With attention turning to 2020, just how much will clinical trials change in the next year? What new trends will emerge? Which technologies will embed themselves further in studies and which will be phased out? We asked 10 clinical trials professionals from pharma, technology providers, patient groups and biotech for their one prediction for how clinical trials will most change in 2020.
Patricia Moenaert, Director, Portfolio Sourcing and Relationship Management (PSRM), Celgene Intl
“Sourcing/outsourcing will be supported by more automated systems by 2020 and sponsors will mainly do oversight and less micro-management since both CROs and Sponsors will join the same most common technology. This will allow sponsors to be more efficient in resourcing internally and avoid duplication of task by both CRO and sponsor. Non-core activities will be delegated to CROs who are becoming the experts, whilst science will stay core at the sponsor. Probably support from ad hoc consultancy will be part of the main business and become more efficient and cost effective including in science support.”
Sol Yates, Associate Director, Global Regulatory Affairs, Grünenthal
“There will only be minimal changes as I expect the European Clinical Trial Regulation will not be fully implemented until late in 2020. Brexit and data privacy will be the main issues of focus.”
Sol Yates is speaking on the EU Clinical Trials Regulation: An update of the current status and some thoughts on its implementation at Clinical Trials Europe on 20 November in Barcelona.
Dr. Frank Berger, Head of Analytics, Global Clinical Operations, Boehringer Ingelheim
“I don’t expect revolutionary changes. The trend towards more data-driven decisions regarding inclusion/exclusion criteria, country and in particular site selections will continue, reducing the dependence on know-how and experience of individuals. I hope we get a better understanding of the impact of trial complexity, in particular protocol complexity, on our ability to execute our clinical trials according to plan. We will see more efforts towards virtual/digital trials, but this will be a slow shift.”
“The change I want to see is the industry focusing on relieving the burden on patients. The good news is technology need no longer be a barrier. The next step is to better design studies around patients, rather than looking for mythical patients that fit a particular protocol.”
Jenny Royle, Patient-centricity Senior Program Leader, digitalECMT at CRUK Manchester Institute, and The Christie NHS Foundation Trust
“Trials ongoing in 2020 need to be developed now, and as such I think two of the largest changes are likely to relate to. Firstly, computer-enhanced patient identification. And secondly, an increase in the number of trials exploring drugs that also incorporate devices to optimise patient behaviour with those medications. These have potential to increase benefits of treatment, as well as monitor or mitigate some of the adverse effects, thereby rapidly improving potential patient benefit with technologies already available.”
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Harry Yeates, Strategy Director, Langland UK
“I'm not sure, given we're already nearing the end of 2019, that we'll see a huge shift in the next 15 months. However, it's increasingly hard to ignore the transfer of wearables from the world of consumer health (where they carry disclaimers about not being medical devices) into clinical research. The recent Apple announcement of three observational trials with major US health providers, organised around its watch and Research app, attracted a lot of attention, and it seems a welcome inevitability that trial protocols will increasingly look to wearables (and other solutions) for opportunities to minimise in-person site visits. Certainly, talk about virtual and hybrid trials is everywhere. Exactly how far that trend moves from press release to regular reality by the end of next year remains to be seen, but it's certainly happening.”
Ruby Saharan, Senior Medical Advisor- RWE, Novartis Oncology UK and Ireland
“I think we will see an increase in utilisation of wearables to supplement data that is captured formally by the physician.”
Ruby Saharan will be speaking at Clinical Trials Europe in Barcelona, 20 November, on using clinical EHRs, including Artificial Intelligence and Machine Learning to assist the drug commercialization process.
Michael Song, Senior Manager R&D, MedImmune
“We have seen the adoption of digital inhalers in clinical trials. Today’s connected device for injectables is not that user friendly, but I do see a few that are integrated, low cost and easily applied to both trials and commercial. They can help clinical trials become more robust, ensuring adherence and compliance to the treatment regimen. Key to those systems is that they are integrated and capture just the essential information. They have the capability to provide a seamless user experience and benefit all the stakeholders (patients, pharma, health insurance / payers, HCP).”
Micheal Song will be presenting on ‘Building models to engage more and ‘better’ patients in clinical trials’ at Clinical Trials Europe on 20 November in Barcelona.
Robert Corbé, Clinical Trial Manager, Isofol Medical
“In the oncology area, new treatments are getting more and more personalized. This indicates that we need to collect and analyze various biomarkers without solid evidence that each specific biomarker is of interest for the specific indication tested. I see that more tissue samples are being taken to possibly gain knowledge of how to provide tailor made therapies, even in phase III pivotal trials. This causes increased workload for sites and study teams that needs be accounted for.”
Robert Corbé is presenting a case study on ‘How to manage cultural differences, site engagement and patient recruitment when running a global study in a biotech company’ at Clinical Trials Europe on 19 November 2019 in Barcelona.
Siobhan Southam, Strategic Engagement Leader, digitalECMT at CRUK Manchester Institute, and The Christie NHS Foundation Trust
“More devices being added to clinical trials, some of which will be useful and work and some that won’t – not necessarily because they don’t work but because patients won’t use them. The critical success factor will be patient acceptability. If the device means that they need to do more (eg taking their own samples, wearing a device) then there has to be something in it for them and for the clinical team at the sites.”
Siobhan Southam will be speaking about innovation in care pathways for clinical development at Clinical Trials Europe on 20 November in Barcelona.