EMA of­fers method­olog­i­cal con­sid­er­a­tions for tri­als dur­ing Covid-19 pan­dem­ic

The Eu­ro­pean Med­i­cines Agency (EMA) on Wednes­day re­leased for con­sul­ta­tion a new draft guide­line on points that clin­i­cal tri­al spon­sors should con­sid­er on the im­pli­ca­tions of the coro­n­avirus dis­ease (Covid-19) on method­olog­i­cal as­pects of on­go­ing tri­als.

While not­ing that “it is not pos­si­ble to give gen­er­al ap­plic­a­ble ad­vice on how the dif­fer­ent as­pects re­lat­ed to the pan­dem­ic should be han­dled, as im­pli­ca­tions on clin­i­cal tri­als are ex­pect­ed to be man­i­fold,” the EMA’s Bio­sta­tis­tics Work­ing Par­ty calls on spon­sors “to pre-plan how sys­tem­at­ic de­vi­a­tions re­sult­ing from the mea­sures and in­di­vid­ual de­ci­sions re­lat­ed to the Covid-19 pan­dem­ic are cap­tured,” as well as to record such de­vi­a­tions and the re­lat­ed rea­sons for them.

The guid­ance comes as last week the EMA re­leased ini­tial guid­ance on con­duct­ing tri­als dur­ing the pan­dem­ic, in tan­dem with the FDA. Since then, Eli Lil­ly said it will de­lay most new study starts and pause en­roll­ment in most on­go­ing stud­ies. And Bris­tol My­ers Squibb said that for both on­go­ing and new stud­ies, no new sites will be ac­ti­vat­ed un­til 13 April – a date that could be ex­tend­ed. BMS al­so tem­porar­i­ly sus­pend­ed screen­ing, en­roll­ment and aphere­sis in its cel­lu­lar ther­a­py clin­i­cal tri­als.

In light of such paus­es, the EMA guide­line notes that spon­sors should col­lect a “suf­fi­cient amount of in­for­ma­tion on pan­dem­ic-re­lat­ed mea­sures and whether tri­al pa­tients or tri­al con­duct were af­fect­ed, as well as on the sub­pop­u­la­tions of ex­posed/non-ex­posed, and in­fect­ed/non-in­fect­ed pa­tients will be nec­es­sary to study the im­pact on the treat­ment ef­fect. Spon­sors should col­lect this in­for­ma­tion to the ex­tent fea­si­ble, and in a prag­mat­ic man­ner.”

In some cas­es, the guide­line says an in­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee may be nec­es­sary, par­tic­u­lar­ly to help spon­sors re-start usu­al tri­al op­er­a­tions, ad­just the tri­al sam­ple size and/or to deal with any po­ten­tial sources of bias.

Most im­por­tant­ly, pa­tient safe­ty is para­mount and at the heart of every de­ci­sion tak­en, re­gard­less of any po­ten­tial con­se­quences for an on­go­ing tri­al. Be­yond this, it is an eth­i­cal man­date to pro­ceed with a tri­al that has been start­ed as long as there is an op­por­tu­ni­ty that the ef­forts tak­en by pa­tients and physi­cians can ben­e­fit drug de­vel­op­ment and pa­tient care,” the guide­line adds.

Points to con­sid­er on im­pli­ca­tions of Coro­n­avirus dis­ease (COVID-19) on method­olog­i­cal as­pects of on­go­ing clin­i­cal tri­als

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Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.