As dig­i­tal tri­als picked up steam amid the pan­dem­ic, some said the tech­nol­o­gy could al­so be used to ad­dress bio­phar­ma’s his­toric lack of di­ver­si­ty in the clin­ic. But if im­ple­ment­ed the wrong way, it could al­so ex­ac­er­bate the prob­lem, the Dig­i­tal Med­i­cine So­ci­ety (DiMe) warns.

That’s why DiMe is look­ing to cre­ate a frame­work and re­sources for suc­cess­ful­ly run­ning dig­i­tal tri­als. And a suite of in­dus­try play­ers — in­clud­ing Am­gen and Glax­o­SmithK­line — are join­ing the new ini­tia­tive.

“We’re at a re­al­ly im­por­tant junc­ture as we think about the dig­i­ti­za­tion of health­care,” DiMe CEO Jen­nifer Gold­sack told End­points News. “What we’re com­mit­ted to, along with our part­ners, is mak­ing sure that we cap­ture this op­por­tu­ni­ty and we pro­vide re­sources not just for par­tic­i­pat­ing part­ners, but for the en­tire field that are ac­tion-ori­ent­ed and en­sure that as we go dig­i­tal, we bring more pa­tients with us.”

The ini­tia­tive is what DiMe calls a “Tour of Du­ty,” in which the or­ga­ni­za­tion spends four to six weeks ad­dress­ing a press­ing chal­lenge in the field. The goal? To emerge with re­sources for the in­dus­try, rang­ing from check­lists to new guid­ance.

Over the past cou­ple years, the pan­dem­ic has cast a harsh spot­light on bio­phar­ma’s di­ver­si­ty prob­lem. Of the 53 drugs ap­proved in 2020, Black par­tic­i­pants rep­re­sent­ed just 8% of par­tic­i­pants in the tri­als reg­u­la­tors based their de­ci­sions on. Lat­inx pa­tients rep­re­sent­ed just above 12% of par­tic­i­pants, and Asian pa­tients just above 6%.

Some have said that vir­tu­al tri­als could help bridge the gap in rep­re­sen­ta­tion — but while that may be a good op­tion for some pa­tients, it ex­cludes every­one who doesn’t have ac­cess to the tech­nol­o­gy or to broad­band.

“Now is the time to en­sure tri­al plan­ning is mind­ful of the po­ten­tial of tech­nol­o­gy as a bar­ri­er to par­tic­i­pa­tion by po­si­tion­ing dig­i­tal health tech­nolo­gies for greater trust, use, and im­pact,” said Pamela Tenaerts, CSO at dig­i­tal tri­al-fo­cused Med­able (which is al­so join­ing the ini­tia­tive), in a news re­lease.

Up­on snag­ging a $91 mil­lion Se­ries C round back in 2020, Med­able told End­points that cus­tomers us­ing its vir­tu­al tri­al plat­form re­port­ed faster pa­tient en­roll­ment and in­creased re­ten­tion rates.

“Clin­i­cal tri­als are a sig­nif­i­cant part of the process for de­vel­op­ing med­i­cines. Yet, for too long, tri­als have lacked di­ver­si­ty with un­der­rep­re­sen­ta­tion of cer­tain groups of peo­ple across many dis­eases,”  said Pon­da Mot­sepe-Dit­shego, VP, glob­al med­ical ther­a­peu­tic area head, and leader of Am­gen’s Rep­re­sen­ta­tion in Clin­i­cal Re­search (RISE) team, in the news re­lease. “Hav­ing the means to en­gage these pop­u­la­tions via new tech­nolo­gies helps us move to­wards a fu­ture where they are no longer un­der­rep­re­sent­ed, un­der­stud­ied, and un­der­treat­ed.”

In ad­di­tion to Am­gen, GSK and Med­able, a slate of oth­er in­dus­try play­ers have joined the ini­tia­tive, in­clud­ing Ac­cli­nate, Light­ship, Ru­bix LS, Sage Bionet­works, Savvy Co­op­er­a­tive, and THREAD Re­search.

“In or­der to say we’re go­ing to do this bet­ter than we have be­fore, we have a re­spon­si­bil­i­ty … to bring every­one to the ta­ble and to deeply un­der­stand how these new prod­ucts work in every­body,” Gold­sack said.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.