Quality Management Consulting

How is the quality of quality metrics in clinical research?


Attendees at the recent 5th Clinical Quality Oversight Forum in Philadelphia were given a reality check by Michael J. Howley, PhD, Associate Clinical Professor, Lebow College of Business, an academic who is widely published on measuring trial performance.


Dr Howley’s research into pharma shows that many metrics used are of uncertain meaning and that “quality measurement” has gravitated to the most easily measured and least controversial indicators which do not gauge “quality” accurately.  Attendees will no doubt be looking forward with interest to his forthcoming Clinical Leader publication entitled ‘Metrics Malpractice’.


Earlier in the forum the audience heard from Mitchel Katz of Purdue Pharma who presented data from the 2013 survey conducted by the Avoca Group.  This survey, of 70 sponsors 66 service providers, showed that most reported that a systematic risk assessment process was [now] used for the majority of their clinical trials, whether conducted in-house or outsourced. It was notable though that many of the risks assessed relate to performance rather than measures of quality. Of the respondents 34% answered ‘yes’ when asked if risk assessment and management had increased quality, with an additional 34% of respondents answering ‘sometimes’, and 6% answering ‘no’. Overall sponsors were more satisfied with the risk management process than CROs but the reasons may be many and varied.


The presentations and discussion fora held over the two days did demonstrate clearly that there is little agreement across industry over what constitutes a key quality indicator (KQI). Indeed, some people’s key performance indicators (KPIs) are being used by others as KQIs, so maybe it’s not surprising that our vision is not crystal clear. The Metrics Champion Consortium (MCC) were represented by their CEO Linda Sullivan, who explained that their membership seeks to improve understanding and standardization across industry (good luck with that Linda – we need it).


So what of the future?


Michael Howley referred to the use of statistical algorithms to predict outcomes (analytics) and suggested that this is where we should be headed. Later on Cheryl Small explained how Pfizer are already working on near-time assessment of quality for clinical trial execution at the site level in order to become proactive and to predict outcomes. Pfizer have used ‘big data’ accumulated over >350 trials to verify their algorithms and interestingly this has led to changes in the beliefs of what factors determine a high quality investigator site.  Sadly maybe, for those wanting a quick fix, Cheryl concluded that “It’s a practice [learned over years], not just the technology”.


So if you’re all at sea with your metrics, or can’t tell your KPIs from your KQIs, then come and get a Wider Perspective and we’ll help you to map out your way forward.


Contact us today at info@widerperspectives.com


“Oversight”:  Now is that supervision, or something we missed?


“More than 75% of industry receive inspection findings concerning oversight”


There is a lot of interest in “oversight” across industry but the view is patchy, at best.  So here’s a different (Wider) Perspective.

At the recent 5th Clinical Quality Oversight Forum in Philadelphia the audience (approximately 100 people from more than 40 different companies) were asked to provide feedback regarding regulatory inspections.


Recent diligence from the regulators was evident in that 79% of the attendees reported that their organizations had undergone at least one Sponsor focused GCP inspection within the past 5 years and 16% had experienced >6 of them.  Furthermore, 84% of attendees had experienced at least one investigator site GCP inspection in the same period and more than a quarter of attendees (26%) reported >10 such site inspections.


Almost all (98%) attendees believed that the regulators are focusing the sponsors’ quality systems for Vendor Oversight during these inspections and 77% indicated that their companies had received inspection findings regarding their oversight activities.


So when sponsors have been working with CROs for decades (at least 3 in my case), how can this be so?  Again, the polling of the audience provides some insight.


Fewer than 40% of the attendees thought their organizations had adequate processes and procedures for oversight and only 31% believed that adequate documentation to substantiate the performance of oversight was available.  Lively discussion groups over the 2 days demonstrated the wide range of sophistication and resource being applied to this topic, which was unsurprising as the audience was drawn from start-up biotech companies to large pharma.  The implementation of out-sourcing strategies, metrics, quality agreements, quality by design and risk-based monitoring provided rich topics for healthy debate and will feature in more detail in future posts.


In summary, when oversight can be the responsibility of a lone individual, through to having dedicated departments and involving all functions across an organization, it’s clear that one size certainly does not fit all. Adapting our approach to fit your circumstances is something we understand well at Wider Perspectives, where our customers range from some of the largest pharma companies to some of the smallest and newest start-ups.


So whether you’re preparing to substantiate your past oversight activities to a regulatory agency, or looking to see how best to achieve this in future, we’d be only too happy to discuss your individual circumstances and to work with you towards a successful outcome.


Contact us today at info@widerperspectives.com

5th Clinical Quality Oversight Forum 15-17 October, Philadelphia, PA, USA ExL’s 5th Clinical Quality Oversight Forum, taking place October 15-17 at the Sonesta Hotel in Philadelphia, PA, focuses on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. The event covers this topic from all angles, answering the broad questions such as why risk-based management and oversight activities are necessary and how effective execution can impact overall clinical performance. It also addresses the more focused aspects of how to integrate effective oversight tactics into all aspects of your vendor and site management, from protocol development to selection process to monitoring to clinical CAPAs.

Wider Perspectives senior management will be attending the event in support of Triumph Research Intelligence (TRI). TRI are sponsoring the event and will be showcasing their clinical quality oversight platform, Visual OPRA.

Contact us today at info@widerperspectives.com

2014 RQA Annual Conference, 12-14 November, Brighton, UK


Wider Perspectives is attending the RQA Annual Conference will be held at the Grand Hotel, Brighton during the 12-14 November 2014.


The Conference has the theme Quality, Quo vadis? -Where is Quality going?

The conference programme consists of plenary and parallel sessions, QA Clinics, workshops and excellent networking opportunities. The 2014 venue is the famous Grand Hotel in Brighton. More than just a hotel; this is an institution, an iconic piece of British history, perched contentedly at the centre of one of the most famous seafronts in the world.

Contact us today at info@widerperspectives.com



Beverley Brummitt +44 7779 257558   bev.brummitt@widerperspectives.com


Peter Brummitt +44 7785 390273   peter.brummitt@widerperspectives.com


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