Technological innovations in clinical trials are increasingly necessary for enabling drug development, and Life Sciences as an industry has an enormous opportunity to improve efficiency and cut costs, whilst extending the scope of its research and improving patient and clinical experiences.
This is happening as industry leaders leverage the latest digital trends such as data science, AI, risk-based monitoring and analytics and machine learning to enhance, streamline and de-risk the drug development process. New platforms are improving the efficiency and productivity of clinical trials, delivering novel outcomes, increased patient engagement, and reduced patient burden.
So, what does Medidata think will be the growing trends in the world of life sciences, pharma and healthcare for 2019?
Driving digital transformation by embracing emerging technologies
Artificial intelligence (AI) has already established a small but growing presence in the life sciences industry, starting with drug discovery and development and now in emerging applications across the product life cycle. While the life sciences industry is full of data-rich processes, AI is only just beginning to be applied to gather, manage and intelligently use all the structured and unstructured data in the domain.
For 2019 and beyond, AI has the biggest potential to support the analysis of the vast amounts of patient data, helping clinicians and healthcare workers to spend more time with their patients, ultimately improving the human touch. The key applications for AI, machine learning and big data analytics in pharma will include, in the year ahead:
- Synthetic control arms created through analytics will reduce the need for placebo arms in trials
- Data curation and ingestion with streamline the 700+ ways we record gender in clinical trials, for example
- Accelerating biomarker discovery – as machine learning groups genomic profiles at the patient level and helps us understand the causes of disease and adverse effects
- Outlier identification through big data analytics will accelerate approvals with regulatory bodies
Today, Pharma companies are sitting on a huge pile of data. Due to the competitive operating environment and strict regulatory compliance standards, this data is hidden behind a firewall and is sealed from the rest of the world. In 2019 and beyond, big data analytics will continue to combine different data sources and bring to light new relationships and insights which might otherwise have been left unknown.
Machine learning will also increasingly become a great tool for pharma R&D, if the most advanced data infrastructures are in place, the right questions are asked, important goals are set, and enough data training is provided. If all these conditions are met, trained machine learning models will exponentially speed up the R&D process.
Virtual trials are the way forward for patient retention
Clinical research organisations are continuing to see the importance of reducing patient burden during trials, as well as wanting to make trials and treatments accessible to as many patients as possible.
As a result, virtual trials that allow patients to record data remotely, often from the comfort of their own homes, will increase in number. This will be facilitated by the advancement of new technologies, such as wearable monitoring devices, and the wider use of smartphones to record and transmit patient data remotely, in real time, as well as more sophisticated anomaly and compliance tracking software to ensure the reliability of this data. For children, being able to take part in trials from their own home becomes particularly beneficial, as it allows them to feel more comfortable during what can be a challenging and often scary time for them.
With built-in location tracking systems, the technology to run medical apps and the ability to empower those who live great distances from their nearest hospital, the smartphone is perfectly positioned to accelerate the advancement of virtual trials.
Additionally, the way virtual trial data is being recorded and transmitted has been proven to be reliable and clinically meaningful, making it a very viable option for pharmaceutical industry researchers.
The rise of digital therapeutics
Digital Therapeutics is already starting to be a treatment option for certain mental health diseases, including alcohol addiction, via everything from digital therapists to the gamification of addiction management. As the life sciences industry continues to exploit the potential of new technologies, digital therapeutics will become increasingly more integrated into traditional drug therapies.
For many chronic conditions the drug therapy is centred on disease management, that therefore requires real-time monitoring and use of therapies. Connected monitors for things like blood sugar, for example, could support with a more automated process for insulin delivery, reducing the risk of hypo or hyper-glycemia incidents and reducing the need for as many home/or site visits, or emergency admissions. We expect to see more innovations in this category in the year ahead.
Christian Hebenstreit, General Manager and Senior Vice President EMEA at Medidata Solutions
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