Drug Evaluation Committee (6) Necessity of Contracts for Follow-up of Adverse Events after the Contract Term Ends
Related classification: clinical trial contracting procedures
First published: December 2004
Revised publication date: April 2013
Question
Regarding the clinical trial that ended on March 31, 2012 (i.e., the research period of the contract), an adverse event (abnormal fluctuation of test values) occurred at the final test at the end of March, and a follow-up survey was conducted in accordance with the clinical trial protocol.
Regarding this, the Clinical Trial Office could not determine whether a contract was necessary or not, and asked the sponsor to provide its rationale (opinion) if it thought it was unnecessary. The sponsor's legal department agreed and asked us to submit the information. The sponsor, however, did not want us to present their personal opinion, but asked us to confirm what the authorities or the Pharmaceutical Manufacturers Association of Japan (PMAJ) thought and present it to them. We asked the clinical trial office if they had any other cases (experience), but they replied that they had concluded contracts in advance covering follow-up investigations in other cases (?) and that this was the first time they had heard of such a case. We asked the Clinical Trials Office if there were any other cases (experiences), but they said that others had concluded contracts in advance covering follow-up surveys, and this was the first case like this.
Since the follow-up survey has already been conducted at this point and we need a response as soon as possible (by the end of May), we think it would be faster to conclude a new contract for the follow-up survey rather than to look for a reason why a contract is not necessary. We are considering concluding a contract at this time that will ensure (cover) the validity of the follow-up survey after April 1.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The "clinical trial period" agreed upon in a clinical trial agreement usually refers to the period until the administration of the investigational drug or the completion of all tests and observations stipulated in the protocol at the medical institution concerned, but of course there is no legal support for this.
Therefore, it is necessary to have a thorough discussion between the parties to the contract in advance to ensure that both parties share the same understanding of the "duration of the clinical trial.
Now, the follow-up investigation for cases of adverse event occurrence should be in accordance with the GCP regulations,
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(1)The necessity is stipulated in the clinical trial protocol.
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(2)Measures such as "the necessity of conducting clinical trials in compliance with the protocol (GCP Article 13, Paragraph 1, Item 13)" and "handling of health damage compensation for subjects (GCP Article 13, Paragraph 1, Item 16)" should be stipulated in the original agreement. In other words, even if the timing of the follow-up survey for cases of adverse events is outside the "duration of the clinical trial," the implementation of the survey is contractually guaranteed, and therefore, no particular inconvenience is expected to occur.
Therefore, it is generally considered that procedures such as renewal of the clinical trial agreement are not necessarily necessary.
The same can be said for contractual items such as "preservation of records (GCP Article 9, Paragraph 9)," "preservation of confidentiality of subjects (GCP Article 11, Paragraph 11)," and "cooperation in inspection of source documents at the site upon request of the sponsor (GCP Article 14, Paragraph 14).
Reason for revision of opinion
With the issuance of the GCP Guidance (December 28, 2012, Pharmaceutical Affairs Agency, Food and Drug Administration, No. 1228, Issue No. 7), the referenced article has been changed.