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”.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

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The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

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Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.