While EDC has been around for many years, we all acknowledge that the percentage of EDC studies has just moved into the majority. Some of the reasons for such a slow uptake include:
1) failure to understand that EDC adoption requires significant change to fundamental business processes hindering pharma from leaving “paper” processes behind;
2) thinking that studies “outsourced” to an EDC vendor means minimal change to a clinical trials organization; and
3) continued evolution of EDC tools and vendors leading to some pharma companies chasing what appears to be the newest and best solution.
One key issue arising from EDC adoption is its disruptive effect on clinical trial site staff. Now, with the majority of clinical trials using web-based EDC tools, clinical site staff are reaching a point where they say no more EDC because the volume of EDC studies severely impacts their ability to maintain source documents and use multiple EDC tools. For example, for one EDC tool, clinical site staff must take training from each sponsor using the tool which produces a huge time burden on those individuals. Broad adoption of EDC (eCRF) standards from efforts like CDISC’s CDASH initiative may alleviate some of that disruption, but clinical site process considerations are largely being ignored. Remember, those folks are critical customers for EDC.
So, there are multiple factors creating problems for EDC adoption and their common threads all point to understanding business processes inside pharma and inside clinical trial sites. Addressing those factors should help EDC move from a simple majority to larger adoption.
The huge number of purely EDC vendors presents problems for the buyer (pharma companies). Many companies are now looking to consolidate numerous vendors to a select few. Therefore, many are looking further into the future than simply choosing an EDC vendor. They may also need an IVRS vendor or perhaps help with the trial design and data monitoring. Many of the EDC vendors cannot provide this one stop shopping. There is a legitimate concern on the part of companies that an EDC vendor may not be around in a couple of years. Many have fallen by the wayside in recent years purely because they could not compete or did not address the needs of the client.
Furthermore, there is a desire for consistency. Difference clinical groups within a company can have different preferred vendors. This can compound the problem of data collection and integration. Lastly, there is the management of the collected data–who owns it, who has access, etc. Internal politics can play a big role here. Many companies (and clinical programs) may simply decide that building is better than buying.
The main problem with EDC in the pharma industry is one of business process change. For many, the technology is very sound, and replaces labor-intensive and cost-intensive historic paper-based approaches. However, the burden of labor shifts from internal data entry staff to site-specific clinical/medical staff. There is an immediate improvement in reducing the number of queries, and that improvement, along with the speed with which data is available, is where many of the benefits reside. THe cost of moving this work to the site is non-trivial.
Research companies can gain more success with EDC systems by altering the business process within their organizations. Because the data is more timely, and more accurate earlier in the process, what else can be done within the business process to leverage the investment in EDC?
EDC is not just about moving data faster, it’s about leveraging the EDC investment of optimize the process whereby new therapies are ultimately approved for use.
RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.
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