How not to run a sin­gle-arm tri­al: EMA high­lights more than a dozen 'bi­as­es' — and ways to mit­i­gate them

The Eu­ro­pean Med­i­cines Agency to­day out­lined some po­ten­tial bi­as­es — and pos­si­ble so­lu­tions — for bio­phar­ma com­pa­nies that wish to sub­mit clin­i­cal da­ta from sin­gle-arm tri­als for po­ten­tial prod­uct ap­provals.

EMA said a re­flec­tion pa­per dat­ed April 17 is now open for pub­lic com­ment, with a fo­cus on the con­cepts and chal­lenges re­lat­ed to sin­gle-arm tri­als (SATs), as well as to look at op­tions to po­ten­tial­ly im­prove how the tri­als are de­signed and run.

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