Data, patient recruitment, and regulators all highlighted in these three predictions for the new year.
At the onset of the pandemic, the industry had to adapt quickly to keep trials afloat. This forced change helped researchers understand when and how to implement alternative approaches to improve clinical research. Methods and technology that were being explored pre-pandemic–from remote monitoring to video visits to phone visits, eConsent and EHR–have come front and center during the past 18 months and will remain for the foreseeable future.
Now, as we head into 2022 the big question remains: Is our industry ready to sustain this pace of change?
According to recent research from Oracle and Informa, the answer is yes. Our study found that 97% of organizations who implemented changes to their clinical trials approach during the pandemic indicated their organization would continue using at least one of these new methods. Remote monitoring, video visits, EHR, and phone visits were the approaches most likely to continue.
Here are three more predictions for the life sciences industry as we enter 2022.
With the introduction of new approaches and technology in clinical trials–especially those related to remote data collection from patients–comes an increase in data volume and variety. More importantly, the data is only as a good as the confidence that people have in it.
Oracle and Informa’s recent study found that 92% of respondents who implemented new clinical trial methods during the pandemic are equally or more confident in the data collected from these methods, compared to data collected via pre-pandemic methods. This confidence will continue to build as comfort with, and expansion of, newly adopted technologies and approaches expand.
In Oracle’s 2020 survey on decentralized trials, nearly half of respondents said that data reliability and quality (50%) and data collection (45%) were key concerns in adopting decentralized clinical trials. This significant increase in confidence in the past year supports the industry’s continued progress towards more decentralized models.
In order to attract new trial participants, it is critical for pharmaceutical companies to make it easier for patients to access trial locations that are convenient for them. Our study found 61% of respondents believe allowing patients’ choices will have a positive impact on clinical research and well over half (58%) said that their organizations plan to give patients the option to choose how they participate in clinical trials moving forward.
To this end, retailers like CVS and Walgreens for example, could become more popular as trial locations. By collaborating with these locations, sponsors will have expanded opportunities for patient recruitment because they will be offering patients the convenience and comfort of visiting community sites in which they are familiar.
With the industry still adjusting to new approaches in aspects of study start-up, recruitment, and data collection, regulators will respond by allowing a wide berth to help accommodate the adoption of these methods. This regulator flexibility will be key, but further implementation of decentralized methods will be driven by the industry at large.
The pandemic has and continues to put enormous pressure on the entire life sciences industry and those organizations running clinical trials. At the same time, it has provided the impetus for moving at least some aspects of clinical trials out of pilot mode and into action. In 2022 we will continue to move into the new era of clinical trials supported by technological innovation.
Henry McNamara, SVP and GM, Oracle Health Sciences