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During COVID-19 pandemic, monitor can review source documents if the site can set up remote viewing portal

Wednesday, September 2, 2020, 08:00 Hrs  [IST]

What are the regulatory expectations of efficacy and safety for a COVID-19 vaccine?
Dr Jyotsna Bhalerao

The US FDA has issued a special guidance for Development and Licensure of Vaccines to Prevent COVID-19. Regulatory requirements include data on chemistry, manufacturing, controls, nonclinical data, clinical trials, and post-licensure safety evaluation. Major safety requirement is assessment of risk for COVID-19 vaccine-associated enhanced respiratory disease (ERD) in animal studies and clinical trials. Immunogenicity studies in animal models responsive to the selected COVID-19 vaccine antigen should be conducted to evaluate the immunologic properties of the COVID-19 vaccine - humoral, cellular, and functional immune - and to support first-in-human clinical trials. Late phase trials, including efficacy trials, should be randomized, double-blinded, and placebo controlled. Follow-up of study participants for COVID-19 outcomes for severe COVID-19 disease manifestations should continue as long as feasible, ideally at least one to two years, to assess duration of protection and potential for vaccine-associated ERD. Either laboratory-confirmed COVID-19 or laboratory-confirmed SARS-CoV-2 infection is an acceptable primary endpoint for a COVID-19 vaccine efficacy trial. The primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%. The general safety evaluation of COVID-19 vaccines, including the size of the safety database to support vaccine licensure, should be no different than for other preventive vaccines for infectious diseases. Serious and other medically attended adverse events in all study participants should be recorded for at least 6 months. The pre-licensure safety database for preventive vaccines for infectious diseases typically consists of at least 3,000 study participants vaccinated with the dosing regimen intended for licensure.

How does an investigator obtain informed consent from a patient unable to travel to a clinical trial site and/or print a consent form?
Dr Nayan Shah

The US FDA recommends the site can document the informed consent using electronic informed consent process. However, if this is not feasible,  methods other than a face-to-face consent interview may still be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the person signing  consent plans to enrol as a participant in the clinical trial or is the legally authorized representative (LAR) of the trial participant. For example, the consent form may be sent to the trial participant or LAR by email, and the consent interview may then be conducted by telephone when the trial participant or their LAR can read the consent form during the discussion. After the consent discussion, the trial participant or LAR can sign and date the consent form and return the consent form as a photographic image or scanned format sent through electronic means.  Alternatively, the trial participant may bring the signed and dated consent form to his/her next visit to the clinical site, if restrictions on traveling to the clinical trial site are eased or mail it to the clinical investigator.
In case the trial participant can not print the consent form, the investigator can mail the consent form and arrange a telephone call or video conference call with the prospective participant or legally authorized representative, the investigator and an impartial witness and if  desired by the patient next of kin. If it is not possible to use a witness, a recording of the conversation can be made. The recording should include  a) identity of attendees,  b) review of the informed consent document with the prospective participant or LAR by the investigator and response to any questions from the prospective participant or LAR c) verbal confirmation by the prospective participant or LAR that their questions have been answered and that they would like to participate in the trial. Verbal confirmation by the participant or LAR should include that they signed and dated a blank piece of paper with a written statement that they voluntarily agree to participate in the protocol, noting both the Protocol identification and brief protocol title. The photograph or scan of the signed and dated statement is emailed to the investigator.

If it is not feasible for investigators to receive the signed consent form prior to beginning study-related procedures, the investigators should have the potential trial participant or LAR confirm verbally during the consent interview that the participant or LAR has signed and dated the form. However, the ethics committees should have reviewed and approved the planned informed consent process.

During COVID-19 pandemic, how does a monitor perform source document review?
Aparna Morarka

The monitor can review source documents if the site can establish a remote viewing portal that would permit site staff to provide access to the site’s study documentation and/or trial participants’ source documents. 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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