Paul O’Donohoe, Senior Director, eCOA Product and Science, Medidata
The healthcare industry has not been immune to the digital transformation of the modern world over the last few decades. It has, however, tended to transform at a much slower pace compared to other industries, due in no small part to a more conservative regulatory environment. This gradual digital transformation has undoubtedly accelerated over recent years as a result of COVID-19.
A newfound willingness to adopt digital tools – from wearable technologies, to leveraging data analytics tools like AI and ML – and accept that these tools can offer huge benefits beyond the necessity caused by the pandemic, marks an important turning point for the sector. It also proves just how nimble the industry can be when it sets its mind to it, quickly adapting to new challenges and developing solutions that solve problems and make patients’ experiences in clinical research more positive.
Flexibility in adopting new solutions
During the height of the pandemic, support and guidance from regulators was vital, and signalled commendable flexibility and openness to new, problem-solving ideas, giving the industry the confidence it sometimes lacks to change their approaches.
This instilled more certainty and courage to try new things, leverage newer solutions, and even challenge fundamental assumptions about what a clinical trial might look like. Over the past two years, the industry has begun to unlock the benefits of many digital tools that may have been around for years, but that perhaps hadn’t been widely or synergistically adopted yet.
The regulators responded quickly to the pandemic, working with the industry to reduce disruption, while maintaining the integrity of the thousands of studies running worldwide. There was a conscious move from traditional clinical trial processes, where activities which usually revolved around central clinical research site, to a decentralised model, using one or more digital or virtual elements. This allowed for a more flexible approach which also put patient centricity at the centre of the study design. Decentralisation is not an ‘all-or-nothing’ approach, but rather attempting to be more mindful about when and what patients are coming in for.
Keeping patients at the core
Patient burden remains one of the biggest challenges facing the industry. About 30% of patients are said to drop out before a study ends, resulting in study delays or studies being cancelled.1 Considering the costs associated with running a study, having them cancelled due to a lack of participation is not only a huge loss in terms of the drug development process, but also does a massive disservice to patients who would benefit from those new treatments.
There’s been demand across the industry for more patient-centric approaches. In clinical research, this involves truly putting the patient at the centre of a trial, which has historically been difficult for companies to meaningfully implement, given the complexity of clinical trials. However, the increased use of technology, accelerated by the pandemic, has given the industry an opportunity to revisit and question all aspects of trial design and ensure that patients are at the heart of the clinical trial process.
Patients are more engaged with clinical research than ever before – they are often deeply knowledgeable on their disease and the current state of the research landscape, and they have expectations about how they should be included in the research process. Having patients engaged in the design of the trial itself is key in conceptualising how to build technologies and solutions to support their individual journey throughout.
To cater to those at the heart of clinical trials, we must understand that there is no typical patient, and we must continue to harness the use of technology. However, technology alone cannot improve the patient experience – we need to adopt a holistic approach and ensure that we are maintaining an open dialogue with patients and utilising their expert insights throughout. It is only with this open collaboration can we benefit from the hard lessons of the pandemic.
Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata, a clinical software platform provider. 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 in studies using eCOA. He also provides strategic oversight to the development of Medidata’s eCOA solutions. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice Director of the C-Path ePRO Consortium.