Five Interesting Articles on Patient-Reported Outcomes and Real World Evidence in Oncology

Use of Wearable, Mobile, and Sensor Technology in Cancer Clinical Trials Link: https://ascopubs.org/doi/10.1200/CCI.17.00147 Summary: A broad overview of sensors in clinical trials. The information was not specific to cancer trials. Rather, the author provided a summary of options to monitor potential problems in oncology patients. An example is using a Fitbit to record how many steps a patient takes per day- ambulation is associated with better clinical outcomes in oncology.

The HOPE Pilot Study: Harnessing Patient-Reported Outcomes and Biometric Data to Enhance Cancer Care Link: https://ascopubs.org/doi/10.1200/CCI.17.00149 Summary: 10 gynecologic cancer patients receiving palliative chemotherapy participated in a mobile health intervention that collected data on heart rates and daily step counts. Patients reported an increase in symptom management and physical activity. A further study is needed to assess the impact of data collection on survival.

Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment Link: https://jamanetwork.com/journals/jama/fullarticle/2630810 Summary: When patients reported a chemotherapy-adjunct adverse event via an online questionnaire, an assigned nurse was alerted and clinical management was delivered to the patient over the phone. Median survival increased in the PRO group vs control (31.2 months vs 26.0 months, p = 0.03) and PRO patients were able to tolerate chemotherapy treatment longer than control patients (8.2 months vs. 6.3 months, p = 0.002).

Real-world Data for Clinical Evidence Generation in Oncology Link: https://academic.oup.com/jnci/article/109/11/djx187/4157738 Summary: Electronic health records are the best available source of real world evidence (RWE). RWE can be used in pharmacovigilance, disease history modeling, and pragmatic clinical trials. However, more interoperability between disparate systems is needed to take full advantage of RWE. RWE clinical trials also need a defined structure for internal validity, set and agreed upon by stakeholders.

Real world evidence on gemcitabine and nab-paclitaxel combination chemotherapy in advanced pancreatic cancer Link: https://www.ncbi.nlm.nih.gov/pubmed/30621618 Summary: Using real world evidence, a Swedish study examined the clinical benefit and toxicity of a gemcitabine/nab-paclitaxel (Gem/NabP) chemotherapy in the setting of advanced pancreatic ductal adenocarcinoma. Evidence of clinical outcomes was retrieved from electronic medical records and standardized. Robust data, including overall survival, progression-free survival, disease progression, and adverse events, were obtained from the patients’ health records. The authors concluded these results were similar to outcomes achieved in a traditional Phase III clinical trial evaluating Gem/NabP efficacy. The median overall survival and progression-free survival confidence intervals in the two analyses overlapped one another.