Assessing  the  Quality  of  {Company’s}  Rela8onship  with  its  Inves8ga8ve  Sites  

A=er  Conduc8ng  a  Study          

 {Date}  

1  

Table  of  Contents  

Slide  #  

Project  Background   3  

Business  Objec9ves   4  

Survey  Methodology   5  

Execu9ve  Summary   6  

Overall  Rela9onship  Quality  Ra9ng   13  

Training  Evalua9on   19  

Sponsor  Contact   22  

Diagnos9cs  -­‐  Project  AOributes   27  

Clinical  Research  Process   37  

Benchmark  Analysis   44  

Background   69  

2  

Project  Background  •  {Sponsor  Company}  conducted  a  clinical  study(ies)  {domes9c  and/or  interna9onal}  {Protocol  Title},  las9ng  X  weeks.      

•  The  study(ies)  were  completed  in  {Year}  and  involved  X  number  of  pa9ents.  

•  Some  of  the  challenges  associated  with  the  study  included:  –  An  extremely  complex  protocol  –  The  requirement  of  a  high  level  of  pa9ent  care  –  The  use  of  new  EDC  technology  

3  

Business  Objec8ves  •  Given  the  complexity  of  the  protocol  and  the  various  study  challenges,  {Sponsor  Company}  was  interested  in:  –  Assessing  how  inves9ga9ve  sites  perceive  their  overall  rela9onship  with  {Sponsor  Company}.  

–  Determining  how  {Sponsor  Company}  performed  as  a  clinical  trial  sponsor:  •  Specifically,  determine  areas  of  strength  and  areas  where  improvement  is  necessary.  

•  {Sponsor  Company}  intends  to  apply  the  learning  from  this  research  to  future  clinical  studies.  

4  

Survey  Methodology  

•   Base  survey  instrument  ini9ally  developed  by  CenterWatch  for  its  global  sponsor/contract  research  organiza9on  and  site  rela9onship  surveys.    This  base  survey  instrument  was  then  customized  with  {Sponsor  Company’s}  input  to  produce  the  final  ques9onnaire.  

•   Survey  conducted  online  in  {DATE}.  •   Survey  emailed  to  X  number  of  inves9gators  and  study  coordinators  worldwide.    

•   Final  sample  size  was  n=X,  indica9ng  a  X%  response  rate.  

•   Respondents  had  an  average  of  10  years  clinical  research  experience  •   The  final  sample  was  composed  of:  

•   39%  Inves9gators  •   60%  Study  Coordinators  

5  

6  

•  Overall,  inves9ga9ve  sites  rate  the  quality  of  their  rela9onship  with  {Sponsor  Company}  highly  and  enjoy  working  with  the  company  as  a  clinical  trial  sponsor:  –  The  suppor9ve,  knowledgeable  and  professional  staff,  as  well  as  the  crea9on  of  a  team  environment  primarily  drove  posi9ve  percep9ons  of  the  company.  

–  When  compared  to  previous  CenterWatch  inves9ga9ve  site  surveys  conducted  in  the  US  and  Europe,  {Sponsor  Company}  overall  rela9onship  quality  ra9ng  surpasses  the  average  sponsor  ra9ngs.  

–  Study  coordinators  and  inves9gators  share  the  same  posi9ve  percep9ons  of  {Sponsor  Company}.  

 

Execu9ve  Summary  

What  Worked  Well  

7  

•  Training  programs  achieved  strong  ra9ngs.    The  inves9gator  mee9ng  and  the  Workshop  were  rated  par9cularly  highly.    

•  Sites  also  perceived  {Sponsor  Company}  to  communicate  effec9vely  -­‐  responding  to  inquiries  in  a  9mely  manner  and  generally  being  sa9sfied  with  the  responses  to  their  inquiries.    

•  The  Electronic  Data  Capture  technology  was  perceived  to  be  very  user-­‐friendly,  regardless  of  one’s  experience  level  with  EDC.      

 

8  

What  Worked  Well  (cont’d)  

PERSONNEL  

STUDY  INITIATION  AND  MAINTENANCE  

Professional  and  knowledgeable  staff  

Informa9ve  inves9gator  mee9ngs  

Timely  drug  availability    

Study-­‐related  materials  readily  available  

Study  Reference  Guides  provided  and  updated  

On  specific  project  aOributes,  {Sponsor  Company}  performed  par9cularly  well  in  these  areas…  

Improvement  Areas  •  While  most  were  generally  very  sa9sfied  with  their  experience  with  {Sponsor  Company},  it  is  worth  no9ng  that  issues  were  expressed  in  the  following  areas:  –  High  monitor  turnover  –  Infrequent  monitoring  visits  –  Quality  issues  with  third  par9es:    

•  {X  Company}  (delayed  lab  results    and  poor  responsiveness  to  inquiries)    •  {X  Company}  (high  monitor  turnover)  

–  Lack  of  flexibility  with  the  budget,  especially  in  cases  where  the  study  is  extended  

–  EDC:      A  few  men9oned  some  difficulty  entering  correc9ons  in  the  system  and  some  experienced  issues  with  the  speed  of  the  system  (i.e.  opening  the  program).    

9  

10  

FINANCIAL  

CLINICAL  DATA  MANAGEMENT  

Fairness  of  grant  payment  amounts  

Promptness  of  grant  payments  

Efficiency  of  the  query  handling  process  

Monitor  turnover  

On  specific  project  aOributes,  there  is  room  for  improvement  in  these  areas…  

Improvement  Areas  

PERSONNEL  

Willingness  to  modify  study  budgets  

Provide  adequate  funding  for  pa9ent  recruitment  

OVERALL  RELATIONSHIP  QUALITY  RATING  

{Sponsor  Company}  

11  

Overall  Ra8ng  of  Rela8onship  

16.3%  

41.3%  

42.3%  

0%  

25%  

50%  

75%  

100%  

(n=104)  

Excellent  

Good  

Average  

Fair  

Poor  

0%  

12  

0%  

Percent  Ra8ng  

Poor   Excellent  

4.3  

5  1  

Mean  Ra8ng  

Respondents  rate  their  overall  rela0onship  with  {Sponsor  Company}  as  Good  to  Excellent.  

*May  not  add  up  to  100%  due  to  rounding  

General  Rela8onship  Quality  Drivers  LIKES  SUPPORTIVE,  PROFESSIONAL  AND  KNOWLEDGEABLE  STAFF/READILY  AVAILABLE/FELT  LIKE  PART  OF  TEAM  

73.0%  

REALISTIC,  WELL-­‐DESIGNED  PROTOCOL   9.5%  

GREAT  COMMUNICATION/  INFORMATION  SHARING  

7.9%  

AVAILABILITY  AND  QUALITY  OF  TRAINING  PROVIDED  

6.3%  

OTHER   3.2%  

13  

DISLIKES  NONE   64.7%  

   MONITOR  TURNOVER/INFREQUENT        MONITOR  VISITS/LACK  OF  IMMEDIATE        ASSISTANCE  

11.8%  

QUALITY  ISSUES  WITH  THIRD  PARTIES   7.8%  

LACK  OF  RESPECT  FOR  SITES/OPINIONS  OF  INVESTIGATOR  

5.9%  

OTHER   9.8%  

The  professionalism,  friendliness  and  responsiveness  of  the  staff,  as  well  as  the  crea0on  of  a  team  environment,  primarily  drove  posi0ve  percep0ons  of  {Sponsor  Company}.    While  most  respondents  did  not  men0on  any  dislikes,  some  expressed  issues  with  monitor  turnover/lack  of  monitoring  visits,  quality  issues  with  third  par0es  involved  and  the  occasional  lack  of  respect  for  the  judgment  of  inves0gators.  

TRAINING  EVALUATION  {Sponsor  Company}  

14  

Training  Evalua8on  

TRAINING  TYPE  

Inves9gator  mee9ng  

Workshop  

Training  on  study  specific  procedures  

Ini9a9on  visits  

Training  on  worksheet  comple9on  (SAE,  weight  &  dose  calcula9on  worksheet)  

Training  on  EDC  technology  

Source  document  verifica9on  (SDV)  data  review  process  

Disease  ac9vity  proficiency  test  

On-­‐site  GCP  training  

15  

Poor   Excellent  

1   5  4.41  

4.34  

4.28  

Mean  Ra8ng  

4.27  

4.26  

4.24  

4.20  

4.18  

4.11  

Respondents  rate  all  training  programs  favorably,  with  the  inves0gator  mee0ng  and  the  Workshop  ranked  highest.  

SPONSOR  CONTACT  {Sponsor  Company}  

16  

Sponsor  Contact  During  Studies  

5.7%  

78.4%  

5.7%   10.2%  Times  per  Month  

Mean     3  

High   30  

Low   0  

17  

Just  Right  

Too  Low  

Don’t  Know   Too  High  

Was  the  number  of  different  personnel  who  contacted  you  during  studies…  

On  average,  how  many  8mes  a  month  were  you  in  contact  with  {Sponsor}  or  designee  in  a  typical  month?  

Most  respondents  perceive  the  number  of  personnel  who  contact  them  during  studies  appropriate.    The  frequency  of  contact  varies,  averaging  3  0mes  a  month.  

Measuring  Communica8on  Effec8veness:  Timeliness  of  Responses  to  Communica2on  from  Site  

2.3%  

18.2%  

27.3%  

50.0%  

0%  

25%  

50%  

75%  

100%  

Timeliness  of  Responses  

Excellent  

Good  

Average  

Fair  

Poor  

0%  

18  

Percent  Ra8ng  

Poor   Excellent  

4.3  

5  1  

Mean  Ra8ng  

Most  respondents  perceive  {Sponsor  Company}  to  respond  to  inquiries  in  a  0mely  manner.  

DIAGNOSTICS  –  PROJECT  ATTRIBUTES  

{Sponsor  Company}  

19  

Project  Ahribute  Summary  

20  

Improvement  Areas  

Areas  of  Strength  

ü Professional  and  knowledgeable  staff  ü Providing  appropriate  inclusions/exclusions  for  disease  under  study  ü Timely  drug  availability  ü Study-­‐related  materials  readily  available  ü Study  reference  guides  provided  and  updated  as  necessary  ü Informa9ve  inves9gator  mee9ngs  

ü Flexibility  –  willingness  to  modify  study  budgets  ü Providing  fair  overall  grant  payment  amounts  ü Monitor  turnover  ü Query  handling  process  ü Providing  prompt  payment  of  grants  ü Providing  adequate  funding  for  pa9ent  recruitment  

*No  significant  differences  were  found  between  the  inves2gators  and  study  coordinators  across  all  project  aAributes.  

CLINICAL  RESEARCH  PROCESS  {Sponsor  Company}  

21  

Electronic  Data  Capture  Technology:  Ease  of  Use  

2.5%  

24.1%  

34.2%  

36.7%  

0%  

25%  

50%  

75%  

100%  

EDC  

Extremely  easy  to  use  Very  easy  to  use  

Easy  

Somewhat  not  easy  to  use  Not  easy  to  use  at  all  

0%  

22  

Percent  Ra8ng  

Not  easy  at  all  

Extremely  easy  

4.1  

5  1  

Mean  Ra8ng  

While  most  respondents  perceive  the  electronic  data  capture  technology  to  be  user-­‐friendly,  some  indicated  issues  with  entering  correc0ons/revising  data.    

Looking  Ahead:    Improvements  for  Future  Studies  

OVERALL  GREAT  EXPERIENCE  –  NO  RECOMMENDATIONS   51.9%  

SHOW  FLEXIBILITY  WITH  REGARDS  TO  BUDGET    -­‐    ESPECIALLY  IF  STUDY  IS  EXTENDED   14.8%  

LESS  MONITOR  TURNOVER/ISSUES  WITH  INTERMEDIARIES   11.1%  

OTHER:   22.2%  

 Early  feedback  in  protocol  process  reduces  amendments  later  

 Design  a  simpler  protocol  and  CRF  

 Training  for  new  coordinators  (site  may  not  provide  adequate  training)  

 Involve  inves9gators  more  in  data  analysis  and  presenta9on  

23  

Half  of  respondents  had  a  great  experience  overall  with  {Sponsor  Company}  and  did  not  have  any  recommenda0ons  for  the  future  .    15%  recommended  reviewing/upda0ng  the  budget  when  a  study  extension  occurs.    Finally,  some  expressed  dissa0sfac0on  with  {Company}  for  high  monitor  turnover  and  (Company}  for  delayed  laboratory  results.  

Par8cipa8ng  Countries  

Country  

United  States   39.4%  

Argen9na   8.5%  

Brazil   8.5%  

Taiwan   5.6%  

Korea   4.2%  

Germany   2.8%  

India   2.8%  

Israel   2.8%  

Italy   2.8%  

Mexico   2.8%  

Philippines   2.8%  

Canada   1.4%  

24  

Country  

Australia   1.4%  

Chile   1.4%  

Colombia   1.4%  

Czech  Republic   1.4%  

France   1.4%  

Peru   1.4%  

Poland   1.4%  

Puerto  Rico   1.4%  

Romania   1.4%  

Spain   1.4%  

Sweden   1.4%