DCT – a short history of the sector

Down the ages

Care and medicine evolved in the home long before there were hospitals.?It has forever been the case that people care for each other at home and visit experts in their community for advice and treatments.?The same tradition continues today.?In fact, we are presently witnessing a post-industrial move back to healthcare delivered more and more in the community and less and less in hospitals throughout first world societies, as social forces shift towards models focused on effectiveness rather than simply efficiency, and as we realise that people are key stakeholders in all social activities, have emotions and don’t just do what they are told!

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Modern history

Our sector has been through several eras. The definitions I have used below are mine alone and need to be seen only as very high level summaries of what happened…

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Patient Centricity Era (1998 to 2014)

·?????I date the sector from 1998 with the creation of Mytrus - the first truly patient centric business model, rather than site or sponsor centric.?Their digital and clinical model was a bit before it’s time and only digital – specifically e consent – really survived.?2004 and 2006 saw the formation of CRN and MRN respectively, kicking off a period of sustained growth in patient centric clinical trial services - Home Healthcare.?These newly founded businesses with patient centric models were nurse based, incorporating pharmacy and laboratory services as required for the home visits.

·?????The ‘liquidity crunch” created a recession of unprecedented length, lasting essentially from late 2008 until 2012, putting these new businesses under strain and slowing growth.

·?????However, by 2010, Patient Centricity was gaining wide recognition, and the FDA set up POCRA, still driving growth in the new sector despite the headwinds.

·?????By 2013 the Biopharma industry had started to embrace this trend in all areas – sales, marketing, R&D etc.

·?????Within Biopharma R&D, MRN grew into a trail blazer, building our international capabilities and improving our service, to ensure we reduce the burden of trials on patients, and becoming the largest provider in the field by visit volume and revenue.

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Digital Era (2014 to 2021)

·?????The clinical and digital vision was reignited in 2014 by Science37, using a very similar model to Mytrus, and shortly thereafter eCOA start-up companies hit the market - notably Medable in 2015 and Thread in 2016, who grew up just prior to the pandemic.?Many more (possibly as many as 100) followed in the next 3 years.

·?????The COVID 19 pandemic merits a story all to itself.?However, in the interest of brevity, the capacity of long-standing incumbents in the DCT sector and the new entrants that appeared due to the increase in need was not anywhere close to enough to meet the escalated demand.?Workload exploded.

·?????Just as the pandemic got going, first one (late 2019), then 2 more (late 2020)?of the top 5 clinical service providers were sold to global CROs.?The founders left after a year or so, leaving these guys in the midst of a pandemic with little long term experience of the new sector in the top teams.

·?????New clinical organisations also appeared, the most interesting focused on an ‘alternate location’ concept, utilising a pharmacy, a community lab or a local medical clinic to host patient visits for those patients nearby, reducing but not eliminating travel.?The nurse in a van also surfaced, as a more mobile version.?These generally ?worked well in large scale trials with multiple patients close to any given clinic/van/lab location, such as in COVID 19 related trials, but the high fixed costs make it expensive in other models.

·?????A trial managers assessment of the services on offer switched from questions around ROI (return on investment) to simple survival.?Every provider, new or old, was inundated with work.?Many found it hard, and many immature solutions were implemented at scale which they were under prepared for, leading to today’s level of dissatisfaction with the new solutions.

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Normalisation Era (2022 to present day)

·?????Geopolitical and macroeconomic events post-pandemic have led to the global economy tottering on the edge of recession.?The war in Europe has caused untold supply chain issues, fuelling inflation.?With high levels of debt and the withdrawal of cheap money supply from governments, these factors mean we find ourselves in the midst of a sustained reduction in the availability of capital to invest in company growth, severe salary pressure and a withdrawal from globalisation in general.

·?????DCT tech companies, many of whom are powered by capital that is no longer freely available, have now plunged into the depths of despondency that is typical after the innovation peak in adoption curves.?The next part of that curve – where there is typically a slow ?and sustained recovery and subsequent increase in adoption – has started, due to a grinding out of improvements and lessons that will slowly build the more sustainable tools and services from the initial rush of broad innovation.?

·?????Clinical organisations are significantly further along the adoption curve, having started 10 years before, although many of the new players are struggling due to the immediate economic headwinds and / or the high level of their fixed costs.

·?????Customers are wary, sites are wary – but the market is clear that benefits are potentially profound.?The post pandemic slump looks like it is giving way to renewed but more sophisticated interest in the whole range of services.

·?????‘Normalisation’ is starting to take place, but which I mean service providers are integrating these tools into their full set of solutions to apply in whatever way works for any given trial.

·?????The next stage – deeper integration…

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This short history is both a normal and abnormal map of growth of a sector.?Normal, in that there have been ups and downs of adoption of various components within the sector over a long time scale (healthcare innovation is a slow process).?Abnormal in that the COVID 19 pandemic and subsequent global economic and political events amplified the peaks and deepened the troughs.?Despite this abnormal warping of typical trends, the underlying reasons for recovery in any adoption curve are still at work, namely the drive to learn critical lessons from the innovation peaks, which will be considered in my next blog - “The Normalisation Era (or Back to Basics)”, coming out shortly!

For more info on how to manage community based trials, go to the MRN web site

https://themrn.io/

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Medical Research Network