New clin­i­cal tri­al di­ver­si­ty plans, which FDA will soon ex­plain fur­ther, were fea­tured in the gov­ern­ment spend­ing pack­age that Pres­i­dent Joe Biden signed late last week and are com­ing at a time when they’re very much need­ed, ac­cord­ing to a new analy­sis pub­lished in the BMJ to­day.

Of the 25 com­pa­nies re­viewed for the new di­ver­si­ty rank­ings, Unit­ed Ther­a­peu­tics was the on­ly one with a per­fect fair in­clu­sion score of 100, but sev­en oth­ers — Puma Biotech­nol­o­gy, Sanofi, Take­da, Am­gen, Bris­tol My­ers Squibb, Eli Lil­ly, and Mer­ck KGaA — re­ceived a score in the top quar­tile on clin­i­cal tri­al di­ver­si­ty per­for­mance, ac­cord­ing to the analy­sis from Stan­ford, Yale and Bioethics In­ter­na­tion­al re­searchers, which was sup­port­ed by a grant from the Su­san G. Komen Foun­da­tion.

More than half of the 25 spon­sors par­tic­i­pat­ing (56%) fair­ly in­clud­ed women, the re­searchers said, but just five spon­sors (20%) fair­ly in­clud­ed old­er adults and on­ly one spon­sor (4%) fair­ly in­clud­ed racial­ly and eth­ni­cal­ly mi­nori­tized pa­tients in tri­als. For in­di­vid­ual prod­ucts’ piv­otal tri­als, the analy­sis found that 80% fair­ly in­clud­ed women, 24% fair­ly in­clud­ed old­er adults, and 5% fair­ly in­clud­ed racial­ly and eth­ni­cal­ly mi­nori­tized pa­tients.

At the prod­uct lev­el, 42% (25/59) of the can­cer ther­a­peu­tics re­viewed in­clud­ed trans­par­ent da­ta on the pro­por­tion of racial and eth­nic mi­nor­i­ty par­tic­i­pants in their tri­als, the re­search showed.

The so-called fair in­clu­sion score, which is in­formed by da­ta from 64 piv­otal clin­i­cal tri­als of nov­el drugs and bi­o­log­ics ap­proved be­tween 2012 and 2017, con­sid­ers trans­paren­cy of re­port­ing and the rep­re­sen­ta­tion of three de­mo­graph­ic groups that are of­ten un­der­rep­re­sent­ed in clin­i­cal tri­als in com­par­i­son to the dis­ease-spe­cif­ic pop­u­la­tion: sex (per­cent­age of par­tic­i­pants that were fe­male), age (per­cent­age of adults old­er than 64) and race/eth­nic­i­ty (per­cent­age of par­tic­i­pants iden­ti­fy­ing as Black, Asian and/or Lat­inx).

Jen­nifer Miller

“The lack of di­ver­si­ty in clin­i­cal re­search is a so­cial jus­tice and a pub­lic health prob­lem,” co-au­thor Jen­nifer Miller, founder of Bioethics In­ter­na­tion­al and an as­so­ciate pro­fes­sor at Yale School of Med­i­cine, said in a state­ment.

While on­ly a few spon­sors have done well in the rank­ings, the au­thors not­ed that “most have sub­stan­tial room for im­prove­ment on their in­clu­sion of old­er adults and racial­ly and eth­ni­cal­ly mi­nori­tized pa­tients, and to a less­er ex­tent women.”

The rank­ings fol­low a Gov­ern­ment Ac­count­abil­i­ty Of­fice re­port from last month that found that af­ter more than three decades of in­sti­tut­ing gov­ern­ment poli­cies to im­prove clin­i­cal tri­al di­ver­si­ty, cer­tain racial and eth­nic groups, as well as ado­les­cents, old­er adults, women, low-in­come in­di­vid­u­als, and in­di­vid­u­als from rur­al com­mu­ni­ties “re­main con­sis­tent­ly un­der­rep­re­sent­ed in can­cer clin­i­cal tri­als.”

Mov­ing for­ward, spon­sors will soon be re­quired to sub­mit to FDA a “di­ver­si­ty ac­tion plan” for Phase III tri­als, in­clud­ing spec­i­fy­ing en­roll­ment goals up­front.

But the FDA has the abil­i­ty to waive such a re­quire­ment if an in­di­ca­tion is too small or for oth­er dis­cre­tionary rea­sons. Con­gress is man­dat­ing that FDA pub­lish guid­ance on such ac­tion plans with more de­tails, in­clud­ing on whether to grant a spon­sor’s re­quest to waive the re­quire­ment.

The agency will have two years to is­sue a re­port on what the di­ver­si­ty ac­tion plans have done up un­til then, in terms of boost­ing the en­roll­ment of mi­nori­ties and typ­i­cal­ly un­der­rep­re­sent­ed pop­u­la­tions.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.