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EDC: electronic data capture or eliminating data corruption?

Published on 08/10/03 at 01:23pm

Managing a successful clinical trial is probably one of the hardest tasks known to man. Getting a drug to work on a mechanism as complex and varied as a human body, especially one that is, by definition, ailing and failing, is as near to magic as humans can get. The easy part should be collecting and managing the data, but often it isn't.

Lets look at some of the data issues that clinical trials managers face:

  • dirty data  mainly through transcription errors when a reading is copied from a handwritten piece of paper to a computer
  • limited access to data because most of it is on paper, and scattered among possibly hundreds of trials centres
  • data entry issues such as whether the trial is being slowed down by unresolved queries or whether the necessary patient diary data is complete.

Total clinical development costs for a new drug are around £300 million and it is estimated that 30% of the total cost of a clinical trial budget relates to managing data collection, review and integration. The great white technological hope for reducing this cost is electronic data capture, which, according to its proponents, prevents trial delays and rework by providing quick access to data and knowledge of outstanding queries.

With clinical research co-ordinators able to resolve issues and answer queries along the way, time-consuming data cleaning at the end of the trial should be a thing of the past. Co-ordinators and physicians enter data only once directly into the system at the source. Edit checks and validation can be applied immediately, eliminating errors that routinely create queries six to nine months later in paper-based processes. EDC can reduce overall query rates by more than 80% compared with paper workflows.

There are several flavours of EDC. One approach depends on the trial centre, which might be a clinic a hospital or an individual doctors surgery, having adequate computing power available. This isnt always the case, and there is no clear correlation between the quality of data that the clinic delivers and its computer skills.

The other approach is to provide electronic patient diaries. Companies can oversee the collection of data from study patients-patient diary data-which can be obtained through the use of hand-held technology such as the Palm Pilot or telephone-based systems. Hand-held units can be distributed to the patients for daily data collection or distributed to sites for per visit data collection.

So if EDC is such a boon, why doesn't everyone use it? Only 13 approved drugs have used EDC in their development programmes. As with many other applications of new technology to pharmaceuticals (e-detailing is the obvious current example), the Catch 22 inhibiting a ramping up of demand is the lack of any return on investment, which in turn means there is no clear value proposition. The problem for EDC is compounded by a common belief in the industry that it is more expensive than paper-based data collection.

The evidence for these opinions comes from older models of deployment that involved hardware distribution to every research site before the Internet made that business model redundant. The data generated from these outdated deployment models is obviously not applicable in todays rapidly moving technology environment. These misperceptions include a belief that EDC is too expensive, too slow, that regulators will not accept EDC-generated data for submissions, and that investigators won't use it. From a historical perspective, such beliefs are simply outdated. The early EDC applications often lacked suitable infrastructures like help desks, which are critical success criteria. Poor design and performance of early EDC systems led to extensive complaints from users. That seems to be a thing of the past.

More recent public information shows documented user satisfaction rates of between 71% and 95%. Not only that, but there is now some comparative research that suggests cost savings in excess of $50 million for an average successful clinical development programme are possible. In research by Datatrak International, the costs of four EDC trials in phase I, II, III and IIIb were assessed against the known costs of outsourcing to CROs. EDC was, says Datatrak, an average of 5.8-fold less expensive than paper.

Using publicly available metrics of improvements in clinical workflow with EDC versus paper, combined with longitudinal expenditure data on programme development costs from the Center for Drug Development Research at Boston University, an extrapolated Value Proposition for an entire drug development programme was evaluated. In these comparisons, double data entry and data management fees averaged 44% of the total budgets and typically exceeded the entire actual EDC budget. By eliminating mistakes, says Datatrak, EDC can shorten the overall length of the clinical trial process by 30% compared to manual methods. EDC implementation is capable of providing an additional $60 million in revenue value (as opposed to cost savings) to a sponsor from a new drug with first year sales potential of $200 million.

We'll look at other ways in which technology can  or might  help to fix the clinical trials problems in future articles.

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