Drug Evaluation Committee 2010-08 Support for Clinical Trials by Multiple SMOs
Related classification: Other
First published: Jun 2010
Question
Each SMO directly contacts the person in charge of the clinical trial office (pharmaceutical department staff) at the medical institution to inquire about the case and, if the case is accepted, the medical institution and the SMO conclude an outsourcing agreement for the clinical trial office support and IRB office support services for the relevant clinical trial. However, starting from April this year, medical institutions and SMOs have been able to enter into an outsourcing contract.
However, as of April of this year, the medical institution has outsourced all of its clinical trial secretariat and IRB secretariat operations to a completely different SMO, and the SMO that had been providing operational support up to this point will now provide only CRC operational support for new cases it is approached for. The other day, the person in charge of the Pharmaceutical Department informed us that from now on, when each SMO approaches a medical institution for a project, the person in charge of the SMO entrusted with providing clinical trial and IRB administrative support will always be present, and will also be present at the meeting with the potential responsible physicians.
If multiple SMOs provide support to a medical institution and one SMO provides exclusive support for the clinical trial secretariat and IRB secretariat, how should we consider confidentiality of the case? Naturally, a confidentiality agreement is concluded between the sponsor and the SMO that referred the case to us. However, there is no guarantee that the SMO that provides secretariat/IRB support has concluded a confidentiality agreement with the sponsor.
If a confidentiality agreement has been concluded between the medical institution and the SMO that provides secretariat/IRB administrative support, is there any particular problem if the SMO is present when a case is discussed with the sponsor?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If a nondisclosure agreement is concluded between the site and the SMO to which the site outsources its clinical trial secretariat and clinical review committee secretariat services (hereafter referred to as "secretariat SMO"), any information obtained from another SMO (hereafter referred to as "CRC SMO") when the site is approached is considered information that belongs to the site and the secretariat SMO is obligated to keep it confidential. The SMO is obligated to maintain confidentiality. In addition, as mentioned in your question, the CRC SMO and the sponsor have concluded a confidentiality agreement. Therefore, there should be no problem if the SMO for secretariat services is present when a case is discussed with the site.
Some sponsors may not wish to disclose information or conduct business with an SMO that is entrusted with clinical trial secretariat and clinical trial review committee secretariat services, apart from the confidentiality agreement.