Chimica Oggi - Chemistry Today November/December vol 32 n Stella Stergiopoulos, Leon Surgeon

Transcription

1 ISSN X CHOGDS Innn Jun f Csms, Dmgy, Hm C nd I&I REPRINT uhs: Chm Ogg - Chmsy Tdy Nvmb/Dmb v 32 n S Sgpus, Ln Sugn f h : : w v R P T n C d? Th F P d G n u p g n b y h Is h

2 PHARMA CONTRACT SERVICES STELLA STERGIOPOULOS*, LEON SURGEON Cspndng uh* 1. Tufs Cn f h Sudy f Dug Dvpmn 75 Knnd S S 1100 Bsn, MA USA 2. Mdd Suns 350 Hudsn S, F 8, Nw Yk, NY S Sgpus Ln Sugn Th Fd Cn T P Rvw: Is h hy bng pu n Gd P? KEYWORDS: P dsgn, Fd vw, P mpxy, P mndmns, P fsby, Cn dsgn Smnng nd pmzng ps s ky sgy mpvng h ffvnss f n s. In Absy 2013, h Tufs Cn f h Sudy f Dug Dvpmn (CSDD) mpd n n sudy wh 10 mj phmu mpns ssss h gvnn mhnsms n p f mngng h p smnng pss. Th sm y, Mdd Suns bd wh Tufs CSDD nd ndud fw-up sudy b undsnd h ndusywd dpn f pu gvnn mhnsm: fd n p vw (fd vw) mngs. Rsus ndd h g png f phmu nd bhngy mpns hv mpmnd hs p nd hv sn mpvmns n ky n pfmn ms: dn n h numb f mndmns nd ds n p mpxy. Hwv, h mjy f spndns hv nd h mngs smwh ffv, suggsng h hugh fd vws hv psvy mpd n ms, h s s m f mpvmn n h fd vw pss mk mngs m ffv. Suggsns f m ffv mngs nud nng mng fs nd hvng fw mngs wh m d nyss ndud nd dsussd. INTRODUCTION Lf sn mpns hv vy bn shng nd dvpng psss du p mpxy, ns ffny nd mpv fsby w dug dvpmn ss. Esnsn sbshd n xp pn dnfy ffny-nhnng ps. On mmndn ws dsgn s h f n p wkfw, (1).., n ps h n m mpx hn un sndd f (2). C bd hs fndngs n h sudy, nng h ICU nuss n vg hs ss mpx nsun p f s ffny n mnnng bd gus vs whn skd s bwn ss mpx nd m mpx p. In h sudy, sm numb f pns xpnd hypgym psds fwng h ss mpx p mpd hs fwng h m mpx p (3). A gwng bdy f u ss hpu s s suggss h n mpxy s b bh physn nd pn ppn (4-6). Mv, nsng sudy mpxy hs bn ssd wh ds n v dug suss s nd p d quy (7-9). Sn 2008, Tufs CSDD hs pvdd ndsp nyss f v n p dsgn, ngng fm sudy mpxy (10-13) h ndn nd uss f p mndmns (14-16). Tufs CSDD suds shw h p mpxy hs nsd pdy dung h ps dd, wh nng h h sm m n pfmn nd ffny hv wsnd. In ddn n ns n guy nd mpn budns, sudy y ms nd ss hv nsd. Ths s n p du ps bng dsgnd by n ms whu h npu fm skhds nvvd n n xun. Ths p nvby ds nffns n h pss, nghnng h m ks mp sudy nd sgnfny nsng sudy s. On sudy dsgn h hs gwn shpy s h ns n h numb f y nd xpy ndpns, nd h pdus qud supp hm (17). Th Tufs CSDD sudy shwd h n vg, 22.3 pn f pdus supp y nd xpy pdus (vs h dn mp sudy s ky bjvs), whh muns 17.9 pn f h d sudy budg. In gh f hs gwng bdy f knwdg (nd h mp f mpx p dsgns n n pfmn nd s), phmu nd bhngy mpns hv dpd nw ps nd nn mhnsms hng sudy dsgn fsby nd y nd xpy dsgn ps. In 2013, Tufs CSDD nvwd 10 sn phmu xuvs whs mpns w pnng nw fd n p vw (fd vw) mms skd wh hngng sudy dsgn fsby (18). Ths mms hd mngs, n whh h spns bngs gh ss-funn dpmn psnvs wh nvvd n h dug dvpmn pss hughy nyz h p bng dvpd. 52 Chm Ogg - Chmsy Tdy - v. 32(6) Nvmb/Dmb 2014

3 Es nffns h fund nd d v hs mhnsm hv pvdd mndus dwnsm bnfs. Invws p h hs vw mms hv sussfuy smnd p dsgn nd wd n budgs. Ths quv sudy, hwv, sd nd fdbk fm 12 xuvs nd hus my n b gnzb h ndusy s wh (19). In spns, Tufs CSDD bd wh Mdd Suns b undsnd fd vw mms nd h hy py n h p dsgn pss. Th sudy s md xmn h p dsgn pss f gnzns h dd n ndu fd vw mngs. METHODOLOGY Fgu 1. Suvy Rspndn Pf nd Dmgphs Mdd nd Tufs CSDD ndud suvy mng phmu nd bhngy pfssns bwn Juy 2013 nd md-augus Hsd n Suvymnky.m, h suvy nnd 23 qusns, 15 f whh w nswd by ndvdus whs mpns hv p fd vw mms n p, h f whh w nswd by ndvdus whs mpns d n hv fd vw mms n p nd fv f whh w nswd by ps. Suvy qusns psd spndns nudd pfssn dmgph qusns: mpny nd funn, mpny yp (phmu, bhngy, md dvs nd n sh gnzn (CRO)), numb f ps p y h mpny gns nd whh h gnzn hs mpmnd p fd vw mm pss. Suvy qusns psd hs whs mpns pk n fd vws nudd qusns n hw h pss hs bn pnzd (dpmns nvvd, mng ms nd nghs, mng fs), s w s hw ng h pss hs bn n p. Indvdus w s skd bu h bnfs f h vw pss. N spndns nswd qusns h w psd. Appndx Fgu On nns s f qusns nd h numb f spndns wh nswd. Tufs CSDD nd Mdd hd u pn spndns usng n ss n ddn dvsng h suvy n LnkdIn, Fbk nd Tw. Advsmns w s sd n h CnWh wbs s w s n Mdd s wbs. T s ns, pn spndns w nd n gf d dwng. Suvy spndns mnd nnymus unss hy w nsd n vng gf d. Thus, spndn mpny nm ws n pud, mpyng h mup spndns my wk f h sm mpny. Rgdss, spndn d hs bn ddnfd nd s pd n h ggg. RESULTS Fgu 1 ss suvy spndns dmgphs by psn n h gnzn, gnzn sz nd gnzn xpn wh fd vw psss. A f 83 ndvdus ppd n h suvy, wh 33 spndns n d-v psns (ngng fm ss d xuv d). 54 pn f spndns (45 f 83) w mpyd by phmu mpns, wh 17 pn (14 f 83) w mpyd by bhngy mpns. 71 pn f spndns n h h mpns pdu ss hn 51 ps p y, wh h mjy f spndns n h gup mng fm mpns h pdu bwn 1-10 ps nnuy. 73 pn f spndns (61 f 83) hv psss mngs n p f p fd vw, wh 27 pn (22 f 83) d n. Gs, pvy, v mp nd ffvnss f fd vws Of 38 spndns, 28 spndns mpns hv hd fd vw mhnsm n p f fv ys ng. Th mjy f spndns (39 f 43) s n h fd vw sssns mndy. Dung suh mngs, 37 u f 44 spndns mnnd h wng h sk f h sudy ws n f h gs f h mng. Anh g ws dung h ndn f p mndmns (N=34 f 44), s ws wng ss by dung pdus nd ndpns (17 u f 44 mnnd wng h ss by dung pdus, wng h ss by dung ndpns bh). Fgu 2 ss h bkdwn f gs f h fd vw mngs. Rspndns p h h ms h Vy Rpv (23 f 44) Smwh Rpv (21 f 44) fdbk fm fd vw sssns. Whn skd f h bnfs f fd vw, mwk ss funn s nd ss nd ng b ps vd h gs numb f mnns (h vd 11 mnns u f 23 spndns). Fv ndvdus s mnnd h fd vw nbs ms dnfy sks nd s. As n ndvdu nd, fd vw ws f m budng; fus n busnss nds nd bjvs (pbby f suss, s, y m), nd ns vu f mpund. Whn skd bu ppns n hw fd vws hv mpd ky pfmn ms (TPMs), spndns v sw mpvmns n v quy n dwnsm y ms: 19 f 35 sw ds n mpxy; 16 f 37 sw ds n s wk ff; 16 f 37 sw ds n sudy y ms; nd 27 u f 37 sw ds n h numb f mndmns. Rspndns w m mxd n h Chm Ogg - Chmsy Tdy - v. 32(6) Nvmb/Dmb

4 hs wh fnd mngs smwh ffv un 2.7 nyss (sndd dvn = 1.5; N = 29) nd hs wh fund h mngs n b ffv un ny n nyss p mng (sndd dvn = 0; N = 2). Fgu 2. Mn Gs f Fd Rvw Sssns ppns f h mp h fd vw pss hs n ss h fd n sng pn (13 u f 45 sw n mpvmn n quy wh 14 f 45 sw n hng). Th sm ws u f h ppn f h mp f fd vws n m s pn n (17 u f 39 sw n mpvmn wh 16 f 39 sw n hng) nd m fs pn n (12 u f 37 sw mpvmns wh 19 f 37 sw n hng). Fgu 3 ss h bkdwn f hw spndns vw h mp f fd vw n pfmn ms. Rgdng mng ffvnss, 66 pn (29 u f 44) f spndns sd h fd vw mngs Smwh Effv, wh 30 pn (13 u f 44) bv h h mngs Vy Effv. Ony w spndns nd h suh mngs N Vy Effv. Of h fv ndvdus wh mnnd h h fd vw nbs ms dnfy sks nd s, fu fund mngs b smwh ffv. Anyss Cndud f Fd Rvw Mng 32 u f 43 spndns n h h n dvpmn pn f h v pgm s dsussd dung fd vw; nd 63 pn (28 u f 44) f spndns n h d nyss s ndud s p f h fd vw nsu gnmn wh bjvs. Fgu 4 ss h bkdwn f d nyss dn s p f h fd vw. Ov, spndns ndu n vg 2.8 d nyss p fd vw sssn (Sndd Dvn = 1.5; N = 44). Ths spndns wh fnd mngs vy ffv un n vg 3.2 nyss p mng (sndd dvn = 1.5; N = 13), wh Fd Rvw Mng Lgss Fgu 5 ss h funn s nd ndvdus nvvd n h fsby vw, sfd by spndn ppn f mng ffvnss. Rspndns wh fnd mngs vy ffv hv n vg bwn fu nd fv (5.5) ndvdus p mng (Sndd Dvn = 2.3; N=13) wh spndns wh fnd mngs smwh ffv s hv n vg bwn fu nd fv (5.3) ndvdus p mng (Sndd Dvn = 1.5; N=29) nd h w spndns wh d n fnd mngs vy ffv hv n vg 3.5 ndvdus p mng (Sndd Dvn = 0.7). Th w spndns h dd n fnd mngs ffv ny hd psnn fm sn mngmn, d mngmn nd ndvdus whn h n m, wh spndns wh fnd mngs smwh vy ffv hd psnn ss vus funn ms. Fgu 4. D Anyss Cmpd s p f h Fd Rvw Pss Ov, 39 f 44 spndns hv n sn ms n h sm hpu pk n mngs; 38 f 44 spndns hv n pns psn; nd 32 f 44 spndns hv sn mngmn psn. Of hs mmbs, sn mngmn nd ndvdus h d v w d s bng h mn mng fs (15 nd 11 f 37 spnss). Hwv, h ws n gn nsnsus n whh funn s h ds nd sn mngs hd. 39 f 42 spndns s ndd h mng fs hv n sp nng n gds sudy dsgn nd fsby. 24 u f 44 spndns sy h h bwn n nd w mngs p p, nd 31 u f 44 mnn h hs mngs s bwn n nd h hus. Of h nn spndns whs mpns m m hn fu ms f gvn sudy, svn m fm mpns h pdu ss hn 51 ps p y (.., h spndns wk f sm mpns), nd gh f hm bv h mngs smwh ffv s mpd vy ffv. DISCUSSION Fgu 3. Imp f Fd Rvw Mngs n T Pfmn Ms Mdd nd Tufs CSDD ndud hs sudy undsnd h dpn f fd vw mhnsms dsgn m 54 Chm Ogg - Chmsy Tdy - v. 32(6) Nvmb/Dmb 2014

5 Fgu 5. Indvdus nd Funn As Invvd n Fd Rvw Mngs * Sdv s sndd dvn fsb nd smnd ps nd whh h fd vw mhnsms n p ffv. 83 ndvdus fm vus phmu nd bhngy gnzns ppd n h suvy. Of hs ppns, h mjy (73 pn) f spndns n h h mpns hv fd vw mms n p, ng wng sudy sk nd dung mndmns s h w mn gs f hvng vw sssns. Ov hf f spndns hv bn zng susss wh hs gs, s 73 pn hv sn ds n h numb f mndmns nd 65 pn hv sn ds n sudy mpxy. A ds n sudy mpxy suggss h spndn mpns hv bn dsng bh h numb f pdus n ddn h numb f ndpns p sudy, hby hvng h mn gs f h fd vw mng. Fv ndvdus s nd h fd vws nbs ms dnfy sks nd s. Th ny spndns wh hv n bn hvng h gs f fd vws m h w spndns h dd n fnd fd vw mngs ffv. Ths w spndns nd h f h n ky pn ms hv sn mds sgnfn hngs f h ws. A 44 spndns sd h h ms h smwh vy pv h fdbk ghd dung hs mngs. Rgdss f m pvy nd whh n h mn gs f fd vws m, h mjy (66 pn) f spndns hv nd h hs mngs ny smwh ffv, wh (30 pn) fnd hs mngs vy ffv. In f, f h fv ndvdus wh nd h h g f dung sks s bng hvd n fv vw mngs, fu fnd mngs ny smwh ffv. Th spndns vws f mng ffvnss suggs h h hy f fd n p vw s n y bng pu n gd p;.., h mjy f spndn mpns hv y fnd bs ps pmz fd vw mngs n d vw mngs s vy ffv. On xpnn f why h mjy f spndns fndng mngs ny smwh ffv ud b h mny spndns n sng ds n n ss: ny 42 pn f spndns hv sn mds sgnfn ds n ss vn hugh h gs suh s ds n p mndmn ndn nd mpxy bng hvd. Of h 14 spndns wh hv sn n hng n ss, 11 f hm vw fd vws s ny smwh ffv (nd n vws hm s n ffv). Addny, h mjy f spndns hv n sn mpvmns n ky pfmn ms (TPMs) h n d sy h n p,.g. m fs pn n nd pn f ss h fd n sng pn. Th w spndns wh hv sn wsnng n m s pn n s fnd fd vw mngs nffv, wh h fu spndns wh hv sn wsnng n m fs pn n fnd hs mngs h smwh n ffv. Hwv, h nfundng fs, suh s s mvn, s ff hs TPMs. Nvhss, spndns my f h m pduv nd ffn fd vw mngs wud ddss hw mpv TPMs suh s hs. Fuh fw-up s qud undsnd f hs h TPMs nfun spndns vws n mng ffvnss. Anh xpnn f why h mjy f spndns vw fd vw mngs s smwh ffv my b bus f hw h mngs bng fd, mngd nd pd;.., mng ffvnss my s b funn f mng xun. Th mjy f spndns hv hd mndy fd vw mhnsms n p f ng hn fv ys, whh suggss h h sn mngmn vws fd vws s pvdng vu. Cuny, sm xun mhnsms n p hp nhn fd vw mngs: h mjy hv sn mngmn nd ndvdus h d v fng h mngs; psnvs fm mny funn s nd ss psnd h mngs; hy ndung d nyss supp h gs; nd h n dvpmn pn s dsussd. Hwv, h sps f h xun mhnsm my nd b fnd. On suggsn wud b n mng fs nsu pduv mngs, s spndns wh fnd mngs vy pduv my hv fs h, hugh n nd fmy, my b b kp mngs. Addny, h w spndns h d n fnd fd vw mngs mpfu d n hv psnvs ss dffn funns nd hv n vg bwn h nd fu ndvdus h mng. Th spndns wh fnd h mngs s smwh ffv hv psnn fm h funn s,.g. sudy mns; ss nd nvsgs; nd fnn. Tw f h spndns h fnd mngs vy ffv s nud pns pn dvy gups n hs mngs. Wh h smp sz f spndns wh d n fnd mngs ffv s sm, hs pmny fndngs suggs h nh bs p f mng ffvnss wud b nud psnn fm mup funn s s h funn s n vw h n p. Anh suggsn wud b hv sh nd fw mngs h v m gund. Of h nn spndns h m m hn fu ms f gvn sudy, gh spndns Chm Ogg - Chmsy Tdy - v. 32(6) Nvmb/Dmb

6 REFERENCES AND NOTES Fgu 6. Gudns f Opmzng Fd Rvw Mngs fnd mngs smwh ffv, suggsng h mny mngs my ds mng ffvnss. Addny, hugh h smp sz s sm, h w spndns h d n fnd fd vw mngs mpfu un ny n nyss p mng. Rspndns wh fnd mngs smwh ffv un 2.7 nyss p mng, nd hs wh fnd mngs vy ffv un 3.2 nyss p mng. Ahugh h d n ssy sgnfn, h sus suggs h hvng m d nyss mpd s p f h fd vw pss ud mk mngs m ffv. Fgu 6 summzs ppsd gudns f hvng vy ffv fd vw mngs. Th mpns f hs sudy shud b d wh sm un gvn d mns. Fsy, h smp sz f hs wh fd vw mhnsms s vy sm, wh ny 61 spndns f h 83. I s s pssb h sm f h ndvdus wk h sm mpns, suggsng h vn fw mpns psnd. Fuu suds w k ddss hs sudy bss nd vs. A m gus suvy wh g numb f mpns psnd w gy nfm hs n ff. As h dpn s f gvnn mhnsms nd fd vw nnu gw, h s g nd undsnd m y h mpns f hs mng sgs nd s f hy gn psv vu v. Ths sudy md ddss h ffvnss f fd vws nd h n ng m bus n ps. Umy, hs sgs py ky n nhnng v dug dvpmn, bngng b mdns pns n nd. ACKNOWLEDGEMENTS Th uhs wud k knwdg Ig Amn f Mdd Suns nd Kn Gz f Tufs CSDD f h nbuns h pdun f hs mnusp. Appndx Fgu 1. Suvy Qusn nd T Numb f Rspndns 1. Esnsn, E. L., Cns, R., Ckn, B. S.,., Snsb pphs f dung n ss. Cn Ts, 5(1), d: / (2008) 2. Fy, D., Mdd, C., & Eswd, A., A sysm vw hghghs hs vdy n suds f bs n ppn. Jun f Cn Epdmgy, 60(10), d: /j. jnp (2007) 3. Cê, T. D., Amd, F. P., Cvn, A. B.,., Avçã d ppçã d nfms sb ês ps p n gêm m pns ís. Ensn (Sã Pu), 10(3), d: /S (2012) 4. Andsn, J. W., Fss, R., & Hs, C. V., Fs ssd wh y sudy dsnnun n AACTG suds, DACS 200. Cnmpy Cn Ts, 28(5), d: /j (2007) 5. Rss, S., Gn, A., Cuns, C.,., Bs Ppn n Rndmsd Cnd Ts. Jun f Cn Epdmgy, 52(12), d: /S (99) (1999) 6. Ms, E. J., Sy, D., Rhs, B.,., Bs ppn n n s f n: A m-nyss nd sysm vw f pn-pd fs. Th Ln Ongy, 7(2), d: /S (06) (2006) 7. Abms J, Ewn R, Fyf G,., D submssn sndds nd vdn qumns. Psnd : Th nfn n Cn Cn Rsh; Spmb 3-10, Wshngn DC. (2008) 8. Fdmn, L. M., Fubg, C., & DMs, D. L., D Cn nd quy n. In:Fundmns f n s. Nw Yk: Spng; 2010: (2010) 9. Nhm M. D Quy n Cn Rsh. In: Cn Rsh Infms, Hh Infms (R.L. Rhssn J.E. Andws, ds.) Lndn: Spng, (2012) 10. Gz K. P dsgn nds nd h ff n n pfmn. Rguy Affs Jun - Phm 19(5) (2008) 11. Gz, K. A., Wng, J., Cmp, R. A.,., Assssng h Imp f P Dsgn Chngs n Cn T Pfmn. Amn Jun f Thpus, 15(5), d: / MJT.0b b9027 (2008) 12. Gz K.A.. Assssng h dwnsm mp f p dsgn mpxy. Tuh Bfngs (2009) 13. Gz, K. A., Cmp, R. A., & Kn, K. I., Vby n P Dsgn Cmpxy by Phs nd Thpu A. Dug Infmn Jun, 45(4), d: / (2011) 14. Gz, K. A., Zukmn, R., Cpp, A. B.,., Msung h Indn, Cuss, nd Rpussns f P Amndmns. Dug Infmn Jun, 45(3), d: / (2011) 15. Gz, K. A., Sgpus, S., Mbugh, M.,., Qunfyng h Mgnud nd Cs f Cng Exnus P D. Amn Jun f Thpus, 1. d: / MJT.0b f4 (2014) 16. Gz, K., & Sgpus, S., Thpu vby n h n f d suppng p nd pns nd bjvs. Cn Invsgn, 4(2), d: / (2014) 17. Gz, K. A., Sgpus, S., Mbugh, M.,., Qunfyng h Mgnud nd Cs f Cng Exnus P D. Amn Jun f Thpus, 1. d: /MJT.0b f4 (2014) 18. Gz, K. A., Km, J., Sgpus, S.,., Nw Gvnn Mhnsms Opmz P Dsgn. Thpu Innvn & Rguy Sn, 47(6), d: / (2013) 19. Gz, K. A., Km, J., Sgpus, S.,., Nw Gvnn Mhnsms Opmz P Dsgn. Thpu Innvn & Rguy Sn, 47(6), d: / (2013) nf@mds.m mds.m Chm Ogg - Chmsy Tdy - v. 32(6) Nvmb/Dmb 2014