A Peek at GCT 2012

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3rd Annual Executing Global Clinical Trials, Sept 2012, Mitchell Katz, Purdue Pharma L.P.

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A Peek at GCT 2012

  1. 1. 3rd$Annual$Execu.ve$Global$ Clinical$Trials$ Mitchell(Katz,(Ph.D.( Execu3ve(Director,(Medical(Research(Opera3ons( Purdue(Pharma(L.P.( September(2012(
  2. 2. 2( Pharma’s$Largest$Layoffs$in$2012$
  3. 3. 3( CRO$Consolida.on$ !  INC( "  Kendle( !  Theorem( "  Omnicare( "  IBAH( !  Pharmanet/i3( "  Inven3ve(Health( !  Private(Equity( "  PPD( "  RPS( "  PRA(
  4. 4. 4( Outsourcing$Buzz$Words$ !  Partnerships( !  Alliances( !  Preferred(Models( !  Hybrid(Models( !  Func3onal(Models( !  Transac3onal(Models( !  Offshoring( !  “Strategic(Rela3onships”(
  5. 5. 5( Johnson$&$Johnson$and$ICON$ #1(–(Failure(to(ensure(proper(monitoring(of(the(clinical( inves3ga3ons([21(CFR(312.50(and(312.56(a)( #2(–(Failure(to(ensure(that(an(inves3ga3on(was(conducted(in( accordance(with(the(general(inves.ga.onal$plan$and( protocols(as(specified(in(the(IND([21(CFR(312.50]( #3(–(Failure(to(secure(inves.gator$compliance$with(the( inves3ga3onal(plan(and(applicable(FDA(regula3ons([21(CFR( 312.56(b)]( #4(–(Failure(to(ensure(that(only(inves3gators(who(were( qualified(by(training(and(experience(were(selected(as( appropriate(experts(to(inves3gate(a(drug([21(CFR(212.53(a)](
  6. 6. 6(
  7. 7. 7( It’s$All$About$.$.$.$ ( ( QUALITY$
  8. 8. 8( Avoca$Quality$Consor.um$ ( Pharma(and(Biotech(members((to(date):( !  Alexion(Pharmaceu3cals,(Amgen,(Astellas(Pharma,(AstraZeneca,(Biogen( Idec,(BristoldMyers(Squibb,(Cerexa,(Cubist(Pharmaceu3cals,(Daiichi( Sankyo,(Eli(Lilly(and(Company,(GlaxoSmithKline,(Grünenthal,(ImClone( Systems,(Janssen(Research(&(Development,(Otsuka,(Pfizer,(Purdue,(and( Roche( CRO(members((to(date):( !  Chiltern(Interna3onal,(Covance,(INC(Research,(ICON,(Harrison(Clinical( Research,(PAREXEL(Interna3onal,(PharmaNet/i3,(PRA(Interna3onal,( Quin3les,(Theorem(Clinical(Research,(and(RPS( ( Corporate(Sponsors:(
  9. 9. Quality$Management$and$CRO$ Oversight$
  10. 10. 10( Agenda$ !  Overview:(Background(and(context( !  Part$1:(Overall(percep3ons(and(the( “disconnects”(between(sponsors(and(CROs( around(issues(of(quality( !  Part$2:(Root(causes(of(quality(issues(and(the( issue(of(“micromanagement”( !  Part$3:(Best(prac3ce(approaches(associated( with(sa3sfac3on( !  Open(discussion(
  11. 11. 11( Context$for$Research$on$Quality$and$ CRO$Oversight$ !  Increase(in(clinical(outsourcing( !  Consolida3on(of(spend(with(few(clinical(service(providers( !  Globaliza3on(of(clinical(trials:(increase(in(number(of(studies(in(lessdexperienced(developing( regions( !  Focus(on(efficiencies(and(cost(savings( !  Increase(in(the(number(of(highdprofile(FDA(warning(lemers( Focus(on(Avoca’s(2011(Industry(Survey:(percep3ons(from(sponsors(and(CROs(on(the(quality(of( outsourced(trials( Focus(of(Avoca’s(Quality(Consor3um:(proac3ve(quality(management( The$focus$and$vision$of$the$Quality$Consor5um$are$to$accelerate$the$development$of$an$industry$ standard$and$best9prac5ce$approach$to$the$quality$management$of$outsourced$trials$through$the$ sharing$of$best$prac5ces$
  12. 12. 12( Methods$ !  Surveys(explored(respondents’(views(and(experiences(regarding:( "  Sa3sfac3on(with(quality(of(work(delivered(by(clinical(service(providers( "  Approaches(to(managing(quality(in(outsourced(clinical(trials,(including( quality(metrics,(repor3ng(tools,(and(desktop(analy3cs( "  Scope(and(u3lity(of(Quality(Agreements( "  Other(tools(used(to(set(expecta3ons(for(quality(in(outsourced(clinical( trials( "  Quality(concerns(and(management(when(outsourcing(in(Emerging( Markets( "  Quality(considera3ons(in(selec3ng(CROs(
  13. 13. 13( 2011$Industry$Survey$ !  104(sponsor(surveys(from(66( companies( "  73%(pharma,( 17%(biotech( "  52%(“Top(20”( "  44%(Opera3ons,( 40%(Outsourcing( "  17%(execu3ves,( 58%(middle(management(( !  143(provider(surveys(from(88( companies( "  78%(CROs( "  64%(“Top(20”( "  38%(Opera3ons,( 31%(BD,( 22%(Management( "  48%(execu3ves,( 39%(middle(management(( 247(Surveys(
  14. 14. 14( Quality$Consor.um$Assessment$ !  428(sponsor(surveys(were(deployed(resul3ng(in(feedback(from(334( individuals( "  Overall(response(rate:(78%( "  Completed(surveys/company:(10d46((note(that(there(was(no(associa3on( between(company(size(and(number(of(respondents)( "  Range(of(response(rates/company:(50%d100%( !  298(CRO(surveys(were(deployed(resul3ng(in(feedback(from(207(individuals( "  Overall(response(rate:(69%( "  Completed(surveys/company:(4d59((note(that(there(was(no(associa3on( between(company(size(and(number(of(respondents)( "  Range(of(response(rates/company:(27%d100%(
  15. 15. Part$1:$$Framing$the$Quality$Issue$ Overall(percep3ons(and(the( “disconnects”(between(sponsors(and( CROs(around(issues(of(quality(
  16. 16. 16( Methods$ !  “Quality”(was(defined(as(“The$ability$to$effec.vely$and$efficiently$answer$ the$intended$ques.on$about$the$benefits$and$risks$of$a$medical$product$ or$procedure$while$assuring$pa.ent$safety$and$protec.on$of$human$ subjects”$ !  As(examples,(elements(of(a(quality(clinical(study(were(said(to(include,(but( not(limited(to:( "  Scien3fically(valid(and(ethically(sound(experimental(design( "  Adequate(protec3on(of(subjects’(rights,(safety(and(welfare( "  Qualified(personnel( "  Adequate(monitoring( "  Current,(complete,(and(accurate(data( "  Accurate(presenta3on(and(interpreta3on(of(data(
  17. 17. 17( Industry$Survey$Sponsors:$Overall$ Sa.sfac.on$
  18. 18. 18( Consor.um$Sponsors:$Sa.sfac.on$ with$Quality$
  19. 19. 19( Consor.um$Sponsors:$Comparison$of$ CRO$Quality$to$Sponsor$Internal$ Teams$
  20. 20. 20( Sa.sfac.on$with$Quality$
  21. 21. 21( Industry$Survey:$Provider$Sa.sfac.on$
  22. 22. 22( Sponsors:$Sa.sfac.on$with$Quality$ Areas(with(rela3vely(high(sa3sfac3on(included:( !  Compliance(with(SOPs(and(other(wrimen(procedures( !  Data$quality$and$integrity$ !  Audit(plans(and(execu3on( Areas(with(rela3vely(high(dissa3sfac3on(included:( !  Oversight(of(third(party(vendors( !  Governance(of(quality( !  Communica3ons(surrounding(quality( !  Availability(of(quality(personnel(for(projects( !  Efficiency/.meliness$in$achieving$clean$data$ !  Adherence(to(monitoring(plan(
  23. 23. Part$2:$$Causes$of$Quality$Issues$
  24. 24. 24( Causes$of$Issues$with$Quality$ “CROs,$as$service$providers,$are$heavily$incented$to$ deliver$and$measure$quality$–$and$are$prepared$to$do$ so.$$Too$many$sponsors$are$not$prepared$to$do$their$ part$in$assuring$a$rela5onship$focused$on$quality.$$So$ CROs$are$forced$to$implement$one$model$for$sponsors$ ready$to$focus$on$quality,$and$another$for$the$many$ focused$on$ac5vi5es$and$unit9level$cost.”$ ( ( (d(Quota3on(from(an(Industry(Survey(Provider(Respondent( ( (
  25. 25. 25( Causes$of$Issues$with$Quality:$Sponsor$ Consor.um$Data$
  26. 26. 26( Industry$Survey:$Causes$of$Issues$with$ Quality$
  27. 27. 27( Quality$vs.$Costs$
  28. 28. 28( Causes$of$Issues$with$Quality$ #1:$Cost$Pressures$ “The$focus$on$price$has$driven$out$the$reality$of$adequate$ monitoring$and$proper$Quality$Control$processes$to$ensure$quality$ at$the$site$level…$Too$many$procurement$officers$are$making$ decisions$purely$on$cost$without$regards$to$quality$product.”$ “Price$pressures,$especially$discounts…have$caused$some$CROs$to$ cut$corners$and$send$work$to$low$cost$regions$without$adequately$ trained$staff.”$ “Price$reduc5ons$required$to$‘play$the$game’$in$the$preferred$ provider$selec5on$process$make$it$very$difficult$to$con5nue$to$ resource$adequately.$$Sponsors$say$they$will$streamline$processes$ going$forward$to$reduce$workload$but$hardly$ever$do.”$
  29. 29. 29( Causes$of$Issues$with$Quality$ #2:(Sponsors(DecisiondMaking(with( Impacts(on(Quality((without(provider( input)( !  Oversight((level(of(monitoring)( !  Protocol(design( !  Inves3gators(&(regions( !  Timelines( !  Processes( !  Thirddparty(vendors( “It$is$difficult$to$ensure$quality$for$a$func5onal$provider$for$monitoring,$when$ the$protocol$design/site$selec5on$are$done$by$another$CRO/sponsor.”$ “There$is$a$percentage$of$work$that$we$perform$that$is$working$with$the$ sponsor$processes,$etc…in$these$circumstances,$quality,$5meliness,$training,$ governance$and$oversight$are$dictated$by$sponsor$requirements.”$
  30. 30. 30( Causes$of$Issues$with$Quality$ #3:$Sponsor$Failure$to$Proac.vely$Make$Decisions$or$ Communicate$with$Providers$about$Quality$Expecta.ons$ Industry(survey(data:( !  Only(55%(of(sponsors(are(sa3sfied(with(their(companies’(iden3fica3on(of(process/ deliverables(for(which(quality(expecta3ons(of(CROs(need(to(be(set.( !  Only(58%(feel(that(their(companies(effec3vely(communicate(quality(expecta3ons( to(CROs( !  Strong(associa3on(between(“proac3ve”(management(of(quality(and(ability(to( forego(micromanagement.(
  31. 31. Part$3:$$Results$ What(can(be(done(to(enhance(quality(while( reducing(micromanagement?( What$quality$prac.ces$are$associated$with$ enhanced$sa.sfac.on?$
  32. 32. 32( Industry$Survey$Sponsors:$Quality$ Metrics$
  33. 33. 33( Consor.um$Survey:$Quality$Metrics$
  34. 34. 34( Quality$Agreements$
  35. 35. 35( Industry$Survey$Sponsors:$Quality$ Agreements$
  36. 36. 36( Industry$Survey$Sponsors:$Quality$ Agreements$
  37. 37. 37( Other$Prac.ces$Impac.ng$Quality$ Risk$Based$Approaches$ !  57%(of(sponsors(and(58%(of(CROs(use(a(formal,(riskdbased( approach(to(levels(of(site(monitoring((industry(survey(data)( "  About(2/3(have(had(primarily(posi3ve(experiences(–(1/3(mixed( !  Most(sponsors((67%)(and(CROs((79%)(do(maintain( documenta3on(of(site(performance(on(previous(trials(to( factors(into(such(models.( "  Performance(data(most(commonly(includes(number(of(protocol( viola3ons,(number(of(queries,(type(and(severity(of(protocol( viola3ons,(promptness(of(data(entry,(types(of(queries,(and(3me( to(resolu3on(of(queries.(
  38. 38. 38( Quality$by$Region$
  39. 39. 39( Summary$ !  While(developing(standards(and(more( efficient(ways(for(sponsors(and(CROs(to(work( together(is(necessary,(it(has(been( challenging.( !  There(is(greater(poten3al(for(success(in( terms(of(the(ability(to(quickly(move(towards( standards:( ( ( (Quality(Agreements( ( ( (Quality(Metrics( !  There(is(no(onedsize(fits(all(CRO(model(
  40. 40. Open$Discussion$ ( Thank(You(
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