New universe

The life sciences sector continues to bring exciting, potentially life-changing new treatment options to patients.

Clinical trials are a vital component of the drug development process that allows for the assessment of new drugs and medical devices on patients, both in terms of efficacy and safety.

Trial recruitment can be a long and expensive process so it is imperative that the industry provides patients with the best experience, ensuring that they will sign-up again in the future – and be less likely to drop out during trials.

That is easier said than done. Clinical trial participation has often been associated with a significant burden for patients, requiring frequent site visits with long appointment times, and leaving patients feeling out of the loop due to limited control and understanding of the trial process.

To counteract these issues, we are seeing patient-centric approaches being increasingly integrated into clinical trials and forming a crucial element of trial design, with patients themselves often included in the trial design process.

A greater recognition of the role that they play in advancing new treatments has seen the industry increasingly promote patient-centricity, revolutionising in recent years the way that the industry approaches patient engagement.

Although there is increasing recognition of the commitment that patients make when participating in research, however, there is still work to be done to ensure patient-centricity remains at the forefront of clinical trial design.

Careful engagement and new technology may offer a significant opportunity to further support patients and advance patient- centricity within clinical research.

There is a greater understanding that patients need to be placed at the forefront of discussions within the industry and increased patient engagement has been evident through a variety of methods and channels.

A notable development in the last few years has been the way in which clinical trial organisers are working with patient advocacy groups more frequently in order to engage with patients directly and understand their needs and concerns.

The focus on reaching out to patients has meant that not only can their insights and perspectives be factored into trial design (which invariably improves the in-trial experience for patients), but it also means that potentially relevant patients are being made aware of the potential to participate.

This latter point speaks to a key issue in trial recruitment – many people are not aware that they are eligible to participate in clinical research or know how to find appropriate trials to sign up for.

The industry needs to ask itself whether it is doing enough to raise awareness of clinical research and the opportunities to participate in trials.

The focus must be on engaging with patients and listening to them to boost recruitment. This is particularly important within patient populations that may have historically been underrepresented within trials.

There has been a significant focus on diversity in trials in recent years, and this remains a vital factor to consider in designing trials and engaging with patients.

In ongoing efforts to improve patient engagement, the industry has begun to embrace new technologies and digital solutions.

New tools have emerged that have revolutionised the entire clinical trials process and transformed recruitment for trials as well as the experience of research. AI solutions can identify suitable sites for a trial and even people that are eligible to participate in order to improve recruitment.

Further, the adoption of decentralisation tools, such as wearable devices for at-home monitoring, telehealth visits and eConsent, has drastically reduced the burden on trial participants.

They can significantly reduce the requirement for site visits, and therefore ease the time and cost burden for patients who wish to participate in trials.

These tools are also increasingly being designed with patient-centricity in mind; the focus must be on implementing new solutions in a way that improves the patient experience.

At Medidata, we have been leveraging our Patient Insights Program in order to integrate patient perspectives into the trial design process to better understand ways to improve trial experience.

This involves the use of our ‘patient-centricity by design’ methodology, which makes use of patient insights in the design of new software and other technology solutions that are used in trials to ensure patients are at the centre of the decisions that are made regarding the use of digital tools.

This brings the patient perspective into the design room and ensures that new tools are focused on improving patients’ experience in trials, listening to their concerns and ideas.

With the implementation of a variety of new technologies across the clinical research space, it is important to continue engaging with patients and to consider some of the concerns that they may have regarding these new tools.

For many, the increased use of digital tools in clinical trials is overwhelmingly positive for their experience when participating in research. For some, however, there may be some additional challenges associated with new technologies.

Notably, data privacy has been a significant concern for many with cybersecurity remaining a global issue, while tech literacy and access to the internet may be an issue for others.

It is vital to consider these issues when designing trials and to leverage patient insights in order to ensure that these concerns can be addressed.

Amid ongoing efforts to increase diversity in trials and widen access to research, it is important not to exclude those who may not have access to some of the tools that are being introduced.

The clinical research sector relies on people participating in trials and, without them, it would be impossible to deliver advances in treatments, vaccines and medical devices in order to improve outcomes for patients.

New tech solutions are revolutionising the way researchers engage with patients and significantly alleviating the burden for those participating in trials. However, these solutions must be accessible and beneficial for trial participants.

Therefore, patient-centricity is vital and the patient perspectives gained through regular engagement must remain at the heart of discussions around trial design and, increasingly, the use of technology within trials.

Alicia Staley is Vice President, Patient Engagement at Medidata.
Go to medidata.com