what does a patient-focused clinical trial really … · 2019. 3. 12. · in a clinical trial, why?...
TRANSCRIPT
#Patients2019
WHAT DOES A PATIENT-FOCUSED CLINICAL TRIAL REALLY LOOK LIKE?
D I S R U P T I N G T H E C U R R E N T C L I N I C A L T R I A L P A R A D I G M
SCOTT SCHLIEBNERMARCH 11 , 2019
#Patients2019
WHAT DO THESE TERMS REALLY MEAN?
P A T I E N T - F O C U S E D
P A T I E N T R I C I T Y
P A T I E N T - C E N T R I C
P A T I E N T S A S P A R T N E R S
P A T I E N T - C E N T E R E D
D I R E C T - T O - P A T I E N T S
P A T I E N T C E N T E R E D N E S S
“When you/your organization include and involve patients
and their perspective in everydecision you make”
#Patients2019
IS TRULY “PATIENT-FOCUSED” REALISTIC?
• A CRAWL, WALK, RUN APPROACH
• AT WHICH STAGES IS PATIENT INVOLVEMENT MOST CRITICAL?
• WHAT DOES THE END USER/CONSUMER WANT?
• MINIMIZE THE BURDEN OF PARTICIPATION
#Patients2019
THE WORLD’S FIRST CLINICAL TRIAL
#Patients2019
CURRENT PARADIGM: CLINICAL TRIAL LIFECYCLE
#Patients2019
WHAT IS WRONG WITH THIS PICTURE?
• PROTOCOL DESIGNED WITHOUT INPUT FROM SITE STAFF OR PATIENTS
• IS THE SCHEDULE OF EVALUATIONS REALISTIC?
• DOES THE STUDY APPEAL TO PATIENTS?
• HOW MUCH WILL PARTICIPATION COST ($)?
• HOW BURDENSOME WILL PARTICIPATION BE?
#Patients2019
THIS IS OUR COLLECTIVE EXPERIENCE
BUT HOW DO PARTICIPANTS, PATIENTS, AND CAREGIVERS FEEL?
WE ASKED THEM.
#Patients2019
W H A T W A S Y O U R P R I M A R Y M O T I V A T I O N F O R P A R T I C I P A T I N G I N
A C L I N I C A L T R I A L ?
1 . A D V A N C E M E N T O F R E S E A R C H I N T O M Y D I S E A S E
2 . N O O T H E R T R E A T M E N T O P T I O N S A V A I L A B L E
3 T O R E C E I V E A C C E S S T O H I G H Q U A L I T Y M E D I C A T I O N
4 . C U R R E N T A P P R O V E D T R E A T M E N T I S N O T W O R K I N G
PRA Health Sciences Rare Disease Patient Survey:Data collected 01Aug18 – 30Sep18: N=47
#Patients2019
W H A T W E R E T H E M O S T C H A L L E N G I N G B A R R I E R S Y O U
F A C E D W H I L E P A R T I C I P A T I N G ?
1 . T R A V E L T O / F R O M S I T E V I S I T S
2 . T I M E C O M M I T M E N T
3 . F I N A N C I A L S T R A I N
4 . S T R A I N O N F A M I L Y A N D / O R C A R E G I V E R S
5 . I N V A S I V E P R O C E D U R E S ; C U L T U R A L B A R R I E R S ; A C C E S S I B I L I T Y ; S I D E E F F E C T S
PRA Health Sciences Rare Disease Patient Survey:Data collected 01Aug18 – 30Sep18: N=47
#Patients2019
I F Y O U H A V E N ’ T P A R T I C I P A T E D I N A C L I N I C A L T R I A L , W H Y ?
1 . D I D N O T M E E T E L I G I B I L I T Y C R I T E R I A
2 . C L I N I C A L T R I A L W A S N O L O N G E R E N R O L L I N G
3 . T H E T R I A L S I T E W A S T O O F A R A W A Y
4 . I T W A S N E V E R O F F E R E D T O M E
5 . S O C I A L , E M O T I O N A L , F I N A N C I A L ; U N F A M I L I A R W I T H T H E P R O C E S S ; S C A R E D
PRA Health Sciences Rare Disease Patient Survey:Data collected 01Aug18 – 30Sep18: N=47
#Patients2019
H O W D O W E O V E R C O M E T H E S E C H A L L E N G E S A N D B A R R I E R S ?
H O W D O W E B R I N G C L I N I C A L T R I A L S D I R E C T LY T O P A T I E N T S A N D F A M I L I E S ?
W H A T D O E S A S U S T A I N A B L E , F E A S I B L E , A N D P A T I E N T- F O C U S E D P A R A D I G M L O O K L I K E ?
#Patients2019P R A H E A L T H S C I E N C E S
W H A T D O E S A P A T I E N T - F O C U S E D C L I N I C A L T R I A L R E A L L Y L O O K L I K E ?
C L I N I C A L T R I A L S S H O U L D F I T S E A M L E S S L Y
I N T O A P A T I E N T ’ S L I F E
#Patients2019
SPIROMETERS 12-LEAD EKG
BLOOD PRESSURE
GLUCOMETERS
SCALEPULSE/OX
W H A T D O E S A P A T I E N T - F O C U S E D C L I N I C A L T R I A L R E A L L Y L O O K L I K E ?
T H E V I R T U A L I T Y O F C L I N I C A L T R I A L S
#Patients2019
THE BIGGEST HOTELIER IN THE WORLD……HAS NO HOTEL ROOMS
THE LARGEST TAXI SERVICE IN THE WORLD……OWNS NO VEHICLES
OUR FUTURE CARS……WILL HAVE NO DRIVERS
THE FUTURE OF CLINICAL TRIALS……WILL REVOLVE AROUND PATIENTS AND SEAMLESSLY FIT INTO PATIENT’S LIVES
W H E R E A R E W E H E A D E D ?
#Patients2019P R A H E A L T H S C I E N C E S
O V E R C O M I N G T H E C H A L L E N G E S O F R A R E D I S E A S E C L I N I C A L R E S E A R C H
T H A N K Y O U !T H A N K Y O U !
SCOTT SCHLIEBNER
Senior Vice President
Center for Rare Diseases
PRA Health Sciences