The COVID-19 pandemic has forced rapid transformation in the clinical research industry, with many ideas being pioneered by oncology research. The pandemic accelerated the adoption of what were once thought of as “next generation” approaches. From genetic engineering to complex protocol design and cross-organization collaboration, the new clinical research landscape affirms oncology’s groundbreaking contributions.
Genetic Engineering and Gene Therapy
The oncology field was among the first to explore the possibility of gene therapy treatments. Immunotherapy approaches such T-cell transfer therapy use genetically modified cells to stimulate the immune system to attack cancer cells. Genetic engineering now plays a central role in the race for a coronavirus vaccine. Researchers can introduce single genes from the novel coronavirus (SARS-CoV-2) into weakened vaccine strains of existing viruses, delivering only the key target antigen for the immune system to attack without the added risk of using an attenuated or killed coronavirus.
Complex and Efficient Protocol Design
Novel clinical trial designs such as platform studies (also known as “umbrella” or “basket” studies) are being heralded by the research community as ways to quickly eliminate less-promising investigational treatments and hasten development of COVID-19 therapies. These novel approaches were initially explored by oncology researchers for similar reasons and helped increase our understanding of specific genetic mutations and biomarkers in different types of cancers. Platform studies permit ongoing evaluation of multiple interventions under the same basic infrastructure, unlike traditional randomized controlled trials which require a separate infrastructure for each product tested.
Clinical research can be competitive, with research teams vying against one another to be the first to deliver a new or improved therapy. But the common goal of eradicating cancer helped break down barriers and encourage collaboration that led to research breakthroughs, bringing together cross-discipline expertise to sift through mountains of data and to understand the biology behind all that data. In responding to the current pandemic, researchers have similarly banded together: early on the Chinese government made the SARS-CoV-2 genome publicly available, and collaborations like the NIH public-private partnership can help streamline research efforts to develop therapeutics and vaccines.
The urgency of COVID-19 has certainly affirmed and propelled the oncology field’s groundbreaking contributions. The pandemic has also encouraged the adoption of virtual capabilities previously not common in oncology, such as telemedicine and eConsent technologies. Now that these approaches have proven viable on a large scale, many hope the oncology field and other areas of research continue their use to further improve and streamline trial conduct. The pandemic has also brought a surge of awareness of the importance of clinical research. According Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease, over 250,000 Americans have registered with NIH to take part in COVID-19 clinical trials. This presents the opportunity to increase participation, diversity, and cross-organization collaboration in clinical trials.
Oncology’s innovations have sparked advancements in the clinical trial industry and empowered COVID-19 research. To find out more, attend Advarra’s free virtual event The New Urgency of Clinical Trials: How Oncology Leads the Evolution. 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.