Medidata reflects on how clinical trials have evolved over the past year, as well as emerging patterns and drivers of change for the coming year. Paul O’Donohoe and Fiona Maini from Medidata explain.
1. The future of clinical trials is decentralised
Decentralised clinical trials, described as the ‘new normal’ in clinical research, harness remote technologies to enable patients to participate in clinical trials from their home or preferred location, thus decreasing patient burden and offering greater flexibility. With Covid-19 lockdowns threatening to halt the progression of clinical trials, the increase in decentralised clinical trials enabled the continued progression of clinical research throughout the pandemic.
According to Paul O’Donohoe (Senior Director, eCOA Product and Science at Medidata): “Covid-19 shed a light on the benefits of implementing more flexible solutions to ensure study teams have robust systems which can be adapted to rapidly changing conditions, while ensuring patient burden is minimised. The future of clinical trials is flexible decentralisation, with well-designed solutions improving the quality of clinical trials while allowing us to be meaningfully patient centric.”
“As we move into this new year and beyond, I believe that industry technological transformation is going to continue,” says Fiona Maini (Principal – Global Compliance and Strategy at Medidata). She continued: “Some technologies allowing trials to be decentralised have been around for a while and the pandemic emphasised the availability of these established technologies and processes and the necessity to further leverage them going forward.”
2. Data collection and analysis will be increasingly integrated
Going forward, the powerful combination of remote data capture and cloud-based data and imaging analytics will reach its full potential. Over half of clinical trials already involve medical imaging. As this becomes even more widespread, cloud-based imaging management platforms will optimise workflows and improve data quality.
3. Key watchwords are efficiency, security and accessibility
By reducing the manual workload of both data collection and analysis, trials become more efficient, freeing up time and resources. Highly secure, cloud-based and AI-driven technologies will ensure the secure storage of trial data and transform safety procedures will real-time AI monitoring of participants’ wellbeing. Patients are empowered to enrol in trials from the safety and comfort of their own homes, reducing the traditional barriers to access such as the time and expense of travel.
“It’s important to remember that we’ve been decentralising aspects of clinical trials for decades,” states O’Donohoe. “The use of Electronic Clinical Outcome Assessments (eCOA), where the patient provides data on symptoms via their own smartphone or computer, has long allowed us to capture vital data on the patient experience outside of clinical sites. Today’s decentralised trials are enabling the industry to become more flexible in delivering those trials, allowing it to shift an increasing number of trial tasks to locations that are more convenient for patients. DCTs have played an important role in reducing burden and barriers of entry previously hindering patients from partaking in trials. Trials are becoming more efficient, and patients are empowered to enrol in clinical trials from the safety and comfort of their own homes – with less or no travel to sites, and with new engaging ways of monitoring patients during trials.”
Maini comments that, as a result of the wider adoption of technology, “the industry is able to increase the pool of participants, trials are becoming more accessible and are reaching more patients. Wider adoption of technology also increases diversity in clinical trials, leading to better treatments and enables trials to reach patients with specific rare diseases.”
Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata. He is responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials and supports internal teams and Sponsors around the implementation of industry and regulatory best practices when using eCOA.
For the past 20 years, Fiona has been providing advisory services consulting within the pharmaceutical arena and mobile health technologies for Clinical Trials. Currently Principal for Global Compliance and Strategy at Medidata, she is also active in the EU Artificial Intelligence Alliance and ACRO Working Party on Virtual Trials.