Guidance for clinical trial investigators
Conducting clinical research during the COVID-19 pandemic
25 March 2020
GlaxoSmithKline (GSK) is continually evaluating and responding to the rapidly evolving situation in relation to Coronavirus SARS-CoV-2 (COVID-19) and the impact this 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. 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 recognise 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, GSK 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 and executed either by GSK or through a Contract Research Organization (CRO) with the purpose of maintaining patient, site 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.
GSK’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 Patient First Visit (FPFV)
New Patient Enrollment – At this time, GSK remains supportive of enrolling new patients into ongoing clinical studies, provided that you and your site are confident it will be able to conduct the protocol specified safety and efficacy monitoring required for the study. GSK recommends that investigators ensure the appropriate monitoring and follow-up of currently enrolled subjects before considering recruitment of new patients.
There may be exceptional cases that require GSK to pause individual trial enrollment. Such decisions will be taken on a case by case basis considering the therapeutic area and the patient population involved in the clinical study. If a decision is taken to pause enrolment in a study that you are conducting, we will promptly notify you, your team and your institution.
Please also note that regulatory guidance recently issued by major authorities 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 us of any restrictions in place at your site that will impact monitoring and/or patient access to the site and care providers. GSK’s clinical operations team 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, GSK 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, GSK will work with you, your staff and the site to ensure subject privacy. Your respective Institutional review board/Independent Ethics Committee (IRB/IEC) should be consulted, and their approval will be requested, as appropriate. We are also exploring the use of a telemedicine platform to facilitate trial conduct.
Patient Site Visits - For ongoing patients who are unable or prefer not to attend protocol-specified trial visits and procedures, they will remain in the trial for as long as you deem appropriate and for as long as the patient continues to consent to participation. Retaining patients in the trial regardless of whether they remain on investigational product will help to increase the trial and data integrity.
New Clinical Trials - prior to First Patient First Visit (FPFV)
- As appropriate, GSK will 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, GSK will update you and your site as appropriate, carefully considering the benefit / risk profile and feasibility.
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.
Clinical Trials for Vaccines
Given specific benefit / risk considerations pertinent to clinical trials with prophylactic vaccines, GSK has decided to pause recruitment of additional trial participants on a country by country basis until further notice as we continuously assess the evolving situation COVID-19 situation.
Clinical Trials for ViiV Healthcare
For guidance regarding ViiV Healthcare trials, please contact your ViiV Study team.
- 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 needs to be captured as adverse events according to the established safety reporting system specified in the study protocol. Please consider holding dosing of investigational product and consult the Medical Monitor responsible for your study. In the event a participant tests positive for COVID-19, or if no testing is available, hold dosing of the investigational agent until symptoms resolve and contact the Medical Monitor overseeing your trial. If a positive COVID-19 test result is reported, please consult with the Medical Monitor on whether resolution of symptoms alone, without retesting, is sufficient to resume dosing of the investigational product.
GSK is working on developing specific site guidance and a specific case report form page to capture information and follow patients with suspected or confirmed COVID-19 infection.
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.
Investigator-Sponsored Studies (ISS)
- GSK internal operations relevant to the support of ISSs are functioning normally and the necessary preparatory activities required to progress ISSs, such as site activation, drug supply and site payment, are continuing. We will continue to review newly proposed concepts in accordance with our current processes.
- 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 patients have safe access to participate in trials while adhering to local policies and processes instituted as a result of the COVID-19 pandemic.
Please contact your GSK Study Team if you have any questions or become aware of new information that could impact your ability to safely treat patients 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 GSK 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 www.GSK.com 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 GSK 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. We stand ready to help you in those 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.
Sabine Luik, MD, MBA
Chief Medical Officer, Senior Vice President Global Medical, Regulatory and Quality
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