TrialDox Blog – Accelerating clinical trials…

Can personal health records (PHRs) revolutionize the clinical trial industry?  In our opinion: Yes.  We’re interested in what you think, as well.

To foster a discussion to solicit your opinion, find below a primer on PHR and what the public and private sector are doing to promote PHRs.

What are PHRs?

PHR is a patient-controlled document of his or her health information in a format of his or her choice.  (A medical health record, by contrast, is patient health information controlled by a physician, healthcare institution or health insurance company.)  Information documented in a PHR can be as limited as emergency health information to facilitate emergent care or as broad as all provider visits, diagnostic records, prescriptions, and health insurance information.  Storage formats can range from a local computer hard drive, portable hard drive, or internet-based subscription service.

Public sector PHR activity

Medicare (Centers for Medicare & Medicaid Services), since 2006, has undertaken several pilot programs to encourage the use of PHRs.  For more about Medicare pilots, click here.  A number of policy recommendations have been made by the National Coordinator of Health Information Technology.

Certification Commission for Health Information Technology (CCHIT) has assembled a special PHR Advisory Task Force and created an associated workgroup in order to draft a set of certification criteria for PHRs. The certification criteria, which are scheduled for release by 2010, will place an emphasis on industry privacy safeguards while also addressing security and interoperability issues. For more information, click here.

A number of states have introduced legislation to govern the usage of PHRs.  For a survey of state-level legislation, see the National Conference of State Legislatures tracking by clicking here.

Private sector PHR activity

A list of players in the PHRs:

• CapMed.com
• Microsoft HealthVault
• Caregiver Alliance Web Services
• MiVia
• CEND-PHR
• MyGroupHealth (Group Health Cooperative)
• Collaborative Family Health Record
• MyHealtheVet (U.S. Department of Veterans Affairs)
• Dossia
• MyHIN
• FollowMe
• MyMedicalRecords.com
• Google Health
• Myphr.com
• HealthAtoZ
• Patient Gateway (Partners HealthCare)
• iHealthRecord.com
• PatientSite (Beth Israel Deaconess Medical Center)
• LifeOnKey
• RecordsForLiving.com
• Med Alert
• e-Healthkey
• Revolution Health Group
• MedCommons
• VitalChart

While not meant to be exhaustive, the list above suggests that policy announcements have encouraged a proliferation of private sector offerings in the PHR space.  For a more exhaustive list, visit myPHR.  In addition, several non-profit organizations have initiated studies to evaluate standards to optimize interoperability, security and data modification (see Robert Wood Johnson Foundation, PDF).

Opportunity for clinical trials

The “low-handing fruit” for science and clinical research, in our opinion, lies in the intersection of PHRs and these core areas:

• Analysis of diagnostic data for patient identification for clinical trial recruitment
• Self-identification for clinical trial recruitment
• Analysis of historical records for hypothesis creation

Interested in your opinions…

In August 2009, Private Access announced a partnership with large pharma to test a new approach to expedite clinical trials.   Founded upon winning a patent for data privacy technology, the company believes that the solution to clinical trial recruitment lies in unlocking patient health information using their proprietary information privacy technology.

Private Access’s theory is that going directly to patients who are seeking treatment and requesting their permission to share their health information with researchers will decrease the time required to recruit for trials. Seems that Private Access’s strategy is viable if these assumptions are correct:

• Enlisting patients in the Private Access system can be done cost-effectively
• Concerns for privacy of their health data is the major barrier for patients who are seeking experimental treatment to share information with researchers over the internet
• Patients will share information independently without a physician’s guidance
• Patients in the Private Access system can be matched with physicians prepared to conduct a clinical trial

If these assumptions can be or have been validated, as they very well may have been, Private Access will be in a strong position to assist many researchers interested in expediting clinical trials.

Private Access is an innovator in clinical trials. Welcome your perspectives on the Private Access model.

We at TrialDox are students of innovation and applying theories of innovation to clinical trials. Two of the leaders of innovation theory offer food for thought for those who are interested in re-inventing the status quo: Clayton Christensen and his disruptive innovation theories and C.K. Prahalad and his bottom of the pyramid theories.

Disruptive innovation

Over the past ten years, Christensen has developed a theory to describe how incumbents in industries are eventually displaced by upstarts who target “non-users” of prevailing products and services by offering focused solutions.  To summarize his theory, the upstarts do these things right:

• Focus on understanding the “non-users” job-to-be-done
• Identify a technology enabler to deliver a product or service that one would “hire” to do the job
• Build a business model (resources, process) to deliver the product or service
• Encourage the development of a “value network” that supports the business model

There’s more to the theory, but we find much inspiration in applying Christensen and his Innosight teams work to clinical trial processes.  You can find more in The Innovator’s Prescription.

Bottom of the pyramid

A prolific business thinker, Prahalad made waves with his observations that entrepreneurs and companies in emerging markets can take practical approaches to innovate products and services in order to meet requirements of demanding customers with limited ability to pay for quality.  While many of the examples Prahalad cites hold true to Christensen’s disruptive innovation theory, Prahalad’s example tend to focus on bottom of the pyramid markets that are characteristically high volume and low margin.   We find that if a solution can thrive in these conditions, it is a great candidate for application to markets more familiar in North America.

Welcome your thoughts on how you find inspiration from these thinkers.  Leave us a comment!

The inefficiencies experienced by clinical trial sites in study start up are amplified by orders of magnitude for clinical trial sponsors by virtue of the total number of clinical trial sites that are enlisted for a new trial. Adding to these direct costs, the indirect opportunity costs due to days of lost sales of successful products ($600,000 to $8,000,000 revenue per day) make expediting study start-up an important driver of value-creation.

The study start-up problem is significant, and often not always appreciated by clinical trial sponsors. The main contributors to the time and costs of clinical trial start-up include:

• Site selection and site qualification
• Hard copy document courier to sites
• Contract review and approvals
• Budget review and approvals
• Investigator agreement review and approvals
• Signed hard copy document courier to sponsor

Each of these activities involve various combinations of preparation and execution time by sponsor and site team members. For the average study (50 site Phase III study), these time and costs can amount to 6 months and $400,000. The following table summarizes this estimation:

Since approximately 50% of clinical trials experience delays in the study start-up (CenterWatch survey), most sponsors likely spend incur more time and costs than the averages above suggest.

For pharma, this is the curve that needs to be re-shaped:

Source: Morgan Stanley

Most clinical research is happening in oncology, CNS, and cardiovascular:

Source: Company research via Barclays Capital

Pre-phase II R&D accounts for about 35% of total R&D spending:

Source: PhRMA, 2009

TrialDox is a web-based platform that connects clinical trial professionals and expedites the clinical trial process.

The TrialDox team would like to express our sincere thanks for your valuable contributions and advice in 2009 as we proceed toward exciting developments in 2010. Please do read on below about our progress in 2009 and what’s coming up in 2010…

Happy Holidays and best wishes for a happy and healthy 2010!

The TrialDox team

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Exciting progress in 2009
TrialDox has come a long way in 2009 as a viable web-based service to help clinical trial sponsors, CROs and sites expedite clinical study start-up documentation. Our unique approach is to connect clinical trial professionals on a common platform, and provide an elegant web-application to complete clinical trial documentation expeditiously, securely and intuitively. With your help, we have achieved a great deal of progress:

• Refined our platform to differentiate TrialDox and deliver pharmaceutical companies and clinical trial sites tangible cost and time savings
• Assembled a proprietary database of clinical trial sites, investigators and other useful clinical research information
• Expanded the team to include accomplished and experienced clinical research, technology and regulatory compliance experts
• Received positive reviews from a number of potential pharmaceutical, clinical trial site and investigator users

Objectives for 2010
Our objectives for 2010 are to continue to build an advisory team of CRO and Clinical Research leaders, and offer our platform in beta version to key CRO and Pharmaceutical company partners. (If you know of entrepreneurial-minded CROs or Pharmaceutical companies, please don’t hesitate to let us know…we like to keep good company, as we have with you.)

In the meantime, please check on us at http://www.trialdox.com and http://blog.trialdox.com. We look forward to being in touch.

Public transparency of clinical research activities to evaluate the safety and efficacy of drugs and devices offers significant benefit to consumers, sponsors and investigators. As a result, various public and private-sponsored clinical trial registries have been initiated to meet transparency objectives.

Three initiatives have proven to among the most accepted registration forums:

• United States: ClinicalTrials.gov
• Europe: EudraCT
• International: International Clinical Trials Registry Platform (ICTRP)

The mechanics, comprehensiveness and responsibility of managing these registrations has been debated. As a reference, here are a few articles for an overview on the salient issues:

• New England of Journal of Medicine: Registration and Registries for Clinical Trials
• Campbell Alliance: The Era of Clinical Trial Registries

Welcome your additions to this list of registries and reference articles.

True to TrialDox’s core as an entrepreneurial team, we thought it would be worthwhile to our followers to post a few notes on entrepreneurs and organizations from who we draw inspiration. There is quite a bit to learn from the experience, wisdom (and humor) of these people.

In no particular order:

• Jason Calacanis (@jason)
• Guy Kawasaki (@guykawasaki)
• Don Dodge (@dondodge)
• Matt Coffin (Lowermybills.com)
• Steve Case (@stevecase)
• Fred Wilson (@fredwilson)
• Richard Branson (@richardbranson)
• Bill George (@bill_george)
• Mark Suster (@msuster)

The list is certainly not exhaustive and a work in progress. Additions welcome!