Ac­cel­er­at­ing drug de­vel­op­ment with­out sac­ri­fic­ing safe­ty: How phar­ma­covig­i­lance is keep­ing pace with COVID-19 clin­i­cal re­search

2020 gave rise to the most dev­as­tat­ing pan­dem­ic in mod­ern his­to­ry, but it al­so prompt­ed re­mark­able break­throughs across clin­i­cal re­search and prod­uct stew­ard­ship.

Just one year af­ter COVID-19 was de­clared a glob­al health emer­gency, there were 10 vac­cines avail­able for full or lim­it­ed use and more than 80 vac­cines in hu­man tri­als. This ex­tra­or­di­nary and high­ly an­tic­i­pat­ed ef­fort was ex­pe­dit­ed by many fac­tors, in­clud­ing ea­ger tri­al par­tic­i­pants, ag­ile op­er­a­tion strate­gies and ex­ten­sive in­dus­try col­lab­o­ra­tion.

Wide in­ter­est in the ef­fort al­so means that clin­i­cal tri­als and their safe­ty have been in the news and the pub­lic is pay­ing at­ten­tion. While many peo­ple are ea­ger to re­ceive a vac­cine, some have ques­tions about vac­cine safe­ty and the speed with which these prod­ucts were brought to mar­ket. Drug de­vel­op­ment is a com­plex un­der­tak­ing. The gen­er­al pub­lic of­ten doesn’t have a nu­anced un­der­stand­ing of the process or the crit­i­cal role phar­ma­covig­i­lance plays in the de­vel­op­ment and stew­ard­ship of every prod­uct.

Phar­ma­covig­i­lance spe­cial­ists have been at the fore­front of a trans­for­ma­tion­al ef­fort to bal­ance pa­tient safe­ty with prod­uct ef­fi­ca­cy.

AI-Dri­ven Tools

Self-re­port­ing health track­ers across mo­bile de­vices and plat­forms play an im­por­tant role in ag­gre­gat­ing da­ta from wide­ly dis­parate sources. These AI-dri­ven tools, like the Cen­ters for Dis­ease Con­trol and Pre­ven­tion app that prompts vac­ci­nat­ed pa­tients to dis­close any side ef­fects, have not on­ly helped phar­ma­covig­i­lance teams track ad­verse events in re­al time, but al­so cap­ture post-vac­ci­na­tion ad­verse event trends as they un­fold.

In ad­di­tion to lever­ag­ing self-re­port­ed da­ta, phar­ma­covig­i­lance ser­vice providers are wise to in­vest in tools to stream­line re­search and analy­sis. Nat­ur­al Lan­guage Pro­cess­ing (NLP)—an AI tech­nol­o­gy that au­to­mates med­ical lit­er­a­ture re­view, iden­ti­fies and an­a­lyzes facts for con­tex­tu­al in­for­ma­tion and stream­lines da­ta analy­sis with ad­vanced al­go­rithms—of­fers huge ef­fi­cien­cy gains in phar­ma­covig­i­lance op­er­a­tions. From ac­cel­er­at­ing clin­i­cal re­search and re­duc­ing tran­scrip­tion er­ror, NLP lessens the strain on clients’ time and re­sources. Through its re­cent ac­qui­si­tion of NLP tech­nol­o­gy as­sets, Parex­el re­duced lit­er­a­ture han­dling time by as much as 50 per­cent with 100 per­cent ac­cu­ra­cy dur­ing a six-month pi­lot with a client.

Ag­ile In­fra­struc­ture

While demon­strat­ing the need for re­mote, ef­fi­cient da­ta cap­ture, the glob­al pan­dem­ic al­so ex­posed tech­nol­o­gy, per­son­nel and oth­er re­source chal­lenges in clin­i­cal re­search and prod­uct stew­ard­ship. Many bio­phar­ma­ceu­ti­cal or­ga­ni­za­tions with promis­ing vac­cines and oth­er treat­ments lacked flex­i­bil­i­ty to quick­ly scale and mon­i­tor safe­ty pro­files through­out the prod­uct life cy­cle.

Rec­og­niz­ing that health care providers need­ed to spend their time sup­port­ing pa­tients, phar­ma­covig­i­lance op­er­a­tional teams jumped in and worked with cross func­tion­al teams to find quick so­lu­tions and ad­just­ed process­es al­most dai­ly in the ear­ly part of the pan­dem­ic.

One of the ben­e­fits of­fered by con­tract re­search or­ga­ni­za­tions is swift, nim­ble ac­cess to the right re­sources for end-to-end phar­ma­covig­i­lance. As ad­verse event re­port­ing vol­umes were sky­rock­et­ing, COVID-19 dis­rup­tions caused some phar­ma­covig­i­lance ser­vice providers to sus­pend op­er­a­tions. The ad­van­tage of out­sourc­ing to a phar­ma­covig­i­lance part­ner through a Func­tion­al Ser­vice Provider (FSP) mod­el is greater flex­i­bil­i­ty to main­tain ser­vices—es­pe­cial­ly amid un­fore­seen cir­cum­stances.

Parex­el’s Func­tion­al Ser­vice Provider (FSP) team quick­ly tran­si­tioned to a re­mote mod­el with un­in­ter­rupt­ed ser­vice de­liv­ery. Phar­ma­covig­i­lance teams around the world were able to sig­nif­i­cant­ly in­crease case pro­cess­ing vol­umes with min­i­mal ad­di­tion­al train­ing to en­sure part­ner reg­u­la­to­ry com­mit­ments were met. Glob­al reach and ac­cess to lo­cal ex­per­tise near strate­gi­cal­ly lo­cat­ed op­er­a­tions across mul­ti­ple con­ti­nents is an es­sen­tial com­po­nent for Parex­el’s ag­ile in­fra­struc­ture, with ex­perts who re­cruit and train the most qual­i­fied teams with speed and pre­ci­sion.

Agili­ty in phar­ma­covig­i­lance op­er­a­tions has nev­er been more im­por­tant than it is now as the in­dus­try works to com­bat and con­tain a high­ly con­ta­gious, dead­ly virus.

Mod­ern­ized Process­es

AI-pow­ered tech­nol­o­gy and ag­ile in­fra­struc­ture dri­ve more ef­fi­cient, ef­fec­tive process­es that have helped clin­i­cal tri­al staff, health­care providers and the pa­tients they serve through­out the COVID-19 cri­sis.

In the height of COVID-19, Parex­el’s phar­ma­covig­i­lance teams tran­si­tioned to user-friend­ly dig­i­tal in­take forms, de­vices and tablets for health care work­ers to pro­vide the im­por­tant clin­i­cal tri­al da­ta. With tri­al staff able to in­put re­spons­es in­to struc­tured, dig­i­tal for­mats, clients saved time, cut costs and im­proved re­port­ing ac­cu­ra­cy.

Re­al-World Im­pact

With the re­cent in­crease in de­mand for phar­ma­covig­i­lance ser­vices, adap­tive strate­gies and strate­gic in­vest­ments can make sig­nif­i­cant con­tri­bu­tions to cur­rent and post-pan­dem­ic clin­i­cal re­search—par­tic­u­lar­ly through mo­bile apps and da­ta analy­sis plat­forms for post-ap­proval phar­ma­covig­i­lance.

When COVID-19 vac­cines are de­liv­ered through mass im­mu­niza­tion cam­paigns, many in­di­vid­u­als will be ex­posed to the vac­cines in a short time, with lim­it­ed time for ad­verse events de­tec­tion and analy­sis. In such sit­u­a­tions, ac­tive sur­veil­lance will help ob­tain near re­al-time sur­veil­lance da­ta for all ad­verse events.

Ad­vances in tech­nol­o­gy help the in­dus­try quick­ly cap­ture sig­nal de­tec­tion of the fre­quen­cy and se­ri­ous­ness of ad­verse events. Au­to­mat­ed, da­ta-dri­ven emails are sent to iden­ti­fied re­cip­i­ents across phar­ma­covig­i­lance teams, clin­i­cal sites, health care providers and gen­er­al prac­ti­tion­ers. These dig­i­tal plat­forms will pro­vide re­al-time mon­i­tor­ing of the oc­cur­rence of ad­verse events fol­low­ing im­mu­niza­tion.

In the Unit­ed States, the COVID-19 ini­tia­tive “Op­er­a­tion Warp Speed” prompt­ed fear by virtue of its name. How­ev­er, Parex­el and oth­ers that spe­cial­ize in the sci­ence of safe­ty con­tin­ue to work tire­less­ly on be­half of vac­cine spon­sors and the pa­tients they serve. Every COVID-19 vac­cine spon­sor par­tic­i­pates in ex­ten­sive reg­u­la­to­ry re­views, thor­ough da­ta col­lec­tion and analy­sis and on­go­ing safe­ty checks con­duct­ed long af­ter vac­cines are de­ployed.

To learn more about how Parex­el can turn func­tion­al in­to trans­for­ma­tion­al through com­pre­hen­sive and scal­able so­lu­tions, vis­it Phar­ma­covig­i­lance: Help­ing Re­duce Pa­tient Risk | Parex­el.

AUTHOR

Hope Morse

Vice President, Global Safety Services, Parexel