“CRO in­dus­try is well po­si­tioned to thrive in Asia”

BioSpectrum (Asia) - - BIO CONTENT - Ma­ree Ward, Se­nior Di­rec­tor, APAC, PRA Health Sciences and Jonathan New­ton, Ex­ec­u­tive Di­rec­tor, EAPA, PRA Health Sciences

At more than 4 bil­lion peo­ple, the Asian pop­u­la­tion ac­counts for more than 60 per cent of the world pop­u­la­tion and car­ries an in­creas­ing dis­ease bur­den in car­dio­vas­cu­lar dis­ease, can­cers and Type II di­a­betes.

These pa­tient pop­u­la­tions were pre­vi­ously chal­leng­ing to reach; ex­pan­sion into the Asian mar­ket will give com­pa­nies greater ac­cess. Now the gov­ern­ments are be­com­ing more aware of the eco­nomic ben­e­fit and pos­i­tive health­care im­pact a grow­ing clin­i­cal re­search in­dus­try can have. This ex­pan­sion of tri­als has re­sulted in con­tin­ued growth for the CRO mar­ket in the re­gion.

As the num­ber of clin­i­cal tri­als in­creases glob­ally, the need for Asia as a re­gion for clin­i­cal trial con­duct and sites also con­tin­ues to grow cre­at­ing an in­ten­sively com­pet­i­tive trial land­scape. There has been di­ver­si­fi­ca­tion among spon­sor com­pa­nies to file new drug ap­pli­ca­tions in the Asian mar­kets, re­quir­ing lo­cal tri­als and pa­tients. In par­al­lel, the gov­ern­ments are be­com­ing more aware of the eco­nomic ben­e­fit and pos­i­tive health­care im­pact a grow­ing clin­i­cal re­search in­dus­try can have. This ex­pan­sion of tri­als has re­sulted in con­tin­ued growth for the CRO mar­ket in the re­gion.

At more than 4 bil­lion peo­ple, the Asian pop­u­la­tion ac­counts for more than 60 per cent of the world pop­u­la­tion and car­ries an in­creas­ing dis­ease bur­den in car­dio­vas­cu­lar dis­ease, can­cers and Type II di­a­betes. These pa­tient pop­u­la­tions were pre­vi­ously chal­leng­ing to reach; ex­pan­sion into the Asian mar­ket will give com­pa­nies greater ac­cess.

The Asian mar­ket has a rep­u­ta­tion for hav­ing com­plex health­care sys­tems with a less uni­form ap­proach than the Euro­pean Direc­tive. Tra­di­tion­ally, one of the big­gest chal­lenges has been the vari­abil­ity in what is de­fined as a “healthy” nor­mal, cul­ture and health­care in­fras­truc­ture. How­ever, this is chang­ing. Tech­nol­ogy driven coun­tries such as Ja­pan and South Korea are pair­ing with ef­fi­ciency driven coun­tries like China and fac­tor driven coun­tries like In­dia, and to­gether they are mak­ing progress in de­vel­op­ing strate­gies that can over­come drug de­vel­op­ment hur­dles in the re­gion, par­tic­u­larly now that the mar­ket is open to mak­ing changes. Col­lec­tively, there has been a fo­cus on sim­pli­fy­ing reg­u­la­tory ap­proval pro­cesses, in­creas­ing gov­ern­ment sup­port, and im­prov­ing clin­i­cal trial in­dus­try in­fras­truc­ture.

The most sig­nif­i­cant growth in Asia’s CRO land­scape can be seen in China. With a pop­u­la­tion of nearly 1.4 bil­lion, and changes un­der­way in their reg­u­la­tory en­vi­ron­ment, the drug de­vel­op­ment in­dus­try is see­ing a long-an­tic­i­pated growth curve tak­ing shape. In an­tic­i­pa­tion of an in­crease in clin­i­cal trial work, there has been some move­ment

of spon­sors set­ting up hubs in Bei­jing and mak­ing in­vest­ment in the de­vel­op­ment of the Chi­nese clin­i­cal trial en­vi­ron­ment.

In line with many other Asian coun­tries, the reg­u­la­tory en­vi­ron­ment in China is un­der­go­ing changes which will re­sult in changes to the trial ap­proval process, most no­tably, a re­duced reg­u­la­tory time­line to 60 days to run in par­al­lel to ethics sub­mis­sions, in­creased site selec­tion flex­i­bil­ity, and the abil­ity to uti­lize for­eign data. This will im­prove the trial en­vi­ron­ment by mak­ing it sim­pler and less time con­sum­ing.

If China Food and Drug Ad­min­is­tra­tion (CFDA) reg­u­la­tory re­forms are en­acted, China rep­re­sents one of the largest po­ten­tial growth re­gions for clin­i­cal tri­als and the CRO mar­ket in the next five years. The ac­cess to large num­bers of pa­tients, both dis­ease spe­cific and treat­ment naïve, in ur­ban set­tings will con­tinue to make China at­trac­tive for tri­als. How­ever, Good Clin­i­cal Prac­tice (GCP) and qual­ity chal­lenges can be an is­sue at trial sites with lim­ited trial ex­pe­ri­ence. There­fore, the use of Site Man­age­ment Or­ga­ni­za­tions (SMOs) and the pro­vi­sion of GCP train­ing and site sup­port will be crit­i­cal to en­sure high qual­ity data is pro­duced at these sites. In ad­di­tion to CRO growth in the coun­try, SMO growth will also be re­quired to meet these needs.

From a re­sourc­ing per­spec­tive, Tai­wan and Hong Kong will likely ben­e­fit from growth in China since both lo­ca­tions have demon­strated strong qual­ity and tal­ent. CROs will view both as a po­ten­tial op­tion to sup­port train­ing, mon­i­tor­ing sup­port, lead­er­ship, etc.

In Ja­pan, the clin­i­cal trial mar­ket is fac­ing con­sid­er­able chal­lenges due to a lack of avail­able, ex­pe­ri­enced, clin­i­cal trial re­sources. The rapid ex­pan­sion of tri­als in Ja­pan has put sig­nif­i­cant pres­sure on the labour mar­ket that sup­ports these tri­als. Lim­ited avail­abil­ity of ex­pe­ri­enced, Ja­panese speak­ing clin­i­cal and med­i­cal staff for di­rect site in­ter­ac­tions, cou­pled with an out­dated re­sourc­ing model by lo­cal CROs, has made re­li­able and con­sis­tent staffing a bot­tle­neck for some providers in the coun­try.

How­ever, there con­tinue to be col­lab­o­ra­tions be­tween reg­u­la­tory au­thor­i­ties in Ja­pan and other coun­tries in the re­gion to ac­cept early clin­i­cal sup­port­ive data as jus­ti­fi­ca­tion for Phar­ma­ceu­ti­cals and Med­i­cal De­vices Agency (PMDA) ap­pli­ca­tions. The abil­ity to share safety data be­tween coun­tries such as China, Tai­wan, Ja­pan and Korea may help stream­line clin­i­cal trial ap­pli­ca­tions as well as mar­ket­ing ap­pli­ca­tions in Ja­pan. Both the lim­i­ta­tions in avail­able staff and the in­crease in de­mand for trial sites in Ja­pan present growth op­por­tu­ni­ties in the coun­try for global CRO mar­ket ex­pan­sion.

Cur­rently, ap­prox­i­mately 1.4 per cent of global clin­i­cal tri­als are con­ducted in In­dia; the coun­try has a pop­u­la­tion of 1.3 bil­lion and car­ries ap­prox­i­mately 20 per cent dis­ease bur­den in the world. This low per­cent­age is the re­sult of a pre­vi­ously un­sta­ble clin­i­cal trial en­vi­ron­ment.

The num­ber of tri­als run­ning in In­dia peaked with clin­i­cal trial ap­pli­ca­tions in 2010 how­ever, changes to clin­i­cal trial reg­u­la­tion, and a lack of sta­bil­ity within In­dia, re­sulted in a sig­nif­i­cant de­crease in trial ac­tiv­ity. To­day the num­ber of clin­i­cal tri­als in In­dia has been steadily in­creas­ing and is ex­pected to con­tinue to grow in 2018-19 as a re­sult of clin­i­cal trial reg­u­la­tory changes that are help­ing them be­come more se­cure and pre­dictable. The reg­u­la­tory process has elim­i­nated the three-tier ap­proval sys­tem and now re­quires only a sin­gle ap­proval fol­low­ing an elec­tronic ap­pli­ca­tion, re­sult­ing in faster time­lines and there­fore faster ac­cess to pa­tients.

South Korea con­tin­ues to be a coun­try of choice to con­duct clin­i­cal tri­als. It has seen steady growth in the num­ber of tri­als reg­is­tered largely due to the coun­try’s so­phis­ti­cated in­fras­truc­ture, high level med­i­cal care, and ac­cess to ex­pe­ri­enced staff. Korea has con­ducted more tri­als than any other Asian coun­try in the last five years and has ranked in the top 10 coun­tries in the world since 2011.

Sin­ga­pore also con­tin­ues to be a high-qual­ity

coun­try for clin­i­cal re­search. While there is sig­nif­i­cant in­vest­ment and in­fras­truc­ture to sup­port clin­i­cal tri­als, par­tic­i­pa­tion re­mains lim­ited due to its size.

The re­main­ing South­east Asian coun­tries, (Malaysia, the Philip­pines, Cam­bo­dia, Viet­nam, Myana­mar, Thai­land, Laos, the In­done­sia, Sri Lanka and Bangladesh) all rep­re­sent a small num­ber of ac­tive clin­i­cal trial sites. How­ever, with re­spect to pop­u­la­tions and ac­cess to treat naïve pa­tients, as well as cer­tain ther­a­peu­tic in­di­ca­tions (trop­i­cal dis­ease, in­fec­tious dis­ease, cer­tain can­cers), these coun­tries present ex­cel­lent growth op­por­tu­ni­ties for CROs.

The chal­lenge re­mains in­fras­truc­ture, and ac­cess to well-trained clin­i­cal sites and staff. In many of these coun­tries, the clin­i­cal trial mod­els are still rel­a­tively new, and thus ac­cess to tal­ent for CROs for hir­ing ex­pe­ri­enced, GCP trained staff can be dif­fi­cult. Malaysia, Thai­land, and the Philip­pines rep­re­sent the best op­tion for most in­di­ca­tions, but Viet­nam is also at­tract­ing some in­ter­est.

In the last few years we have seen the in­tro­duc­tion of adap­tive mon­i­tor­ing across the globe, the big­gest change to the in­dus­try since e case re­port forms (eCRFs) came into play. There have been large in­vest­ments in tech­nol­ogy around Adap­tive Mon­i­tor­ing but im­ple­men­ta­tion across Asia has been chal­leng­ing. While there have been enor­mous steps for­ward in im­prov­ing the speed of clin­i­cal tri­als and the way each coun­try em­braces tri­als, this new way of man­ag­ing them has re­quired new so­lu­tions to en­sure smooth im­ple­men­ta­tion and ad­her­ence to lo­cal ethics re­quire­ments. These chal­lenges will con­tinue through the next few years as the in­dus­try adapts.

A key op­por­tu­nity for APAC is to em­brace tech­nol­ogy at the client, site, CRO, and pa­tient level. Every­one should be con­sid­er­ing how tech­nol­ogy can as­sist with faster drug de­vel­op­ment. Pa­tients are con­sumers and we need to of­fer them ways to ac­cess these tri­als in an eas­ier way, tech­nol­ogy can help us to do that. In ev­ery trial we see sites which fail to re­cruit pa­tients. This is a waste of time and money. There has also been a lazy ap­proach to pa­tient re­cruit­ment where we wait for pa­tients to ap­proach us to en­roll in a trial. There is op­por­tu­nity to use data to help with pa­tient re­cruit­ment, re­ten­tion, site selec­tion, the abil­ity to eval­u­ate trends with ad­verse events, etc.

In the US, data is more eas­ily ac­ces­si­ble. In

APAC, we need to look for ways to ac­cess or uti­lize data such as pa­tient claims and out­come data, so­cial lis­ten­ing, in­ter­nal data­bases, li­cens­ing, or pur­chase data from ex­ter­nal sources, me­dia out­reach, study web­sites, ed­u­ca­tional videos/as­sets, mo­bile plat­forms, wear­ables, EDC in­te­gra­tion, etc. This will en­able us to se­lect the best sites, proac­tively en­gage pa­tients to par­tic­i­pate in re­search, col­lect data in real time, and re­tain those sub­jects through­out the trial life­cy­cle. Along with the usual sys­tems like clin­i­cal trial man­age­ment sys­tem (CTMS)/ in­ter­ac­tive web re­sponse sys­tem (IWRS), dash­boards would pro­vide a clear over­view of study progress, re­view cur­rent and past re­cruit­ment rates, and train­ing. The use of ar­ti­fi­cial in­tel­li­gence/ro­bot­ics would re­duce tasks on staff and should be more com­mon­place within CROs.

Vir­tual tri­als and mo­bile plat­forms are a vi­able op­tion for many tri­als and an op­por­tu­nity in APAC to make the pa­tient ex­pe­ri­ence more re­ward­ing. In­te­grated health data and an­a­lyt­ics de­liv­ered as cloud-based so­lu­tions demon­strate a more ag­ile, flex­i­ble and adap­tive fu­ture of clin­i­cal de­vel­op­ment. CROs need to use tech­nol­ogy to pro­vide deep, datadriven in­sights to op­ti­mize global clin­i­cal stud­ies and drug com­mer­cial­iza­tion from con­cept to com­pound to cure. Vir­tu­ally con­nect­ing pa­tients who are be­yond the clin­i­cal set­ting through Blue­tooth wear­ables and con­nected home de­vices re­duces par­tic­i­pa­tion bur­den and fos­ters pa­tient en­gage­ment through­out the con­tin­uum of care, while also sup­port­ing the col­lec­tion of bil­lions of data end­points.

The CRO in­dus­try is well po­si­tioned to thrive in the Asian mar­ket, with some pos­i­tive mo­men­tum al­ready be­ing seen in many of the coun­tries to wel­come clin­i­cal tri­als. It is this di­ver­sity and com­plex­ity that cre­ates a great op­por­tu­nity for

CROs to pro­vide sub­ject mat­ter ex­per­tise to spon­sor com­pa­nies to help guide them in suc­cess­fully con­duct­ing clin­i­cal re­search in Asia.





Ma­ree Ward, Se­nior Di­rec­tor, APAC, PRA Health Sciences and JonathanNew­ton, Ex­ec­u­tive Di­rec­tor, EAPA, PRA Health Sciences

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