Hy­brid Clin­i­cal Tri­als: Chang­ing the dy­nam­ic and build­ing a more ef­fi­cient tri­al ecosys­tem.

In the wake of the pan­dem­ic, the med­ical re­search com­mu­ni­ty moved quick­ly to adopt and lever­age hy­brid and de­cen­tral­ized clin­i­cal tri­als (DCT) as a modal­i­ty for keep­ing tri­als, dis­ease treat­ments and drug de­vel­op­ment pro­grams run­ning. Re­cent re­ports in­di­cate that the glob­al DCT mar­ket (in­clu­sive of the hy­brid clin­i­cal tri­al mod­el), es­ti­mat­ed at $7.71 bil­lion in 2022 is ex­pect­ed to reach $18.29 bil­lion by 2028¹. Giv­en this sig­nif­i­cant an­tic­i­pat­ed growth, it’s crit­i­cal that phar­ma­ceu­ti­cal com­pa­nies look to ad­vance their pipelines us­ing hy­brid and DCT modal­i­ties as this mar­ket con­tin­ues to in­no­vate and cre­ate com­pet­i­tive ad­van­tages for those faster to adopt.

MRN has been run­ning hy­brid, pa­tient-cen­tric tri­als for near­ly 20 years.  While the so­lu­tions we have de­vel­oped fo­cus on mak­ing tri­al par­tic­i­pa­tion eas­i­er for pa­tients and sites, there are clear and proven ad­van­tages for phar­ma­ceu­ti­cal com­pa­nies that have adopt­ed this mod­el. By re­mov­ing bar­ri­ers to par­tic­i­pa­tion and de­vel­op­ing the right mix of so­lu­tions in the com­mu­ni­ty, we have seen in­creased re­cruit­ment as high as 60-100% at some sites and re­ten­tion of pa­tients in the hy­brid mod­el at rou­tine­ly, 95%.

Re­cruit­ment and re­ten­tion of pa­tients in clin­i­cal tri­als con­tin­ues to be one of the largest and most ex­pen­sive chal­lenges for suc­cess­ful clin­i­cal tri­als and there­fore drug de­vel­op­ment. Ap­prox­i­mate­ly 18% of par­tic­i­pants drop out of tri­als. This is ex­pen­sive, with the av­er­age cost to re­cruit one pa­tient at $6,500+ and the av­er­age cost to re­cruit a new pa­tient to re­place dropouts is $19,000+.  The key routes to re­duce these cots are through both pa­tient en­gage­ment and en­sur­ing sites re­cruit pa­tients in the first place. Re­ports have in­di­cat­ed that up to 50% of sites set up to par­tic­i­pate, re­cruit one or no pa­tients in­to their tri­als^2,3.  For MRN, we have seen the most suc­cess for tri­als through adopt­ing and in­te­grat­ing 3 key pa­tient and site-cen­tric so­lu­tions; in-home vis­its for pa­tients, sup­port for re­search sites and tech­nol­o­gy built for in-home and at-site da­ta col­lec­tion.

In-Home de­liv­ery, re­mov­ing par­tic­i­pa­tion bar­ri­ers for pa­tients.

Con­duct­ing clin­i­cal tri­al vis­its at a con­ve­nient place such as home, school, or work, in­creas­es flex­i­bil­i­ty for the pa­tient, as does con­duct­ing a vis­it at a time more con­ve­nient to the pa­tient. MRN’s Home Tri­al Sup­port (HTS) so­lu­tion for sim­ple or com­plex re­search vis­its, brings clin­i­cal tri­als to those un­able or un­will­ing to par­tic­i­pate in the tra­di­tion­al tri­al mod­el at a hos­pi­tal site or clin­ic. This in­no­v­a­tive way to de­liv­er care has evolved in­to a stan­dard tool eas­i­ly uti­lized to re­duce par­tic­i­pa­tion bur­den on pa­tients, ex­pand the ge­o­graph­ic reach of sites in­to more com­mu­ni­ties, and cre­ate ac­cess to tri­als for more pa­tient pop­u­la­tions, all while main­tain­ing da­ta qual­i­ty for sites and drug de­vel­op­ers.

HTS ad­dress­es sev­er­al pa­tient chal­lenges linked to tra­di­tion­al tri­al vis­its, in­clud­ing trav­el lo­gis­tics, cost, and ex­tend­ed site vis­its, as well as po­ten­tial mo­bil­i­ty, cog­ni­tive, or oth­er dis­ease-re­lat­ed chal­lenges.  By bring­ing the tri­al to the pa­tient, HTS can re­duce par­tic­i­pa­tion bur­den and cre­ate ac­cess to tri­als sup­port­ing a more di­verse pa­tient pop­u­la­tion and al­low­ing sites to have a high­er through­put of pa­tients, help­ing them achieve high­er re­cruit­ment and en­roll­ment. An analy­sis of 318 MRN sup­port­ed pa­tients, re­vealed that the me­di­an dis­tance cov­ered was 64 miles from US tri­al sites. This dis­tance is more than three times the dis­tance pa­tients self-re­port they were will­ing to trav­el for rou­tine health care⁴. While this so­lu­tion can be stand­alone, it’s more im­pact­ful run through high­ly trained and sup­port­ed sites.

Site & Pa­tient Sup­port, re­mov­ing par­tic­i­pa­tion bar­ri­ers for sites

Re­search sites are key to suc­cess­ful pa­tient sup­port and clin­i­cal tri­al de­liv­ery. Many sites con­tin­ue to be un­der-re­sourced lead­ing to dif­fi­cul­ty de­liv­er­ing tri­als, not be­ing con­sid­ered for a tri­al, or not want­i­ng to par­tic­i­pate over­all.  The hy­brid tri­al mod­el can ad­vance the suc­cess of sites but they need the ap­pro­pri­ate sup­port.  MRN has cre­at­ed a Site Net­work fo­cused on on­board­ing and train­ing sites to be re­search ready and able to ef­fi­cient­ly run hy­brid tri­als. This glob­al net­work of sites en­com­pass­es a di­verse type of site; ex­pe­ri­enced re­searchers, tri­al naïve sites in new com­mu­ni­ties, and vir­tu­al sites, giv­ing the in­dus­try the ca­pa­bil­i­ty to re­cruit from more un­tapped com­mu­ni­ties around the world. Through MRN’s site net­work, we can iden­ti­fy ap­pro­pri­ate, trained sites to run hy­brid tri­als, staff sites when ap­pro­pri­ate and de­liv­er faster clin­i­cal tri­als through one, in­te­grat­ed tech­nol­o­gy plat­form.

Tech­nol­o­gy to in­te­grate in-home and at-site de­liv­ery

Hy­brid tri­als should be in­te­grat­ed and en­hanced by tech­nol­o­gy plat­forms and tools. The syn­er­gy be­tween in-home and at-site clin­i­cal and dig­i­tal de­liv­ery im­proves the out­comes of hy­brid clin­i­cal tri­als, in­creas­ing flex­i­bil­i­ty and ef­fi­cien­cy, while en­hanc­ing da­ta qual­i­ty. MRN eS­ource serves as an ad­vanced da­ta col­lec­tion tool, al­low­ing health­care pro­fes­sion­als to di­rect­ly cap­ture source da­ta dur­ing in-home clin­i­cal vis­its. The col­lect­ed da­ta is then val­i­dat­ed and seam­less­ly de­liv­ered in­to clients’ EDC sys­tems, en­sur­ing ac­ces­si­bil­i­ty at sites and for spon­sors and en­sur­ing a re­duc­tion in da­ta en­try er­rors. This sin­gle plat­form for in-home and at site de­liv­ery can de­ploy more DCT and dig­i­tal ca­pa­bil­i­ties such as ePRO, eCon­sent and telemed­i­cine and in­te­grate with oth­er dig­i­tal tools and de­vices cre­at­ing seam­less da­ta col­lec­tion and tri­al de­liv­ery.

Con­clu­sion

With its core fo­cus on pa­tient and site cen­tric­i­ty, the hy­brid mod­el is ex­pect­ed to per­sist, ad­dress­ing needs like pa­tient di­ver­si­fi­ca­tion, re­cruit­ment, and re­ten­tion—sig­nif­i­cant chal­lenges in tra­di­tion­al tri­al meth­ods.  MRN find 3 core syn­er­gies to cre­ate the most ef­fec­tive ecosys­tem: Tech­nol­o­gy used in the home and at the site re­duc­ing tech com­plex­i­ty and the work­load on a pa­tient, Home Tri­al Sup­port, pro­vid­ing pa­tient care in the home al­low­ing “hands on” tri­al vis­its ac­tiv­i­ties to not re­quire con­stant hos­pi­tal vis­its, and Site and Pa­tient sup­port pro­vid­ing ex­per­tise, train­ing, and re­sources, en­sur­ing sites can meet the de­mands of high­er re­cruit­ment.  To­geth­er they are more than the sum of their parts.  A hy­brid tri­al mod­el pro­fes­sion­al­ly de­liv­ered can speed up clin­i­cal tri­als, by cre­at­ing strate­gies that in­crease re­cruit­ment and re­ten­tion of pa­tients, dra­mat­i­cal­ly re­duc­ing tri­al time­lines and speed­ing up the IMP reach­ing its next de­vel­op­ment mile­stone.  MRN’s pas­sion for el­e­vat­ing pa­tient care in clin­i­cal tri­als and get­ting drugs to the mar­ket faster, in­spires us to con­tin­ue in­no­vat­ing to max­i­mize rev­enue po­ten­tial or re­duce de­vel­op­ment costs for tri­als over­all.

Con­tact our hy­brid tri­al spe­cial­ists: en­quires@them­rn.co.uk

Them­rn.io

Es­tab­lished in 2006, Med­ical Re­search Net­work is an in­no­v­a­tive mar­ket-leader of pa­tient and site-cen­tric so­lu­tions for clin­i­cal tri­al de­liv­ery. Through in­te­grat­ed in-home, at-site and dig­i­tal tri­al so­lu­tions, we al­low the med­ical re­search com­mu­ni­ty to cre­ate more flex­i­ble, ef­fi­cient and ac­ces­si­ble clin­i­cal tri­als.

MRN’s core com­pe­ten­cy lies in cre­at­ing the op­ti­mal site and pa­tient strat­e­gy to de­liv­er clin­i­cal tri­als. Stay­ing true to this mis­sion, MRN lever­ages its spe­cial­ized ex­per­tise, in­dus­try ex­pe­ri­ence, and a cre­ative ap­proach to de­liv­er nov­el so­lu­tions to drug de­vel­op­ers, health or­ga­ni­za­tions, and in­ves­ti­ga­tors, help­ing ac­cel­er­ate the drug de­vel­op­ment process, get­ting drugs to the mar­ket faster.

Sources

1. Frost & Sul­li­van Sep­tem­ber 2023 Re­port: Glob­al De­cen­tral­ized Clin­i­cal Tri­al Growth Op­por­tu­ni­ties
2. De­loitte In­sights Re­port In­tel­li­gent clin­i­cal tri­als Trans­form­ing through AI-en­abled en­gage­ment
3. Con­sid­er­a­tions For Im­prov­ing Pa­tient Re­cruit­ment In­to Clin­i­cal Tri­als. https://ver­tas­sets.blob.core.win­dows.net/down­load/64c39d7e/64c39d7e-c643-457b-aec2-9ff7b65b3ad2/rd­pre­cruit­men­t­whitepa­per.pdf
4. Do Com­mu­ni­ty Based Tri­als Ac­tu­al­ly Im­prove Pa­tient Ac­cess? https://them­rn.io/news­room/do-com­mu­ni­ty-based-tri­als-ac­tu­al­ly-im­prove-pa­tient-ac­cess/
5. Pa­tient-cen­tered clin­i­cal tri­als im­prove re­cruit­ment and re­ten­tion https://www.bio­phar­madive.com/spons/pa­tient-cen­tered-clin­i­cal-tri­als-im­prove-re­cruit­ment-and-re­ten­tion/647481/