COVID-19 Guidance to Investigators

ViiV Healthcare Investigator Guidance for Conducting Clinical Research during the COVID-19 Pandemic

ViiV Healthcare (HC) is continually evaluating and responding to the rapidly evolving Coronavirus SARS-CoV-2 (COVID-19) situation and the impact it is having on the planning and conduct of clinical trials. Our priority is the safety and well-being of those who support and participate in our trials and our employees and collaborators conducting clinical trials. As such, we are implementing proactive measures to protect the safety of study participants, staff at our clinical trial sites and our employees while ensuring regulatory compliance and the scientific integrity of our clinical trials. We recognize that your time and resources may need to be re-focused in support of the broader community during this time, given the significant challenges many healthcare systems are currently facing.

As the global diversity of the COVID-19 pandemic and its impact on healthcare continues to evolve, ViiV HC has developed an overarching guidance framework to allow robust and rapid decision making in line with recently issued guidance by several regulatory authorities and country-specific situations.

All of our decisions will apply to trials sponsored by ViiV HC and executed either by GlaxoSmithKline (GSK) or through a Contract Research Organization (CRO) with the purpose of maintaining patient, site staff and employee safety, while preserving the integrity and quality of our clinical research in our continued effort to bring innovative products to address unmet medical needs and improve public health. Although this document is focused on ViiV HC sponsored studies, the content may be informative for those external sponsors and collaborators conducting trials on our behalf.

Clinical Trials
ViiV HC’s overall benefit/risk framework used to guide recruitment decisions is predicated on ensuring patient, investigator and employee safety, and preserving trial and data integrity.

Ongoing Clinical Trials - after First Participant First Visit (FPFV)

New participant enrollment – At this time, ViiV HC remains supportive of enrolling new participants into ongoing clinical studies, if you and your site are confident that you will be able to conduct the protocol specified safety and efficacy monitoring required for the study. ViiV HC recommends that investigators ensure the appropriate monitoring and follow-up of currently enrolled participants before considering recruitment of new participants.

There may be exceptional cases that require ViiV HC to pause individual trial enrollment. Such decisions will be taken on a case by case basis, considering the patient population and countries involved in the clinical study. If a decision is taken to pause enrollment in a study that you are conducting, we will promptly notify you and your team.

Please also note that regulatory guidance recently issued by major authorities (including FDA and EMA) in response to the COVID-19 pandemic supports the use of central and remote monitoring programs to maintain oversight of clinical sites. We ask that you please inform your site monitor as soon as possible of any restrictions in place at your site that will impact monitoring and/or study participant access to the site and care providers.

ViiV HC and clinical operations teams supporting ViiV HC will work with you and your site to determine the optimal monitoring approach for the trial and provide support as possible. In case on-site monitoring is no longer permitted, ViiV HC will consider remote Source Data Verification/Source Document Review (SDV/SDR). Remote SDV/SDR will only be proposed to study sites to meet a patient and/or business-critical need, e.g., to assess critical study milestones, patient safety or to ensure data integrity. In case of remote SDV/SDR, ViiV HC will work with you, your staff and the site to ensure participant privacy. Your respective Institutional review board/Independent Ethics Committee (IRB/IEC) should be consulted, and their approval will be requested, as appropriate.

Study participant site visits - For ongoing participants, where possible, and safe to do, please continue to prioritize scheduled study visits in order to keep the participants on the protocol defined regimen and facilitate full safety and efficacy monitoring. For ongoing participants who are unable to attend protocol-specified trial visits and procedures, please continue to assess adverse events remotely and document all deviations to the study conduct in the study source records. For additional guidance on other study-related procedures and protocol deviation documentation, please consult with the ViiV HC study team.

Continuity of HIV treatment for study participants is a priority. In situations where study visits are limited or not possible, we are employing solutions to address study medication provision such as longer duration of investigational supplies for individuals and/or Direct to Patient provision of investigational supplies where this might be appropriate. Please consult with the ViiV HC study team for details on study medication accommodations if needed.

New Clinical Trials - prior to First Participant First Visit (FPFV)
As appropriate, ViiV HC may delay study initiation and re-evaluate as the situation evolves. If you are involved in a new clinical trial where FPFV has not yet been achieved, ViiV HC will update you and your site as appropriate, carefully considering the impact of initiating or delaying the study.

Clinical Trials involving Healthy Volunteers (HV)
Studies involving HV should not initiate and new sites should not be activated until further notice. If the HV study has not begun enrolling (i.e. in screening, but not yet reached FPFV) or if new cohorts need to be started, the study should be paused. Active cohorts of volunteers may be completed, unless a risk assessment indicates otherwise.

Suspected/confirmed COVID-19

New Participant Enrollment - For participants who are exhibiting symptoms consistent with COVID-19 or have tested positive using a test consistent with the institutional standard of care, enrollment and protocol treatment should not be initiated until resolution of symptoms and negative testing results have been obtained.

Ongoing Participant Treatment - For any study participants exhibiting symptoms consistent with COVID-19, these need to be captured as adverse events according to the established safety reporting system specified in the study protocol. Please consult with the Medical Monitor responsible for your study. In the event a participant tests positive for COVID-19, or if no testing is available, ensure appropriate documentation of the AE and/or SAE of COVID-19 is reflected in the eCRF. ViiV HC is working on developing specific site guidance and a specific case report form page to capture information about participants with suspected or confirmed COVID-19 infection and will share guidance when available.

Investigator-Sponsored Studies (ISS)

ViiV HC internal operations relevant to the support of ISSs are functioning normally and the necessary activities required to progress ISSs, such as drug supply and agreed upon financial payments, are continuing. We will continue to review newly proposed concepts in accordance with our current processes, although may not be able to commit to a start date, particularly if drug supply support is to be provided.

We understand that each institution will apply specific COVID-19 guidance to their ISS clinical trial practice(s). We anticipate this may have an impact on study activities, including site activation and enrollment of study participants. We will continue to communicate and work with you to adjust timelines and enrollment plans as needed throughout this period, so that we can help you ensure participants have safe access to participate in trials while adhering to local policies and processes instituted as a result of the COVID-19 pandemic.

Additional points to consider

We ask that you carefully consider public health, the impact of any travel restrictions implemented by local/regional health authorities and local institutions, and individual benefit /risk when taking enrollment and treatment decisions for trial participants during the COVID-19 pandemic.

Please contact your ViiV HC Study Team if you have any questions or become aware of new information that could impact your ability to safely treat participants in any of our studies. We will inform the relevant Health Authorities of our decisions in accordance with local regulations and where this is practically possible.

In general, you may also contact the ViiV HC Medical Information line in your region for customer service, patient assistance information, product information and adverse event reporting. You can find the local contact information at https://viivhealthcare.com/en-gb/ by clicking on the “Global” tab on the top right and selecting your region and country from the drop-down menu. Once you are on your country-specific ViiV HC website, click on the “Contact Us” tab on the top right.

The status of the COVID-19 pandemic is rapidly changing and guidance may continue to evolve over time. We are committed to updating you as circumstances change and we stand ready to help you in these challenging times.

Thank you for your partnership and collaboration to help us continue to develop and deliver innovative medicines for patients during this unprecedented and difficult period.

Harmony Garges, MD, MPH
Chief Medical Officer, ViiV Healthcare