P&G - EDC Challenges

P&G has encountered data collection process inefficiencies that are causing delays and extending the time to data lock.  The problem is the costs associated with the data lock delay which are generated by the delay to deliver a new product to the market.  The symptoms of the problem are redundant data entry using paper based systems, inaccurate reporting using paper based systems, longer approval cycles before roll out using EDC systems and investigator sites unwillingness and inability to use web based EDC systems.   

The scope of the problem consists of three components; trial preparation, data collection and verification and data management and review.  Using EDC trial preparation has not run as efficiently as possible.  Due to inexperience eCRF have taken longer to develop, approve and test than paper based models.  However, with experience eCRF assembly times will decrease and eventually mirror the duration associated with preparing paper CRF’s.  During the data collection and review phase of clinical trials P&G has experienced a costs saving of $3 to $5 per CRF page by switching to electronic data collection forms.  In addition CRA's travel time to investigation sites has been reduced by 50%.  However resistance and challenges have been encountered at investigation sites.  Some investigation sites are unfamiliar with computers in generals.  Others had connectivity issues because of slow internet access.  Other sites refused to use the system.  In addition, some investigator sites experienced extended data entry time because of the instant edit checks performed by the eCDF and corresponding requirement to edit the data to complete the form.  In summary a lead CDM at P&G summed up the implementation of the web based EDC system by saying, “at the investigation sites the EDC system means more work, more trouble and ultimately more stress.  For those reasons some sites may think it’s easier to stay with the paper based system.”  The most successful result of the EDC was the reduction in time to data lock from 8 weeks to 4 weeks during the course of the first few trials.  This decrease in time to data lock could be attributed to improved access to data and more efficient querying.  In addition, the quality of the data increased as eCDF forms required inconsistencies to be edited before allowing the form to be submitted.  CDM and CRA roles have become similar as CDM’s direct interaction with investigation sites has increased while CRA’s had to understand the technology and know how to perform certain EDC functions a task previously performed by CDM's.

The context of the problem revolves around the investigation sites ability to obtain the hardware, understand the software, realize the benefits of using a web based data collection and have the proper internet connectivity to use the system.  Decision criteria:  Can we provide the investigation site with the required hardware?  What will the costs and benefits be if we provide the hardware?  Should we provide training on the use of the e-based data collection system?  How can we overcome internet connectivity issues? Should we look to use the EDC system in specific locations where connectivity is not an issue?  Can we partner with an ISP provider to bring internet to problem areas?

What are the alternative courses of action? 
1. Keep the paper based system. 
2. Develop a hybrid paper based and electronic data collection system and roll out the system according to each investigation sites ability and wiliness to use the system. 
3. Complete conversion to an electronic data collection system.

Keeping the paper based system does not address the key problem of reducing the time to lock the data as the inefficiencies of the paper based system created the problem. A hybrid system would address the time to data lock in some clinical studies however the studies which remained on the paper based system would still be an issue.Complete conversion to an EDC system would address the time to lock problem but global incorporation is complicated by the inability of some investigations sites to use electronic based data collection systems.

The decision criteria should be evaluated by the ability to implement the appropriate decision to address the key problem of reducing the time it takes to lock the data and weigh the costs and benefits of implementing the solution.  The evaluation can be imaginative however the decision must be viable.

My recommendation is to globally implement an electronic data collection system.  The challenges presented by the investigation sites can be overcome by providing the sites with the necessary hardware and offering software training and support.  Sites that have internet connectivity issues should be excluded from the pool of potential investigation sites until connectivity issues are resolved.  As an alternate project we could look into partnering with an ISP’s to deliver internet to sites that lack connectivity.  The per page cost reduction of eCDF, reduction in CRA’s travel time and decrease in time to data lock offered by the implementation of EDC makes global implementation the quality recommendation.