The val­ue of pub­lish­ing clin­i­cal tri­al da­ta can­not be ex­ag­ger­at­ed — it is cru­cial to the pace and di­rec­tion of sci­en­tif­ic progress, and crit­i­cal to the knowl­edge base em­ployed by pa­tients, doc­tors and pol­i­cy­mak­ers to make de­ci­sions about the safe­ty, ben­e­fits and adop­tion of treat­ment in­ter­ven­tions. But not every­body is quite as con­cerned with the toll clin­i­cal tri­al trans­paren­cy trans­gres­sions can take on pa­tient health, pub­lic health pol­i­cy and med­ical ad­vance­ment — a new re­port sug­gests Eu­ro­pean Uni­ver­si­ties are ex­tra­or­di­nar­i­ly guilty of these re­port­ing vi­o­la­tions.

The re­port, pub­lished on Tues­day, eval­u­at­ed the per­for­mance of 30 Eu­ro­pean uni­ver­si­ties that have spon­sored the largest num­ber of clin­i­cal tri­als gov­erned by the Eu­ro­pean Union. Since 2014, the EU has man­dat­ed every study reg­is­tered on the EU clin­i­cal tri­als reg­istry post sum­ma­ry re­sults on­to the reg­istry with­in one year of com­ple­tion (6 months for pe­di­atric tri­als) — these rules al­so ap­ply to tri­als com­plet­ed pri­or to 2014, and must be ad­hered to ir­re­spec­tive of whether re­sults have been pub­lished in aca­d­e­m­ic jour­nals.

Al­to­geth­er the eval­u­at­ed uni­ver­si­ties have spon­sored 4,575 clin­i­cal tri­als, of which re­sults are ver­i­fi­ably due for 940 tri­als. But on­ly the re­sults of 162 (17%) tri­als have been post­ed on the EU Clin­i­cal Tri­als Reg­is­ter, the re­port found. Da­ta for the study was col­lat­ed and analysed by a con­sor­tium of Eu­ro­pean in­sti­tu­tions: UK’s TranspariMED, Ger­many’s BUKO Phar­ma-Kam­pagne, Bel­gium’s Test Aankoop and Nether­land’s Health Ac­tion In­ter­na­tion­al (HAI).

“Fail­ure to ful­ly and rapid­ly re­port clin­i­cal tri­al re­sults is not a vic­tim­less crime…Some (UK) uni­ver­si­ties have al­ready post­ed over 90% of their tri­al re­sults, show­ing that where there is a will, there is a way. Why are uni­ver­si­ties that break the rules still re­ceiv­ing pub­lic funds to run ad­di­tion­al tri­als?” Till Bruck­n­er, founder of TranspariMED said in a state­ment. Truck­n­er co-au­thored a re­port in 2017 that analysed six drug case stud­ies — in­clud­ing Vioxx and Tam­i­flu — in which tri­al opac­i­ty di­rect­ly harmed pa­tients, tax­pay­ers and/or in­vestors.

In the cur­rent analy­sis, most of the 778 clin­i­cal tri­als ver­i­fi­ably miss­ing re­sults were run by uni­ver­si­ties in Den­mark (246 tri­als), Aus­tria (225), and Ger­many (117) and none of the as­sessed uni­ver­si­ties in France, Italy, Nor­way and Swe­den have made a sin­gle clin­i­cal tri­al re­sult pub­lic on the reg­istry, the re­port found.

These num­bers above may not even re­flect the ac­tu­al state of af­fairs, giv­en that many tri­als list­ed as “on­go­ing” on the Eu­ro­pean tri­al reg­istry were in fact com­plet­ed long ago, re­searchers un­der­scored. As it stands, EU uni­ver­si­ties are em­pow­ered to up­load their sum­ma­ry re­sults on­to the EU reg­istry as tri­al spon­sors, but they can­not di­rect­ly up­date the sta­tus (on­go­ing/com­plet­ed) of the tri­als. In­stead, uni­ver­si­ties are sup­posed to no­ti­fy their na­tion­al med­i­cines reg­u­la­tor when a tri­al is com­plet­ed, and the reg­u­la­tor is then meant to re­vise the tri­al’s sta­tus on the reg­istry. “For ex­am­ple, uni­ver­si­ties in the Nether­lands have run 967 tri­als in to­tal, but on­ly 23 of those (2.4%) are marked as “com­plet­ed”. This num­ber is com­plete­ly im­plau­si­ble, as reg­istry records show that many of those tri­als start­ed over five years ago. (In the UK, where a reg­istry up­date is on­go­ing, the pro­por­tion of “com­plet­ed” tri­als in the co­hort is 27.4%.),” the re­port not­ed.

A po­ten­tial rea­son why EU re­searchers  — who are not fac­ing the same lev­el of scruti­ny as their UK coun­ter­parts — have not both­ered with com­ply­ing with their trans­paren­cy oblig­a­tions could be the lack of in­cen­tive, Test Aankoop’s Van Hecke Mar­tine told End­points News. “The fo­cus of re­searchers is pub­li­ca­tion of their study re­sults in sci­en­tif­ic jour­nals, as this is re­ward­ed in their pro­fes­sion­al eval­u­a­tion and so it’s im­por­tant for their ca­reer.”

The on­ly bright spark in the re­port were UK uni­ver­si­ties — some of which have re­port­ing rates of over 90%, large­ly due to en­dur­ing pres­sure from par­lia­ment, the pub­lic and re­search fund­ing bod­ies. Out­side of the UK, 730 out of 785 ver­i­fi­ably due tri­als (93%) are cur­rent­ly miss­ing re­sults, da­ta in­di­cat­ed.

“There is no good rea­son why, if UK uni­ver­si­ties can do it, their coun­ter­parts across Eu­rope can’t. This should be the stim­u­lus oth­ers need to get their act to­geth­er and meet their trans­paren­cy oblig­a­tions. The ap­par­ent con­tempt shown by many Uni­ver­si­ties must not be al­lowed to stand.” HAI se­nior pol­i­cy ad­vi­sor An­cel.la San­tos told End­points News.

Once up­on a time, UK uni­ver­si­ties were sim­i­lar­ly lax about their re­port­ing oblig­a­tions. But con­cert­ed pres­sure has yield­ed im­pres­sive re­turns. For ex­am­ple, King’s Col­lege Lon­don en­hanced its re­port­ing rate from a woe­ful 18% to a re­spectable 93% with­in six months. The Uni­ver­si­ty of Not­ting­ham — spot­light­ed by the UK par­lia­ment’s sci­ence and tech­nol­o­gy com­mit­tee for its weak per­for­mance last year — has now post­ed the sum­ma­ry re­sults of over 95% of its tri­als, the re­port not­ed.

But da­ta com­piled by Ben Goldacre, best-sell­ing au­thor, med­ical doc­tor and re­searcher who fo­cus­es on un­pack­ing the mis­use of sci­ence and sta­tis­tics in his books Bad Sci­ence and Bad Phar­ma, out of his lab at the Uni­ver­si­ty of Ox­ford sug­gests that UK uni­ver­si­ties are less re­li­able than drug de­vel­op­ers at ful­fill­ing their clin­i­cal tri­al re­port­ing oblig­a­tions.

Across the At­lantic things aren’t much bet­ter. An analy­sis pub­lished last month by Uni­ver­si­ties Al­lied for Es­sen­tial Med­i­cines (UAEM) and non-prof­it re­search ad­vo­ca­cy group TranspariMED showed that 40 lead­ing US uni­ver­si­ties should have post­ed the re­sults of 450 clin­i­cal tri­als — but over a third (31%) of those re­sults are miss­ing.

Im­age: Shut­ter­stock

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.