Nearly one in four publicly sponsored cancer clinical trials fail to enroll enough participants, which means progress is impeded and a lot of time and money has been wasted.
What accounts for that? Patients grumble about cost - if you go to Stanford Medical for a consultation about a trial they are doing, you are likely to get a large bill just for the visit - and then there is the risk of side effects that get so much media attention. If real medicines that survived 12 years and $2 billion end up with lawsuits for harm, untested treatments or techniques are likely to be worse. And Big Pharma is evil, activists and the federal government routinely tell us.
Some trials obviously do get filled and a paper in the JNCI: Journal of the National Cancer Institute, says there are a number of measurable trial characteristics are predictive of low patient accrual. Scholars analyzed information on 787 phase II/III clinical trials sponsored by the National Clinical Trials Network launched between 2000 and 2011. After excluding trials that closed because of toxicity or interim results, Caroline S. Bennette, M.P.H., Ph.D., et al. found that 145 (18%) of NCTN trials closed with low accrual or were accruing at less than 50% of target accrual 3 years or more after opening.
Factors associated with poor accrual were increased competition for patients, planning to enroll a higher proportion of the available patient population, and not evaluating a new investigational agent or targeted therapy. The authors developed a multivariable prediction model of low accrual using 12 trial-level risk factors, which they reported had good agreement between predicted and observed risks of low accrual in a preliminary validation using 46 trials opened between 2012 and 2013.
The researchers conclude that "Systematically considering the overall influence of these factors could aid in the design and prioritization of future clinical trials..." and that this research provides a response to the recent directive from the Institute of Medicine to "improve selection, support, and completion of publicly funded cancer clinical trials."
Everyone agrees that clinical trials are important. But with the war on medicine and the companies that produce all of it, clinical trials are likely to remain important for other people to enroll in.