Establishment of a research policy for supportive and palliative care in Japan

Author:

Zenda Sadamoto12ORCID,Uchitomi Yosuke2,Morita Tatsuya3,Yamaguchi Takuhiro4,Inoue Akira5

Affiliation:

1. Department of Radiation Oncology, National Cancer Center Hospital East, Chiba, Japan

2. Innovation Center for Supportive-Palliative and Psychosocial Care, National Cancer Center Hospital, Tokyo, Japan

3. Palliative and Supportive Care Division, Seirei Mikatahara General Hospital, Shizuoka, Japan

4. Division of Biostatistics, Tohoku University Graduate School of Medicine, Miyagi, Japan

5. Department of Palliative Medicine, University Graduate School of Medicine, Miyagi, Japan

Abstract

Abstract Background While several small groups in Japan have attempted to conduct prospective studies in the field of supportive and palliative care, development of exploratory research into multicentre confirmatory studies has been difficult. The main reason for this is the difference in clinical research methodology in supportive and palliative care compared with medical oncology in terms of the style of multidisciplinary approaches, study design and endpoints. Here, we establish a new research policy for cancer supportive and palliative care in Japan. Methods The first draft was developed by a policy working group within the Japanese Supportive, Palliative and Psychosocial Care Study Group. A provisional draft was subsequently developed after review by nine Japanese scientific societies (Japanese Association of Supportive Care in Cancer, Japanese Society of Medical Oncology, Japanese Society of Clinical Oncology, Japanese Society of Palliative Medicine, Japanese Society of Cancer Nursing, Japanese Society of Pharmaceutical Oncology (JASPO), Japan Cancer Association (JCA), Japanese Society of Therapeutic Radiation Oncology and Japanese Cancer Association) and receipt of public comments. The final research policy in the area of supportive and palliative care in Japan (Ver1.0) was completed in December 2018 and underwent its first revision (Ver1.1) in February, 2020. Results The policy includes the following components of clinical research: (i) objective of the research policy in the areas of supportive and palliative care; (ii) definitions of supportive care and palliative care; (iii) characteristics of supportive and palliative care research; (iv) target population for research; (v) research design; (vi) endpoints and assessment measures; (vii) handling of the deaths of subjects and (viii) operational structure and quality management. Conclusions We hope that studies conducted according to this policy will play important roles in the future development of the supportive and palliative field.

Funder

Japan Agency for Medical Research and Development

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Radiology, Nuclear Medicine and imaging,Oncology,General Medicine

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