This is Part II of our blog series, The New Frontier: Neuroscience, Digital Health and Clinical Trials. Click here to read Part I, which investigates the emerging nexus of digital health, data protection, and new medical devices and platforms.
Digital technology is moving at an unprecedented pace, giving rise to new and exciting opportunities, and disruptive and innovative thinking. For neuroscience research and public health, these advancements have facilitated and will continue to facilitate to the development of new treatments, medical devices and management protocols for diseases, conditions and disorders. One intersection of digital technology and health that is on the precipice of mass adoption is the use of digital platforms, such as social media and search engines, for clinical trial recruitment, and patient engagement and retention.
While broader consumer uptake of social media and search engines has been swift and almost absolute, it remains a piece of relatively unexplored territory by the healthcare sector. The hesitation is understandable, with clinical trials being a highly regulated and sensitive space, built on trust and consent involving a number of different parties. This hesitation has been compounded by recent and very public breaches in user data privacy and transgressions in user trust, most notably the Cambridge Analytics scandal. However, that is not to say these digital platforms cannot be used in a compliant and ethical manner by the clinical trials space.
Recruiting for Clinical Trials
Recruiting for clinical trials is a key determinant of success. However, it can be difficult, particularly for later-stage trials or in regions where populations are smaller. In a 2015 study of registered trials in Canada, it was found that 19% were terminated early due to an insufficient number of participants. While several studies have reported that up to 86% of trials do not meet recruitment goals within specific time periods. This failure during enrollment has important scientific, financial, ethical and policy implications and hinders the process of testing and progressing potential new treatments.
“There has been a lot of research over the years to identify, understand and address the recruitment challenges in clinical trials. However, they persist in spite of this, which tells us it’s time to try to break new ground and use new tools to help with this issue,” said Dr Tina Soulis, CEO of Neuroscience Trials Australia. In a recent paper published in Contemporary Clinical trials, recruitment communication planning was listed as an integral factor in improving the efficiency and efficacy of clinical trials recruitment planning. This includes identifying ‘participant locations based on where participants may seek treatment and relevant information,’ developing tailored messaging and creative material and selecting appropriate channels for delivery.
The powerful potential of digital platforms in the clinical trials space is beginning to be recognised both in Australia and abroad. Recently, the Australian government established the Australian Clinical Trials website, an online portal that provides information to consumers, healthcare providers, researchers and industry, and allows people to search for a clinical trial based on health condition. In addition to this, with search engines and social media becoming key portals to information for both young and old, the Internet provides a powerful opportunity to not only educate the public about clinical trials, but also to become a funnel that recruits participants. It allows for repeated and targeted, as well as tailored and nuanced messaging, and an expansive reach, often for relatively little cost. When a user is turning to a search engine to find out more information about a disease with which they or a relative has been diagnosed, placing an advertisement associated with the search may raise the awareness of a trial.
Similarly, with the advertising tools available on social media platforms, users with an interest in a particular disease or condition or of a certain age demographic or living in a specific location can be targeted with clinical trials information. By casting a wider net, these methods may help sponsors reach recruitment goals more quickly. Indeed, many sponsors outside of Australia are already using social media to recruit for clinical trials.
Engaging and Retaining Participants
Recently, patient engagement and retention has emerged as an increasingly salient factor in the clinical trials space. With pharmaceutical clinical trial dropout rates ranging from 15 to 40%, depending on the trial phase, engagement and retention have become key determinants of a trial’s success. Retaining trial participants is of paramount importance to the economic integrity and scientific rigour of a study; poor retention can negatively affect the overall volume of data for regulatory submissions. One strategy to address this is to engage with patients effectively to control dropout rates. Supporting participants throughout a trial with digital-based programs tailored according on trial phase, therapeutic area and disease type could revolutionise the clinical trial space.
However, despite the ongoing conversation in the sector, patient engagement strategies are often listed as low budget priority. With its relative low cost, social media could provide the answer. Social media could become a supportive tool in ensuring participants are and feel informed and involved throughout a trial and even, if it does not interfere with the integrity of trial results, interact with fellow participants. This could take the form of a trial hashtag or a private group on a networking platform. Creating a dynamic, inclusive and safe space, grounded in open communication, can empower participants while also becoming an important source of real-time information, especially in terms of reporting side-effects. The potential for such digital strategies to generate valuable data that can compliment the tangible health data needed to determine the efficacy of a novel treatment.
Indeed, global pharmaceutical companies have begun to employ digital and social media strategies to maintain higher levels of patient engagement during clinical trials. This includes creating video games or applications to not only track the progress of patients and to assist in therapy compliance, but also to help them further understand the complexities of the trial in which they are involved through an interactive platform.
A Brave New World
The digital world is undoubtedly impacting the healthcare and biomedical research sectors in a myriad of ways, both intended and unintended. There are ethical concerns that need to be thoroughly interrogated and navigated. Potentially targeting vulnerable people using their data, whether it be for patient recruitment or engagement, has made many anxious, wary and hesitant. While these concerns are well-founded, it is time to create and refine a regulatory framework that will allow research organisations and companies to be held accountable and to act responsibly. It is time to ensure that data is protected and respected, not misused and abused. This includes establishing rules around anonymisation of data, sharing sensitive information with research collaborators, and defining what data is allowed to be collected and used by researchers.
“While the tension between enabling innovation while respecting patients and their data remains and will likely continue to exist indefinitely, regulation and an understanding of best practice is still inadequate,” commented Tina. “It’s time for our sector to stop ignoring this new normal. It’s time to establish some rules” While using digital tools to its full advantage may never replace traditional methods of patient recruitment and retention in clinical trials, it certainly has the potential to work synergistically to improve the overall conduct of clinical trials.