Prcntag of Non-Caucasians in Clinical Trials from 2000 to 2009 By Mghanadh Yrram E01039061 Spcial Projct Submittd to th School of Halth Scincs Eastrn Michigan Univrsity In partial fulfillmnt of th rquirmnts For th dgr of MASTER OF SCIENCE In Clinical Rsarch Administration Dcmbr 13, 2013 Ypsilanti, Michigan. i
Acknowldgmnts I would lik to thank my Profssor, Dr. Irwin G Martin, for his continud support and guidanc throughout my projct. His valuabl suggstions for this projct hlpd m a lot in its compltion. I would lik to xtnd my gratitud to my advisor, Dr. Stphn Sonstin, for his support to my cours. I would also lik to thank my family and my frinds for thir continud support and ncouragmnt throughout this cours. Finally, I would lik to thank library staff, ISRC ESL GA s from Eastrn Michigan Univrsity for thir hlp with litratur rviw. ii
Tabl of Contnts I. Acknowldgmnts... ii II. III. List of Tabls...iv List of Figurs...iv IV. Introduction... 1 V. Background... 3 VI. Mthodology... 7 VII. Rsults... 8 VIII. Discussion... 17 IX. Limitations... 21 X. Conclusion... 22 XI. Rfrncs... 23 iii
List of Tabls Tabls Pags I. Total Numbr of NDA s and NME s Approvd Pr Yar From 2000-09... 8 II. Clinical Trial Participation by Rac by Yar... 9 List of Figurs Figurs Pags I. Clinical Trial Participation by Rac Ovr th Priod of 2000-09... 10 II. Th Prcntag of Caucasian Participation in Clinical Trials In 2000-09... 11 III. Th Prcntag of African-Amrican Participation In Clinical Trials in 2000-09...12 IV. Th Prcntag of Hispanic Participation in Clinical Trials in 2000-09... 13 V. Th Prcntag of Asian Participation in Clinical Trials in 2000-09... 14 VI. Th Prcntag of Non Caucasian Participation in Yars 2000 to 2009... 15 VII. Th Prcntags by All Rac Sub Group Participation In Clinical Trials for 2000-09.. 16 VIII. Comparison of th Prcntags by Rac in Participation In Clinical Trials in 1995-99 and 2000-09... 18 iv
INTRODUCTION According to mdical trms rac is thnic stock or division of humans. Th Offic of Managmnt and Budgt (OMB) suggstd th classification of racs for rcord kping, prsntation and collction of th data (Offic of Managmnt and Budgt, 1995). Thy vn mntiond that ths should not b considrd as bing scintific or anthropologic in natur and ths wr just dvlopd for fdral statistics and program administrativ. Rac and thnic catgoris ar dfind by th OMB (Offic of Managmnt and Budgt, 1997) as: 1) Amrican Indian or Alaska Nativ: A prson who has origin in any of th original popls of North, south or Cntral Amrica and who maintains community or tribal attachmnt. 2) Asian: A prson who has origins in any of th original popls of th Far ast or south ast Asia or th Indian subcontinnt including lik Pakistan, Philippins, China,India, Japan, Kora tc. 3) African-Amrican: A prson who has origins in any of th black racial groups of Africa 4) Whit: A prson who has origins in any of th original popl of middl ast, north Africa or Europ 5) Hispanic or Latino: A prson who has origins in Cuba, Mxico, south or cntral Amrican or Spanish origin rgardlss of rac. 6) Nativ Hawaiian or Pacific Islandr: A prson who has origins in any of original popl of Hawaii, Guam, Samoa or othr pacific islands. Th rspondnts should b offrd th option of slcting on or mor racs according to th OMB (Offic of Managmnt and Budgt, 1997). FDA also rcommnds using th sam classification as this will hlp in comparing th rsults of clinical trial data btwn othr agncis and FDA. Using th standard catgoris would also hlp th FDA in idntifying and analyzing th diffrncs in rspons (Food and Drug Administration, 2003). 1
Th diffrncs in th rsponss to drugs had alrady bn obsrvd btwn diffrnt racs. Ths diffrncs may b bcaus of many factors lik pharmacokintics, nvironmntal xposur. For xampl, gfitinib, a lung cancr drug prolongd lif on mdication for 9.5 months for Asians, narly doubl th 5.5 month avrag for th gnral population (Zamisak N, 2005). Similarly Bidil (hydralazin hydrochlorid and isosorbid di-nitrat), a drug intndd to trat congstiv hart failur workd far bttr in African-Amricans than in whits (Dustr, 2007). Th srum cratin kinas lvls wr found to b highr in black popl whn compard to whit popl (Brwstr, Coronl, Sluitr, Clark, & Van Montfrans, 2012). An important nzym that mtabolizs drugs blonging to th bta blockr class and antipsychotic class was found to b abnormally low in Caucasians whn compard to Asians and African origin (Xi, Kim, wood, & Stin, 2001). 2
BACKGROUND To assur th safty and fficacy of th drugs in th largr population of intndd us FDA has givn grat dal of attntion to th racial and thnic diffrncs in rspons to drugs during NDA dvlopmnt. In 1988 Th Guidlin for Th Format and Contnt of Th Clinical and Statistical Sctions of An Application nots th importanc of th inclusion of th dmographic data lik ag, sx, rac in th Nw Drug Applications (Food and Drug Administration, 1988). To incras th participation of minority racial groups, FDA has dvlopd guidlins and rgulations which improv th collction of data on racial diffrncs during th rsarch. In 1997 th Food and Drug Administration Modrnization Act (FDAMA) rquird inclusion of minoritis and womn into th clinical trials (Food and Drug Administration, 1997). Sction 115 of th Act rquird a guidanc to hlp incras th inclusion of womn and minoritis in clinical trials. To dvlop th guidanc a working group was stablishd by FDA which rlasd a rport on July 1998 stating that no additional guidanc was rquird but that agncy would incras its comptncy in collcting and valuating dmographic data and thn dtrmin about th additional guidanc in th futur.. Th dmographic rul of Final Rul on Invstigational Nw Drug Applications 1998 mandats that nrollmnt of subjcts b tabulatd by dmographic subgroups (Food and Drug Administration, 1998). Effctivnss and safty data should b analyzd for dmographic subgroups such as rac and should b rportd in th Invstigational nw drug annual rports. Th guidanc for industry on population pharmacokintics (Food and Drug Administration, 1999) xplaind clarly how to gathr information about diffrncs in pharmacokintics, how th analysis should b don and how to rprsnt th data whn a population modl paramtr was includd in labl. Contnt and Format of Th Advrs Ractions Sction of Labling for Human Prscription Drugs and Biologics was dvlopd (Food and Drug Administration, 2006) provids guidanc to rport th advrs ractions for spcific 3
dmographic subgroups. In th guidanc spcific considration was givn about th clinically important diffrncs btwn subgroups. It also mntiond that th prsntr should discuss th diffrncs, and vn if thr is no information about diffrncs thy should xplain why that information was not availabl. Th guidanc Clinical Studis Sction of Labling for Prscription Drugs and Biologics- Contnt and Format suggsts that a summary statmnt should b givn about th rsults of rquird studis and ffcts in diffrnt ag, sx, racial sub groups and th summary statmnt should mntion clarly about th diffrncs (Food and Drug Administration, 2006). According to Crawly (Crawly & Lavra, 2001) mistrust was a significant barrir in inclusion of minoritis into clinical trials. Th USPHS syphilis study (Gambl, 1997) had gratr influnc on African-Amricans rgarding th participation of clinical trials but according to th data from focus group rsarch with African-Amrican groups showd that som of th participants, vn though thy had th information about th syphilis study, statd it did not influnc thir dcision on participation in a trial. Th Offic of Spcial Halth Issus (OSHI) conductd thr projcts which collctd and analyzd dmographic data. Th first study Spcial populations: Tsting and Labling of Nw Drugs (Evlyn, Togio, Banks, Gray, Robins, & Ernat, 2001) collctd dmographic data on nw molcular ntitis (NME S) approvd in 1995-1996. Th rsults from this study indicat that all clinical studis had African Amrican participants but rprsntation of th othr minority racial groups was low. Th scond study Rac Ag and Gndr: A Rviw of Dmographic Subgroups in Clinical Trials of FDA Rgulatd Drugs and Biologics (Evlyn, Togio, Banks, Gray, Robins, & Ernat, 2001) rviwd INDs to chck whthr th sponsors adhrd to th rquirmnts of 1998 dmographic rul. Th rsults showd that 85% of th INDs did not hav all th rquird information according to th dmographic rul. And from th INDs whr rac was mntiond, of th total prcntag of study participants, 9 prcnt wr found 4
to b African-Amricans, 3 prcnt ach for th Latinos, Asians, pacific islandrs, nativ Hawaiians. Thr prcnt wr rportd as non-whits and Amrican Indian and Alaska nativs wr found to b lss than 1 prcnt. Th third study Participation of Racial/Ethnic Groups in Clinical Trials and Rac Rlatd Labling: A Rviw of Nw Molcular Entitis Approvd 1995-1999 (Evlyn, Togio, Banks, Gray, Robins, & Ernat, 2001) collctd data from FDA Mdical Officrs rviws of 185 nw molcular ntitis approvd by th Cntr for Drug Evaluation and Rspons (CDER) 1995-1999. In this study th mdical rviws wr xamind for data rlatd to rac of participants and wr analyzd by yar of product approval and thraputic class. Th rsults from th study show 53 prcnt of participants rac could b idntifid from th Mdical Officr s rviws. Of ths participants, whits wr 88 prcnt, Africans Amricans wr 8 prcntag, Asian or pacific islandr wr 1 prcnt, Hispanic wr 3 prcnt and Amrican Indian or Alaska nativ wr lss than 1 prcnt. Whn th rsults wr analyzd by yar ths prcntags varid for vry racial group. Th prcntag of African-Amrican participants dcrasd from 12 prcnt in 1995 to 6 prcntag in 1999 and had bn dclining ovr th priod. Among th trials conductd only in USA, th prcntag varid from 18 prcnt in 1995 to 10 prcnt in 1996. And according to Gifford and collagus (Gifford, Cunningham, Hslin, & al., 2002) in a clinical study conductd for human immunodficincy virus infction in USA in 1996-1998, only 25 prcnt of th total African-Amricans who nrolld at start of th study wr nrolld in follow-up clinical trials. This prcntag was low whn compard to whits whos prcntag was 53. From th abov information prsntd, thr has bn a dcras in th prcntag of th non-caucasian rac participation in th clinical trials. Rsarch qustions: Th numbr of drugs which show a diffrnc in rspons in diffrnt rac has bn incrasing as mor clinical trials ar conductd. During th clinical trials it is important that 5
participants from diffrnt racial groups ar includd that rprsnt th whol targtd patint population. By this mthod th diffrncs in rsponss can b dtrmind during th initial stags of drug dvlopmnt. This information would b usful in product labling and minimiz unwantd ffcts in th patints who will b using th drug. Th main purpos of this rsarch is to answr following qustions: 1) Has th prcntag of th non-whits incrasd or dcrasd during 2000-2009 priod? 2) What is th prcntag of th diffrnt racial groups participation in clinical trials during 2000-2009 priod? 3) Has th prcnt of participation incrasd or dcrasd within ach racial subgroup? 6
METHODOLOGY For this projct, th findings of Evlyn t al (rf yar?) wr xtndd to nxt 10 yar priod and followd th sam mthodology. Th data was collctd from th FDA wbsit whr drug approvals by month ar listd. For ach nw molcular ntity approvd, a mdical officr rviw was availabl. From thos rviws data rlatd to dscription of racs and information about th total numbr of participants in trial and thir division by rac was collctd. This information was collctd from all th NMEs approvd during 2000-2009. All th data collctd was analyzd by individual racial subgroups and compard th prcnt of participation by yar for individual racial subgroups and also btwn racial subgroups. From ths data a chart was dvlopd that includ prcntag of non-caucasians, prcntag of diffrnt racial participation in clinical trials on x axis and yar on y axis and th chart will show whthr th prcnt has incrasd or dcrasd. And th prsnt trnds wr compard to 1995-1999 trnds. Data Analysis: From th clinical trials mntiond in th 218 nw molcular ntitis Mdical Officrs rviws, racial data wr collctd for analysis. Data wr collctd for ach rac mntiond in ach NME approvd in ach yar. Th sam data was gathrd for all th 218 NMEs. Th total participants by rac pr yar wr calculatd. Th total numbr of participants by rac ovr th priod 2000-09 was calculatd by adding th numbr of participants in ach rac pr yar. Th prcntags wr calculatd for ach yar and ovr th priod 2000-09 by adding th total participants. Th prcntags hav bn calculatd by using th following formula: Prcntag of a spcific rac participation = Total numbr of participants in a spcific rac in clinical trials from NDAs approvd in th spcific yar dividd by th total numbr of participants in clinical trials from NDAs approvd that yar tims 100. 7
RESULTS Tabl 1 provids th total numbr of NDAs approvd and NMEs approvd by yar. YEAR NDA'S APPROVED NEW MOLECULAR ENTITIES APPROVED 2000 98 27 2001 66 24 2002 78 17 2003 72 21 2004 * 119 36 2005 80 20 2006 101 22 2007 78 18 2008 89 24 2009 90 26 Total 871 235 Tabl 1. Total numbr of NDA S and NME S approvd by yar. *Th numbr of approvals aftr 2004 includs both nw molcular ntitis and biological licns applications transfrrd from th Cntr for Biological Evaluation and Rsarch (CBER) to th CDER. From th clinical trials mntiond in th 218 nw molcular ntitis, most of th Mdical Officrs rviws did not hav clinical trials participants rac and thnicity mntiond clarly. From th 218 NMEs for which th rac and thnicity could b dtrmind, 81.9% of th participants wr Caucasians, 6.8% wr African-Amrican, 3.5% wr Hispanic,0.1% wr Amrican Indians, 4% Asian and 3.7% mntiond rac as othr. Tabl 2 provids th prcntags of th diffrnt racial subgroups participation by yar from 2000-09. 8
African Yar Caucasian Amrican Hispanic Asian Othr 2000 87.1 7.3 2.6 0.64 2.4 2001 73.8 10 6.9 4.8 4.4 2002 79.8 4.3 6.8 2.6 6.5 2003 87.3 6.6 0.4 1.7 3.6 2004 76.2 7 6.8 2.5 7.33 2005 76.5 6.8 4.2 7.3 5.2 2006 79.7 6.3 4.3 4.2 5.2 2007 82.5 8.3 3.4 0.1 4.7 2008 85.4 7.1 2.6 4.8 3.6 2009 75 5.5 5.3 9 5.7 Tabl 2. Clinical Trial Participation of Diffrnt Racs pr Yar. Total numbr includs only for thos whos rac and thnicity was mntiond in mdical officr s rviws of approvd NME s ovr th priod of 2000-09. Th avrag prcntag of th participation by rac ovr th priod 2000-09 has bn calculatd by adding up th total participants by ach racial subgroup. Th prcntags ar dpictd in Figur 1. 9
Clinical Trail Participation by Rac Ovr th Priod 2000-2009 0.12 3.53 6.8 4 3.65 81.9 Caucaisan African Amrican Hispanic Amrican Indian Asian Othr Figur 1. Clinical Trial Participation by Rac Ovr th priod 2000-09. Total numbr includs only thos whos rac and thnicity wr mntiond in Mdical Officrs rviws of approvd NMEs ovr th priod of 2000-09. Participation of Diffrnt Racs in Clinical Trials by Yar For ach racial group, th prcntag of participation varis from yar to yar. Ovrall, th Caucasian rac participation has dcrasd from 87.1% in 2000 to 75% in 2009. For African-Amricans, participation varid from 7.3% in 2000 to 5.5% in 2009. For Asian and Hispanic racs th prcntag incrasd from 0.6% in 2000 to 9% in 2009 and 2.6% in 2000 to 5.3% in 2009, rspctivly. Figurs through 2 to 7 display th diffrnt racial participation by yar. 10
Prcntag Of Caucasian Rac Participation in Clinical Trials in 2000-2009 P r c n t a g 90 85 80 75 70 65 87.1 87.3 85.4 82.5 79.83 79.7 76.2 76.5 75 73.8 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Yar Figur 2. Th Prcntag of Caucasian Participation in Clinical Trials in 2000-09. Caucasian participation has dcrasd from 87.1% to 75% by 2009. Total numbr includs only for thos whos rac and thnicity was mntiond in Mdical Officrs rviws of approvd NMEs ovr th priod of 2000-09. 11
12 Prcntag Of African Amrican Participation in Clinical Trials in 2000-2009 P r c n t a g 10 8 6 4 2 7.3 10 4.33 6.58 7 6.76 6.32 8.25 7.1 5.5 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Yar Figur 3. Th Prcntag of African Amrican Participation in clinical trials in 2000-09. African Amrican participation has bn on an avrag of 6.8% ovr th 10 yar span. Th highst bing 10% in 2001 and lowst bing 4.33 in 2002. Total numbr includs only for thos whos rac and thnicity was mntiond in Mdical Officrs rviws of approvd NME s ovr th priod of 2000-09. 12
Prcntag of Hispanic Participation In Clinical Trails in 2000-2009 8 P r c n t a g 7 6 5 4 3 2 2.6 6.9 6.76 6.8 4.23 4.3 3.4 2.6 5.33 1 0 0.4 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Yar Figur 4. Th Prcntag of Hispanic Participation in Clinical Trials in 2000-09. Hispanic population participation has varid from 2.6% in 2000 to 5.33% in 2009 with 6.9% bing th highst in 2001 and 0.4% bing lowst in 2003. Total numbr includs only for thos whos rac and thnicity was mntiond in Mdical Officrs rviws of approvd NME s ovr th priod of 2000-09. 13
P r c n t a g 10 9 8 7 6 5 4 3 2 1 0 Prcntag of Asian Participation in Clinical Trails in Yars 2000-2009 0.64 4.74 2.58 1.67 2.5 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Yar 7.3 4.23 0.98 4.76 9 Figur 5. Th Prcntag of Asian Rac Participation in Clinical Trials in 2000-09. Asian participation in clinical trials has incrasd from 0.64% in 2000 which lowst in th 10 yar span to 9 % in 2009 which is th highst in th 10 yar span. Total numbr includs only for thos whos rac and thnicity was mntiond in Mdical Officrs rviws of approvd NME s ovr th priod of 2000-09. 14
Prcntag of th Non-Caucasian Participation in Clinical Trails by Yar from 2000-2009 30 P r c n t a g 25 20 15 10 5 12.94 26.01 20.17 12.71 23.8 23.49 20.44 17.34 18.09 25 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Yar Figur 6. Th Prcntag of Non-Caucasian Participation by Yar from 2000 to 2009 which has an incras from 12.94% in 2000 to 25% in 2009. Th highst bing 26.01% in 2001 and lowst bing 12.71 % in 2003. Total numbr includs only for thos whos rac and thnicity was mntiond in Mdical Officrs rviws of approvd NME s ovr th priod of 2000-09. 15
P r c n t a g 100 90 80 70 60 50 40 Prcntag of all Racs participation in Clinical Trails by Yar from 2000-2009 30 20 10 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Yar Caucaisan african amrican hispanic amrican Indian asian othr Figur 7. Th Prcntags of All th Racial Subgroups Participation in Clinical Trials for 2000-09. Total numbr includs only for thos whos rac and thnicity was mntiond in Mdical Officrs rviws of approvd NME s ovr th priod of 2000-09. 16
DISCUSSION Participation of Racial/Ethnic Groups In clinical trials during th 10 yar priod 2000-09 obsrvd, th prcntag of participation of Caucasian and non Caucasian rac varid. Caucasian participation dcrasd ovr th priod whr as th African-Amrican participation did not s a ris. African- Amricans had an ovrall avrag of 6.8%. On th othr hand, th highst ris in trms of participation was sn in Asians which ros from 0.64% in 2000 to 9% in 2009. To dtrmin yar-to-yar diffrncs, no diffrncs wr sn in product approvals which could provid insight to ths diffrncs. No comparisons wr don to dtrmin whthr th approvals of diffrnt drug classs, such as cardiology products, anti-infctiv products, mtabolic or ndocrin products, which hav highr prcntag of minoritis, had any ffct on th total prcntags by yar. Comparison of data from 1995-99 with 2000-09 Th data of diffrnt racial participation in clinical trials for 1995-99 was obtaind from Participation of racial/thnic groups in clinical trials and rac rlatd labling: A rviw of nw molcular ntitis approvd 1995-1999 (Evlyn, Togio, Banks, Gray, Robins, & Ernat, 2001). During this 5-yar priod Caucasian rac participation was 88%, African- Amrican participation was 8%, Asian participation was 1%, and 3% Hispanic/Latino and lss than 1% wr Amrican Indians. Ths yars ar compard to th nxt 10 yars in Figur 8. 17
Comparision of diffrnt Racial participation in clinical trials btwn 1995-99 and 2000-09 P E R C E N T A G E 100 90 80 70 60 50 40 30 20 10 0 88 81.9 Caucaisan 8 6.8 African Amrican 1 3.53 0.12 3 Hispanic Rac Amrican Indian Asian 4 3.65 Othr 1995-99 2000-09 Figur 8. Comparison of th Prcntags of Diffrnt Racs Participation in Clinical Trials for Yars 1995-99 and 2000-09. Th data includ only of thos whos rac was mntiond in th Mdical Officrs rviws of th NMEs approvd during thos yars. Basd on ths data, th following obsrvations may b mad: Th prcntag of Caucasian rac has bn dcrasd from 88% to 81.9%. African Amrican participation also dcrasd, from 8 % to 6.8% Hispanic participation saw small incras from 3 % to 3.5% Asian participation saw highst ris from 1% to 4% Amrican Indian rac rprsntation was lss than 1% for both of th priods Thr was no dscription of th option OTHER in th racs during th 1995-99 priods whr as during 2000-09 priod thr was 3.7% of participants mntiond thir rac as othr. From th prcntags of participation of various racs in clinical trials mntiond in th Figurs 1 9 it is vidnt that th non-caucasian racial participation has incrasd ovr 18
th priod vn though th prcntags varid from yar to yar. Thr might b various rasons bhind th incras of th non-caucasian participation but th major would b th globalization of clinical trials, chang in th attitud of th minoritis, planning and implmnting ffctiv rcruitmnt stratgis. Still thr is undr rprsntation of minoritis in randomizd clinical trials and cancr trials (Shark, t al., 2002). Thr wr diffrnt studis that wr conductd to idntify th motiv of th racial/ thnic minority group s participation in clinical trials. Waltr JK, Bruk JF, Davis MM, conductd a study Rsarch participation by low incom and rac/thnic minority groups: how paymnts may chang th balanc to find th ffct of paymnts on th participation among th minority racial groups (Waltr, Burk, & Davis, 2013). Th rsults from thir study suggstd that highr paymnts yildd a proportional rprsntation of minority racial groups. Ths authors also found that Hispanics wr rqusting highr paymnts for participation which might b th caus for thir undrrprsntation in clinical trials. In contrast, th study conductd by Wndlr D t al. to find out th willingnss of th racial/thnic minoritis to participat in clinical trials yildd diffrnt rsults (Wndlr, t al., 2006). From thir study thy found out that African Amrican and Hispanics in US hav vry small diffrncs in willingnss to participat in clinical trials whn compard to non-hispanic whits. Furthr invstigation should b carrid out to vrify th rasons for minoritis participation in clinical trials. Idntification of th rason for undr rprsntation in th clinical trials is th first stp to solving this problm. During th confrnc for Incrasing Participation of Minoritis in Clinical Trials: Summary of Th Moving Byond Th Boundaris by Nancy Shark t al. som stps to incras th participation of minoritis in cancr clinical trials wr prsntd (Shark, t al., 2002).In th confrnc, th stps to rduc physician-basd barrirs wr givn as ducating th physicians rgarding th importanc of minority rac/thnicity participation in clinical trials, rducing th physician tim in rcruiting th patints, ducating th nurs and ancillary 19
staff about th importanc all racial/thnic participation and to answr qustions of patints. To rduc th conomic barrirs th stps mntiond wr (1) lgislation which would mandat mdical insuranc and managd car covrag of xprimntal thrapis, (2) covrag of othr financial costs raisd during th trial priod, and (3) stipnds for participation should b approvd. To rduc prsonal and cultural barrirs, th stps mntiond wr: Assur th subjcts undrstand th consnt form Build th community trust by linkag with community ladrs Dvlop and maintain rlationships within th community and involv th community in rsarch To dvlop trust with minority community, try to undrstand and answr th cultural blifs that might b causing th concrns among th minority community concrning participation in clinical trials and hir staff form th community. Dvlop flxibl schduling Us community basd srvics to improv accss and transportation to clinic. Ths stps would b hlpful for incrasing th participation as wll as dvloping th trust and confidnc of minority population. Improvd trust should incras minority participation in clinical trials as wll as provid th altrnat car which might hlp th community halth car. 20
LIMITATIONS Thr ar svral limitations to th study. Th study was basd on th Mdical Officrs rviws and th participant racial data wr collctd from ths rviws. Rac could not b dtrmind for all th participants in clinical trials from th rviws. Th rac rprsntation and analysis dos not rprsnt th complt analysis of sponsors or th FDA as only th approvd NMEs, but not th NME s submittd for approval and not approvd. Th study did not dtrmin th racial sub-groups participation in clinical trials was comparabl to prvalnc of th spcific disas for which th clinical trials wr conductd. In som clinical trials Hispanic was mntiond as rac and in othr as thnicity, th prcntag of Hispanics may b undrratd. As th data collctd and usd for analysis dos not rprsnt th total participants in clinical trials, it is not possibl to say whthr w can gnraliz th rsults obtaind for this study to total population who participatd in clinical trials during th priod 2000-09. 21
CONCLUSION Non-Caucasian racial participation incrasd during th priod 2000-09 whn compard to th priod 1995-99 on an avrag prcntag basis. Asian rac participation saw th highst incras. Thr is a slight dcras in African-Amrican participation ovr th priod. Attntion to rac in Mdical Officr s rviws of NMEs was not consistnt. Evn though clinical rviw standard tmplat has bn implmntd with a sction of spcial population which was intndd to rcord th various racial/thnic participation or xposur of th drug to thm, th rprsntation of th total population was not consistnt. Evn though thr is an incras in th participation of non-caucasian racs, thr is still thr undrrprsntation of crtain racial. To incras th minority participation, stps should b followd which will dcras th racial and prsonal barrir btwn th participants and physician. Furthr studis should b conductd to idntify th potntial barrirs which ar ffcting th minority subgroups participation in clinical trials and also to find out if thir participation in spcific disass diffrs from th ovrall participation rat. 22
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