Clin Eval. 12: :303-304, 1984.Apr.


Nature, Aim and Actiyities of the Controller-Committee


Controller Committee

The document on "Nature, Aim and Activities of the Controller-Committee" is issued basing on the conclusion of discussions within all members of the Controller Committee

[1] Nature of the Committee
The Controller Committee (C-Committee) is a voluntary organization independcnt of the government or of any pharmaceutical company. It consists of clinicians in various medical specialties, siatisticians and lawyers as regular member and pharmacologists, pharmacists. toxicologtsts and clinicians as advisory member. Its activity started in 1972 and has been contributing much in the fieids of drug evaluation and centrelled clinical trials.

[2] Aim of the Committee
The aim or the committee is to maintain the fairness or clinical triails concerning effi cacy, safety and usefulness or therapies or therapeutics, to make triais better from the view point or clinical medicine, medical administration and clinical pharmacology. to make the trials ethically as well as legally acceptable in view of esteeming the fundamental human rights of the subjects, to survey or study about methodology, results, guidelines and reguiations concerning clinical trials and to issue the relevant informations, thus, to make clinical trials be conducted properly and to maintain and develop the health of Japanese people by contributing to the progress of clinicai medicines.

[3] Activities of the Committee
(1) To take part in controlled ciinical trials; On request from a pharmaceutical company, a research institution or a research group, we engage ourselves in the followings [1)-14)]. Problems concering evaluation procedure are discussed by the committee and rest of the problems mainly concerning actual pro cess of the trial are dealt with throughout the trial by two controllers of whom at least one person must belong to the C-Cemmittee. If another person does not belong to the C-Comrnittee, he is expected to be well experienced about controlled clinical trials.
1 ) Te investigate and to evaluate the preclinical data, and to request additional infor rnations if necessary.
2 ) To check the protocol of clinical trial and to propose necessary alterations.
3 ) To be consulted about obtaining informed consent and to give trial group neces sary advices.
4 ) To test the indistinguishability between the study drug and the cantrol drug.
5 ) To prepare random allocation table.
6 ) To label the drugs with codes accordiiig to the allocation table.
7 )To draw the samples at random from the test and the control drugs, and then to inspect the indistinguishability of them. In addition, to examine whether each of them meets their standard and/or specification of pharmaceutics.
8 ) To hold the key-table in secret.
9 ) To monitor the process of the trial and to attend the periodical meeting or the trial.
10 ) To review and determine the drop-out or etclusion cases.
11 ) To store all the original data of clinical trial.
12 ) To check the data recorded in computer magnetic tape against the original case cards.
13 ) To perfform thc statistical analysis on the final data of clinical trial from a neutral standpoint.
14 ) To check whether the report was exactly written based on the final data/analysis and to review about evaluation of the test drug.
(2)To edit and publish the journal ' Clinical Evaluation' of which main articles are on controlled clinicaI trials.
Almost all of the articles resulted from following activities [(3)-(7)] appear in the journal ' Clinical Evaluation'. In order to make evaluation of the drug done fairly, the C-Committee encourages the publication of the article of which conclusion does not ravour the new drug.
(3) To investigate or research the methods of clinical trial.
(4) To explore and develop new program for data precessing.
(5) To review and study ethical and legal preblems, guidelines, and regulations, etc. of clinical trial and licensing procedure of new drugs.
(6) To study clinical pharmacology, clinical medicine and statistical analysis, etc.
(7) To engage ourselves in other activities reciuired to accomplish the committee's purpose.

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