The past decade has seen a significant shift in consumer behaviour in the pharmaceutical industry due to technological development, but the drug trials sector has, so far, failed to evolve as quickly. Although many patients have come to expect technology enablement to help them better manage their medication, long-term treatment and overall health, pharmaceutical companies have faced hurdles to on-boarding similar technology for the development of the drugs themselves.
The industry and its stakeholders must now look to make their environments as fertile for new technology as possible and embrace innovation, if they hope to bring better products to market more quickly, and more efficiently, than their competitors.
Early clinical trials
The first controlled clinical trial, according to reports, was conducted by James Lind in 1747 (Collier 2009) – long before the digital era materialised around the world. Data was collected from 12 sailors suffering from scurvy as part of the study, all of whom were assigned to one of six different forms of treatment. While most of the treatments assessed had no demonstrable effects or benefits, those who were treated with citrus recovered after just six days of therapy.
Although the number and nature of successful clinical trials proliferated in the ensuing years, the adoption of digital record keeping during the industrial revolution introduced key efficiencies into the data collection and analysis required for drug development.
The sheer amount of systemic and cultural hurdles – both in the UK and across the rest of Europe – entrenched in every aspect of the pharmaceutical industry make it difficult for any new product or process to get pick-up right away. When it comes to drug and medical device development, for example, innovating processes only ever occur slowly, often over the course of a ten or fifteen-year product lifecycle. Then, once a product is brought to market, it’s locked, which means it’s almost impossible for any new product to penetrate the process while it’s being manufactured, or improve the product once approved. While iteration may be constant in the digital world, it can be difficult for the pharmaceutical industry to maintain the same flexibility; especially when developing highly regulated drugs and devices.
New product or process in the pharmaceutical industry must, of course, adhere to regulations to the letter – which takes time and money. Trickier still, EU regulations, for instance, differ widely from regulations in Asia, the US, and the rest of the world, which means that, although a new technology might be approved in one country, it won’t necessarily be possible to use the same innovation when bringing the same drug to market elsewhere. This can make organisations reluctant to adopt innovation when it might have limited use worldwide.
Lastly, the difficulty with integrating new technology into any area of the pharmaceutical industry is convincing businesses of the benefits, especially when the success of new trial-types is never fully guaranteed. While drugs developed using innovative processes are (in most cases) much more likely to be launched, and drugs developed using innovations much more likely to be added to nationally approved-drug lists, the drug development process still remains a high risk one and can lead to aversion in a number of areas for drug companies, one being the adoption of innovation.
However, pharmaceutical businesses unwilling to overcome these hurdles in order to adopt and utilise new technology ultimately risk being left behind in an increasingly competitive market.
Data, data, data
Last year, PAREXEL partnered with Microsoft to form a “Cloud Technology Alliance” aimed at accelerating the pace of drug development through innovative and cloud-based technologies that automate and streamline workflows and provide greater access to quality data, an increasing hurdle for today’s sponsors. By leveraging innovative new technologies to deliver advanced data analytics, critical drug development processes can be better informed for improved outcomes.
Where trials might previously have collected data from patients a few times each month, data from wearable technologies (such as fitness trackers and blood pressure monitors) can be collected at shorter intervals or even on a continuous basis, creating millions of data points. The challenge then will be for companies to implement the appropriate data analytics to define what data needs to be collected and then what to do with it. National, government-led standards will be needed in future to regulate these new dynamic data collection methods, to ensure pharmaceutical companies do not become overwhelmed with volume of theoretically useful data that they do not know how to analyse.
There is a great opportunity to streamline this process with the use of data technology – and particularly patient registries – having the potential to become a mechanism to increase the efficiency of patient enrolment. For instance, AI can be used so that only patients eligible for certain clinical trials are notified of the trial recruiting, thus minimising the amount of time used. Other benefits include identifying those patients with rare diseases, those in particular geographies, and those in ethnic minorities for trials.
Predictive analytics can then also be used to estimate the outcome of a trial that has had to be cut short – ultimately saving pharmaceutical companies time and money and bringing drugs to market much faster.
Innovation means progress
It is no secret that the pharmaceutical industry has faced several challenges when it comes to modernising its processes. Given that strict regulations and legislation govern much of the pharmaceutical industry – and that these vary widely country to country – any updates to the drug trials sector must evolve very slowly, and with caution, over time; as has been the case with digitising the industry’s products and services.
However, now that improvements in trial efficiency and flexibility can be seen once new technologies – such as wearables and the cloud – are adopted, the benefits of digitisation can no longer be ignored by the bigger pharma players. There is a growing call to action for the industry and other stakeholders to collaborate now and find creative ways to adapt their organisations, behaviours and systems to foster a more fertile environment for innovation.
Kemi Olugemo, Senior Director, Global Therapeutic Area Head, CNS, PAREXEL
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