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2014 ; 11
(6
): 615-21
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Clinical trials in crisis: Four simple methodologic fixes
#MMPMID25278228
Vickers AJ
Clin Trials
2014[Dec]; 11
(6
): 615-21
PMID25278228
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There is growing consensus that the US clinical trials system is broken, with
trial costs and complexity increasing exponentially, and many trials failing to
accrue. Yet, concerns about the expense and failure rate of randomized trials are
only the tip of the iceberg; perhaps what should worry us most is the number of
trials that are not even considered because of projected costs and poor accrual.
Several initiatives, including the Clinical Trials Transformation Initiative and
the "Sensible Guidelines Group" seek to push back against current trends in
clinical trials, arguing that all aspects of trials-including design, approval,
conduct, monitoring, analysis, and dissemination-should be based on evidence
rather than contemporary norms. Proposed here are four methodologic fixes for
current clinical trials. The first two aim to simplify trials, reducing costs,
and increasing patient acceptability by dramatically reducing eligibility
criteria-often to the single criterion that the consenting physician is uncertain
which of the two randomized arms is optimal-and by clinical integration,
investment in data infrastructure to bring routinely collected data up to
research grade to be used as endpoints in trials. The second two methodologic
fixes aim to shed barriers to accrual, either by cluster randomization of
clinicians (in the case of modifications to existing treatment) or by early
consent, where patients are offered the chance of being randomly selected to be
offered a novel intervention if disease progresses at a subsequent point. Such
solutions may be partial, or result in a new set of problems of their own. Yet,
the current crisis in clinical trials mandates innovative approaches: randomized
trials have resulted in enormous benefits for patients, and we need to ensure
that they continue to do so.
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