{"id":6105,"date":"2025-04-17T15:16:51","date_gmt":"2025-04-17T19:16:51","guid":{"rendered":"https:\/\/colpittsclinical.com\/?p=6105"},"modified":"2025-04-17T15:32:16","modified_gmt":"2025-04-17T19:32:16","slug":"the-impact-of-using-travel-and-expense-providers-on-patient-retention-and-recruitment","status":"publish","type":"post","link":"https:\/\/colpittsclinical.com\/cs\/the-impact-of-using-travel-and-expense-providers-on-patient-retention-and-recruitment\/","title":{"rendered":"Dopad vyu\u017e\u00edv\u00e1n\u00ed poskytovatel\u016f cestovn\u00edch slu\u017eeb a v\u00fddaj\u016f na udr\u017een\u00ed a n\u00e1bor pacient\u016f"},"content":{"rendered":"

Dopad vyu\u017e\u00edv\u00e1n\u00ed poskytovatel\u016f cestovn\u00edch slu\u017eeb a v\u00fddaj\u016f na udr\u017een\u00ed a n\u00e1bor pacient\u016f v klinick\u00fdch studi\u00edch je novou oblast\u00ed z\u00e1jmu.
\nNa toto t\u00e9ma existuje n\u011bkolik z\u00e1sadn\u00edch studi\u00ed a zpr\u00e1v.<\/p>\n

Glob\u00e1ln\u00ed v\u00fdhled spole\u010dnosti Deloitte pro rok 2021 v oblasti v\u011bd o \u017eiv\u00e9 p\u0159\u00edrod\u011b<\/strong> zd\u016fraz\u0148uje, \u017ee finan\u010dn\u00ed a logistick\u00e1 pomoc m\u016f\u017ee v\u00fdznamn\u011b zlep\u0161it n\u00e1bor pacient\u016f do klinick\u00fdch studi\u00ed, zejm\u00e9na t\u00edm, \u017ee p\u0159il\u00e1k\u00e1 rozmanit\u011bj\u0161\u00ed demografick\u00e9 skupiny pacient\u016f.
\nPodle zpr\u00e1vy je poskytov\u00e1n\u00ed takov\u00e9 pomoci, jako je \u00fahrada cestovn\u00edch n\u00e1klad\u016f a logistick\u00e1 podpora, \u0159e\u0161en\u00edm n\u011bkolika kl\u00ed\u010dov\u00fdch p\u0159ek\u00e1\u017eek pro potenci\u00e1ln\u00ed \u00fa\u010dastn\u00edky, zejm\u00e9na pro ty, kte\u0159\u00ed poch\u00e1zej\u00ed z nedostate\u010dn\u011b zaji\u0161t\u011bn\u00fdch nebo ekonomicky znev\u00fdhodn\u011bn\u00fdch skupin obyvatelstva.<\/p>\n

Zpr\u00e1va spole\u010dnosti Deloitte zd\u016fraz\u0148uje, \u017ee nab\u00eddka cestovn\u00ed asistence a finan\u010dn\u00ed podpory je jednou z kl\u00ed\u010dov\u00fdch cest ke zlep\u0161en\u00ed n\u00e1boru t\u00edm, \u017ee zajist\u00ed \u00fa\u010dast \u0161ir\u0161\u00ed a rozmanit\u011bj\u0161\u00ed populace pacient\u016f, co\u017e povede k inkluzivn\u011bj\u0161\u00edm a reprezentativn\u011bj\u0161\u00edm v\u00fdsledk\u016fm klinick\u00fdch hodnocen\u00ed.<\/p>\n

\u201cVliv \u00fahrady n\u00e1klad\u016f pacient\u016f na n\u00e1bor a udr\u017een\u00ed pacient\u016f v klinick\u00fdch studi\u00edch\u201d (2015) Studie publikovan\u00e1 v \u010dasopise Clinical Trials<\/strong> <\/em>kter\u00e1 se zab\u00fdv\u00e1 t\u00edm, jak m\u016f\u017ee \u00fahrada cestovn\u00edch n\u00e1klad\u016f, ubytov\u00e1n\u00ed a stravov\u00e1n\u00ed ovlivnit n\u00e1bor a udr\u017een\u00ed pacient\u016f. Auto\u0159i zjistili, \u017ee pokud sponzo\u0159i studie poskytuj\u00ed finan\u010dn\u00ed podporu na tyto v\u00fddaje, doch\u00e1z\u00ed ke znateln\u00e9mu zlep\u0161en\u00ed n\u00e1boru i udr\u017een\u00ed pacient\u016f, zejm\u00e9na u pacient\u016f z ni\u017e\u0161\u00edch p\u0159\u00edjmov\u00fdch skupin nebo pacient\u016f \u017eij\u00edc\u00edch daleko od m\u00edsta studie.<\/p>\n

\u201cPosouzen\u00ed \u00falohy dopravy p\u0159i n\u00e1boru a udr\u017een\u00ed pacient\u016f v klinick\u00fdch studi\u00edch: (2020) Tato studie, zve\u0159ejn\u011bno v \u010dasopise Contemporary Clinical Trials<\/strong>, konkr\u00e9tn\u011b zkoumal roli n\u00e1klad\u016f na dopravu a vliv \u00fahrady n\u00e1klad\u016f nebo podp\u016frn\u00fdch program\u016f na rozhodov\u00e1n\u00ed pacient\u016f o za\u0159azen\u00ed a setrv\u00e1n\u00ed v klinick\u00fdch studi\u00edch. V\u00fdzkumn\u00edci dosp\u011bli k z\u00e1v\u011bru, \u017ee logistick\u00e1 podpora, jako je \u00fahrada dopravy a souvisej\u00edc\u00edch v\u00fddaj\u016f, v\u00fdznamn\u011b zvy\u0161uje m\u00edru setrv\u00e1n\u00ed v klinick\u00e9m v\u00fdzkumu, zejm\u00e9na u pacient\u016f ve venkovsk\u00fdch nebo nedostate\u010dn\u011b obsluhovan\u00fdch oblastech.<\/p>\n

\u201cEffect of patient support services on retention and recruitment in clinical trials\u201d (2021) Tato studie publikovan\u00e1 v \u010dasopise Clinical Researcher se zab\u00fdv\u00e1 r\u016fzn\u00fdmi podp\u016frn\u00fdmi slu\u017ebami, v\u010detn\u011b cestovn\u00edch, kter\u00e9 mohou zlep\u0161it n\u00e1bor a retenci pacient\u016f. Zjistila, \u017ee pokud jsou hrazeny cestovn\u00ed n\u00e1klady, pacienti se s v\u011bt\u0161\u00ed pravd\u011bpodobnost\u00ed z\u00fa\u010dastn\u00ed pl\u00e1novan\u00fdch n\u00e1v\u0161t\u011bv, co\u017e vede k vy\u0161\u0161\u00ed m\u00ed\u0159e retence a lep\u0161\u00edmu dodr\u017eov\u00e1n\u00ed protokol\u016f hodnocen\u00ed.<\/p>\n

Zpr\u00e1vy organizac\u00ed jako nap\u0159. Iniciativa pro transformaci klinick\u00fdch studi\u00ed (CTTI)<\/strong> CTTI provedla studie zam\u011b\u0159en\u00e9 na zlep\u0161en\u00ed p\u0159\u00edstupu pacient\u016f ke klinick\u00fdm studi\u00edm a jejich udr\u017een\u00ed v klinick\u00fdch studi\u00edch. N\u011bkter\u00e9 z jejich iniciativ zahrnuj\u00ed \u0159e\u0161en\u00ed finan\u010dn\u00edch a logistick\u00fdch p\u0159ek\u00e1\u017eek \u00fa\u010dasti, v\u010detn\u011b podpory cestov\u00e1n\u00ed, co\u017e prokazateln\u011b pozitivn\u011b ovliv\u0148uje n\u00e1bor a udr\u017een\u00ed pacient\u016f.<\/p>\n

Zat\u00edmco FDA<\/strong> neposkytuje v\u00fdslovn\u00e9 pokyny k propl\u00e1cen\u00ed cestovn\u00edch a jin\u00fdch v\u00fddaj\u016f pacient\u016fm v klinick\u00fdch hodnocen\u00edch, podporuje v\u0161ak sni\u017eov\u00e1n\u00ed p\u0159ek\u00e1\u017eek \u00fa\u010dasti a n\u00e1boru, v\u010detn\u011b logistick\u00fdch a finan\u010dn\u00edch. Zadavatel\u016fm se doporu\u010duje, aby zohlednili pohodl\u00ed a podporu pacient\u016f s c\u00edlem zlep\u0161it n\u00e1bor a udr\u017een\u00ed pacient\u016f, a to i prost\u0159ednictv\u00edm postup\u016f, jako je propl\u00e1cen\u00ed cestovn\u00edch n\u00e1klad\u016f.<\/p>\n

Tyto a dal\u0161\u00ed studie nazna\u010duj\u00ed, \u017ee \u00fahrada cestovn\u00edch a souvisej\u00edc\u00edch n\u00e1klad\u016f pom\u00e1h\u00e1 zm\u00edrnit jednu z kl\u00ed\u010dov\u00fdch p\u0159ek\u00e1\u017eek \u00fa\u010dasti v klinick\u00e9m hodnocen\u00ed, co\u017e vede k lep\u0161\u00edmu n\u00e1boru a udr\u017een\u00ed pacient\u016f.<\/p>\n

Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) nem\u00e1 \u017e\u00e1dn\u00e9 zvl\u00e1\u0161tn\u00ed p\u0159edpisy, kter\u00e9 by se t\u00fdkaly v\u00fdhradn\u011b propl\u00e1cen\u00ed cestovn\u00edch v\u00fddaj\u016f pacient\u016f v klinick\u00fdch studi\u00edch. \u00da\u0159ad FDA v\u0161ak uzn\u00e1v\u00e1, \u017ee je d\u016fle\u017eit\u00e9 sni\u017eovat p\u0159ek\u00e1\u017eky br\u00e1n\u00edc\u00ed \u00fa\u010dasti a podporovat n\u00e1bor a udr\u017een\u00ed pacient\u016f v klinick\u00fdch studi\u00edch, zejm\u00e9na u skupin obyvatelstva, kter\u00fdm nen\u00ed poskytov\u00e1na dostate\u010dn\u00e1 p\u00e9\u010de. To zahrnuje \u0159e\u0161en\u00ed logistick\u00fdch a finan\u010dn\u00edch p\u0159ek\u00e1\u017eek, jako jsou cestovn\u00ed n\u00e1klady.<\/p>\n

Zde je n\u011bkolik kl\u00ed\u010dov\u00fdch bod\u016f, kter\u00fdch se FDA a souvisej\u00edc\u00ed pokyny t\u00fdkaj\u00ed:<\/strong><\/span><\/h2>\n

Pokyny FDA k n\u00e1boru a udr\u017een\u00ed pacient\u016f<\/strong><\/span><\/h2>\n

\u00da\u0159ad FDA vyz\u00fdv\u00e1 zadavatele, aby p\u0159ijali opat\u0159en\u00ed, kter\u00e1 zlep\u0161\u00ed n\u00e1bor a udr\u017een\u00ed pacient\u016f v klinick\u00fdch studi\u00edch, a uzn\u00e1v\u00e1, \u017ee \u00fa\u010dast pacient\u016f je pro \u00fasp\u011bch klinick\u00e9ho v\u00fdzkumu z\u00e1sadn\u00ed. \u201cPokyny pro pr\u016fmysl\u201d \u00fa\u0159adu FDA: E6(R2) Spr\u00e1vn\u00e1 klinick\u00e1 praxe: R1\" obsahuje obecn\u00e1 doporu\u010den\u00ed t\u00fdkaj\u00edc\u00ed se dobr\u00fdch \u017eivotn\u00edch podm\u00ednek pacient\u016f, jako je minimalizace rizik spojen\u00fdch s \u00fa\u010dast\u00ed, kter\u00e1 mohou zahrnovat logistick\u00e9 p\u0159ek\u00e1\u017eky, jako je nap\u0159\u00edklad cestov\u00e1n\u00ed.
\nZd\u016fraz\u0148uje v\u0161ak, \u017ee n\u00e1vrhy studi\u00ed by m\u011bly zohled\u0148ovat pohodl\u00ed \u00fa\u010dastn\u00edk\u016f, minimalizovat nepohodl\u00ed a poskytovat pacient\u016fm odpov\u00eddaj\u00edc\u00ed podporu.<\/p>\n

Cestovn\u00ed a finan\u010dn\u00ed podpora v klinick\u00fdch studi\u00edch<\/span><\/h2>\n

\u00da\u0159ad FDA nestanov\u00ed konkr\u00e9tn\u00ed pravidla pro \u00fahradu cestovn\u00edch n\u00e1klad\u016f, ale finan\u010dn\u00ed pob\u00eddky a \u00fahrada n\u00e1klad\u016f, kter\u00e9 vznikly z vlastn\u00ed kapsy, jako je nap\u0159\u00edklad cestovn\u00e9, se v klinick\u00fdch hodnocen\u00edch b\u011b\u017en\u011b pou\u017e\u00edvaj\u00ed. Na\u0159\u00edzen\u00ed FDA \u201cZve\u0159ej\u0148ov\u00e1n\u00ed finan\u010dn\u00edch informac\u00ed klinick\u00fdmi zkou\u0161ej\u00edc\u00edmi\u201d (21 CFR, \u010d\u00e1st 54) na\u0159izuje transparentnost v oblasti finan\u010dn\u00edch st\u0159et\u016f z\u00e1jm\u016f, ale nezakazuje propl\u00e1cen\u00ed cestovn\u00edch nebo jin\u00fdch souvisej\u00edc\u00edch v\u00fddaj\u016f. Poskytov\u00e1n\u00ed n\u00e1hrad je ve skute\u010dnosti pova\u017eov\u00e1no za \u00fa\u010dinn\u00fd zp\u016fsob, jak zlep\u0161it udr\u017een\u00ed pracovn\u00edk\u016f, nesm\u00ed v\u0161ak vytv\u00e1\u0159et nep\u0159im\u011b\u0159en\u00fd n\u00e1tlak.<\/p>\n

Etick\u00e9 aspekty a p\u0159\u00edstup<\/span><\/h2>\n

\u00da\u0159ad FDA uzn\u00e1v\u00e1, \u017ee pro zlep\u0161en\u00ed p\u0159\u00edstupu ke klinick\u00fdm zkou\u0161k\u00e1m m\u016f\u017ee b\u00fdt nezbytn\u00e9 poskytnout kompenzaci a uhradit n\u00e1klady, zejm\u00e9na pro \u00fa\u010dastn\u00edky, kte\u0159\u00ed se pot\u00fdkaj\u00ed s p\u0159ek\u00e1\u017ekami, jako je doprava. V iniciativ\u011b \u201cFDA Patient-Focused Drug Development\u201d (V\u00fdvoj l\u00e9k\u016f zam\u011b\u0159en\u00fd na pacienty) vyz\u00fdv\u00e1 FDA zadavatele klinick\u00fdch hodnocen\u00ed, aby zohlednili r\u016fzn\u00e9 skupiny pacient\u016f a zavedli strategie, v\u010detn\u011b finan\u010dn\u00ed a logistick\u00e9 podpory, k zaji\u0161t\u011bn\u00ed \u0161irok\u00e9ho p\u0159\u00edstupu.<\/p>\n

Iniciativy zam\u011b\u0159en\u00e9 na pacienty a nov\u00e9 p\u0159edpisy<\/span><\/h2>\n

\u00da\u0159ad FDA je tak\u00e9 sou\u010d\u00e1st\u00ed \u0161ir\u0161\u00edch iniciativ zam\u011b\u0159en\u00fdch na to, aby se klinick\u00e9 studie v\u00edce zam\u011b\u0159ovaly na pacienty. To zahrnuje snahu o pou\u017e\u00edv\u00e1n\u00ed flexibiln\u011bj\u0161\u00edch n\u00e1vrh\u016f klinick\u00fdch hodnocen\u00ed a zohledn\u011bn\u00ed toho, jak mohou logistick\u00e9 faktory, v\u010detn\u011b cestov\u00e1n\u00ed, ovlivnit \u00fa\u010dast pacient\u016f. Nap\u0159\u00edklad iniciativa FDA Real-World Evidence (RWE) podporuje vyu\u017e\u00edv\u00e1n\u00ed \u00fadaj\u016f z re\u00e1ln\u00e9ho sv\u011bta jako dopl\u0148ku klinick\u00fdch hodnocen\u00ed, co\u017e m\u016f\u017ee pomoci sn\u00ed\u017eit pot\u0159ebu pacient\u016f cestovat do m\u00edst hodnocen\u00ed na velk\u00e9 vzd\u00e1lenosti.<\/p>\n

Konkr\u00e9tn\u00ed a pou\u017eiteln\u00e9 pokyny mohou zadavatel\u00e9 hledat u jin\u00fdch agentur, jako jsou N\u00e1rodn\u00ed \u00fastavy zdrav\u00ed (NIH) nebo organizace pro klinick\u00fd v\u00fdzkum (CRO), kter\u00e9 tyto postupy \u010dasto zahrnuj\u00ed do protokol\u016f o zkou\u0161k\u00e1ch.<\/p>","protected":false},"excerpt":{"rendered":"

The impact of using travel and expense providers on patient retention and recruitment in clinical trials is an emerging area of interest There are some key studies and reports on this topic. 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