A Brief History of Trials

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Since their inception in the 1940’s, double-blinded randomised controlled trials (RCT) have been the pinnacle of good clinical practice for scientistis and healthcare providers worldwide. To truly test the scientific method, participant randomisation, placebo-controlled interventions and blinding of users at all levels are the foundation of any good study. However, despite offering the potential to provide revolutionary steps forward in healthcare, trials are often branded as expensive, difficult to reproduce and time-consuming. With technology in healthcare evolving so rapidly, it's perhaps only logical that we use new tools to improve some of the debilitating facets of trials operations.

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There are currently more than 37,000 trials worldwide being registered each year, and there is plenty of room for radical innovations in this space to improve the clinical trials process. In recent years - and particularly in the aftermath of the COVID-19 pandemic - trials investigators have been adopting new methods to attract the population towards participation in human trials. This strategy has enabled much needed research to continue and support the involvement of otherwise vulnerable people.

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Bringing "trials to the people" and allowing greater engagement without the need for specific site attendance for participation is what we have come to call Decentralised Clinical Trials (DCTs). DCTs have been gaining significantly in popularity in recent years and new digital innovations - including platforms, apps and wearables - are engaging participants in ways we couldn't have imagined possible before now.

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Times are changing

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If you have been involved in a clinical trial - as a participant or a professional - you will likely be aware of the tribulations of trials management of the past. Trials have traditionally involved one central space or site where participants will visit for appointments, checkups, procedures, submission of data, provision of material and healthcare. Technology has certainly helped pave the way for multi-site functionality but managing this process has been logistically challening, has become frought with limitations, and these very limitations are what DCTs hope to challenge as this new practice methodology blossoms.

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The Top 5 Problems DCTs Are Challenging Today

1. Scheduling Difficulties

Even relatively small trials will consist of more than 50 people and managing these people, their expectations and availability has been taxing to say the least. Trials adminitrators have been caught-up in letters, emails and phonecalls, relaying information which can be eaisly lost or misinterpreted. Digital platforms both on the web and through native mobile apps enable a strong sense of participant empowerment, control and self-management. They can engage in trials data submission at their convenience and feel fewer scheduling restrictions by not always needing a physical presence. With mobile and smartphone useage at an all-time high with 85% of both Americans and Europeans having access to such tools, it is easy to visualise the scalability of success with a DCT-approach.

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2. High Staff Costs

The burden of administrative responsibilities to manage participants can cost a lot of salary resource, and with some longitudinal trials taking place over years it's quite easy to see how millions of dollars, pounds or euros can quickly be allocated to staff costs. The challenge to this by DCTs is the provision of novel digital innovations with a strong focus on user experience and product useability. Many accessibile communicative tools we use today require no human training element at all. In fact, some of our favourite social media platforms including TikTok, Snapchat, Twitter, Instagram and Facebook do not come with an instruction manual but still manage to engage even the most self-proclaimed technophobes. DCT digital innovations enable participation at all levels and removes the need for a hefty payroll of administrators, both in training and data collection.

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3. Poor Data Quality and Volume

Communication is key, and while more resources are becoming available to support greater comunication and record-keeping, humans are always a high risk step on the trials data managment ladder. Language barriers, poor training, language and communication skills and even mild iliteracy can all be very impactful to risks of data collection. Transcription of information from phonecalls, conversations and emails always carries error risks and many research organisations require spot- or entire proof-checking of data-sets for typographical errors even after the trial has completed. While this is also hugely impactful on the previous point regarding staff costs, top quality data is more pertinent to trials success. Introduction of even the smallest errors can drastically change data trends and tip the scales from 'proof-of-efficacy' status to 'amiguous results'. The DCT process perhaps performs best in this regard by providing digital solutions, such as electronic Case Report Forms (eCRF) on the web and on mobile, to restrict data input to validated data types. This can mean that making data entry mistakes is near impossible and as the speed of data input becomes greater, the reasonable volumes and breadth of data that one can request of participants becomes greater also.

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4. Limited Participant Demographic

In a traditional single-site setup, trials will have been restricted to data from individuals of a certain demographic. While data from such a population is indeed informative, it imposes immediate restrictions on translatability to the wider population. Many readers of the scientific literature will be familiar with studies conducted in niche demographics - sometimes a sore thumb in a pool of studies which have so far been unable to reproduce findings. The very nature of DCTs means accessibility for all. Participants fitting the inclusion criteria for a study need not be local, and may even be from a different country. Platforms enabling multi-site functionality over the cloud offer incredible advantages to data representation from cohorts wholly representative of the human condition.

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5. Participant Burdening

Engaging participants in a trial can be difficult enough. Adding to this the pressures and costs of travel, needing to take time off work, be available for data entry throughout the day and night, one can quickly see how compliance in trials becomes difficult. Frustrations with burdering responsibilities might reduce the care taken to submit accurate and reliable data, and while traditional paper and pen methods are less validated, who can say when data was actually "submitted"? Bringing technology to participants hands allows trials to seamlessly integrate with their day-to-day lives.

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It currently takes up to $3 billion (£2.4 billion / €2.8 billion) to bring an approved therapy to market in the United States. DCTs have a long way to go, but are challenging the ways in which we run trials and can offer benefits such as improved data accuracy and volume, reduced costs and efficiency.