Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of an­a­lysts at Glob­al­Da­ta tracked 322 bio­phar­ma com­pa­nies — biotechs, phar­mas, CROs and such — re­port­ing on the trou­ble Covid-19 has caused for their clin­i­cal de­vel­op­ment plans.

Slight­ly more than half — 179 — are US op­er­a­tions, with about 1 in 4 scat­tered through­out Eu­rope and in Cana­da. And the dis­rup­tions are clus­tered around mid-stage de­vel­op­ment, though a hefty num­ber of late-stage de­rail­ments may well blunt the stream of ap­provals down the road.

“The ma­jor­i­ty of dis­rupt­ed clin­i­cal tri­als are in Phase II, at 44.8%, fol­lowed by Phase I with 26.1%, Phase III with 21.7%, and Phase IV with 7.4%,” says Brooke Wil­son, as­so­ciate di­rec­tor, tri­als in­tel­li­gence at Glob­al­Da­ta. “Of these tri­als, 12% are specif­i­cal­ly Piv­otal/Reg­is­tra­tional, giv­ing an in­di­ca­tion that there will be an im­pact on reg­u­la­to­ry ap­provals in the fu­ture.”

Glob­al­Da­ta al­so con­clud­ed that:

(T)he ma­jor­i­ty of dis­rupt­ed clin­i­cal tri­als — 67.3% — were due to the sus­pen­sion of en­roll­ment. The de­layed ini­ti­a­tion of planned tri­als fol­lows at 18.4%, then, fi­nal­ly, 14.4% of tri­als are cur­rent­ly be­ing im­pact­ed due to slow en­roll­ment. With­in the 14.4% of tri­als af­fect­ed by slow en­roll­ment, 20.7% of these are specif­i­cal­ly due to the avail­abil­i­ty of sites and in­ves­ti­ga­tors.

The big fo­cus now will be how fast the de­vel­op­ers can move these de­layed tri­als along, or re­place them with fresh ef­forts. Reg­u­la­to­ry groups on both sides of the At­lantic have been help­ing out with new rules that al­low tri­als to con­tin­ue, when pos­si­ble, with home drug de­liv­ery and at-home mon­i­tor­ing and the use of telemed­i­cine a more com­mon fea­ture.

Al­so of note, while we’ve seen plen­ty of ev­i­dence of wide­spread dis­rup­tion, a host of bio­phar­ma com­pa­nies have been ramp­ing up new work on drugs and vac­cines for Covid-19, strik­ing a whole new set of deals and di­vert­ing re­sources to new pro­grams. So it’s not a ze­ro-sum game.

Glob­al­Da­ta has been track­ing more than 700 drugs — from dis­cov­ery through piv­otal pro­grams — linked to Covid-19. “There are now over 2,000 clin­i­cal tri­als glob­al­ly – 398 of these clin­i­cal tri­als are for chloro­quine or hy­drox­y­chloro­quine and 22 of these tri­als are for remde­sivir,” the com­pa­ny re­port­ed a week ago. “There are al­so over 583 com­pa­nies and in­sti­tu­tions dri­ving pro­phy­lac­tic and cu­ra­tive in­no­va­tion.”

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