On-line clinical trials recruitment
pharmafile | October 22, 2003 | Feature | Research and Development | clinical trials, digi pharma, patient recruitment
Sometimes, solutions don't really solve anything. Let me tell you a story about on-line clinical trials recruitment. A couple of years ago, as dotcom businesses were dropping like flies, I received an offer from a US clinical trial recruitment company to be their European development director. That meant working out how the fledgling business would tap into existing sources of clinical trials, sell some business to big pharma, and make best use of the web to keep costs in the basement.
The opportunity was pretty clear. Pharma companies have been wrestling with the costs of clinical research – about 20% of their sales revenue – for years, and the dearth of blockbusters to justify development costs of anywhere between £300 and £600 million was, as it turned out, about to turn the boom era of pharma share prices into, if not exactly a bust, then at least something that should exercise the chief executive and the board.
Clinical trials, which used to be an operational issue, were becoming a high profile strategic issue. With up to 75% of trials being delayed or, in some cases, failing completely because they couldn't recruit enough patients to make the research statistically meaningful, the opportunity to take recruitment on-line was a chance to tap into a £30 to £40 billion marketplace.
The proposed solution was to create a database of potential patients to -supplement an existing database of doctors to manage the trials – and make them available to pharma companies. The branding of the company would be directed at making it the place that patients would come to, to register in order to search for trials, and that registration information would then be made available to drug companies. This was all made perfectly plain on the website, and patients welcomed this. Privacy concerns come a very distant second to finding a cure for a dreadful disease.
So we set to with a will, but pretty soon encountered problems. The first was the need to educate the market. Many pharma companies couldn't see a problem, or perhaps to be more precise, their trials managers saw a threat to their own livelihoods, and spun things as though there was no problem.
The second was dealing with the consequences of market fragmentation. We had a pretty good database in the US, but nothing in the UK, and the opportunity to partner with someone who already had such a database – a strategy that we had used successfully in the US – was going to be a long old slog, because databases like that didn't actually exist. The same was true in France and Germany.
Anyone entering the marketplace now will find that a lot easier, because significant strides have been made in collating all the various public sector trials into one place, although the private sector has been moving more slowly.
Which leads us neatly to the third problem with the marketplace, which is that most pharma companies dont want to publish their trials protocols since the information contained within them is basically the company crown jewels. Nearly every compound in a trial will have at least one direct competitor, and many more will have near-competitors. Publishing trials on the web is, in many trials managers' minds, a sure and certain route to bankruptcy.
As if that wasn't enough, then there was the really bad news. The original promise of the on-line recruitment business was that costs would be cut dramatically. As it turned out, that was true only up to a point. Under the old 'off-line' process, pharma companies paid doctors who had performed well in previous trials to recruit patients who fitted a specific protocol. The doctor can't solicit patients for a trial, so he sits and waits for them to turn up.
Under the new on-line model, patients would present themselves. The problem with this is that most protocols are so narrowly drawn that most patients would be excluded. Under the old model, doctors working with the patients would know that the patient wasn't eligible and so would not raise their hopes by proposing the trial to them in the first place.
So not only would doctors have to be paid to give patients bad news, but the patients themselves, their carers and families would realise that the glitzy new system that promised so much could not actually help them. Bad news travels fast. If you are pleased with something, you are likely to tell about three people. If you are disappointed with something, you will probably tell 10 people.
So while web-based recruitment does provide pharma companies with a way to find more patients, they still need to be filtered and selected by doctors, and so far, no one has found a way to automate that.
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