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Available from: https://www.congress.gov/bill/114th-congress/house-bi
ll/34.
2. U.S. Department of Health and Human Services FDA, Center for Drug
Evaluation and Research (CDER), Center for Biologics Evaluation and
Research (CBER), Center for Devices and Radiological Health (CDRH)
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2009]. Available from: https://www.fda.gov/media/77832/download.
3. European Medicines Agency. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in
the evaluation of medicinal products [Internet]. [cited 2005]. Available
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c_guideline/2009/09/WC500003637.pdf.
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(PRO) measures in oncology studies [Internet]. [cited 2016]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/O
ther/2016/04/WC500205159.pdf.
5. Terada M, Nakamura K, Martinelli F, et al. Results from a 1-day workshop on the assessment of quality of life in cancer patients: a joint initiative
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clinical trials. Ann Intern Med 2013;158:200.
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Guidelines for inclusion of patient-reported outcomes in clinical trial
protocols the spirit-pro extension. JAMA 2018;319:483–94.
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of radiation-induced pain flare after palliative radiotherapy for bone
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The situation surrounding the development of new cancer treatments has become complicated, and various stakeholders such as
pharmaceutical companies and clinical trial support organizations,
as well as patients, healthcare providers and regulatory authorities,
are involved in the evaluation of PRO/QOL in cancer clinical trials.
Furthermore, as mentioned earlier, statistical methods such as the
handling of missing data and the optimal selection of analytical
methods have not been fully established. Under these circumstances,
an international project, The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints
Data (SISAQOL-IMI) Consortium, is currently underway to establish
recommendations for standardized methodology to evaluate and
analyse PRO/QOL data in cancer clinical trials (18,19). The JCOG
PRO/QOL research committee has joined this consortium to standardize PRO/QOL research methodologies in the future.
In addition, the status of PRO/QOL data collection in clinical
research and practice is changing as well. First, the number of
PRO/QOL assessment tools is rapidly increasing. To record patient
experiences with increased depth and precision, PRO/QOL assessment tools for specific diseases (e.g. breast cancer, lung cancer)
and populations (e.g. adolescents and young adults, elderly, cancer
survivors) are being developed internationally. Hence, catching up
with this trend in Japan is mandatory to make the latest PRO/QOL
tools available. Second, the methods of collecting and managing
PRO/QOL data can be improved. PRO/QOL data have traditionally
been collected from patients using a paper-and-pencil approach;
in recent years, however, real-time data collection and electronic
monitoring have become possible and have allowed patients to
directly enter their information via internet terminals or to send their
information using wearable devices (20). Third, collected PRO/QOL
data will be increasingly used for decision-making in clinical practice.
Clinical decision-making has mainly relied on clinical examinations
such as imaging tests or blood examinations. PRO/QOL data have
been less important because of the variety of assessment tools and
complexity of data handling. However, it was reported that the use of
PRO data improves not only QOL but also clinical outcomes (21,22),
and guidelines regarding PRO in clinical use have and will continue
to be published by academic societies (23).
These innovative changes will bring about a paradigm shift in
PRO/QOL data management in clinical research. We will adopt these
advances and update this PRO/QOL research policy based on future
global trends in PRO/QOL research.
201
202
JCOG PRO/QOL research policy
17. Basch E, Abernethy AP, Mullins CD, et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness
research in adult oncology. J Clin Oncol 2012;30:4249–55.
18. Bottomley A, Pe M, Sloan J, et al. Analysing data from patient-reported
outcome and quality of life endpoints for cancer clinical trials: a start in
setting international standards. Lancet Oncol 2016;17:e510–4.
19. Coens C, Pe M, Dueck AC, et al. International standards for the analysis
of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL consortium.
Lancet Oncol 2020;21:e83–96.
20. Sim I. Mobile devices and health. N Engl J Med 2019;381:956–68.
21. Basch E, Deal AM, Kris MG, et al. Symptom monitoring with patientreported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 2016;34:557–65.
22. Basch E, Leahy AB, Dueck AC. Benefits of digital symptom monitoring
with patient-reported outcomes during adjuvant cancer treatment. J Clin
Oncol 2021;39:701–3.
23. Di Maio M, Basch E, Denis F, et al. The role of patient-reported outcome
measures in the continuum of cancer clinical care: ESMO clinical practice
guideline. Ann Oncol 2022;33:878–92.
24. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported
outcomes in randomized trials. JAMA 2013;309:814–22.
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