Evidence map›Paper›PMID 35347493›Full record

ArticleInternational journal of clinical oncology2022

Guidance on the need for contraception related to use of pharmaceuticals: the Japan Agency for Medical Research and Development Study Group for providing information on the proper use of pharmaceuticals in patients with reproductive potential.

Nao Suzuki, Yasushi Takai, Masahito Yonemura, Hiromitsu Negoro, Shinya Motonaga, Noriko Fujishiro, Eishin Nakamura, Seido Takae, Saori Yoshida, Koji Uesugi and 7 more

Open access · hybridAbstract read
In one paragraph

Article in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 3 countries.

Nao SuzukiDepartment of Obstetrics and Gynecology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan. nao@marianna-u.ac.jp.ORCID http://orcid.org/0000-0002-7440-8127
Yasushi TakaiDepartment of Obstetrics and Gynecology, Saitama Medical Center, 1981 Kamoda, Kawagoe-shi, Saitama, Japan.
Masahito YonemuraDepartment of Pharmacy, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, Japan.
Hiromitsu NegoroDepartment of Urology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba-shi, Ibaraki, Japan.
Shinya MotonagaPharmacovigilance Section, Office of Clinical Research Support, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, Japan.
Noriko FujishiroPharmacovigilance Section, Office of Clinical Research Support, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, Japan.
Eishin NakamuraDepartment of Obstetrics and Gynecology, Saitama Medical Center, 1981 Kamoda, Kawagoe-shi, Saitama, Japan.
Seido TakaeDepartment of Obstetrics and Gynecology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, 216-8511, Japan.
Saori YoshidaQol Co., Ltd, 4-3-1 Toranomon, Minato-ku, Tokyo, Japan.
Koji UesugiPfizer R&D Japan G.K, 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan.
Takashi OhiraTakeda Pharmaceutical Company Limited, 2-1-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan.
Aiko KatsuraNovartis Pharma K.K, 1-23-1 Toranomon, Minato-ku, Tokyo, Japan.
Michio FujiwaraJapan Pharmaceutical Manufacturers Association, 2-3-11 Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan.
Itsuko HoriguchiThe Support Center for Clinical Pharmacy Education and Research, Tokyo University of Science, 1-3 Kagurazaka, Shinjuku-ku, Tokyo, Japan.
Kenjiro KosakiCenter for Medical Genetics, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan.
Hiroshi OnoderaDivision of Pathology, Center for Biological Safety Research, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa, 210-9501, Japan.
Hiroyuki NishiyamaDepartment of Urology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba-shi, Ibaraki, Japan.
National Cancer Center Hospital East · JPJapan Chemical Industry Association · JPSocial Insurance Saitama Chuo Hospital · JPSt. Marianna University School of Medicine · JPUniversity of Tsukuba · JPEuropean Federation of Pharmaceutical Industries and Associations · BEKeio University Hospital · JPNational Institute of Health Sciences · JPPharmaceutical Research and Manufacturers of America · USTokyo University of Science · JP

Funding

Environmental Restoration and Conservation Agency JP20mk0101139
6 · The paper itself

Abstract

backgroundThe U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have published guidelines on the use of cancer treatments in young people of reproductive potential. However, no such guideline is available in Japan. Therefore, this project aimed to gather relevant data and draft a respective guidance paper.

methodsFrom April 2019 to March 2021, the Study Group for Providing Information on the Proper Use of Pharmaceuticals in Patients with Reproductive Potential at the Japan Agency for Medical Research and Development gathered opinions from experts in reproductive medicine, toxicology, and drug safety measures. The group considered these opinions, the FDA and EMA guidelines, and relevant Japanese guidelines and prepared a guidance paper, which they sent to 19 related organizations for comment.

resultsBy November 2020, the draft guidance paper was completed and sent to the related organizations, 17 of which provided a total of 156 comments. The study group finalized the guidance paper in March 2021.

conclusionsThe "Guidance on the Need for Contraception Related to Use of Pharmaceuticals" (The report of the Study Group for Providing Information on the Proper Use of Pharmaceuticals in Patients with Reproductive Potential, Research on Regulatory Science of Pharmaceuticals and Medical Devices, Japan Agency for Medical Research and Development: JP20mk0101139) is expected to help Japanese healthcare professionals provide fertility-related care and advice to adolescents, and young adults with cancer and their families.

Indexed as

ContraceptionResearchAdolescentHumansJapanPharmaceutical PreparationsUnited StatesUnited States Food and Drug AdministrationYoung AdultPharmaceutical PreparationsAdolescent and young adultsAnticancer drugsBirth controlDissemination of informationOncofertilityProper use of drugs

Identifiers

PMID35347493
PMCPMC9023394
OpenAlexW4220909000

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.