Not so new technologies
pharmafile | July 28, 2010 | Feature | Research and Development | EDC, Les Rose, digital research
Let me take you back to a time that is now only dimly remembered. I don’t mean a time when clinical trials were carried out using paper case report forms, because that time is still with us. I am doing it right now.
I mean when a few people looked at hypertext markup language and thought “My goodness, you can write forms with this, that people can fill in on a website. Isn’t form-filling what we do with clinical trials? Hmmm …. now where could this take us?”.
Business red in tooth and claw
Well it could take us to realms far more interesting than just form-filling. What struck me about the internet, when I first started using it about 15 years ago, was the sense of community that very quickly emerged. All sorts of people worldwide were happy to help each other, initially with computer problems, but this diversified quickly.
With clinical trials such a dispersed activity, and so dependent on external investigators, would not this sense of community overcome many of the barriers to good management?
It was an exciting time because, for anyone working in clinical research, with an understanding of how the web worked, the world seemed to be their oyster. The beauty of it was that writing web forms in those days was simple stuff, even hard-coding them as was the standard then.
Pretty soon a rash of companies broke out, offering systems variously called remote data capture (RDC), electronic data capture (EDC), or remote data entry (RDE). What they called their systems revealed how they saw them, and the focus was almost universally on data entry rather than on project management.
It was an explosion of diversity, but within a narrow remit. What nobody predicted was just how conservative the pharmaceutical industry was.
Paper survives the mass extinction
Instead, the predictions were that in five or ten years’ time, nobody would be using paper CRFs any more. It wasn’t only the vendors who were saying that, a lot of the potential customers did as well. This new supplier sector thought it was sitting pretty, as if even a small percentage of the customers who agreed, actually wrote out some cheques, the market would do very well. The reality was different. The information superhighway did not exist, especially in more remote territories – I can remember waiting minutes for a page to load in Poland.
Whereas many clinical research managers were enthusiastic, their bosses were often not, and agonised over security, costs, and a host of imagined problems. Viable proposals withered on the vine while customers vacillated. A mass extinction of EDC companies seemed on the cards, not necessarily driven by selection of the fittest, but largely by the lottery that is business life. EDC applications went through repeated incarnations as companies merged, were bought, went to the wall, or were ripped off by their erstwhile partners. It made biological evolution look benign.
In 1998, there was just one company exhibiting a web-based system at the UK’s foremost clinical research conference. Within two years there were several, spawning dedicated showcase events for computer technology in the field. This year, there were no EDC companies exhibiting at the Institute of Clinical Research’s spring meeting.
A love-hate relationship
So has the industry fallen out of love with EDC? Not really, as the latest data show that more than half of today’s trials are using EDC – not all of them as the pundits thought all those years ago. It appears to be a love-hate relationship. True, some EDC vendors have done very well indeed. Phase Forward was recently purchased by Oracle for $685 million, three times its annual turnover. Some other vendors have had big financial challenges, so it remains a high-risk sector.
So what were the promises made by EDC vendors at the outset? Have they not been met, explaining why the enchantment with technology is now a bit tarnished?
People are the problem
Charles Wilbe at Project Doctors, formerly head of IT project management at Glaxo, always says that IT projects never fail because of the technology, they fail because of the people.
There is not much you can’t do with software, but there is a lot you might miss because you never imagined it. That agrees pretty closely with the potted history I have just given, but the users might be justified in being such ‘late adopters’.
A major claim from the vendors right from the start was a massive saving in time scales, so that databases could be locked in days rather than weeks or months with paper.
My own experience with a self-developed system confirmed that, but I have recently seen data from CMR Consulting Services showing a somewhat more modest shortening of that metric. The median time from last patient visit to database lock, for phase III studies completed in 2006-2008, was 58 days for paper and 55 days for EDC.
While individual pharmaceutical companies report wonderful case studies, leading them towards corporate roll-out of big systems, the CMR data comes from a cross section of 29 companies and tells a different story. What is happening here – or rather not happening?
Neither one thing nor the other
Digging a bit deeper, and I am speculating a little here, there is a possible explanation. The marching speed of a regiment is that of the slowest man, so what is the point in investing heavily in whizz-bang high speed systems for part of your trial, while still going at a snail’s pace for the rest of it?
Don’t laugh, this happens, and I know from personal experience. For this reason, I have never been able to see the logic of the ‘hybrid’ offerings of some vendors, whereby you can design your CRF in one interface, and then render it either as a web form (for people who like the web) or as a paper form (for those who don’t). My guess is that it is intended to pander to those clients who are wary of new technology and like the reassurance of being able to revert to paper if it all goes wrong.
My next guess is that these clients never get the benefits of EDC because they are not committed to it.
“If you can measure it …. you know something about it” (Lord Kelvin)
The CMR data do not confirm one complaint about EDC, that set-up time is longer. It was actually shorter by 15 days.
Conventionally, the visit by the clinical research associate is vital, as it is the primary tool for achieving data quality. These visits are extremely expensive and labour-intensive, but involve a lot of pretty mundane checking of data for legibility, accuracy, and completeness. CRAs do this by applying rules which they get from the protocol. With EDC, the CRA role should be much reduced, as the rules are pulled forward into the online data validation that the web form carries out.
The visits are still needed for other essential tasks, such as document checking and (especially) source data verification, but even those can be automated to a large extent.
Nevertheless, all this up front intelligence is not causing a delay in getting started. How well I remember the furious debates that went on in the late 1990s. “Investigators won’t stand for it, you have to let them enter without validation and then clean up the database later” – “No, quality starts at the beginning, you save time by not allowing dirty data into the system”.
I am not sure who won that, but I still know who was right – and my investigators supported me.
It’s a wide wired world
OK, the web is a different place now. There is hardly a city in the world without high bandwidth data access available, and we are promised speeds that were unimaginable ten years ago.
When I started online searching in the mid-80s, we thought 1200 bits per second was a lot. There are not many places in the world with a health system where you can’t deliver sophisticated online applications, sufficient to run most if not all of the functions of a trial.
Again, the IT systems are not the problem, but the vision of the users may still need some development.
Les Rose is a freelance clinical scientist and medical writer. www.pharmavision-consulting.co.uk
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