Transcript patients - Community

Getting Engaged:
OC15 Closing Session
Cal Collins
CEO, OpenClinica
1
Amsterdam Canal Cruise
©
#OC15Europe
2
The ‘Which’ Problem
Which patients are
[eligible for my clinical trial]?
- Leonard D’Avolio, Harvard Medical School
©
#OC15Europe
3
The ‘Which’ Problem
Which patients are
[likely to benefit from this drug]?
©
#OC15Europe
4
The ‘Which’ Problem
Which patients are
[likely to benefit from this device]?
©
#OC15Europe
5
The ‘Which’ Problem
Which patients are
[able to manage their chronic condition]?
©
#OC15Europe
6
The ‘Which’ Problem
Which patients are
[able to access needed care]?
©
#OC15Europe
7
The ‘Which’ Problem
Which sites are
[likely to recruit patients to my trial]?
©
#OC15Europe
8
The ‘Which’ Problem
Which intervention is
[most cost effective]?
©
#OC15Europe
9
The ‘Which’ Problem
Which doctors are
[likely to prescribe this drug]?
©
#OC15Europe
10
The ‘Which’ Problem
 Pharma, government, and healthcare are grappling with
what really provides value, how to evaluate/measure it
 Better answers require better solutions that:
 Enable more cost-effective randomized trials
 Advance translational medicine
 Better incorporate “-omics” science into clinical research
and practice
 Get more and higher quality real-world ‘big data’
 Engage patients as first class stakeholders in research
©
#OC15Europe
11
‘Which’ Solution?
 Our community is using OpenClinica as part of the
solution, often by integrating with other powerful tools or
augmented with custom built extensions.
 The difficulty of meaningful, timely engagement with
study participants is a large obstacle to successful
research. After all, there are no trials without these
valued volunteers.
©
#OC15Europe
12
It’s 2015!
 90% of adults have smartphones, 81% text, and 63%
use their phone to go online (Pew). Even older age
groups are adopting smartphones at a rapid pace.
©
#OC15Europe
13
Get Engaged
 Technology revolutions happen by democratizing and
commoditizing information, through automation and scaling
with low-to-zero marginal costs.
 Everyone (almost) carries a network-connected
supercomputer around with them 90%+ of their waking
lives
©
#OC15Europe
14
Designing Research Closer to the
Participant
©
#OC15Europe
15
The Best of Both Worlds
An approximate answer to the right problem is worth a good deal more
than an exact answer to an approximate problem.
-John Tukey
Can we…
 Combine the rigor and exactness of RCTs with a big
data approaches that yields richer answers about how
the real world works,
 Move at Internet speed; save money and increase the
pace of research,
 While ensuring patient safety, dignity, and privacy are
protected better than ever before?
©
#OC15Europe
16
The Best of Both Worlds
OpenClinica’s foundations are
 Strong data provenance, audit trails, privacy protections,
and GCP compliance,
 An open Source community that rapidly disseminates
ideas and code, collaborates openly, welcomes new
participants, and hold each other to rigorous quality
standards.
The OpenClinica platform of the future will be
 Mobile-centric
 Real-time
 Patient and esource focused.
©
#OC15Europe
17
What is holding us back?
 In the race to ‘mHealth’, apps are not always what they
are cracked up to be:
A recent study in BMC Medicine found 67% of insulin
dose calculator smartphone apps may contribute to
incorrect dose recommendations
- mobihealthnews.com
 However, obsolescence is nearly as bad:
“In mHealth… the technology may be obsolete before the trial is
completed. Components of mHealth interventions may need to
continuously improve during a trial. mHealth’s capabilities may
change… existing research methods and may even enable
development of new, more efficient designs
-Kumar et al. doi: 10.1016/j.amepre.2013.03.017
©
#OC15Europe
18
What is holding us back?
 New methods take time to adopt. Consider a pain scale:
Source: xkcd.com
©
#OC15Europe
19
What is holding us back?
 Regulatory burden - the ‘triple whammy’ of BYOD ePRO:
 Instrument validation - across devices and screen sizes
 Attributability - ensure it was the patient who completed it,
in a way that’s at least as good as paper
 eSource concerns – investigator control/retention of
records
©
#OC15Europe
20
The Big Bet
 Mobile technology can be a highly effective way
to meaningfully engage participants in research:




Improving recruitment and retention
Reducing in-person visits while getting better data
Improving medication adherence
Getting a better picture of AEs and side effects
©
#OC15Europe
21
The Big Bet
 Engagement with patients using a mobilecentric, real-time approach can be a big part of
solving our ‘which’ problem.
©
#OC15Europe
22
OpenClinica Toolkit
Going forward, OpenClinica will offer a richer, more diverse
solution for meet the challenges of modern research
 New mobile-friendly form engine
 Dynamic, customizable dashboards
 Easier to build reusable custom modules in a consistent
manner
 Better REST API
 Visual design environment
 Make sharing easy and seamless
©
#OC15Europe
23
Engaging as a Community
 Continue to participate and share as global & open
community
 Ensure data provenance is the strongest part of our
foundation
 Build ties with other OSS health technology communities





OpenRosa/JavaRosa
Enketo
tranSMART
TraIT
Sage
©
#OC15Europe
We can answer the ‘which’ questions!
24
Thank You!
 All our presenters, demonstrators,
and workshop facilitators including
keynote John Wilbanks
 Rodica, Tia, and Rob, conference
center and hotel staff, and all those
who planned the event
 All of our attendees!!!
©
#OC15Europe
25