Using Patient-centered Technology to Improve Recruitment and Retention

Sponsors of clinical research must increasingly focus on improving patient engagement in order to meet many of today’s research challenges. Promising disruptions are already under way that could define new models for patient recruitment and retention.

In a time when drug development success is becoming scarcer and more expensive, the industry is looking everywhere it can for new, innovative approaches to improving health. Meeting recruitment goals is one of the biggest challenges for traditional clinical research. Less than one-third of people who come in for a screening end up completing a clinical trial.1 Thinking in a more patient-centric manner can help is in recruiting patients. A fundamental idea behind patient-centered research is to “amplify the patient’s role in the research process.”2 Employing new ways to engage patients and physicians while increasing their level of knowledge and trust can improve the sponsor’s ability to meet recruitment goals.

One often overlooked factor for study participation and retention is convenience. Raising the level of convenience for both the investigator and participant can eliminate a huge obstacle to non-participation or non-completion. There are many ways to incorporate increased levels of patient and physician convenience into trial design and execution, particularly using Internet-based technologies. For instance, social media can be an effective recruiting tool and an important way to build trust with targeted populations. Disease-specific online communities are becoming more and more prominent for chronic diseases. Matchmaking tools act as mediators that draw together researchers and participants. “Traditional” social media offers a less targeted, but no less effective, way to engage patients and investigators.

In general, the four key determinants of a person’s likelihood to participate in a trial are prior participation in research, existing relationships with researchers, involvement of trusted leaders, and trust in the organization. Keys to recruiting success in social media should keep these determinants in mind, and engage communities in a thoughtful, ethical way while respecting the norms of the community you are targeting.

Participant retention post-recruitment can be improved by strengthening the connections between participants and researchers, and enhancing communication structures to support these relationships.3 Capturing Patient Reported Outcomes electronically (ePRO), through the web or mobile devices, offers a way to interact with the participant in a meaningful way while also capturing critical data. For instance, offering the ePRO user risk scores and health recommendations based on their data, or using gamification techniques to increase protocol adherence, can enhance the traditional ePRO experience by offering direct, immediate value to the user. Enabling a “Bring Your Own Device” (BYOD) strategy can increase convenience for populations who already own their own smartphones or tablets. Of course, the study design and applicable regulatory considerations should drive when and how these techniques are used.

Increased focus on the patient experience is not a phenomenon unique to research, but something that is rapidly permeating healthcare systems. These rapid changes can enhance research engagement. There is enormous potential to capture far more robust data and have better follow up than ever before as widespread infrastructure is put in place for coordinated team-based care, home-based continuous monitoring, and wireless data reporting from medical devices. The (still elusive) promise of using the Electronic Health Record system in research to identify participants and capture clean, accurate trial data is more critical than ever before. As medical practices become more electronic and less paper-driven, investigators and staff should be engaged by providing them trial-specific information at the points in their workflow when they can best make use of it. Conversely, requiring them to go outside the workflows and systems they use in routine practice creates complexity and hassle that can deter research participation. A new level of integration between research and health data systems, based on standards (which exist) and open interfaces (which are coming, as part of Meaningful Use), will be necessary to make good on this potential.

As difficult research questions drive increased complexity in trial designs, many feel that the answer is to use technology in simple, scalable ways to engage more participants in research and capture more data. Dr. Russ Altman, a physician and Stanford professor recently told the New York Times, “There’s a growing sense in the field of informatics that we’ll take lots of data in exchange for perfectly controlled data. You can deal with the noise if the signal is strong enough.”4

References

1. Getz, Ken, The Gift of Participation: A Guide to Making Informed Decisions About Volunteering for a Clinical Trial, 2007, p40.

2. Pignone, Michael, MD, MPH, Challenges to Implementing Patient-Centered Research, Ann Intern Med. 18 September 2012;157(6):450-451

3. Nicholas Anderson, Caleb Bragg, Andrea Hartzler, Kelly Edwards, Participant-centric initiatives: Tools to facilitate engagement in research, Applied & Translational Genomics, Volume 1, 1 December 2012, Pages 25-29, ISSN 2212-0661, 10.1016/j.atg.2012.07.001.

4. http://www.nytimes.com/2013/01/15/health/mining-electronic-records-for-revealing-health-data.html?ref=health?src=dayp&_r=3&

OpenClinica creates a fresh brand perspective

OpenClinica is rolling out a new brand this year! We’re spiffing up our look with a new logo and visual identity.

The fresh aesthetic aligns well with our unique approach to clinical trial software and the innovation and freedoms it provides. Look for the new OpenClinica brand on the web, social media, industry conferences, and other places.

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OC13: Early Bird Registration Ends Friday, March 22!

Friday, March 22 is your last chance to get early bird registration for OC13! Take advantage of this final opportunity to obtain discounted pricing on conference admission, workshops and training.

We have a superb line-up of useful content this year, including a new series of in-depth workshops taught by subject matter experts:

  • Moving from paper to EDC
  • Advanced Edit Checks and Rules
  • Operating OpenClinica in a Regulatory Compliant Environment
  • OpenClinica Web Services & Enabling Modularity
  • Orientation of OpenClinica Code Base
  • Installing and Administering OpenClinica

OC13 also coincides with this year’s DIA annual meeting, so now you have TWO great reasons to come to Boston this June.

Does EDC Help or Hurt Site Relations?

Getting reluctant clinical research sites to embrace technology such as electronic data capture (EDC) software can be difficult. This is a recipe for troubled relationships between the sponsor/CRO and sites. However, just as it is possible for a poor EDC implementation to erode sponsor-site relations, it is also possible for the EDC software to help cultivate improved relationships. Take a look at the new whitepaper, “Improving Site Relationships through EDC” to learn about some important considerations when thinking about site relations in the context of EDC.

OC13 – OpenClinica 2013 Global Conference draws clinical research community to Boston

OC13 is an educational event open to anyone looking to obtain insight into the OpenClinica clinical trial software platform, learn useful new skills, and build relationships within the vibrant OpenClinica community. This year’s event features best practices, case studies, demos, and hands-on activities. View the conference program to choose from a list of valuable sessions such as: “Utilizing CDISC Standards to Drive Efficiencies in Study Set-up and Build,” and “The Changing Face of Clinical Trials – Patient-Centered Research,” to a sneak peak at exciting future developments for OpenClinica.

Attendees can also choose to participate in a set of hands-on workshops and training classes. These workshops deliver highly-relevant information on key subjects such as regulatory compliance and validation, web services and integration, edit checks and rules, and moving from paper to electronic data capture (EDC). For a more thorough understanding of OpenClinica, you can take full “Central User” or “Developer” training on this robust platform.

Early bird registration is available until March 22.

Kicking-off the conference as keynote speaker is Douglas Bain, a recognized veteran in the eclinical industry who has worked in a leadership role with many prominent clinical research technology leaders. In his address, Mr. Bain will focus on the emerging dynamics of patient-centered clinical trials.

“I am thrilled to deliver the keynote at this year’s OpenClinica conference,” said Mr. Bain. “Clinical research modalities are changing, and I look forward to sharing my insights into where things are headed with such an innovative community.”

Conference attendees are invited aboard the Odyssey for a dinner cruise and unique views of the city from Boston Harbor.

Also in Boston, immediately following OC13, is the 49th DIA Annual Meeting, June 23-27 at the Boston Convention and Exhibition Center.

About OpenClinica

OpenClinica is the leading open source clinical trials software platform, and increases the quality and pace of clinical research worldwide. With a global community of users and thousands of implementations, OpenClinica presents a compelling way to obtain greater value in clinical trials. The OpenClinica software is backed by Waltham, Massachusetts-based OpenClinica, LLC, who provides commercial grade support for the open source platform. For more information – including product downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.

OC13: OpenClinica 2013 Global Conference

We’re gearing up for a fantastic conference, June 21 in Boston. You don’t want to miss the informative workshops, sessions, and demos that will help you optimize your research based on the cutting-edge OpenClinica open source platform. And, Doug Bain from eClinicalHealth is planning an engaging keynote presentation that covers the critical movement toward patient-centric trials. Oh, and I should mention the amazing dinner cruise on Boston Harbor.

Haven’t registered yet? Get a jump on it (and a discounted fee).
Early-bird Registration >>

I need some training!
Sign up for Training >>

Get invaluable practical experience.
Sign up for Workshops>>

I have something great to share.
Submit a Session>>

Show off your work.
Get a Demo Table>>

Have a blast!
Welcome aboard the Odyssey Dinner Cruise>>

OpenClinica 3.1.3 Now Available

We are thrilled to announce the general availability OpenClinica 3.1.3. This latest release of the OpenClinica clinical trial software provides over 100 fixes and enhancements, including:

  • Improved performance and stability, including 80% increase in max user load and 40% faster page turn times
  • Numerous improvements to OpenClinica’s internationalization/localization support
  • Support for CRF version migration of individual event CRFs
  • Enhanced security with strong password configuration options
  • Greater reliability when entering or editing data in repeating groups
  • Ability to run rules at data import and when loading data via web services
  • Fixes to nested simple conditional displays in CRFs

For a more complete overview, you may view the 3.1.3 release notes.

Download OpenClinica 3.1.3 Community Edition

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