A revolutionary approach to clinical trial design
February 2nd 2017
Within the pharmaceutical industry there is an increasing need to update clinical trial design, in order to demonstrate the effectiveness of treatments in everyday clinical practice and get them to market faster. Conventional randomised controlled trials (RCTs) are currently essential in these clinical research phases but are associated with many challenges. Not only are RCTs time- and resource-intensive, but they are usually conducted in tightly controlled conditions that can intervene with patients’ everyday lives. This affects normal patient behaviour and therefore the response does not necessarily give a true representation of how patients in everyday clinical practice would respond to a drug.
EHR-enabled clinical trials
These are key reasons for the increasing interest in using electronic health records (EHRs) to enhance RCTs through extraction of real-world data. The implementation of EHRs has been growing significantly around the world, as countries work towards a more efficient, digitalised healthcare system. As a result, it is now feasible to include collection of data from EHRs in the clinical trial, and this could greatly accelerate the currently lengthy timelines as well as reduce costs of clinical research, ultimately improving patient outcomes.
Technology plays a critical role in EHR-enabled trials. EHRs across primary and secondary care need to be connected to effectively use these data in clinical trials.
This is exactly what our Linked Database System (LDS) technology is able to do by linking consenting patients across their everyday interactions with health professionals. Whether the patient visits their GP, pharmacy or hospital this information will be captured as an electronic footprint. The LDS software is linked to a fully validated electronic Case Report Form (eCRF) on a secure NHS server allowing us to monitor patient safety in near real time. This real-time monitoring is an invaluable capability that just cannot be delivered using standard RCTs.
In order to create a homogenous population, conventional RCTs tend to exclude many patients, including those with comorbidities. This strict inclusion data does make it easier to measure the effectiveness of a therapy, but we have to consider that in reality when such medicines are prescribed it will be for a much wider group of patients than the drug was actually tested on. Using LDS technology for RCTs means that we can now include a range of patients with multiple conditions in the trial, making it more representative and increasing patient recruitment. The real-world data these trials produce will more closely reflect everyday clinical practice and could provide evidence for effective targeting of drugs to stratified patient groups, which in turn could allow for the development of precision medicines.
Salford Lung Study
A real testament to our LDS technology is its recent success in delivering the world’s first digitally enhanced RCT in the Salford Lung Study (SLS). The SLS was a new way to explore the effectiveness of COPD treatment in everyday clinical practice. This study relied on our LDS technology for real-time safety monitoring, reporting and measurement of outcomes. We developed a bespoke system that was securely hosted within the NHS network and integrated the EHRs of 2,802 consenting patients throughout their interactions with their GPs, pharmacists and hospitals. Our LDS technology was selected, quite simply, because we are the only organisation in the world with this technology and the necessary acceptance within the NHS. Using LDS meant that the trial data was far more relevant to everyday clinical practice and representative of a much larger proportion of patients. Due to the near real-time capabilities of our LDS technology we were also able to include a broader population of patients and monitor any effects and interactions of the treatment with any other medications patients may have been taking for their secondary conditions.
It is extremely challenging to design a trial methodology that allows for effective development of new drugs and keeps patients safe, whilst also not interfering with their lives. As we move towards fully digitalised healthcare systems, pharma companies are increasingly adopting the less conventional EHR-enabled trials. EHR-enabled trials improve safety, quality and efficiency of care, by demonstrating the effectiveness of treatments in the real world. Technology such as LDS is critical here to connect the EHRs across primary and secondary care and therefore in utilising data effectively for clinical trials. One of the most exciting aspects of the LDS technology is that it could be applied to any established health economy across the globe. In the future, primary and secondary health data could be obtained, not only from hospitals, GPs and pharmacies, but also from other sources like smartphones, Fitbits or other wearable technology. LDS has the potential to change the way clinical trials are conducted in the future by accelerating drug development timelines, reducing costs and ensuring that drugs get to market faster, ultimately improving patient outcomes.
Professor Martin Gibson
Chief Medical Officer