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Statistical Tools Sought for Smaller Placebo Group Sizes

Calculator keys (Jorge Franganillo/Flickr)A new challenge on InnoCentive seeks a technique for reducing sizes of placebo group samples in clinical trials — patients who do not receive the test treatments, to whom the patients getting the treatments are compared — without compromising the ability to interpret the results. Proposals describing the solution to this challenge are due by 21 February 2013, with a total purse of $25,000 (free registration required to view details).

InnoCentive, in Waltham, Massachusetts, conducts open-innovation, crowd-sourcing competitions for corporate and organization sponsors. The sponsor of this challenge is not revealed.

In clinical trials, a placebo acts as a yardstick or constant for measuring the safety and efficacy of new active drugs or medical devices, known in clinical trials as the target treatment. Some clinical trials use a control group where patients receive a placebo that resembles the medication or treatment instead of an active drug or experimental treatment.

In these trials, the investigators try to duplicate the exact conditions for placebo patients as the patients receiving the target treatments to minimize potential biases, typically resulting in one placebo patient for each patient treated with a candidate drug or test device. The 1 to 1 matching of placebo and test patients means that clinical trials recruit large numbers of placebo patients that do not receive a real therapy.

Even if the ratio of test to placebo patients is raised to 2 to 1 or 3 to 1, the need for placebo patients remains high, particularly for later-stage efficacy trials where sample sizes are usually large. As a result, pharmaceutical companies, medical device developers, and medical centers have enormous costs conducting these trials, while making a large imposition on clinical study participants in the placebo groups.

The challenge therefore seeks an answer to the question: how can the efficiency of randomized controlled clinical trials be increased by reducing the number of patients needed in placebo groups? The sponsor of the challenge requires a firm understanding of statistical methods in experimental design, but specialists from outside the health care field are invited to submit proposals.

InnoCentive calls this kind of compeition a theoretical challenge that requires a written proposal for the submission, which will be reviewed by the sponsor. Winning contestants will be asked to provide the sponsor with a non-exclusive license to their intellectual property to practice their solutions.

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Photo: Jorge Franganillo/Flickr

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