If there is one positive thing about 2020, it is the speeding up of medical innovation and rearrangement of priorities in the clinical research sector. It became clear that clinical trials cannot go on as usual and a shift in the way they’re planned is needed.
Which are the big trends in clinical research that will be pivotal in 2021? The Covid-19 pandemic made them easy to predict – number one on the list is certainly decentralized trials.
Global decentralized clinical trials
2020 was a transformative year for the way trials are being conducted and 2021 will take this even further. Decentralized trials which became a necessity during the multiple 2020 lockdowns are not only a way to ensure your trial can continue even in a situation of global crisis but also a way to diversify study participants and attend to the needs of patients in trials.
Virtual technologies and remote care will continue to support trials affected by the Covid-19 crisis. The decentralized approach will be considered more and more in the planning of new studies as well.
To make this easier for CROs and Sponsors, TrialHub launched the first global database of decentralized trials. The more trials go virtual/hybrid/remote – the more data will be available to make feasibility for decentralized trials a more familiar endeavor. From predicting average recruitment rates to partnering with already experienced investigators, data is needed to make this big shift, especially considering the monetary cost of remote trials.
Addressing data hurdles
Speaking of data, clinical trials stand to hugely benefit from optimizing their data collection and storage processes. 2020 revealed the need for unblocking common bottlenecks in clinical research one of which is the way data is being stored and accessed.
The massive data sets that life science companies rely on in the process of drug development need to be made easier to organize and access. We’ve written extensively about how data gets in the way of clinical research. Drug development cannot be optimized without addressing the storage of and access to the massive amount of data the industry produces.
Just as an example (although the issue with data spans wider than this) public clinical trial registers suffer from a chronic lack of systematic, regular updates. As a result, they are not only difficult to use by patients and industry professionals alike but also misleading. The planning stages of any research study rely on accurate and accessible information.
But while the issue of accuracy can be better addressed through policy, the issue of access might have a more technological solution: NLP. Natural language processing has been used to extract data from text-based sources and in a way catalog this data to make it scalable.
TrialHub uses NLP to extract all the data from public registers and analyze it based on perimeters set by the user.
In other words, if you need to be able to plan for RR ( Recruitment Rate) you can get the ARR (Average RR) of similar trials in your chosen locations under the Eligibility criteria of your protocol. This is one way NLP makes data easy to access and work with. 2021 is going to make easy data access even more of a priority.
Digital therapeutics will accompany drugs
Another aspect of digitalization that 2020 brought about and will continue to grow in importance is digitally collecting data from patients not only in but also outside of trials. And we’re not talking about patient reported outcomes although these are important as well.
Digital therapeutics such as wearables that monitor important indicators 24/7 will start being prescribed alongside drugs as part of more holistic treatment. What this means for clinical research is that real-world data will be potentially made easier to collect and access.
Another aspect of this, according to Kuldeep Singh Rajput, CEO of Biofourmis, is increase in the number of drugs developed ‘in conjunction with’ digital therapeutics. In other words, digitalization of data will be the theme of 2021.
Covid-19 and the lockdowns that followed spelled change for the way trials are being conducted and the most notable one is in the way data is and will be collected, stored and accessed. At TrialHub we’re more than optimistic about this shift as it will make the process of planning clinical studies even more precise and scalable – ultimately benefitting more patients.