Rapid growth in oncology precision medicine challenges conventional clinical trial conduct, changing the landscape considerably. As such, hybrid clinical trials in oncology are becoming the mainstream, as there is increasing demand from regulatory authorities such as the FDA and EMA and decentralized clinical trial (DCT) technology is enabling better and more data to be captured directly from patients.

For example, in the final EMA Final Oncology Guidance Appendix 2 (2016), the EMA called out the fact that “electronic data capture methods may offer more convenience to some patients and may increase data quality, reduce missing data (allowing automatic reminders to be sent) and potentially reduce data entry errors

More Accurate Collection of AEs

In oncology, early detection of adverse events is critical, especially since there is such a demand and need for accelerated approvals. Digitized capture of potential AEs and SAEs can significantly improve safety signal quality.

Research has shown that patients report symptoms/AEs earlier and more frequently than clinicians detect them and that clinicians routinely downgrade patient symptom severity (Basch, 2010). In a head-to-head comparison of usual care (symptoms discussed at clinic visits and ad hoc patient calls to doctors’ office) versus a patient reported outcomes (PRO) groups, self-report of 12 common symptoms at and between visits via a web-based questionnaire showed that an ePRO-based strategy enabled detection and intervention of AEs sooner than usual care. Algorithms were programmed such that if there were severe or worsening symptom(s), an email alert was sent to a nurse and a report reviewed. The results showed that this increased level of monitoring and tracking of symptoms/potential AEs resulted in an improved overall survival (mean: 8.7 mon PRO group vs 8.0 mon in usual care group; P = .004) (Basch, 2017). Similarly, recent studies have shown that the median overall survival benefit in the PRO arm was 19.0 months vs 12.0 months in control arm, (Denis, 2017).

Basch E, 2010, NEJM, 362;10;865 / Basch E, et al., JAMA. 2017 Jul 11;318(2):197-198 / Denis F et al., 2017, JNCI, 109(9):1