Every modern healthcare system professes to use and need data analytics to provide care for patients. The acceptance and use of data and tools to support this is different dependent on geography and culture. Conversations with healthcare providers in Russia, Europe and the US in recent months have enabled a magnifying glass to be applied to these differences. What these differences reveal is that there could be a model that breaks down the known issues relating to healthcare provision through ‘magnificent use’ of information and that this can be learnt through an understanding of geographic or cultural differences to enable a data rich healthcare system based on access to information that delivers insight.
The promise of data to support healthcare and clinical research is here. The European Commission believes that the mobile health market alone will reach a value of $6.9 billion by 2017. Imagine the data and the controls required to manage a market that buoyant. Also consider the data asset that the penetration of technology will bring and the disruptive improvement to healthcare.
However let us not let the obvious go unnoticed. The inefficiencies of two ‘IT Worlds’ become obvious at the interface between them. Inefficiencies between lifesciences delivery and care provision supported by information systems that have seen significant investment are quite profound, wherever you apply the magnifying glass. And the problem will become more impactful without a disruption that is the catalyst for a collaborative response across several care settings.
Countries, clinical research organisations and the life science industries all have a desire to change how they deliver clinical research. Each day that a drug is delayed from entering the market sponsors lose up to $8m1. Data collected comparing Europe wide statistics to the US puts only 18% of trials in Europe achieving time and target whilst in the US it is just 7%2. Everyday that a new drug is not on the market is another day that a person with an illness can not access the new innovative cure or drug that will ease the illness.
Take the sheer size of the diabetes population. There are 283 million people with diabetes, which makes diabetes the third most populous country in the world!3 In 2012 there were 212 new diabetes drugs in development4, innovations that with the right environment to trial are trying to expand treatment options that improve quality of life and provide value for money.
What does history tell us?
Healthcare professionals and business intelligence experts that were part of the conversations in the development of this piece from Russia have an eye on the NHS in England as an example of how to make this work. From an NHS perspective this concept probably makes the UK professional stop and think more carefully about the current situation within the NHS. It is, let’s face it, perceived to be controversial from inside the UK. The NHS has a cradle to grave clinical record. A healthcare system that is free at the point of care, and a system that the UK NHS should be proud of. It may not quite be a digital system and in recent times it has been portrayed as controversial in its approach; however it is the envy of other countries that would thrive on the opportunity to have the level of data available. Yet for many reasons the NHS is still to activate this asset to its full potential, which is something that the Russian participants in this research look at with incredulity.
The NHS is there for all to see, how it is structured, its coverage of the UK and its sheer size and volume. It has a rich history from which lessons can be learned in relation to information systems and access to data, and many organisations are looking here to understand how to do it. The NHS understands what its data asset is, but is still not quite able to release the asset appropriately.
The Russian perspective, they made clear, is very much based on culture and how their system has evolved over time. Perhaps the easiest way to illustrate this is to initially remove the healthcare element. Deploying business intelligence capability into Russian business arenas has been met with resistance. Whilst perhaps something of a stereotype, the average Russian business does not expect to have open data in any form, and would not expect to share business intelligence capability across the organisation, unlike in the UK and US where concepts of business intelligence have moved so close to open data initiatives that they often fall under the same executive responsibility. Therefore the application of business intelligence into the Russian environment initially met with resistance. This was until the implementers realised the ‘sales pitch’ for business intelligence should be to make it clear to the ‘coal face’ worker that access to data would help them do a better job for the good of their position.
With this in mind a conversation with healthcare professionals about how they share information with clinicians about patients with a specific focus on clinical research was enlightening. The starting point for research data in Russia is that if it is research that can be applied to the Russian healthcare economy then information would and should be provided freely based on the clinician’s approval. A patient could opt out, by talking to the specific clinician who was providing the information. However it would be a clinician- based decision that would be related to the healthcare outcome rather than the patient’s wishes.
Patients in Russia are said to be aware of research opportunities but are not likely to drive access to such research; this will often be prompted by the clinician. Quite a different model to other countries, which are moving to consent based models driven by patients.
The future
Industrial leadership, societal challenges and excellent science are the three key headlines for EU wide prioritisation of research. The 2020 programme within Europe is not disease centric; it has a goal of integrating research innovation into the care pathway and tries to ensure that the impact on the participant from an information point of view is kept to a minimum. However, the European programme is not about utilising any single data source or standard, it is about the integration and innovation of systems at the centre of care provision. Adopting the European 2020 approach however is a political decision that each country considers and interprets in a slightly different way. This European goal has an additional priority of international cooperation. Understanding why international collaboration has not yet been successful pan-EU or indeed between the UK and the US was also considered during the creation of this piece.
Delivery of care and access to clinical research from the patient perspective is different in each of the countries considered here. However the parallel industry- centric growth in IT and the delivery of trials is clear and yet significant benefit is still to be released. It is reported that over 40% of clinical trial data is entered into a health record or Electronic Data Capture (EDC) system of some type5, 57% of R&D spend is within clinical development and in some countries clinical records have been digitised to cover 90% of the population, and yet there is no real solution to make linkages in a seamless fashion that exploits technology and standards.
A suggested move to data citation when delivering clinical research could be a route to try to bring about an additional data standards based revolution without creating a rule book. If this were made a part of the pathway from a clinical trial then this could change thinking to such a degree that the barriers to the use of this technology asset could begin to be removed.
A revolution in waiting
The difference between countries is striking. The European 2020 programme is about putting the patient at the centre of any trial with information ‘floating’ out, whereas the Russian model appears, on initial analysis, to be about the excellence of the clinical researcher and supporting that learning with an outcome that can be applied locally. The model in the UK is about facilitating research conducted by the NHS as professionally and with as high a quality outcome as possible. In the US, the model seemed to be more akin to a hunting analogy. Researchers and scientists at the National Institute for Health in the US discussed how their current programmes of work are geared towards early stage research, before the patient is involved, the testing of ‘failed’ compounds to understand what failed means and where success may be grabbed from the jaws of failure.
European time to grant to be no more than eight months is the desire described by the senior team at the EHR4CR collaboration in Brussels in the first quarter of 2014. The median time taken from ethics approval to an NHS organisation having permission to run a trial and being open for recruitment was 21 days in quarter three of last year in the NHS. The focus on set-up times is bringing rewarding outcomes across EU countries.
General legal and ethical issues around the reuse of data for clinical research remain an issue for many countries worldwide. The World Health Organization Global eHealth Observatory survey in 2009 contained five legal questions. The questions were very general due to the nature of the audience, however the output indicated concerns around the legality of consent to take part in research and how it should be collected.
In Europe we are obliged to gain consent and apply it to the access of patient information; we treat this as one of the most important elements of the research pathway and yet this is probably the single largest barrier to the resolution of the problem. The need to ensure the patient has consented, record the consent, make it easy to change the consent, and the ability to access the information of the consented is the ‘golden fleece’ for clinical research.
At EHR4CR a change to the approach to data was suggested: to change the approach to be about who makes use of the information rather than who owns it. This was compared to the aboriginal concept of land ownership. Those that make use of it have control of it; they must take care of it and protect it at all times and if it is not useful to them they must, with permission, hand it to the next person who can make use of it. It’s a nice theory and may well be acceptable to the researcher and participant if a trust in this care could be built and applied, but the change to legislation, and global attitudes, would have to be significant to enable this to work.
Competing with the EU revolution: the US approach
Moving analysis to the US and its approach to the access of clinical information for the provision of care and clinical research provides an indication of even more differences, barriers and opportunities. In the US, data is without doubt an asset that is so prolific it is almost tangible. Organisations from tech start-ups through to large behemoth sized consultancies profess to be delivering something new, something that can revolutionise care at the point where the patient is directly impacted.
Data in the US has been collected for over 30 years based on inputs and outcomes. The concept of public and open data exists and yet until recently perhaps had not been latched upon. The expertise that exists in the technology market in the US is astounding and is starting to release benefits into the care pathway, often without the same consideration for privacy that certainly exists in the UK. This exposure of data is often from open data and the application of big data solutions that enable data linkage that generates insight.
Attitudes to the delivery of clinical research in the US are a key difference noted during the preparation of this article. In the UK a large proportion of clinicians are willing and able to deliver clinical research when their institution or patient asks, however in the US there appears to be a reluctance to take part in clinical research unless that is the role you have chosen. Whilst the number of open global trials is said to be increasing, the number of clinicians that consider research part of the ‘day job’ is decreasing and more so in the US. When asked why, several researchers cited a fear of the unknown and the quantification of the risk factor for them and their patients. A survey conducted by the Duke University in Durham, North Carolina, observed that patients taking part in a trial still consider themselves the equivalent of a guinea pig.
Despite the attitudes, and to some degree the missed chances to use the commercial care model to fuel the research model in the US, there is a success to be understood. The success is two-fold: the NIH who focus on the delivery of academic clinical research and who are starting to build infrastructure to be able to make use of each data set as it becomes available and Clinical Research Organisations (CRO) have realised that the data they have and the data they can get hold of is as strong an asset to them as a commercial relationship. Indeed several CROs are beginning to market themselves as data organisations. Will the CRO be the way that the global need to enable clinical research can reach a position where standardisation of systems is possible? If it is, it will be at a pound and dollar cost; CROs are after all commercial organisations, and yet it will be for the good of research delivery globally and will achieve a standardisation of sorts, even if that is driven to some degree by market forces.
What the world needs
There is a lot to learn from each other: large pharmaceutical companies are beginning to come together and share data and experiences. Europe has the EHR4CR group where nations are starting to share how to make the environment work, and yet there is still much to do. Delivery of high quality clinical research to a timescale and quantity required can be achieved through the use of analytics to support delivery. There are a number of different ways in which this can be achieved; in an ideal world all parties would work together and wherever the opportunity presents itself we will try to do just that.
References – 1. Beasley ‘Recruiting’ 2008. 2. State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics, Centre Watch, 2008. 3. EHR4CR Conference – Brussels 2014. 4. PhRMA 2012 – profile of the pharmaceutical industry. 5. Integrating Electronic Health Records and Clinical Trials: An examination of Pragmatic issues. Michael Kahn, University of Colorado.