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.