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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In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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