Abstract
As this ever-evolving pandemic lays itself, more of its impact is being
understood. Until recently, most guidelines were reported to aid in
managing and treating suspected or confirmed cases. Research
institutions around the world are responding with a sense of confusion.
Some are continuing routinely, especially those who are overseeing
clinical trials that could offer life-saving therapies, particularly
against the novel coronavirus. Since research must continue even in the
face of a shutdown, we aim to collate the currently available
recommendations from various organizations and provide guidance to head
and neck researchers across the world during these trying times.
Introduction
Various challenges exist for researchers during the Coronavirus pandemic
that are resulting from restrictions at healthcare facilities, changes
in availability of staff and unidentified possible interactions. Some
trial participants or investigators might also be required to
self-isolate or be infected by the severe acute respiratory
syndrome-like coronavirus-2 (SARS-CoV-2) causing a moral dilemma in
keeping trials running. Another issue specific to the head and neck
region is the proximity to the areas through which the virus can be
easily transmitted requiring further amendments to protocols and need
for additional equipment. Multi institutional trial conduct can also be
affected by the unavailability of Investigational Medicinal Products
(IMPs) due to the restrictions affecting supply chains across the world.
All these factors might have an impact on the accrual, assessment and
provision of clinical trials.
The impact of Coronavirus pandemic needs to be considered on ongoing and
new clinical trials. Sponsors need to take into account the national
guidelines and restrictive measures imposed including limitations of
trial participants and staff confinements and their ability to perform
visits, interviews and forms and notification of adverse effects.
Funding agencies and sponsors should be informed regarding the impact
the current situation might have on the trial protocol. Currently, most
of the trials are being run based on risk-benefit concerns and
contingencies present locally with the highest priority given to the
health and safety of the trial participants. In the event the
participant is unable to attend a scheduled visit, measures such as
virtual or tele contact may be required to identify ensure adequate
medical oversight. With all these limitations it is of utmost importance
to make provisions for data protection with adequate documentation. It
is also important to note that international publishers have made clear
that in the event of a public health emergency, information with
immediate health implications would be disseminated without any
restrictions. This document aims to collate the currently available
recommendations from various organizations and provide guidance to head
and neck researchers across the world during these trying times.
Initiating new trials
Regulatory bodies have currently paused approvals for non-COVID-19 new
trial registration unless requiring an expedited approval in the event
of public health emergencies with few also advising to withhold
enrollment.(1) The study team should critically assess the feasibility
of starting a clinical trial or enrolling new participants. The risk
benefit section of protocols should include the additional risks that
the participant and trial workers could encounter due to COVID-19 with
adequate risk mitigation measures. Most guidelines suggest a risk
assessment by the sponsor weighed against the anticipated benefit for
the participant and society before initiating enrollment.(2,3) In trials
especially of the head and neck cancer, where the participants enrolled
may be determined as being a risk group for COVID-19 or in trial that
involve increasing the risk to contract COVID-19 such as chemotherapy
related trials, should be carefully considered before starting or
continuing such trials.
Considerations for ongoing trials
Ensuring safety of trial participants is paramount and decisions should
be taken on an individual participant basis focusing on the potential
benefit. Decisions regarding further trial recruitment, continuing use
of IMPs for enrolled participants and need to change the monitoring
methods and site during an ongoing trial should be kept in mind. At any
stage, it is very important for participants to be kept informed of
changes to study and other plans that could impact their care.