We often here talk about digital technology having the capacity to transform and modernise the life science industry. But on a practical level what does this actually mean and moreover when will this market shift begin to come to fruition? The following insight is Origin’s perspective on the likely changes which will be imparted across the R&D clinical trial discovery field over the next five years:
Adoption of digital technologies
Digital Technologies are tools that can help to speed up the rate of innovation and development throughout the whole of the clinical trial (drug evaluation) process. The benefit of this approach will impact all facets of the clinical engagement programme from patient recruitment, to improved patient engagement, compliance monitoring, companion diagnostic devices and wearables, finally ePRO`s. The industry has never been better placed to embrace change and adopt digital transformational technology. In the near future manual, paper written reporting and telephone interventions will become less prevalent. Digital outcome will become the benchmark for accurate data collection which will (in time) become a composite of all drug discovery FDA dossier submissions.
Virtual Clinical Trials
Virtual Clinical Trials place patients at the centre of the study design. This patient centric approach should be well received by new recruits to the clinical trial field. Participating in a trial should not always require travel to a clinical research facility or a doctor’s office. Virtual clinical trials represent a relatively novel method of collecting important data directly from cohorts based (at home).From the start of the programme through to the execution and follow-up. This adaptive approach should prove to be more agile, yet less stressful for many patients, particularly those living in rural locations.
Synthetic Control Arms
Synthetic Control Arms represent a way to take a safe (as well as time- and money-saving) leap forward into real-world evidence. They work like this: Instead of collecting data from patients recruited for a trial who have been assigned to the control or standard-of-care arm, synthetic control arms model those comparators using real-world data that has previously been collected from sources such as health data generated during routine care, including electronic health records; administrative claims data; patient-generated data from fitness trackers or home medical equipment; disease registries; and historical clinical trial data. The benefits to the life science industry are clear. By reducing or eliminating the need to enrol control participants, a synthetic control arm can increase efficiency, reduce delays, lower trial costs, and speed lifesaving therapies to market.
AI, Machine learning
AI and machine learning are buzz words which are circulating the industry. To give you some context, machine learning (in this case) should help researchers to analyse huge amounts of multi-dimensional data that is often too difficult and cumbersome for scientists to disseminate effectively. AI learning can help predict which sites will be best placed to enrol patients. Alongside the algorithms can be built to make recommendations in respect of the most efficient trial design and which protocol should be deployed. In time it is expected that we will be using AI, machine learning to predict which patients are more likely to respond to which medication and which patients are at risk of poor compliance or drop out. This level of insight will empower the sponsor, clinicians to choose the right patient for the right study using predictive analysis. In turn this will drive up the efficiently and the efficacy of each clinical study. Ultimately the aim is to reduce the time to market for all new (safe) drug combinations, whilst retaining a firm handle on the rising costs which are associated with the drug discovery arena.
Apps and Social Media
Apps & Social Media can be used to help engage and capture new patients to become more aware of upcoming trials. Likewise this generation are likely to be digital tech savvy and therefore more comfortable having access to real-time health metrics. This will allow them to poetically track their medication regime 24/7 using digital technology which can be connected to remote patient compliance devices, companion diagnostics and where applicable wearables. This level of interaction and on line support will allow physicians to track progress, identify side effects, adjust therapy and better manage patient outcomes.
In closing, we are living in an exciting era, this is a time when we are becoming ever reliant on our mobile phone, laptop and technology in general. As a result of these market conditions, we are shifting to business models which will invariably create an enormous amount of data. Having the ability to protect your data and understand it`s intrinsic value will be two of the foremost drivers for determining the successful realisation of the digital revolution.
In closing, we are living in an exciting era, this is a time when we are becoming ever reliant on our mobile phone, laptop and technology in general. As a result of these market conditions, we are shifting to business models which will invariably create an enormous amount of data. Having the ability to protect your data and understand it`s intrinsic value will be two of the foremost drivers for determining the successful realisation of the digital revolution.
Article written by Graham Howieson – Origin Pharma www.orginltd.com
Origin Pharma hold proprietary IP in the field of Perennial Encryption which is a safe, secure methodology for upholding data integrity.
Origin Pharma are a packaging, design development resource with a credible track record of delivering product innovation and manufactured supplies.
