Half of all tri­als sup­posed to be re­port­ed in a Eu­ro­pean data­base are not, de­spite clear le­gal re­quire­ments, re­searchers have found in the first such study of com­pli­ance, which al­so notes that phar­ma com­pa­nies do bet­ter in this re­gard than aca­d­e­m­ic in­sti­tu­tions, char­i­ties and hos­pi­tals.

Ben Goldacre

Comb­ing through 7274 tri­als on the EU Clin­i­cal Tri­als Reg­is­ter (EU­C­TR) that have passed the due date for post­ing da­ta, a team out of Ox­ford’s Ev­i­dence-Based Med­i­cine Data­L­ab not­ed that on­ly 49.5% re­port­ed their re­sults — mean­ing half of the time, tri­als spon­sors have breached a 2012 Eu­ro­pean Com­mis­sion guide­line that man­dates dis­clo­sure with­in 12 months of study com­ple­tion.

The team — led by the high-pro­file Ox­ford re­search Ben Goldacre — has launched an in­ter­ac­tive on­line data­base that they plan to up­date month­ly in ad­di­tion to post­ing a pa­per in The BMJ. The old­est tri­al tracked dates back to 2004.

In gen­er­al, com­mer­cial spon­sors are much more like­ly to post re­sults; 68% of their tri­als are re­port­ed, com­pared to 11% for a non-com­mer­cial spon­sor. Scale al­so mat­tered, as the big­ger spon­sors tied to a large num­ber of tri­als col­lec­tive­ly re­port­ed more of their tri­als (78%) than their small­er coun­ter­parts (18%).

Fur­ther­more, all 11 en­ti­ties record­ing a 100% re­port­ing rate are phar­ma com­pa­nies: Boehringer In­gel­heim, Chiesi Far­ma­ceu­ti­ci, Almi­rall, Gilead, Ot­su­ka, CSL Behring, Al­con, Ver­tex, Genen­tech, Dai­ichi Sankyo and Leo Phar­ma. Even the worst per­form­ing phar­ma— Pierre Fab­re — re­port­ed 55% of the tri­als it’s sup­posed to.

No­var­tis and Glax­o­SmithK­line, the on­ly two spon­sors with more than 1,000 tri­als on the EU­C­TR, have re­port­ed rates of 94.7% and 92.1% re­spec­tive­ly.

“Al­though poor re­port­ing rates in some sec­tors is a source of con­cern, the ex­treme­ly high rate of com­pli­ance among com­mer­cial spon­sors con­duct­ing a large num­ber of tri­als is pos­i­tive: it shows that, with an un­am­bigu­ous re­quire­ment for all tri­als to re­port re­sults, near per­fect com­pli­ance can prac­ti­cal­ly be de­liv­ered,” the re­searchers wrote.

There’s a catch, though.

The re­searchers didn’t tech­ni­cal­ly count all the tri­als that were due to re­port. That’s be­cause omis­sions and in­con­sis­ten­cies in tri­al com­ple­tion dates made it im­pos­si­ble to de­ter­mine whether a spon­sor was com­pli­ant in 3392 cas­es — which makes up 29.4% of all tri­als marked “com­plet­ed” or “ter­mi­nat­ed.” And these prob­lems show up even in tri­als con­duct­ed by the 100% com­pli­ant spon­sors.

It’s just as much of a prob­lem as non-re­port­ing to reg­u­la­tors — and the EMA can do a bet­ter job mon­i­tor­ing it while spon­sors al­so clean up their act.

“We can’t make in­formed choic­es if the re­sults of clin­i­cal tri­als are with­held from doc­tors, re­searchers, and pa­tients,” the re­searchers wrote on their data­base, adding in the pa­per: “We hope that the ac­ces­si­ble and time­ly in­for­ma­tion on the com­pli­ance sta­tus of each in­di­vid­ual tri­al and spon­sor pro­vid­ed by our EU.tri­al­strack­er.net will help to im­prove re­port­ing rates”.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

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