workshop patient-centric clinical trials · 2020. 9. 15. · ii-iii studies used a patient-centric...

© 2019 Parexel International Corporation / CONFIDENTIAL

Patient-centric

Clinical Trials

Pia Schmidt

5th & 6th June 2019, Med. Logistica, Leipzig

© 2019 Parexel International Corporation

Agenda

Introduction

The patient centric study design

Direct to patient clinical trial supply

2

virtual trials/ “Trials at home”/ direct to patient shipments


right now, there are more than

40,000 clinical

studies recruiting patients in the U.S. alone,

with some requiring thousands of participants,

each of whom must meet precise criteria to join.

So it’s not surprising that 80% of these

important studies are delayed due to

recruitment problems

Facts and Figures

85% 30 %

of clinical trials fail to

retain enough patients…

average dropout rate

across all clinical trials

estimated average

clinical trial cost

per-patient phase III

equates to

participants live more

than two hours away

from their nearest study

center, something which

hits recruitment and

retention

of potential

over 75% of

respondents reporting

that a home delivery

service was considered

helpful

http://phrma-docs.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-

clinical-trials-impact-on-state-economies.pdf

http://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-

trials-offering-science-37

https://forteresearch.com/news/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/

http://mediaroom.sanofi.com/sanofi-launches-digital-clinical-trials-to-improve-recruitment-

and-reduce-trial-times/#!

http://blog.ispe.org/patient-perceptions-imps-survey-part-2


The same EIU study also found that Phase II-III studies that used a patient-centric

approach were 19% more likely to launch. That percent increased in certain

therapeutic areas like oncology and neurology.

Phase II-III Studies using a patient-centric approach are

19% more likely to launch

Source: Pharmaprojects® | Pharmaintelligence, 2018. Data: 2012-2017.

Phase II and III likelihood of

launch for patient-centric

trials vs. all trials By therapy area

All therapy areas

Neurology Oncology Rare diseases

All trials Patient-centric trials 100%

80%

60%

40%

20%

0%

4


In the June 2018 report,

The Innovation Imperative:

The Future of Drug Development

by The Economist Intelligence

Unit and commissioned by

Parexel, only 5.3% of phase

II-III studies used a patient-centric

approach

Only 5% of phase II-III studies using a patient-centric

approach

*Innovation adoption rate is defined as the number of phase II and phase III trials indicating use of innovation during the above period, as

percentage of trials where innovations were not present from the same period of time.

Source: Trialtrove® Pharmaintelligence, 2018. Data: 2012-2017.

0,6%

5,2%

13,7%

0,3%

Adaptive Patient-centric Precisionmedicine

Real-worlddata

Adoption rates of the selected innovation*

5


Case studies demanding for „trial at home“ setting

Health claim verification trial, child nutrition

> 60 investigational sites

2000+ patients >10 countries in EMEA and APAC

Challenges:

Investigational product is of huge volume + long timelines between dispensation visits

patients cannot carry dispensed product home

Competitive trial: DtP ideal to guarantee patient enrolment and patient retention

Child nutrition and health claim studies are handled differently per country regulations


Case studies demanding for „trial at home“ setting

Orphan drug for pulmonary disease

>50 investigational sites

~80 patients in US

Challenges:

Investigational product is dangerous goods (medicinal gas)

Limited number of eligible Patients, often living far away from clinical sites

Homecare required for treatment of critically ill patients


The new patient journey

Patient

Patient Centric Protocol Optimization (PCPO): Understand patient study burden to aid virtual trial strategy creation

Patient Advocacy Group (PAG) Relationships: Raising awareness of study opportunities in the patient community

Consent+: Online study consenting

Mock Trial Visit: Walk a day in the life of a study with stakeholders

Patient Education Materials: Provide clear and simple study information to participants. Recruitment, retention and disease awareness materials. Mention digital e.g. PRR platform

Home Nursing: Study tests/ procedures provided in patient’s home

Patient App: Study information and support provided on patient’s smartphone/computer

Direct-to-Patient (DTP) Drug Shipments: Study drug/device delivered direct to the patient’s home

Wearables/Sensors: Continuous monitoring of patient health outcomes

Virtual Trials: Bringing the study to a patient’s home to reduce burden Study-Specific / Trial Alumni Communities:

Online information and support for current and past participants

Lay Study Results / Thank You: Acknowledging patient efforts in the study

Post-Trial Surveys: Eliciting participant feedback to make future studies more patient friendly

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How are operations

impacted?


Clinical operations and supply logistics are impacted

Direct

Communication

Remote

Communication

Immediate / direct

control & oversight

Self-control and

remote oversight

Batch Supply Patient Tailored Supply

© 2019 Parexel International Corporation 11

How to organize a homecare visit

PI obtains consent

and screens

patient on site

PI refers patient

to homecare vendor

Patient visits

scheduled nurse

allocated

Nurse trained

on protocol

Nurse contacts

patient and

confirms the visit

Nurse re-contacts

patient 24 hours

in advance

Courier(s) booked

to coincide with

home visit

Nurse conducts

home visit

Nurse liaises

with courier at

patient’s home for

sample shipping

Source data

captured

and securely

transmitted to site


Systems integrate to facilitate direct-to-patient shipments

Pharmacy tech

Study nurse

Shipment

Patient

Kits IRT

IMP shipment to site Pharmacist collect and pack

packages allocated to

patients

Shipment to patient‘s home

Hand-over to patient or

home care nurse

Courier

Booking

System

IRT allocates

kit numbers to patient

and issues dispensing

information

Shipment

Doctor

Site provides patient

name and address to

courier system

Site staff logs into courier system, enters patient‘s

number, name and address

Patient data

Study Nurse

Shipment booking

IRT: Interactive Response Technology


Links the medication package to IRT and study systems

Allows direct interaction of patients and sites with the medication package

IoT Technology enables direct Patient interaction and

ensures oversight…

Connect medication to IRT

Mobile App and Patient

Engagement App

Allows easy tracking and

additional information

E Labels

Barcoded

Packages

Intelligent Packages

Change label text e.g. expiry

date and study code by

external signal

Allows easy updates. Can

support pooling through IRT

integration

Track and transmit data e.g.

temperature, drug

consumption by sensor

Allows real time tracking and

provide compliance data


Summary

Increased patient recruitment

Improved patient compliance

Increased probability to launch

Special systems/ technologies needed

Special logistics/ courier requirements

Special site staff/ clinical trial staff training


For more information please contact:

Pia Schmidt: [email protected]

Nicola Grehn (Parexel Academy): [email protected]

Questions?


Thank you

workshop patient-centric clinical trials · 2020. 9. 15. · ii-iii studies used a patient-centric...

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