Getting Engaged: OC15 Closing Session

Cal CollinsCEO, OpenClinica

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Amsterdam Canal Cruise

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The ‘Which’ Problem

Which patients are

[eligible for my clinical trial]?

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- Leonard D’Avolio, Harvard Medical School

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The ‘Which’ Problem

Which patients are

[likely to benefit from this drug]?

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The ‘Which’ Problem

Which patients are

[likely to benefit from this device]?

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The ‘Which’ Problem

Which patients are

[able to manage their chronic condition]?

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The ‘Which’ Problem

Which patients are

[able to access needed care]?

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The ‘Which’ Problem

Which sites are

[likely to recruit patients to my trial]?

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The ‘Which’ Problem

Which intervention is[most cost effective]?

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The ‘Which’ Problem

Which doctors are

[likely to prescribe this drug]?

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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

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‘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.

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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.

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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

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Designing Research Closer to the Participant

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The Best of Both Worlds

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?

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An approximate answer to the right problem is worth a good deal more than an exact answer to an approximate problem.

-John Tukey

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The Best of Both WorldsOpenClinica’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.

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What is holding us back? In the race to ‘mHealth’, apps are not always what they

are cracked up to be:

However, obsolescence is nearly as bad:

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A recent study in BMC Medicine found 67% of insulin dose calculator smartphone apps may contribute to incorrect dose recommendations

- mobihealthnews.com

“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

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What is holding us back? New methods take time to adopt. Consider a pain scale:

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Source: xkcd.com

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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

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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

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The Big Bet

Engagement with patients using a mobile-centric, real-time approach can be a big part of solving our ‘which’ problem.

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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

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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

We can answer the ‘which’ questions!24

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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!!!

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