1. Optimization and Management Observations, and Ideas, for Clinical Studies-a
Listing with Commentary
OVERVIEW
This is an outline intended to reference significant expert thinking on the improvement of the uniquely
resource intensive product development process in the life sciences industry. It is a selected
compilation of third party ideas, and has proven to be a subject on an increasing number of minds, from
both within the industry and elsewhere.
Understanding the challenges of this evolving subject requires examination of a wide range of input,
and is something of a moving target. Included are cross sectional matters, as well as those with a more
specialized expertise. New groups will always be surfacing with newly relevant pieces to add. So this
will be a continuously revised list.
At least one major, respected industry expert speaks of the current state of affairs as in a crisis mode. If
nothing else, everyone agrees it certainly is a time-consuming, expensive, largely sequential, full of ever
shifting regulatory gauntlets, error prone, increasingly complex, shakily ethical, unpredictable, but
absolutely vital undertaking. You probably have some of these items below on your own pet short list of
anxiety driving trends, but you just might get thinking (or rethinking) about a few by seeing them again:
 The expiry cliff is visible, but where are the new blockbusters? New business model with
niches?
 Trials conducted in parts of the world where they have seldom been conducted before
 Whole world regulatory standards? Ethical standards?
 A per day delay bogey of $.5 million to $6 million depending on the drug
 Inverse relationship between the quantity of study data taken and the effectiveness of the trial
 Increasingly complex trial logistics worldwide
 Increasing complexity and cost of the protocols (time cost is the greatest, over half of total)
 Patient screening and recruitment costs are remaining constant
 Data from new sources is increasingly identified as potentially useful at a later time(EHR's,
pharmacies, payer studies, shared data, etc.)
 Amendments happen 69% of the time, at almost $.5 million each
 The actual trial model lags the availability of technology and technology expertise
 The increasing demand that sponsor studies be audited
 The brave new world of inter-sponsor clinical data sharing; governments, etc., pressuring the
industry to share data
 Revaluation of data from failed trials
 The public perception of the industry and the increase in health care costs overall

2. Could it be that it has taken the impact of these considerations to finally drive a serious Life Sciences
look at devices long established in other industries (Six Sigma, Lean, QbD, activity-based costing,
increased business analytics from Very Big Datasets, closed loop supply chain, etc.) to improve cycle
time? This is a recurring theme that comes up in many of the sources listed below. Yes, the industry is
undoubtedly sui generis, but could still greatly benefit from many pages borrowed from elsewhere, an
event that has not been well accepted in the past. I keep hearing it too consistently in weekly
conversations and in online sources to ignore it. And, believe me, nothing opens your eyes to this more
than calling on the industry with a new product concept and hearing the reactions to it. ( I personally
have had the very special experience of representing some of these; the bad news is it sometimes
brings out the worst in those skeptically entrenched.) But.......
The good news from these same trenches is that I have personally visited companies that listened, and
have adopted some of these......and can tell you it's working. I see several other encouraging trends:
 Re-inventing the trial process and its monitoring to make it "adaptive", i. e., dynamic
 The increasing tech footprint offered by many CRO's
 Use of cloud data and paradigm in protocol design
 Adoption and evolution of user friendly but increasingly powerful portals, dashboards,
simulations, and data management systems, for decision support and cycle acceleration
 Increased use of social media in patient recruitment (providing an patient e-community)
 An ISO 9000 certified IRB and other improvements in the regulatory process
 Determining performance metrics for study activities
 Increasing scrutiny in the protocol design process to minimize noncore activities
 Creation and growth of dedicated interest groups, led and staffed from diverse organizations,
to promote study efficiency and effectiveness
 The ongoing discussion about how best to use new information management capabilities, e.g.,
mobile technology, to greatest advantage
So here is a reasonable manifesto; bring on more of the above. Have the confidence to knock down the
silos and siloists, and create more meaningful advocates and structures of productivity in their place.
Information technology is there to help enable the more powerful decisions that better informed
humans will continue to need to make. That will support the true heroes-the scientists that conceive the
possibilities and the patients that take the risks to actualize them.
SOURCING
 A deep draught directly and indirectly from Tufts CSDD materials; also CTTI, and other LS
related sites/blogs; FDA publications; lots of dialogue from Linkedin groups and vendor
whitepapers; also many conversations with prospects and others about related matters.
 http://blog.pilgrimsoftware.com/clinical-trials-guidance-qa-with-patrick-stone/
 http://www.ecliniqua.com/eclin/2013/2/18/for-efficient-clinical-trials-threes-company.html
 http://www.pharmalot.com/2012/09/the-op-ed-another-word-on-declining-drug-development-
productivity/

3.  http://clinicaltrialist.wordpress.com/productivity/improving-productivity/
 http://clinicaltrialist.wordpress.com/productivity/whence-the-low-productivity/
 http://www.youtube.com/watch?v=b5632yE5GCY
 http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=7919
38
 http://info.pharmicaconsulting.com/blog/bid/257037/Clinical-Operations-Process-
Improvement-Part-II-The-Ultimate-Metric
 http://info.pharmicaconsulting.com/blog/bid/248385/Improving-Clinical-Operations-Metrics-
Part-1-Metrics-That-Matter
 "Mitigating the Challenges of Global Trials," Bedford & Kole, Almac Clinical Services, 11/12
 "Looking Ahead to 2013-Trends and Strategies", Cutting Edge Information
 "Transforming the Economics of Clinical Trials", Kramer & Schulman, Duke University Medical
Center, 4/12
 http://www.nytimes.com/2013/02/28/technology/ibm-exploring-new-feats-for-
watson.html?_r=1&nl=todaysheadlines&adxnnl=1&emc=edit_th_20130228&pagewanted=2&ad
xnnlx=1362046880-iZWMdntA9f7VhytYmLw+rg&
 http://csdd.tufts.edu
 http://www.metricschampion.org/default.aspx
 Lots of "Fierces"
 You. Information, thoughts ,ideas, counterpoints, etc. that I have not heard. Why include this?
1.) The work is not completed 2.)Something just might prove important, now . So, what is your
own take on the matters presented here? What is not here but should be? What else should
the industry be thinking about? You are as much a stakeholder as I am, and if you are moved to
respond, please contact me at rpocot@comcast.net.