Addressing Quality in Clinical Trials

A second event was successfully planned by the Volunteers of London Branch in the Chartered Quality Institute. When a group of people want to achieve something, nothing will stop them. Ten Quality professionals got together and a second talk was in place in London.

Addressing Quality in Clinical Trial turned out indeed to be a very interesting topic.

Quality Professionals should get more involved in the health sector!

This was the message from Dr. Will Stott. Dr Will Stott has over 25 years experience working as contractor/consultant for a wide range of companies in UK and Europe including IBM, Cap-Gemini, Logica CMG and Accenture. However, for the last ten years most of his time has been spent doing research at University College London (UCL) for the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). This large-scale clinical trial was designed to establish the effect of early detection by screening on ovarian cancer mortality.

The talk went in this format: an brief introduction of ovarian cancer, the problem with the ovarian cancer diagnosis in the UK, a potential system solution that was proposed by Dr Will followed by an open discussion with the Quality Professionals in the room.

It is astonishing that the mortality rate in the UK for woman diagnosed with ovarian cancer is 31% only as opposed to a higher rate in Europe: 

37% and 41% in Austria. So what is the problem and what can be done about it?

Ovarian cancer, like any cancer, if caught at an earlier stage, the patient has a better chance of surviving it. The UK Collaborative Trial of Ovarian Screening (UKCTOS) decided to invest £30m to do a research to help analyse whether there is a justification to have a national wide NHS screening programme for ovarian cancer.

The good news is that the research went ahead and took over 10 years. I believe the research included 200,000 women in the UK over 50. The bad news is that the data that was collected was not all valid data. How?

The process for the examination involves experts looking at images to determine whether the ovary is healthy or not. There is a fine line between looking at the ovary vs the bowel. Around 50% of the images were actually looking at the bowel. So while I undoubtedly believe that also you have a mouth wide-open in disbelief, let us focus on the case at hand. What could really be done to avoid such disaster from happening again?

This is when Dr. Stott got everyone engaged. Dr. Stott spoke about combining Project Management and Quality Management to come up with something useful. With his background in software development, he went on to develop a platform that could help experts double check that the image they looked at was indeed ovaries and not bowel. He used agile and scrum approaches to ensure the development of the platform is achieved. And at this point, the discussion was open to the professionals in the room.

• Could ISO9001 have supported UKCTOS in this research?
• What metrics should have been considered?
• Would technology really take over experts?
• How could the Quality Profession add value to an industry like Healthcare that is one of the oldest industries?
• Do we need to train Quality Professionals in the Healthcare? or do we need more Healthcare professionals trained under the Quality profession?

All of those questions were thoroughly discussed. While the entire room was astonished to how an entire research was done for years without ensuring the availability of clean valid data, there was also a sense of realisation that we – Quality Professionals – have a lot to offer to several sectors. What we consider as standard approach is easy for us because we understand it.

Having valid data from the very start of any analysis is key for a factual based decision. And yes, I agree that approving research does not always happen based on the analysis of factual data, but I can only be optimistic to see how much value the Quality Profession can add to an industry so well established like the Health sector.