UMIN-CTR Clinical Trial

Public title

Study on the survey of clinical trial protocols

Acronym

Study on the survey of clinical trial protocols

Scientific Title

Study on the survey of clinical trial protocols

Scientific Title:Acronym

Study on the survey of clinical trial protocols

Region

Japan

Condition

protocol

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Study on the survey of clinical trial protocols

Basic objectives2

Others

Basic objectives -Others

Make the way to make paper better.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

SPIRIT 2013 check list item

Key secondary outcomes

Institution name, number of institution, department, classification, drug or device, period, randomization, sample size, phase, surrogate end point, arrange protocol, clinical trials registration, version , informed consent form, research ethics approcal , data monitoring, auditing biological specimens, plans for harms, , SPIRIT item. statistician, language, coordinating center, steering committee, other team

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

protocols which were registered in Tokyo university hospital Clinical Research Support Center or Juntendo Clinical Research Center in the past 3 years.

Key exclusion criteria

none

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Masaya Goto

Organization

Tokyo Women's medical university

Division name

Institute of advanced Biomedical Enginerring and science

Zip code

Address

8-1, Kawata-chou, Shinjyuku-ku, Tokyo

TEL

09035540449

Email

masaya1984j_med@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Masaya Goto

Organization

Tokyo Women's medical university

Division name

Institute of advanced Biomedical Enginerring and science

Zip code

Address

8-1, Kawata-chou, Shinjyuku-ku, Tokyo

TEL

09035540449

Homepage URL

Email

masaya1984j_med@yahoo.co.jp

Institute

School of Public Health, The University of Tokyo, department of biostatistics

Institute

Department

Personal name

Organization

School of Public Health, The University of Tokyo, department of biostatistics

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院

Date of disclosure of the study information

2012

Year

09

Month

15

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.lifescience.co.jp/yk/yk14/ykj14s2.html

Number of participants that the trial has enrolled

Results

Among the 55 items in SPIRIT 2013, the 44 items applicable to all protocols were used for checking. Although the protocols largely adhered to the essential items required in the protocols, the average score was 29.4 items in 44 items. The least described items (less than 10% of the protocols) were newly introduced items: WHO trial registration data set, individuals who can access to the final data set and plans for granting public access. The less described items (in 10%-40% of the protocols) were 7 items including individuals who contribute protocol development, roles of study sponsor and funder, recruitment method, interim analysis and audit. Taking into account that some of the 44 items are not necessarily applied to all protocols, our study showed that most protocols largely meet the standard of SPIRIT 2013. However, there is room for further improvement especially in some newly introduced items. We also found that the protocols had been amended for the extension of trial period in 28%, mainly due to the delay in recruitment, indicating the importance of the adequate recruitment plan in the protocol development.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2012

Year

07

Month

25

Day

Date of IRB

Anticipated trial start date

2012

Year

08

Month

02

Day

Last follow-up date

2013

Year

03

Month

22

Day

Date of closure to data entry

2014

Year

04

Month

01

Day

Date trial data considered complete

2014

Year

12

Month

01

Day

Date analysis concluded

2015

Year

01

Month

31

Day

Other related information

check protocol.

Registered date

2012

Year

09

Month

08

Day

Last modified on

2014

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010420