Revolutionising Clinical Trials

Despite aiming to include a broad and inclusive population of patients, clinical trials often exclude certain groups and are therefore not always representative of the wider patient population. NorthWest EHealth hopes to help overcome this issue, with the adoption of Electronic Health Record (EHR) enabled clinical trials.

We spoke to Martin Gibson, NorthWest EHealth Chief Executive, to learn more about their Linked Database System and the benefits of EHR enabled Randomised Controlled Trials (RCT).

AM: Can you tell us a little about NorthWest EHealth and how it was formed?

MG: NorthWest EHealth (NWEH) is a UK-based Academic and NHS collaboration that specialises in leveraging existing EHRs to develop medicines more quickly, with improved safety monitoring for the benefit of patients, pharmaceutical companies, and approvers.

Established in 2008, NWEH was set up to develop links between academia and the NHS in the area of health informatics, to identify opportunities for improving health outcomes. NWEH now employs over 70 staff, including software engineers, database analysts, statisticians, researchers and support staff who develop leading software and services for our partners and the wider health research community.

Our focus is the innovative and trustworthy use of routinely collected healthcare data. We have recently delivered the Salford Lung Study, the first late-phase RCT using EHRs, with GlaxoSmithKline.

AM: Can you tell us more about the Salford Lung Study?

MG: The SLS is the world’s first digitally enhanced RCT to include a broad and inclusive population of patients in an everyday clinical practice setting. It examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease (COPD) in over 2800 consenting patients around Salford, England.

It was designed to include those patients who would often be excluded from a traditional randomised trial, for example individuals also being treated for other chronic diseases. This inclusive approach to a trial is important because it is representative of a much wider patient population.

This collaborative study was placed in Salford because of the existing infrastructure of integrated EHRs. The study relied on a Linked Database System (LDS), developed by NWEH and securely hosted within the NHS network that integrated the EHRs of consenting patients across all of their interactions with their GPs, pharmacists and hospitals. This bespoke software allowed close monitoring of patients’ safety in near real-time, but with minimal intrusion into their lives.

AM: What is ‘routinely collected healthcare data’ and how does the LDS help to collect this?

MG: Every patient interaction with a healthcare provider produces data. The LDS makes use of these existing, routinely collected healthcare records to minimise contact with patients, whilst extracting as much trial data as required “directly from source”. This therefore reduces time and money spent transcribing, checking and approving data.

There is a growing interest in using EHRs to enhance clinical trials to allow drugs to get to market faster. NWEH’s extensive expertise in EHR-enabled clinical trials, combined with its proven LDS technology, could be a game-changer for the way future clinical trials are conducted. Using LDS technology in clinical trials enables rapid patient recruitment, reduced clinical development time and costs, and increased responsiveness to patient safety through real-time monitoring. This technology has the potential to revolutionise clinical trials by ensuring drugs get to market faster, and improving patient outcomes as new treatments become available earlier.

AM: How can the LDS support new approaches to running trials, in addition to enhancing traditional RCTs?

MG: Compared to some traditional RCTs, EHR-enabled RCTs can deliver the following benefits:

• Access source data directly so reducing the need for large-scale electronic Case Report Forms (eCRF) and accompanying transcription errors.
  • Richer and more inclusive data.
  • Healthcare utilisation data.
  • Availability of historic data on enrolment.
  • Potential to follow up trial cohort at a much reduced cost at study end if required.
  • Adaptive study design.
  • Significantly improved real-time safety monitoring.
  • Lower trial monitoring costs.
  • Fewer trial resources needed (which enables trial resources to be re-assigned to other study tasks such as subject recruitment).
  • Real-time data from multiple sources.
  • Better-managed trials and better business intelligence on the trial.

Traditional RCTs require trial data about each patient to be entered into an eCRF. This information is either created specifically for the trial or is transcribed from existing "source" data normally held within an EHR. When transcribed, the data must be independently checked through Source Data Verification (SDV) before being reviewed and approved by a Principal Investigator (PI). Entering data into an eCRF is time consuming, expensive, and is prone to human error. This error is removed using NWEH’s fully validated LDS as the data is extracted “directly from source”. It also removes the need to expend time and money to transcribe, check and approve data. 

In addition to these benefits associated with using source EHR data, there is an opportunity to expand the type of data that is normally captured in clinical trials. For example, it is highly likely that historic patient data will be available, enabling tracking of disease progression and treatment for patients several years before they entered the study. Depending on the healthcare system or country that the data is sourced, it may also be possible to accurately identify detailed healthcare utilisation costs at a patient level throughout, before, and following their time on the trial. The ability to reliably extract additional data even when patients have left the study creates the opportunity to utilise adaptive study design.

Due to the design of the LDS (and supporting services) patient safety can be monitored in near real-time. As patient records are received daily from the healthcare locations engaged in the trial e.g. hospitals, primary care, community pharmacies and others, it is possible to determine if there has been a Serious Adverse Event (SAE) and to automatically report this to the PI for further investigation. Near real-time safety monitoring by LDS creates an opportunity for study designs that simply could not be delivered using standard RCTs.

Using existing EHR data enables studies to be designed that do not require interventions from trial staff. These studies can be designed where patients are closely monitored, and data captured, without them being aware of the influence of a researcher on a day-to-day basis. This means that the possibility of the "Hawthorne effect" can be significantly reduced leading to a study that reflects more closely the normal care pathway.

AM: As the world’s first digitally enhanced RCT, what challenges did you face?
MG: Information Governance: ensuring system compliance with regulatory standards.

•  Satisfying the MHRA that we would provide adequate safety reporting for a late phase III trial and complying with NHS Information Governance.
  
•  Managing volume of patient safety data in a clinical trial, through near real-time (24h) monitoring.
•  Developing cooperative and collaborative partnerships with healthcare providers.
• Accessing and making sense of everyday patient data: linking multiple, disparate data sets across 229 sites, comprising primary care, secondary care, pharmacy and out of hours services.
  
  Find out more about NWEH:

Martin Gibson was speaking to Anna MacDonald, Editor for Technology Networks.