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Are you using Patient-Reported Outcomes (PROs) in your oncology trials? If not, why not?
Written by Sally-Anne Vincent on Thursday, November 21, 2019
A recent blog, published by Sarah Tressel Gary and Rinah Yamamoto called “Patient-Reported Outcome Data in Oncology Trials – Part 2: Clinical Benefit and Patient Preference”, has sparked our interest. This blog has been written to provide commentary on a topical issue relating to the use of Patient-Reported Outcomes (PROs) in oncology trials.
The authors of this blog presented the findings from several studies (Basch et al., 2016/2017; Denis & Basch et al., 2019) which showed improved health-related quality of life (HRQoL) and overall survival in cancer patients when completing electronic PROs. One of the studies concluded that patients are more engaged when self-reporting their symptoms.
The blog then went on to discuss the findings of a preference study implemented by ERT (a global healthcare company) designed to establish where patients prefer to complete their PROs (at home vs at clinic), how important it is to them to report their symptoms on a daily basis and their preferences on how to report them (electronic diary, directly to their doctor, paper diary, not at all). The findings from this study showed that the majority of cancer patients would prefer to report their symptoms daily than not at all when enrolled in a clinical trial. It was also shown that a larger proportion of patients preferred to report these daily symptoms electronically and most patients preferred to fill the PROs in the comfort of their own home.
As a result of research like this, regulatory agencies are endorsing the use of PROs to be used more in oncology trials as well as taking them into account when assessing the clinical benefit of oncology products.
This blog addresses the importance of using PROs in oncology trials and the benefits it has to clinical outcomes.
References
Basch E, et al. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65.
Basch E, et al. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. 2017 Jul 11;318(2):197-198.
Denis F, Basch E et al. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307.
OPEN VIE is a global, technology enabled, evidence and access consultancy, with a focus on patient centricity. We work with you to understand, demonstrate and communicate value to inspire change. Our Patient Centred Outcome (PCO) research group within OPEN VIE specialise in the generation of data that matter to patients. We look at the data from the patient and/or their family members/friends’ perspective to enable the scientifically robust measurement of disease, treatment benefit or unmet need.
If you would be interested to know how OPEN VIE can help with patient centred data projects, please contact:
Catherine Bottomley, Director of PCO, OPEN VIE