companies that do not have in-house capabilities to implement would require support from a good implementation partner to help and guide them during the validation of the system

Challenges faced at investigator sites for an EDC study

There are several challenges facing companies making a shift to EDC. Primarily among them is investigator site staff still have reservations about EDC - this is because (a) they find data entry a tedious task especially if the system speed is slow. To overcome this issue, companies need to invest some time during site initiations in order to ascertain if site's network firewall and security systems would interfere with communication between the client and server and ensure compatibility between the two exists before start of study. Helpdesk support should also be provided to sites to address any technical issues during the course of the study. (b) Since investigators typically work with multiple sponsors on multiple studies, it becomes extremely inefficient for them if every study uses a different EDC system. Each system requires a different login, a separate password, different requirements for entering the data and resolving queries and each has if. Own instructions for using the system. To a certain extent this problem is being addressed at the industry level as there is growing interest in having the pharma industry adopt a common data collection format. This common format could significantly ease the burden on both investigators and research companies. The growing adoption of the Clinical Data Interchange Standards Consortium (CDISC) standards is likely to drive this effort. The CDISC data standards and data models can be applied to the design of data capture screens so that EDC interfaces are more similar between products.

Will EDC replace paper?

In view of the challenges and advantages of an EDC system, the question still remains will EDC replace paper? While many pharma companies that have used EDC realize that there is no going back to paper a number of them are not

quite ready to completely abandon their paper-based system since that would not only require new technologies but new business processes as well.

Although judging by the current industry requirements, advances in technology and FDA's critical path initiative to standardize data collection at investigative site level, there is a clear trend towards movement to an electronic environment.