Phar­ma com­pa­nies out­per­form in­sti­tu­tions in Eu­ro­pean clin­i­cal tri­al re­port­ing amid prob­lem­at­ic over­all trends — Ox­ford study

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.

Source: The BMJ

Click on the im­age to see the full-sized ver­sion

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.tri­al­strack­ will help to im­prove re­port­ing rates”.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

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