My 3 Key Reflections on Partnerships in Clinical Trials USA 2016

Three themes come to my mind out of the PCT sessions I attended this year, and when you look closely the divisions between them are fairly blurred and a common approach could drive them all forward.    Theme one was best highlighted by Toni Hoover Ph.D., Director, Strategy, Planning and Management for Global Health from the Bill & Melinda Gates Foundation, who very passionately called out that every person deserves to live a healthy and productive life independent of where they are born.   Theme two was around patients, and the guys from Stupid Cancer did a great job (including the first piano performance I have seen at an industry conference) at reminding us that we are all patients at one part or another of our life. We repeatedly heard patients are happy to help in clinical research but view it as a two-way street. What do they get in return? How can they engage much more strongly in the research process? How can they get past the limited visibility of their own doctor/consultant and get full visibility to what is happening in the field? How can they get maximum benefit from participating and how will their life be made easier?   And the third theme also came up in multiple sessions and relates to how to run clinical research more efficiently. We have regulators who are now proactively pushing changes in how clinical trials are run, not just judging if you have done things correctly. They have been very positive in providing a framework, under which new processes can be adopted in areas such as eSource and RBM, yet when we discussed in detail the progress made on challenging and changing the clinical process very little could be identified. In the session on this topic run by Trudie Lang, Professor, Global Health Research and Director, Global Health Network, University of Oxford, she provided great context that doing things differently is however possible. During the recent Ebola and Zika outbreaks (which also overlaps with theme one) trials were planned within days and run within weeks. If needed, further focus was brought to how urgently we need to change our traditional models as the team from Tufts shared the current estimates for developing a new drug – did they really say $2.5 billion of capitalised cost? This is simply not a viable business model...   So how are the answers related? Well, technology of course! Technology advancement has already broken down traditional barriers in much of Africa with the mobile phone being available where landlines never were, and leading the world in the ability to pay and transfer money via these phones, cutting out the charges from middle men and speeding up cash flow. Smart use of technology can allow locations which up to now only provided patients for trials to drive their own research programs, and this in turn can help drive local solutions independent of location.   Technology also sits at the centre of how to better engage patients, enabling them to:

• Talk to others in a similar position through online communities

• Understand the latest clinical thinking in their disease area of interest

• Proactively locate which trials there are to participate in (and receive feedback once the trial is complete)

• Increasingly learn how to understand and manage their own health through rapidly advancing mHealth.

Finally, in addition to the above, the improvement of the clinical trial process has to be intertwined with technology, for example the replacement of paper processes with eProcesses (like the capture of data directly into a database) and the adoption of risk-based processes where an entire paradigm has been led by technology providers. Faster access to data including the expected exponential increase in data collected through mHealth rather than traditional processes should provide a platform to re-examine the entire clinical research framework, so not just how to run a particular trial more efficiently but how to break down the boundaries across clinical research and answer in parallel questions typically posed during discrete phases such as epidemiological research, Phase II, Phase III…   So if technology is the answer, what is the question? At the conference, the question we kept hearing was: How do we accelerate adoption of technology? The barrier was common – we are a conservative industry, even when a regulator says that it’s OK, no one wants to be the first, or the second, or the… We are though not the only highly regulated industry. For example, how I bank has changed beyond recognition over the last five years. I’m afraid no one had a great answer to how we change the behavior of an industry, but maybe the best hope was with the increasing focus on rare diseases, and specific subsets of patients, where trials are too small to be able to absorb the huge amount of processes (and related cost) we currently apply, and maybe if we can bring together some of the blue sky thinking required when you need to run trials in the middle of an Ebola outbreak with just days of warning and weeks of time on the ground, then change may be in the air!   With regard to the event itself: The joint meeting with 3 other events under the biotech week banner had some real advantages – the varied plenary sessions were great, but more generally the PCT event felt overwhelmed by the other bigger events. That said, the single biggest thing the organisers could do to improve the event is redesign the online app for the agenda: I missed sessions I wanted to attend, attended sessions I didn’t know existed and did more networking with folk trying to understand what was on and where, than over coffee! But that’s technology for you – a great enabler when done right!  

Rob Nichols

is a co-founder and the Chief Commercial Officer for Algorics. Email: rob@algorics.com Website:

www.algorics.com