The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Developing oncology compounds is a constantly evolving process, and never more so than now. Pre-pandemic oncology was both the largest and fastest growing therapeutic area in the clinical trials market. This trend is predicted to continue into 2026.
The Number One Challenge Remains
Despite the many adaptations that have emerged over the course of 2020 and into 2021 to ensure that oncology clinical trials are not disrupted, the number one challenge remains. Adequate site selection is astonishingly difficult to pull off.
Perhaps this is not surprising given that in addition to trial complexity, study teams are frequently assembled for the first time working together. Resulting in a group that has never collaborated together before faced with the challenges of planning an extremely complex project. Which may look straightforward on paper, when in reality on average, 11% of sites never enroll a patient, and original timelines often end up doubling in order to meet the desired enrollment goals.
A region that has fared well in regard to continuing to enroll in ongoing oncology clinical trials without disruption over the course of 2020 and into 2021, always a good ‘fall back’ country for oncology trials, is Canada. The sampling in the table here of accrual rates for clinical trials conducted by US oncology biotechs in partnership with Scimega, a niche Canadian CRO with focused expertise in conducting oncology trials in Canada in the context of North American and Global trials, speaks volumes.
Focusing on key attributes such as the value of expertise and experience will only serve to enhance the possibility of successfully meeting enrollment objectives.
Creative & Innovative Solutions Underscore the ‘Next Normal’
We’ll not be going back to 2019 and the way clinical trials were conducted then. In 2020 the clinical trial industry was forced to make rapid changes to ensure mission critical operations continued to protect participant safety, privacy, and data integrity. This required timely, creative, and innovative solutions to address each emerging challenge. This wave of creativity, innovation, and variety in the design of clinical trials — especially clinical trials supporting novel therapeutic agents and mechanisms will continue through 2021 and beyond.
The events of 2020 created opportunities to reconfigure and transform how we do things. In doing this it’s become very clear there is more than one way of doing things. And, there are a number of ‘next normal’ business considerations to be addressed as we move forward into a post-COVID era. In doing so we can expect new solutions will emerge in various facets of clinical trial operations and design.
A Biopharma Revolution in the Making
Could the pandemic be the launching point for a massive acceleration in the pace of medical innovation, with biology meeting technology in new ways? According the McKinsey Global Institute (MGI) study and report on future trends released in January 2021 the way that biopharma and the regulatory bodies have come together with speed and creativity, to establish clear guidelines and encourage thoughtful collaboration without relaxing safety and efficacy requirements is a milestone. A potential turning point that demonstrates how quickly they can collect and evaluate data under the momentum of an urgent need. If the lessons learned in this context are applied to other diseases, this could play a significant role in setting the foundation for the faster development of effective treatments. In an earlier report published in May 2020, MGI estimates that 45 percent of the global disease burden could be addressed with capabilities that are scientifically conceivable today.
Further, if the momentum that pandemic urgency triggered for creative and innovative solutions to the ever-unfolding challenges in health sectors becomes part of our ‘next normal’ MGI predicts this can lead to stronger post pandemic healthcare systems. Healthcare system reform is difficult, and the consequence is that modernization is often slower than it needs to be. If we apply forward thinking efforts of evaluation that emphasizes turning the lessons of 2020 into effective action; this too can contribute to better supporting clinical research and help to quicken the potential ‘Biopharma Revolution’ in the making.
In the MGI May 2020 report the aspects of future trends outlined above expected to emerge in a post pandemic era are part of a much larger Bio Revolution anticipated in nearly all areas of human endeavor for four key domains in which discoveries and innovations are reinforcing each other. Examples include agriculture (genetic modification to create heat- or drought-resistant crops or to address conditions such as vitamin-A deficiency), energy (genetically engineered microbes to create biofuels), and materials (artificial spider silk and self-repairing fabrics).
Of course, all of this bio innovation carries considerable potential risk and unique issues. Risks of which those of us involved in clinical research are well aware.
Back to Basics – Critical Clinical Trial Operation Risk Mitigation & Resiliency Strategies for 2021-2022
Mitigating key risk areas has required significant adjustments to ‘how we normally do things’ when faced with the dynamic and ever evolving landscape encountered in 2020. This includes the following areas: feasibility and start-up; enrollment and maintenance; as well as close out.
Although these are not new areas of risk for clinical trials, the robustness of operational designs employed in the new and ever-changing realty of 2020 have been substantially tested. Leading many to examine what worked and what did not as part of their resiliency planning for 2021-2022.
Scimega, a niche Canadian CRO skilled in collaborative vendor teaming with a proven track record of 23 years unparalleled Canadian oncology experience, is one of many in the industry that has done so.
Key success factors were identified through de-briefing discussions with Scimega’s oncology clinical trial sponsors around clinical trial operations performance in 2020 and the following list emerged as important to risk mitigation under the ‘next normal.’
Did you Know?
Scimega clinical trial start-up times are 50% faster than the North American average, with premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies. Scimega consistently delivers expertise in oncology clinical trial services with a strategic focus on Sponsor program success. This caliber of performance holds true in the pre-pandemic, the new and the next normal context of oncology clinical research.
Contributed by: Julie Martin, CEO & co-Owner