TrialDox Blog – Accelerating clinical trials…

AT Kearney has evaluated a basket of global markets for clinical trials according to the following criteria:

• Patient pool
• Cost efficacy
• Regulatory conditions
• Relevant expertise
• Infrastructure and environment

The result of their evaluation is an interesting chart, showing that China, India and Russia ranking highest on the list.  More interesting is that China is not ranked drastically lower than the United States (6.88 vs. 6.10).

For the full article, click here.

Interesting chart from PhRMA data:

CROs serve a critical function in design and execution of clinical trials.  Some recent CRO market statistics and trends:

Market Statistics

• 1,100 CROs
• Market size: $10 – $25 billion (Centerwatch article)
• Growth rate: 10 – 15%

Recent Trends

• Small to medium size CROs are forming partnerships to overcome limitations in geographic reach and therapeutic area scope
• Appearance of networking platforms to connect CROs with partners
• Undercurrent of private equity interest in CROs (Clinpage article)

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!

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.