In January 2022, DDW’s Megan Thomas spoke to decision-makers from the drug discovery industry about their predictions on what 2022 holds for our sector. As we head into 2023, DDW will be publishing a series of reflections on these predictions. Here, Thomas reflects specifically on Anita Cooper’s prediction relating to the importance of clinical trials.
Anita Cooper, a Non-Executive Director on RareCan’s board, predicted an opportunity to shift to a more efficient outcomes-based, patient-centric drug development and delivery model in the future, but noted that in 2022 and beyond, further stakeholder engagement in clinical trial design and healthcare delivery will be necessary before this opportunity can be realised; a truth that is especially relevant for rare cancers. So, looking back, have efforts been made in this regard in 2022?
Protas was early off the mark when this non-profit organisation was launched on 24 January to design and deliver large, inclusive, randomised clinical trials, working in collaboration with industry partners, medical charities, patient groups, academic researchers, and frontline clinical teams. Following the launch of Protas, DDW spoke with Protas Chief Executive, Professor Sir Martin Landray, who echoed Cooper’s emphasis on the importance of clinical trial design. He said: “The opportunity – which we’re addressing through Protas – is to change the economics of those late-stage trials so that pharmaceutical companies feel they are able to make more bets on treatments for common diseases, which ultimately creates better health outcomes for patients and reduces the burden on the health systems that support them.”
Following a meeting at the Pistoia Alliance’s annual European conference in London, discussions around the sector’s position in the wake of the Covid-19 pandemic took place, and attendees at the meeting highlighted how advances in technology are helping patients become more empowered regarding their health. While some may have been unsure as to whether the post-pandemic landscape would continue as the world returned to normal, the results of a report published in 2022 by Medidata revealed that the improvements in clinical trial processes and more technology-driven approaches are here to stay. The report, ‘European Industry Research Report: The Future of Clinical Trials’, indicated that the clinical trials of the future will include decentralised elements and be more reliant on technologies like artificial intelligence, but also increasingly patient-centric. DDW learnt more about this in an interview with Mark Matson, Senior Solution Specialist for Sensor Cloud at Medidata, focussing on how the use of digital biomarkers in life sciences and how they can help advance our understanding of disease. Thereafter, Medidata launched the Intelligent Trials Diversity Module to help improve the equity of clinical trials. The module will provide site-level participant demographic data including race, sex, age, and ethnicity.
What Cooper could not have predicted was the impact the war in Ukraine would have on the industry, which has arguably slowed down progress in this regard. DDW shared a global data analysis from Phesi, which showed the extent of the impact from the war in Ukraine on clinical development. Additionally, DDW’s Diana Spencer examined clinical trial data from Phesi and spoke to Dr Olena Karpenko, Clinical Research Director at Medical Center Ok!Clinic+, to understand the impact of the war and how the industry has been able to rebuild.
According to Cooper, there has been a culture shift when it comes to healthcare, and she sees this as a benefit looking forward. She hoped that in 2022, this would be utilised. She said: “The rise in the use of wearable reporting devices and of ePRO (electronic Patient Recorded Outcomes), eConsent, eCOA (electronic Clinical Outcome Assessments) and telemedicine throughout the pandemic has facilitated this transition towards more remote health monitoring. As more tools are developed in this space, a greater diversity of patients will be accessible to researchers as geographical and other barriers to participation, are lowered. This may have a much needed and positive outcome, in researchers having a broader base of patients from which to recruit into studies and ultimately facilitate greater patient access to medicines.”
On reflection, it seems like the events of 2022 proved this “much needed and positive outcome” to be true, bolstered when clinical trial support organisations like Medical Research Network (MRN) win a Queen’s Award for Enterprise for International Trade for its work in helping enhance the delivery of clinical trials through decentralisation technology. Or, in the case of Celerion, a clinical research organisation (CRO), when its work was recognised for its contributions to the industry, claiming an award for the seventh consecutive year.
It seems that in 2022, significant efforts were made to ensure the opportunity Cooper sees is realised, which was also made evident when DDW’s Reece Armstrong spoke to Scott Gray, President & CEO of Clincierge, about its unique approach to improving the clinical trial experience for patients. Precision medicine technologies company Iterative Scopes also saw the opportunities that lie ahead and acquired two clinical trial optimisation companies, Clinical Research Strategy Group, LLC and Precision Research (CRSG/Precision), focused on streamlining and accelerating the drug development process for inflammatory bowel disease (IBD). Not to mention, it is clear that virtual clinical trials are a key focus for Cambridge Cognition, as in 2022 the company entered into an agreement to acquire eClinicalHealth Ltd (eCH), a full-service digital technology provider that is working on virtual clinical trials for three of the world’s top ten largest pharmaceutical companies.
Not to be overlooked is clinical stage company Beckley Psytech, who partnered with behavioural health company Ksana Health to use the company’s technology to support its future clinical trials; or the Veeva R&D and Quality Summit Europe, which gathered over 500 life sciences leaders in Zurich to explore new approaches for advancing digital trials and improving the clinical, quality, regulatory, and safety processes throughout.
This one element of the predictions made by Cooper, shows how much is going on concurrently in the drug discovery industry. It also illustrates the process so regularly employed by those across the sector: identify an opportunity, establish what needs to be done to make it a reality… and get to work on the step changes that will make that possible. Through the collaborations, investments and commitments that have been made in 2022 alone, we are that much closer to the more efficient outcomes-based, patient-centric drug development and delivery model that Cooper sees in the future.