Amid the outbreak of COVID-19, the development of new treatments has never felt more important. With more than three-quarters of clinical trial sites¹ reporting an impact from the pandemic, oncology companies have been pausing clinical trial enrollment in the interest of patient safety and data integrity. In a previous blog², ZS discussed the need to consider a “reinitiation journey” for sites participating in clinical trials, including patients’ willingness to consider clinical trials. 

In May, ZS and Continuum Clinical surveyed 250 oncology patients in the U.S., Germany, UK, Italy and Japan to measure  COVID-19’s impact on patient willingness to participate in clinical trials. Here are the key takeaways from the survey, and implications for how to communicate with oncology patients about clinical trials in the COVID-19 era:

Awareness of clinical trials among cancer patients has increased since the onset of COVID-19. Given the amount of media attention on the development of new COVID-19 treatments, it’s unsurprising that awareness of clinical trials has gone up. Sixty-two percentof cancer patients surveyed said that their awareness of clinical trials has increased since the outbreak. This increase in awareness may provide an opportunity to engage with newly-interested patients on access to clinical trials. This is particularly applicable to those in the oncology community who interface with and educate patients, such as patient groups.

Cancer patients are unlikely to participate in clinical trials at COVID-19 treatment sites. Fifty-four percent of cancer patients are unlikely to participate in a clinical trial thatrequires visits to a COVID-19 treatment site, and 58% of patients cite COVID-19 exposure risk as their biggest concern, ranking substantially higher than other concerns such as the number of site visits (28%), and the need to travel (25%). If the heightened concern about COVID-19 exposure isn’t addressed, it likely will be a key barrier to oncology study enrollment.

Cancer patients want clear communication about trial sponsors. In the midst of COVID-19, oncology patients rank clear communication from trial sponsors as their most important priority, over and above any virtual trial elements. In times of uncertainty, open and clear communication with oncology patients should be prioritized, followed by the development of carefully selected virtual offerings and supplemental technology.

Communication with potential subjects should be a key focus for sponsors and CROs engaging with reinitiating sites. COVID-19 will inevitably lead to significant delays in getting new therapies to patients who need them. With an increasing awareness of clinical development, oncology trial sponsors should consider the following three-step strategy to effectively address potential subject concerns:

• Explain what’s expected from the study. Trial sites and sponsors need to, more than ever, maintain an open dialogue with potential subjects so they understand the full picture of site visits, procedures and personnel with whom they will interact. 

• Be open about what can be done to minimize any COVID-19 exposure. Cancer patients need specific resources that help them navigate and de-risk their trial experience for the protocol they will be following, such as an online guide to help trial subjects protect themselves and mitigate risks.

• Develop and roll out mitigation strategies to minimize COVID-19 exposure. The tactics will depend on the protocol, but sponsors should follow an insights-driven approach to consider strategies that keep patients away from clinics, such as at-home drug administration, video-based consultations, online questionnaires or app-based data capture.
  Cancer is a frightening prospect for many patients, and clinical trials can be, too. In a world of COVID-19, that fear has increased. As the oncology community looks forward, these patient needs must be addressed now for studies that will be presented in the future. Communication, as ever, is the key. 

Chris Crabtree is an associate principal and the European lead for ZS’s R&D Excellence practice; and Ben Thomas is a consultant, both in ZS’s London office.

References

1. https://www.clinicalleader.com/doc/survey-shows-one-third-clinical-trial-study-sites-fear-total-closure-impacted-due-covid-0001
2. https://info.zs.com/activeingredient/will-you-be-ready-to-reopen-clinical-trials