Digital Health: Clinical Trials

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Increasing digitisation of healthcare processes is impacting clinical care as well as clinical research industries and there are some major trends emerging such as, transition towards electronic filing in clinical trials started taking shape from 2006 and is shortening time between end of trial and submission of dossier;  more effective and faster patient recruitment of trial subjects especially in rare conditions etc.

Escalating costs of clinical trials and tough economic climate call for increased performance including reducing both cost and time which therefore encourages the creation and adoption of electronic tools.  Healthcare being an industry more regulated than most, the process of carrying out a clinical trial involves exchange of millions of pages information including documents which need to be signed and faxed or transported across the world. This would be an ideal place to apply the power of digitisation. Sure enough this is happening. A report by Frost and Sullivan predicts that the integration of EDC and EHR will certainly happen in the next 5-10 years and will subsequently open up the possibility of an integrated EHR-clinical trials system.

In addition to cost pressures and efficiency arguments, pharmaceutical industry is also facing the growing online presence of patients seeking information about conditions they or their loved ones suffer from. Such activated patients are usually also motivated to participate in clinical trials. Over the last several years innovative companies like TrialReach and Smart Patients have made it easier for pharmaceutical companies to engage with patients strongly motivated to participate in clinical trials.

A 2010 study involving the NCI /CTEP program (at the National Cancer Institute in the USA) estimated that each year their clinical trial effort (which represents 3% of the total number of clincal trials ongoing in the USA alone) generates in excess of 100,000 pages of data.  So a digitised system which is able to validate identities digitally and transfer information securely would have a significant impact on this industry both in time as well as cost of trials. An eCRF (electronic Case Report Form) does just that.

In most industries ‘time is money’ and it seems in the clinical trial business time is a lot of money indeed.  Using a conservative industry estimate any delays approximately cost upwards of $35,000 per day, per trial (although some sources estimate this to be between $600,000 to $8m per day). To make things worse, around 80% of clinical trials experience delay from one to six months and only 10% of trials are completed on time. A lot of these delays can be addressed using digital approaches including eCRF, EDC and electronic recruitment.

As a means of bridging the digital gap, companies have employed EDC during the delivery of clinical trials  and have reported that it definitely speeds up the process, particularly in the “close out” phase (i.e. from the final patient’s last visit to the lock of database). This effectiveness can be expressed quantitatively: the paper based process during the “close out” takes on average between 4-8 weeks, while EDC-based trials typically close within as many days. Digitization of clinical trials documentation could also realise the opportunity to make it more accessible for the wider scientific community which could reduce the risk of bias and attract critical input from other researchers, although pharma companies would probably argue it might have a negative impact on their competitiveness.

Regulators seem to be watching this space with great deal of interest. “Modernisation of clinical trials is a key initiative of the FDA,” said Janet Woodcock, director of the FDA’s centre for drug evaluation and research therefore the agency actively supports innovation in this field. Virtually unlimited opportunities of digital technologies applications seem to be the next recourse pharma industry will try to explore.

Digital approaches have also had an impact on recruitment of patients for clinical trials and we believe we have only seen the tip of the iceberg in digital recruitment. Recruitment is not easy, it involves finding suitable subjects and making them commit is a lengthy and expensive process.  The internet allows researchers to reach for potential subjects across the country or even globally, and with slight adaptations in study design it is possible to conduct trials remotely. This works particularly well for diseases which are not so common and where patients have become accustomed to searching online for resources, traditionally these are the hardest subjects to recruit. The online world, including patient communities, twitter and specialised websites is buzzing with activity and it has not gone unnoticed by the recruiters. For instance, Mayo Clinic has reached for patients using a rare disease-specific social networking site and recruited the subjects in just one week – such rapid response rate shocked the researchers.

Once different aspects of clinical trials started going digital it was only a matter of time for someone to try out a virtual clinical trial! And Pfizer was the first company to get an approval from the FDA to carry out a virtual phase IV clinical trial for an overactive bladder treatment. The company provided the subjects with a mobile platform that gathered patient reported data which ensured patient compliance even when trial logistics were complicated. Patients filled in diary questionnaires when required via a series of text messages which allowed for real time monitoring and therefore improved patient safety. It’s a very convenient data collection approach which could allow the researchers to collect more data on patient’s quality of life, which often gets overlooked. As Craig Lipset , the Head of Clinical Innovations at Pfizer commented, it was not only a clinical trial, but a methodology study as well. The company has observed the need to switch away from researcher-centered trials to introduce patients as active participants and effectively overcome geographical trial barriers.  Those of us who are watching the field of digital health are very excited to know the results of this study which should draw a comparison between the previous “real” trial and the ongoing virtual study, and if the benefits of digital health have to be believed then this study better not be delayed!