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.tri­al­strack­er.net 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.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 104,600+ biopharma pros reading Endpoints daily — and it's free.

An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.