Current practices for patient and investigator recruiting for clinical trials are inefficient and ineffective. This routinely
results in scheduling delays, spiraling costs, and an increased risk of lower quality studies. These deficits are a serious
problem for the drug research and approval process and ultimately hurt patients through delayed approvals and failure to identify
safety risks. In addition, a declining number of physicians are willing to be investigators on clinical trials.
This article proposes integrating clinical trial recruiting with eHealth patient records by searching automatically for protocol
qualified patients from among those who have consented to allow their records to be searched for such opportunities. This
approach can be applied in today's environment, and then grow with the Regional Health Information Organization (RHIO) "movement."
The aggregation of eHealth records provides a way to identify patients, as well as potential investigators, for trials. Since
this approach brings links to clinical trial information directly to the qualified patients and their physicians in the health
care environment, it affords a "best practices" means of enrolling patients. Such eRecruiting and eHealth record integration
will vastly improve the efficiency and selectivity of the recruitment process and can be extended to facilitate other aspects
of clinical trial participation for investigators.
Lost opportunity costsA retrospective benchmarking survey1 of 4000 clinical trials over a five-year period found that about half of the time spent on the trials was allocated to recruiting
sites, investigators, and patients. Consistent with this, survey findings2,3 report that patient enrollments fall behind schedule in up to 86% of clinical trials, with 13% behind by more than six months.
Moreover, delays in two or more stages of premarketing clinical trials have a compound effect and can result in cancellation
of clinical research on potentially important medications.
The Case for Alternative Approaches Case for Alternative Approaches
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As trial sponsors struggle to complete and maintain enrollments for premarketing clinical trials, the financial opportunity
cost of inefficient and ineffective recruiting is the sales revenue that is not realized due to delays or outright failures
in bringing new drugs to market. For example,3 for a new drug that is expected to generate a half billion dollars in annual sales, the sponsor will forgo sales of $1.3
million for every day the drug is not available for sale. Even when a trial fails to produce sufficient evidence of safety
and efficacy, there is a financial opportunity cost if this conclusion is delayed by enrollment problems.
The social opportunity cost of inefficient and ineffective recruiting is the morbidity and mortality that could be avoided
by new drugs coming to market sooner. In addition, too many patients are not aware of a trial for which they qualify. Just
as sponsors have an incentive to minimize the operational costs of clinical trials, including recruiting, patients likewise
have an interest in learning about trials that might improve their overall health and quality of life.
Investigator participation in trials
Studies4,5 have found that patient and physician investigator choices to participate in clinical trials depend on their expectations
of the time and inconvenience that may be involved. A CenterWatch5 survey found that almost three-quarters of physicians interviewed had an interest in learning more about investigational
treatments to supplement their knowledge. Yet, less than half of the physicians without clinical trial experience would refer
patients to a clinical trial. For those who had clinical trial experience, 85% would refer their patients. The main reasons
doctors gave for their lack of interest in trials were: a lack of information on clinical trials (58%), not enough time to
learn about the trial (30%), and not knowing where to refer patients (28%).
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