In the pharmaceutical industry there is a growing need for a new approach to clinical trial design that will increase the speed that drugs get to market. NorthWest EHealth (NWEH) writes.
Clinical Trials
In order to drive this forward, pharmaceutical companies need to demonstrate the effectiveness of their new treatments in everyday clinical practice. Current guidelines are frequently derived from evidence gained during a trial, which does not typically reflect the patients who will be using these drugs in their daily lives.
EHR-enabled clinical trials
In recent years, the implementation of electronic health records (EHRs) has increased significantly as countries worldwide work towards more efficient healthcare systems. There is profound interest in the use of EHRs to enhance randomised clinical trials (RCTs) through extracting real-world data. The adoption of EHR-enabled clinical trials and improved digital infrastructure could allow for more efficient and effective research processes for clinical studies. By accelerating timelines and reducing drug development costs, this would ultimately improve patient outcomes. Technology must play a key role in connecting EHRs across primary and secondary care in order for patient health records to be used effectively for clinical trials.
NorthWest EHealth (NWEH) has recently developed Linked Database System (LDS) technology to support the collection of real-world evidence. The LDS links consenting patients across all of their everyday interactions with doctors, pharmacists and hospitals. The software has the ability to link primary and secondary care data, with 24-hour download intervals to a secure National Health Service (NHS) server, to provide an integrated EHR linked by the patient’s NHS number.
LDS technology has been designed to monitor patient safety in near real time. Every time a patient comes into contact with a healthcare professional, this leaves an electronic footprint (e.g. note entry, prescription, or blood results) and this is recorded by the LDS. The LDS is linked to a fully validated electronic Case Report Form (eCRF) that ensures prompt safety monitoring and reporting of adverse events to end users (healthcare providers or researchers). The near real-time safety monitoring capabilities of the LDS creates an opportunity for study designs that could not be delivered using standard RCTs.
RCTs are usually conducted following strict inclusion criteria such as excluding patients with comorbidities. Using LDS technology for RCTs means that studies could be carried out to include those patients that would normally be excluded from traditional RCTs, increasing patient recruitment. Ultimately, this approach could change the way that future clinical trials are conducted, allowing studies to be designed that include a broad and inclusive population of patients, producing data that more closely reflects everyday clinical practice. This real-world patient data could provide evidence for effective targeting of drugs to stratified patients groups, enabling the potential development of precision medicines.
Accessing existing EHR data through technology such as LDS allows studies to be designed so that patients can live their regular lives throughout the trial, with no intervention from trial staff. Patients can be closely monitored using LDS software, but with minimal intrusion. This means that the possible ‘Hawthorne effect’, often experienced in RCTs, can be largely reduced.
Salford lung study
NWEH’s LDS technology was recently used to deliver the world’s first digitally enhanced RCT in the Salford Lung Study (SLS). The study examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease (COPD). The LDS software collected healthcare information quickly and efficiently from a network of hospitals, doctors and pharmacies, accumulating data on the effectiveness of the new treatment in everyday clinical practice.
It’s been estimated that traditional RCTs, which have strict inclusion criteria, would only allow 7% of COPD patients to take part in such a trial. However, the SLS was designed to include all patients over 40 years old who have experienced exacerbation in the previous three years. This meant the trial data would be far more relevant to everyday clinical practice and representative of a much larger proportion of patients. It also allowed observation of the effects and interactions of the new treatment with patients’ other medications that they may be taking for their secondary conditions.
Conclusion
The adoption of EHR-enabled clinical trials will be essential for pharmaceutical companies to demonstrate the effectiveness of their new treatments in the real world. NWEH’s LDS technology connects EHRs across primary and secondary care, and enables rapid patient recruitment, reduced clinical trial development time and costs. It also increases responsiveness to patient safety through near real-time monitoring. This technology could be applied to any established health economy across the globe. This has the potential to change the way that clinical trials are conducted in the future by ensuring drugs get to market faster and therefore improving patient outcomes.