The COVID-19 pandemic has challenged every aspect of the clinical research industry. As many sites have pivoted to accommodate to a newfound remote way of conducting research, many “someday” wish-list items became must-haves almost overnight. This new urgency has affirmed certain clinical trial innovations originally pioneered in the oncology space, especially in the areas of genetic engineering and gene therapy, complex and efficient protocol design, and cross-organization collaboration.
Genetic Engineering and Gene Therapy
Gene therapy investigational treatments are currently popular among oncology studies due to the targeted approach they can offer. The cancer immunotherapy approach of T-cell transfer therapy uses genetically modified cells to stimulate the immune system. Once the immune system is stimulated, these cells work to attack cancer cells. Genetic engineering technology has also become pivotal in vaccine creation and production, particularly in response to the current pandemic. Researchers have found introducing single genes from the novel coronavirus (SARS-CoV-2) into weakened vaccine strains of existing viruses delivers only key target antigens for the immune system. This allows the antigens to attack without risking the use of a diminished or killed coronavirus. The approach also speeds the vaccine development process far beyond what was possible with the traditional approach of serially culturing a virus to weaken its disease-causing ability.
Complex and Efficient Protocol Design
Platform studies, also known as “umbrella” or “basket” studies, allow the research community to weed out ineffective investigational treatments and accelerate promising studies toward the development of COVID-19 therapies. These innovative study designs apply a similar approach used in oncology trials to help researchers better understand specific genetic mutations and biomarkers in various types of cancers. Different from traditional randomized controlled trials, platform studies offer increased efficiency by conducting multiple interventions within the same infrastructure, rather than evaluating each intervention within its own individual protocol.
While there are many research teams racing against time to deliver an effective therapeutic against COVID-19, the goal of every team is the same: understand the data available and produce positive results. Working toward a monumental shared goal seems to encourage collaboration among teams and institutions to produce research breakthroughs. The goal of eradicating cancer led to collaborative efforts like the Cancer Moonshot , and this pandemic has been no different. The Chinese government made the SARS-CoV-2 gene publicly available early in 2020, which helped drive public-private partnerships like Operation Warp Speed and other accelerating efforts toward a vaccine and effective therapies.
While COVID-19 has affirmed the oncology field’s innovations and efforts in clinical research, it has also pushed the research community to adopt additional capabilities such as telemedicine and eConsent technologies. As sites have quickly shifted to virtual and remote modalities to conduct research during the pandemic, many sites are looking to adopt those techniques permanently. Given the immunocompromised nature of many cancer patients, the oncology field may find such modalities useful ways to further protect participants.
Research as a whole has been brought into the spotlight due to COVID-19 as well. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease, states over 250,000 Americans are registered with the NIH to participate in COVID-19 trials. Researchers now have the opportunity to educate the public about other areas of research, thereby increasing participation, diversity, and collaboration throughout the entire industry.
Oncology’s innovations have certainly sparked advancements in the clinical trial industry and empowered COVID-19 research. To find out more about oncology’s contributions to the future of clinical research, attend Advarra’s free virtual event The New Urgency of Clinical Trials: How Oncology Leads the Evolution on September 10. In this panel discussion, experts from industry and academia explore the unique ways oncology led the charge in clinical trial advancements, how the pandemic encouraged virtual capabilities, and discuss the future of clinical trials participation through the lens of oncology research.