6 key clin­i­cal tri­al trends that we should em­brace and build on

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When peni­cillin was dis­cov­ered in 1928 by Alexan­der Flem­ing, the av­er­age clin­i­cal tri­al time was 12 years. In 2021, the av­er­age in­dus­try tri­al time is 10 years, an im­prove­ment of on­ly 2 years. In al­most a cen­tu­ry, there have been no ad­vance­ments that have de­liv­ered a sub­stan­tial change to how clin­i­cal tri­als are con­duct­ed.

While the Covid-19 pan­dem­ic it­self had a dev­as­tat­ing im­pact on tri­als around the world, the dis­rup­tion it caused al­so car­ries with it the chance for in­no­va­tion. The ur­gency and ac­cel­er­a­tion to adopt new ways of work­ing caused by the pan­dem­ic is al­so an op­por­tu­ni­ty. By main­tain­ing the in­no­va­tion mind­set that ini­tial­ly came from ne­ces­si­ty, the in­dus­try can dri­ve durable, sus­tain­able in­no­va­tion with the po­ten­tial to trans­form the clin­i­cal de­vel­op­ment mod­el. Here are 6 key trends that we should em­brace and build on mov­ing for­ward.

The first key trend that should pre­vail is a mind­set of not “just in time,” but “just in case.” By proac­tive­ly think­ing about what might go wrong and build­ing “dis­rup­tion-proof­ing” steps in­to tri­al pro­to­cols from the very start, teams can piv­ot more quick­ly, min­i­miz­ing in­ter­rup­tions for staff, in­ves­ti­ga­tors, and most im­por­tant­ly, peo­ple par­tic­i­pat­ing in the clin­i­cal tri­al.

Sec­ond­ly, the pan­dem­ic forced the in­dus­try to quick­ly move as much of our busi­ness to vir­tu­al as pos­si­ble, with teams con­duct­ing site vis­its and in­ves­ti­ga­tor en­gage­ment re­mote­ly. Even as reg­u­la­tions ease, we are see­ing that sites, in­ves­ti­ga­tors and pa­tients are all em­brac­ing vir­tu­al as the new norm. In­dus­try should fol­low suit and con­tin­ue to in­clude ac­tiv­i­ties such as re­mote mon­i­tor­ing and dig­i­tal pa­tient so­lu­tions in­to tri­als where ap­pro­pri­ate.

Em­brac­ing vir­tu­al so­lu­tions will al­so help sup­port the third key trend – home is the new tri­al site. With many sites be­com­ing Covid treat­ment cen­ters, it be­came both dif­fi­cult and po­ten­tial­ly dan­ger­ous for some clin­i­cal tri­al pa­tients to go to the hos­pi­tal. Im­ple­ment­ing tac­tics around this trend, teams worked to set up so­lu­tions such as in-home nurs­ing pro­grams or di­rect to pa­tient ship­ments of their study med­ica­tion. These are op­tions that pa­tients may pre­fer, re­gard­less of re­stric­tions, and many tri­al sites have now ex­pand­ed their ca­pa­bil­i­ties to ac­com­mo­date these ser­vices. There­fore, we need to pri­or­i­tize build­ing as­sess­ment of de­cen­tral­ized clin­i­cal tri­al el­e­ments, such as home nurs­ing, di­rect to pa­tient drug de­liv­ery or telemed­i­cine op­tions, in­to tri­al pro­to­cols.

That com­mit­ment to pa­tient pref­er­ences leads to the next trend – the rise of the pa­tient as a con­sumer. Dur­ing Covid, in­dus­try and var­i­ous teams worked at an al­most in­di­vid­ual lev­el to en­sure every clin­i­cal tri­al pa­tient had ac­cess to their treat­ment. Why should this end? The needs of each pa­tient are unique and it is up to us as re­searchers to de­vel­op flex­i­ble tri­al en­gage­ment op­tions that re­duce their bur­den. In fact, based on the changes im­ple­ment­ed dur­ing the pan­dem­ic, pa­tients have the right to ex­pect that tri­als can be struc­tured to suit them, ver­sus adapt­ing their life to the tri­al. We be­lieve the so­lu­tions, process­es and tech­nol­o­gy that were put in place dur­ing the pan­dem­ic set a strong foun­da­tion of pa­tient-cen­tric­i­ty that all can con­tin­ue to build up­on.

The key un­der­ly­ing com­po­nent that en­abled teams to lead in the ar­eas above is tech­nol­o­gy. Pri­or to Covid, clin­i­cal tri­als were a large­ly man­u­al op­er­a­tion, re­quir­ing peo­ple to vis­it hos­pi­tals and sites. The sit­u­a­tion man­dat­ed that com­pa­nies em­brace in­no­v­a­tive so­lu­tions, in­clud­ing tech­nolo­gies that en­abled re­mote mon­i­tor­ing and vir­tu­al­iza­tion. Adopt­ing these new tech­nolo­gies en­sured that com­pa­nies and teams could re­main ag­ile and sus­tain en­gage­ment with sites and pa­tients to keep tri­als pro­gress­ing while en­sur­ing tri­al and da­ta in­tegri­ty. There­fore, the fifth key trend is the ev­i­dence that tech­nol­o­gy en­ables re­silience dur­ing dis­rup­tions.

As de­scribed above, the pace of the pan­dem­ic caused phar­ma­ceu­ti­cal com­pa­nies to very quick­ly make de­ci­sions and put so­lu­tions in place. In fact, as an in­dus­try we did not wait for guid­ance and in­stead fo­cused on do­ing what was right for our pa­tients, sites and in­ves­ti­ga­tors. By forg­ing ahead and do­ing what was need­ed, the prac­tices that we put in place were then fol­lowed and for­mal­ized by pol­i­cy. This achieve­ment il­lus­trates the sixth and last key trend: let prac­tice in­form pol­i­cy ver­sus pol­i­cy dic­tat­ing prac­tice. Col­lec­tive­ly, we demon­strat­ed to pol­i­cy mak­ers that we can lead and bring for­ward the right ap­proach­es, shift­ing our role from wait­ing for pol­i­cy to shap­ing pol­i­cy.

For the first time in al­most a cen­tu­ry, we have the op­por­tu­ni­ty to change the clin­i­cal de­vel­op­ment mod­el. While each of these trends has po­ten­tial on its own, by em­brac­ing them to­geth­er we can cre­ate durable and sus­tain­able change. For ex­am­ple, com­pa­nies con­duct­ing tri­als for Covid saw the time it took for each stage of the tri­al – start-up, ex­e­cu­tion and close-out – re­duced by as much as 10-fold. This is proof of what can be achieved. It is up to us to seize this mo­ment where, as an in­dus­try, we can trans­form how clin­i­cal tri­als are con­duct­ed.

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