Tresting new drugs is a costly and frustrating headache for pharmaceuticals companies-and the pain is about to get worse. Clinical trials are at best difficult to manage and dogged by delays, and now the genomics revolution and stricter regulatory standards are compounding the problems. For pharma companies, managing the newly increased demands of clinical trials may become the greatest obstacle to realizing the full benefit of the new health technologies.
Not surprisingly, it is the clinical aspects of these trials that pharma companies concentrate on: making sure that the research methodology or protocol leads to results capable of standing up to the scrutiny of authorities such as the US Food and Drug Administration (FDA). But another crucial element- the recruitment of patients-is often overlooked, causing expensive delays that can drain much of the sales potential from any new drug. More than half of all US clinical trials from 1993 to 1998 missed their deadlines by at least a month (Exhibit 1, on the next page). A failure to get enough patients in time accounts for 85 to 95 percent of all days lost during clinical trials (Exhibit 2, on the next spread).
The fresh opportunities unleashed in the year 2000, when the human genome was finally charted, are set to increase the demand for patients in clinical trials. Drug research focuses on discovering novel targets: the biological mechanisms, usually receptors or enzymes in human cells, through which drugs work. By mapping the genome, scientists have increased the number of potential targets-to as many as 10,000, from about 500-and the R&D costs associated with developing new drugs could double. (1) As more new drug targets enter the R&D pipeline, poor recruitment could become a bottleneck, hampering a company's ability to bring new drugs to market expeditiously.
Delays can cost pharma companies at least $800,000 a day in lost sales for a niche medication, such as Amaryl, an oral antidiabetic treatment, and as much as $5.4 million for a blockbuster like Prilosec, a gastrointestinal medication. If some of this revenue is merely deferred, it may be recouped once a drug goes on the market, but millions of dollars in revenue can vanish if a competitor catches up or, worse, gains the advantage with an earlier debut. Delays can also affect a company's valuation, since investors closely watch the progress of new drugs: efficient clinical trials put them on the market more quickly, so they take market share more quickly. Pharma companies may also gain a strategic edge by setting a new standard for treating a disease, and speed to market gives physicians and patients a broader, and potentially lifesaving, choice of treatments in less time.
Finding people for trials is always hard: too many patients don't realize they can participate. Further, deaths and questionable practices in isolated trials have made potential participants wary. Moreover, designers of clinical trials are now seeking more narrowly defined sets of patients, in part to distinguish new drugs from rivals on the market. But the most important problem is regulatory change: over the past decade, the number of patients needed for each FDA approval has almost doubled. (2)
The pharma industry could therefore create enormous value by more efficiently recruiting participants in clinical trials. Taking a single month off a trial by improving recruitment could generate an additional $40 million in sales for an average drug. But to do so, pharma companies must radically alter their R&D efforts by improving the speed and efficiency of recruitment, and this in turn will streamline the whole clinical-trials process.
Thinking like marketers
To get patients into trials more efficiently, pharma companies must begin to think like marketers. By setting a target for the number of patients needed in a trial, the R&D team in essence creates a sales challenge: to get enough patients to buy the "product"--in this case, participation in the trial. …