SHORTCOMINGS

Identifying Patients for Clinical Trials

It’s not always easy to identify patients who are likely to participate in the many trials required to prove a new drug is safe and effective. The challenge of recruiting participants and making sure that enough of them follow the trial to its completion is one of the main challenges that result in delays and cost overruns for R&D departments. ISR estimates that for each day that a trial goes past its deadline, the company loses up to $600,000 in sales for small drugs and up to $8 million for “blockbuster” drugs. The current approach:

  • Currently, 72 percent of clinical trial patients are “pulled” into a trial because they are already a patient of one of the medical professionals running the trial or are a patient at the site of the trial.
  • Another 28 percent are “pushed” into trials via a variety of recruitment strategies, including conventional advertising campaigns (online, TV, radio) and through coordination with advocacy groups, such as the American Cancer Society, which refer patients to trials that might lead to a cure.

The traditional approach has plenty of shortcomings, particularly when it comes to trials that depend on a highly specific population of people, such as those dealing with a rare condition. A study from the Tufts Center for the Study of Drug Development found that more than a third of clinical trials do not achieve their recruitment goals. Another 11 percent of trials do not even manage to attract one participant.