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During pandemic, regulator allows changes to investigational plan without prior review to eliminate hazard for the participants

Thursday, August 6, 2020, 08:00 Hrs  [IST]

What is potential conflict of interest (CoI) if spouse of an investigator is also a member of EC?
Dr. Radha Onkar
When an Ethics Committee (EC) reviews and approves clinical study,  and if an EC member with CoI participates in the review process, there is likelihood of compromise of Ethical responsibilities; Independence of EC functioning; Objectivity, fairness, and transparency of research ethics review; Trust of human subjects participating in clinical trial and the trust of society. Such a CoI situation will be considered regulatory non-compliance during registration, accreditation, or audit of EC.

Personal relationship of an EC member with the protocol’s principal investigator or investigator or another member of the research team, for example, spouse, children can create non-financial CoI. Such relations would have interest in supporting the approval of the study protocol and are likely to vote in favour of approving the study protocol.

You need to consider (1) what would be their professional roles/responsibilities of the couple as EC members; (2) likely situation where both cannot participate in the deliberations e.g. one of them has submitted a project proposal and impact on quorum; and (3) in case of voting on a study, both may vote on the same side irrespective of the ethical impact of a decision.

Can a sponsor initiate virtual clinical trial visits for monitoring patients for an ongoing trial during pandemic?
Dr Suresh Desai

During the pandemic US health regulator, the US FDA allows for changes to be made to the investigational plan or protocol without prior review or approval, if the change is intended to eliminate an apparent immediate hazard for the participants or to ensure the protection of rights, safety, and well-being of trial participants. Therefore, changes in protocol conduct necessary to immediately assure patient safety, such as conducting telephone or video contact visits for safety monitoring rather than on-site visits, can be immediately implemented with subsequent review by the EC and notification to regulatory authorities. Since this reflects a protocol deviation, documentation of the required deviations, would generally be acceptable. For example, documenting that all protocol-specified visits will be done by telephone contact rather than on-site visits, and that procedures requiring in-person visits will not be conducted. Since the change to telephone or video contact visits would likely result in some protocol-required procedures not being conducted e.g., vital signs, blood samples for safety laboratory studies, the sponsor must evaluate the potential impact on patient safety, and consider how to mitigate risks to patients, including the need to discontinue the investigational product.

How does a sponsor manage on-site monitoring of trials during COVID-19 pandemic?
Ketan Deshpande

Regulatory agencies expect the sponsor to consider alternative approaches to ensure safety of trial participant and trial data integrity e.g. central monitoring, telephone contact with the sites to review study procedures, trial participant status, and study progress, or remote monitoring of individual enrolled trial participants. Delays in on-site monitoring may result in delayed identification of GCP non-compliance at the clinical trial sites. The sponsor should document situations where monitors were unable to access, or had to delay monitoring of, a clinical site, and document protocol deviations or other GCP non-compliance issues identified at clinical sites whether delayed identification was due to postponed monitoring. If the remote monitoring requires review of  participants’ medical records that normally would be reviewed at the site, this may be explored with trial sites to complete source document review. If the site has appropriate resources and technical capabilities, the site can consider establishing a secure remote viewing portal that would permit site staff to provide access to the site’s study documentation and/or trial participants’ source documents for the study monitor’s review. Alternatively, the sites could upload certified copies of source records to a sponsor-controlled electronic system or other cloud-based repository that contains appropriate security controls.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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