2021 is going to be the year of healthcare, and with February 4th celebrated as “World Cancer Day”, a focus on innovations in oncology clinical trials and the trends to look out for, is but natural. This is the dawn of a new decade in oncology research and drug development, characterized by reshaping cancer at the therapeutic level. It is the fastest growing therapeutic area, expected to constitute 26% of pharmaceutical sales in 2022.
Nearly 2 million new incidences of cancer are expected to be diagnosed in the U.S in 2021. A combination of public health measures and advancements in cancer diagnosis and care have ensured that these, once terminal illnesses, are now chronic conditions for many survivors. As a case in point, better therapeutics have ensured that many individuals diagnosed with prostate cancer or multiple myeloma have a higher risk of mortality due to conditions other than cancer.
There has been transformational change in oncology care over the past 50 years, with a significant increase in survival rates among individuals with cancer. According to the American Cancer institute, for all cancers combined, the 5-year relative survival rate is substantially higher when compared to the rates in the 1970s.
Oncology Clinical Trials in 2020
In 2020, the profound uncertainty caused by COVID-19 affected clinical trials globally, including the pace of oncology research. During the initial days of the pandemic, patient safety and helping curb the spread of infection remained the focus. Mammoth efforts by medical workers and front-line staff helped navigate through the global crisis, on the health care front.
Within the oncology clinical trials space, it has been important to continue trials to bring lifesaving drugs to the market sooner. COVID-19 may have been an immediate threat to public health but, according to the International Agency for Research on Cancer (December 2020), there are 50 million people globally who have been diagnosed with cancer in the past 5 years.
There is a lot to do in oncology. The five-year survival rate for certain cancers, including non-small cell lung cancer and pancreatic cancer is only 50%. The five-year survival rate for non-Hodgkin’s lymphoma is 50% for individuals from Eastern Europe while it is 63% for individuals from Northern Europe. There are 4 million new incidences of cancer in China, every year. Cancer numbers continue to rise, with longer life spans and socio-economic factors being important contributing factors. Better diagnosis, better treatment solutions and care will help with substantial unmet needs, while constant innovation and research are driving factors.
Key Oncology Clinical Trial trends in 2021
1) Driving innovation- Immuno-Oncology (IO): Accelerating change in oncology involves infusing innovation and adaptive strategies. When the first therapy for HER-2 positive patients was released to the market in 1999, it took 8 years of study. The PARP-inhibitor therapy for HER-2 positive patients was available in 2013, while the next therapy was available within 2 years.
After treatment measures like surgery, radiotherapy, chemotherapy and other targeted therapies, Immuno-oncology is fast emerging as a strong 5th pillar of treatment. According to Global Data, immuno- oncology is expected to have the most impact on the pharmaceutical industry in 2021.
At Navitas Life Sciences, we have been accelerating oncology products to market for over 30 years. Nearly 25% of our clinical trials are on oncology. Our Proprietary OneClinical Analytics platform has played a pivotal role in spearheading innovation in clinical research by providing near real time data insights for informed and faster decision making.
2) Remote Monitoring: In the current state of the global oncology market, investments to ensure remote monitoring have become a necessity rather than an added feature. In fact, Global Data reports that remote monitoring was at the forefront of clinical trials in 2020.
There has been a permanent surge forward, in terms of technological advancements for decentralized clinical trials, leaving far behind the pre-COVID times. The use of digital tools to effectively augment clinical trials during COVID-19 was possible when sufficient infrastructure and expertise in utilizing artificial intelligence and machine learning tools existed.
Navitas Life Sciences has always strived to help bring scientific advancements to the oncology market, making it time and cost efficient. A pulse on industry trends has helped in investing in digital strategies, positioning Navitas Life Sciences as a highly efficient and strategic partner, even with COVID-19 restrictions.
3) Capabilities to cope with Complexities in Oncology Clinical trials:
Drug development in oncology is expected to see a significant rise with a paradigm shift in treatment measures, and an expected rise to 240$ Billion by 2024, according to a McKinsey report. Though oncology is grouped as a single therapeutic area, it includes multiple indications with varied 5-year survival rates and prognosis. There are multiple complexities that exist in oncology clinical trials, that require expertise and experience to navigate.
Oncology therapies include biomarker or genetic profiling that limit the number of patients recruited in the study. Moreover, their immunocompromised state could potentially place study participants at higher risk of COVID-19 infection and severity. Therefore, patient recruitment and management requires specialized support and strategies.
There is a need to build capacity, adopt innovative methods, ensure clarity with stakeholders, and enforce a structured workforce to carry out oncology clinical trials. There is a synergy with indications and multiple call points that is required to forge through the trials.
Capability building also includes the use of accessible digital technology, making it patient centric and risk free. According to a report by Deloitte, mobile phone penetration is nearly 90%, while smartphone use is steadily increasing. While internet availability is high in most developed countries, it is a little over 50% in developing countries. 40% of respondents in developing countries stated that 4G via their smartphones was faster than their home WiFi.
Fitbits and other wearables are also making a strong presence in the wearable health device sector. Nearly 9% of individuals own a Fitbit, which was recently acquired by Google. Leveraging information from such technological advancements will help improve study participant retention and reduce the need for site visits.
Considering that one-third of smartphone users check their phones within 5 minutes of waking, utilizing this digital tool for better patient engagement and management is a well-articulated strategy.
Navitas Life Sciences has been constantly utilizing innovative solutions and harnessing proprietary technology support to build robust systems that run efficient oncology trials. The evolving oncology drug development landscape requires agile support to study emerging therapeutics, and to provide transformative support to patients. We have structured our best practices to include these measures, with the ability to rapidly bring together the required facilities and support to drive better clinical trial outcomes.