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Figure 1: % of Total Number of trials https://www.who.int/research-observatory/monitoring/processes/clinical_trials_1/en/ 30% 25% 20% 15% 10% 5% 0%


RWD is being used extensively to inform Health


Technology Assessment (HTA) and the value of therapies. Projects such as the MIT Leaps project5 are using AI and Machine Learning (ML) to enable patients to receive timely access to the most appro- priate therapeutics for their needs, while providing key stakeholders with the Real World Evidence (RWE) they need to improve their decisions related to the development, access and use of therapeutics for the target disease.


Precision medicine: The promise of genomics- based, precision or personalised/stratified/autolo- gous medicine came to fruition enhanced by the increasing scientific understanding and targeting of combination therapies6. The fundamental work of organisations such as UK Biobank7, Genomics England8 and the All of Us Research Program9 from the NIH provided much-needed insight into the correlation between phenotype and genotype. The age of patient empowerment arrived in the mid-2020s with a handful of start-up companies leading the way through secure, patient-friendly applications; these apps allowed patients to choose whether or not to participate in research and share elements of their medical records with participants in the healthcare ecosystem. The improved data security offered by compa- nies decreased the cost of end-user sequencing by


42


moving some of the cost to the researchers who accessed the data, and then compensated the end- users when researchers accessed their data. By the early 2020s it was possible to get one’s genome sequenced and to retain ownership and control of the data. This could be achieved via web-based, blockchain-based, third-party providers such as Nebula Genomics10 and Shivom11. The break- throughs in medical devices, monitoring and diag- nostics (including companion diagnostics) have also continued rapidly to expand and show consid- erable promise, although often their deployment has been based on the ability to pay12.


Patient registries: Patient registries have been a long-term facilitator of patient-centric research. Now in 2030, In this era of ‘very big real world data’, they have been harmonised to align with commonly-agreed standards so that patient reg- istries could effectively be mined to promote research – helping organisations to find the right patients in the right places with the right inclusion criteria, and the right principal investigators for clinical trials. One of the major challenges in drug develop-


ment has been an historic under-representation of patients recruited into clinical trials from regions other than the USA and Europe. For example, in 2019 as a percentage of world-wide


Drug Discovery World Winter 2019/20


USA Japan


Unknown China Germany


UK France Canada India


Netherlands


Australia Italy Iran Spain


Republic of Korea Belgium


Brazil Denmark


Poland Sweden


Israel Austria


Switzerland Czechia Hungary


China: Province of Taiwan only Russian Federation


Thailand Mexico


Turkey Finland


New Zealand Norway


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