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This is the tenth piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.
Across pharma, we’re seeing a rapid shift in clinical trial execution, as it moves towards a more virtual model. These changes have moved from optional to mandatory in order to reduce delays in clinical trial conduct and maintain momentum in drug development during COVID-19. The transition towards remote clinical trial execution is already underway across the industry. A recent survey taken during a webinar hosted by 4G Clinical showed that 90 percent of the webinar attendees were either in the process of adapting current study protocols to make use of virtual or hybrid study execution models or were planning for a future clinical investigations to be administered remotely.
And while this move requires complex coordination among multiple parties at the sponsor, CRO, and study sites, it also seems to have broad support among trial volunteers. A survey of clinical trial participants conducted by Clinical Leader found that 61 percent of participants are open to using telehealth solutions as part of their monitoring.
The component technologies that enable remote trials are nothing new. Telehealth solutions, eLearning applications, Direct to Patient (DTP) shipping, OPI, wearables, omnichannel communications – have been available for many years. The difference is that now, the remote nature of the current times requires their assembly into a solution suite that supports remote clinical trial execution.
Sponsors are focused on how to monitor trial volunteers’ ancillary communications and keep them engaged while they’re participating in trials with limited onsite interaction with the site staff. Multinational late-phase trials often run beyond six months or a year, especially when including safety follow-up to generate the necessary clinical data. For such pivotal trials, is critical to patient retention and drop-outs reduction rates during trial conduct.
Telehealth solutions work well for follow-up appointments such as patient monitoring visits and visits not requiring intervention or onsite investigator assessments. Also, virtual trial execution can work for patient-reported-outcomes or instructions on how to self-administer investigational drugs or do home-testing for certain procedures not requiring intervention by a physician. But how do pharma sponsors keep an ear out for conversations that may be occurring in un-moderated arenas? Part of the answer is social media listening.
Social media listening leverages several elements of technology to allow sponsors to survey public forums such as social media, blogs and chat rooms, in order to assess patient sentiment, regardless of language or medium. The process allows CROs, sponsors and researchers to “overhear” real time patient reactions—physical, emotional and mental—to their trials. The casual conversation style on social media platforms and the (sometimes) public settings can reveal information a patient may not consider pertinent—or remember—when communicating with study staff. Using natural language processing and sentiment analysis, social media listening programs can select phrases for review that may have useful information, include adverse effects.
While the remote trial model may rely on patients’ diligence in keeping visits via telehealth solutions and patient diaries, the reality is that, during periods of social distancing and travel restrictions, usage of social media is especially prominent in people’s daily lives. Clinical study participants are no exception.
It’s common for people to use social media to communicate with friends and family in order to discuss their progress, adverse events and their overall experience with the study process itself. Social media penetration is approaching 50 percent, according to Statista, and the growth of mobile-first markets creates fertile ground for increase social media use. In the US alone, about 70 percent of adults use social media, defined as either public or private profiles and posts.
By using social media listening, sponsors can tap into a rich source of patient sentiment, all shared publicly but in unsupervised settings, and benchmark participant feedback about their treatment, comparable medications, the sponsor, and the study itself, both qualitatively and quantitatively. Social media listening is an important technology that helps close the loop on participant communications and ensure that the sponsor is hearing all the necessary participant input, even when a study is conducted remotely.
Lionbridge’s Life Sciences team can enhance your control of the clinical trial process by offering social media listening as well as a variety of services across the complete trial life cycle. Contact us to learn more.