Sponsored Insight
By Hesham Abdullah, SVP, Global Head of Oncology Development at GlaxoSmithKline; Tracy Vanderslice, VP and Head of Pharma Global Clinical Operations at GlaxoSmithKline; and Tai-Tsang Chen, VP and Head of Oncology Biostatistics at GlaxoSmithKline
The Covid-19 pandemic has had a devastating impact on oncologists and cancer patients across the globe. Before the pandemic, the field of oncology research was growing rapidly due to the development of more targeted therapies. However, following strict lockdown restrictions and resource constraints at hospitals globally, patients faced severely limited access to timely medical care, resulting in a drastic reduction in cancer diagnoses and delayed treatment.1
As resources were reallocated, activation of new clinical trials studying cancer treatments declined by 60% globally2 compared to pre-pandemic numbers, while nearly 80% of non-Covid trials were delayed or suspended altogether.3 In response, the Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) encouraged the use of de-centralized approaches to oncology research, including remote consenting and monitoring to allow the continuation of oncology studies while prioritizing patient safety.4
Avoiding disruption to cancer research in a pandemic
GlaxoSmithKline (GSK) adopted several strategies to ensure the continuation of its clinical trials, none of which were suspended or delayed due to Covid-19. For their Phase II-IV studies, GSK employed patient-centric solutions, such as digital recruitment campaigns, e-consenting, telemedicine, digital screening assessments, and remote research staffing, to minimize site visits. Published data suggest that the use of patient-centric strategies have the potential to maintain enrollment at a site level, with one site reporting a 10.5% relative gain in enrollment compared to pre-pandemic numbers. 5
GSK also optimized its supply chains to ensure access to investigational products. Where appropriate, direct-to-patient delivery and home health safety assessments were used to eliminate site visits. To allow for cell and gene therapy trial continuity, GSK used alternative transport (ground versus air), contingency planning for manufacturing continuity, and adapted treatment procedures to meet changing patient and site resource demands.
Using a standardized risk-based assessment framework, GSK captured the impact of the pandemic on study integrity (Figure 1).4 The framework assessed data integrity (study design assumptions, recruitment, and data quality), patient safety, and efficacy across all studies in GSK’s biopharmaceutical portfolios. Standardized methods were also rapidly developed and implemented to capture the overall impact of the pandemic on study integrity. Findings were then used to direct study adaptations, protocol amendments, and communication with regulatory agencies.
Implications for future clinical programs
The pandemic has resulted in the rapid adoption of decentralized methods like telemedicine, which decreases both patient and site burden.1 Adaptive study designs can increase efficiency, while maintaining scientific and data integrity. At GSK, these study designs were adopted pre-pandemic and allowed an agile drug development process, by facilitating the rapid evaluation of multiple hypotheses across varying indications and therapies. GSK hopes these adaptations to clinical trial design and execution will have sustainable implications for future oncology clinical research; already, the company has seen benefits in its oncology drug development sector, particularly its cell and gene therapy program.
Another important consideration for future oncology studies will be the development of a systemized approach to continued Covid-19 vaccination for patients, whose impaired immune systems increase their risk of infection.6 GSK has already applied consistent approaches to vaccination data collection including booster shots and analyses across its oncology portfolio.
The global challenges created by Covid-19 have allowed GSK to innovate clinical study design, execution, and management. By working together, pharmaceutical companies, physicians, and patients can achieve the common goal of improving the development of and access to novel cancer therapies, thereby increasing treatment options for cancer patients.
To learn more, visit www.gsk.com.
References
1Pennell, N.A. et al. American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. Journal of Clinical Oncology 39, 155-69 (2021).
2Lamont, E.B. et al. Trends in Oncology Clinical Trials Launched Before and During the COVID-19 Pandemic. JAMA Network Open 4, e2036353-e (2021).
3van Dorn, A. COVID-19 and readjusting clinical trials. Lancet 396, 523-4 (2020).
4U.S Food and Drug Administration. FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency> (2020). Accessed March 16, 2021.
5Yeboa, D.N. et al. Effectively Conducting Oncology Clinical Trials During the COVID-19 Pandemic. Adv Radiat Oncol 6, 100676 (2021).
6U.S Food and Drug Administration. COVID-19 Vaccines. <https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines> (2021). Accessed March 16, 2021.
Figure Legend
Figure 1: Covid-19 data integrity risk-based framework
Key: CSR, clinical study report; ICF, informed consent form; IDMC, independent data monitoring committee; SAP, statistical analysis plan.
