Clinical trial DTC? It may not be right for your drug candidate

SUMMARY: Over half of all clinical trial sites are outside the U.S. 78 % of all subjects were enrolled outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S.. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient.

More than 40 million patients are needed to meet the demand of currently enrolling trials.  According to

  • More than 18,000 clinical trials are actively recruiting patients in the U.S.
  • The FDA approved 309 new drugs between 2011 and 2018, 38 per year on average.
  • In 2018, the FDA approved 59 new drugs – an all-time high.
  • 80% of clinical trials will not meet their patient enrollment deadlines.
  • The industry loses an average of $40 billion per year on drug development, part of which is due to trial delays.
  • 95% of medical research volunteers would consider participating in another trial, according to a patient survey we conducted.
  • 85% of patients are either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis.
  • 75% of patients said they would have been willing to enroll in a clinical trial had they been aware of one
  • 33% of clinical trial participants join to help further medical research.

We’ve been asked, a lot of times, to give our opinion on using DTC for clinical trial recruitment. The answer is that every clinical has different needs and audiences and that DTC may not be the right way to get patients for clinical trials. For most potential new drugs, DTC is not a good way to recruit patients.

 Approximately 80% of clinical trials are delayed or closed because of problems with recruitment. In addition:

  • 9 out of 10 trials require the original timeline to be doubled in order to meet enrollment goals
  • 11% of research sites fail to enroll a single patient
  • Clinical trials account for nearly 40% of the US pharma research budget and total around $7B per year. The estimated cost of patient recruitment is 40% of the total budget, or $1.89B.
  • Delays can cost sponsors between $600,000 and $8 million for each day that a trial delays a product’s development and launch
  • Screen failure rates are significantly costly for sponsors and the cost (on average) across the industryis roughly $1,200 per failure.

Our research HAS shown that people are checking out clinical trials more and more, even with COVID, and the greater the risk, the more likely patients will NOT enroll in trials. Does this mean DTC won’t work? No, not at all. It means that drug companies need to choose their clinical trial recruitment channels carefully.

We don’t know right now how patients perceive clinical trials concerning doubts around the FDAs drug approvals. There certainly has been a lot of noise around the approval of Biogen’s Alzheimer’s drug, which experts did feel should have been approved. Still, clinical trials for potentially life-saving or quality of life-altering drugs may be different.