With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
This time last year none of us imagined we were about to go through a year like no other, and as we enter 2021 the environment remains very dynamic. In 2020 the clinical trial industry was forced to make rapid changes in order to ensure mission critical operations continued to protect participant safety, privacy, and data integrity. Particularly at clinical sites, research teams have had to restructure their operations according to institutional directives to prevent the spread of COVID-19, with some regions more deeply affected than others.
This has led Sponsors, and the CROs they partner with, to identify and explore critical clinical trial operation mitigating tactics and strategies for prevention and recovery, to help determine how to continue to build resiliency in 2021.
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 this ‘new reality’ have been substantially tested. Leading many to examine what worked and what did not as part of their resiliency planning for 2021.
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 under the ‘new normal’ and include the following.
Beyond having solid site relationships, Scimega established proximity as a key success factor in 2020. This meant staying abreast of upcoming policy changes to allow the group to develop adapted working methods as proactive ahead-of-time scenarios. This was key in reducing the lag on source data verification at all active sites.
Becoming aware of official policies when they are released is one thing, knowing they are in the making ahead of time is a whole other level of advantage.
Study Coordinator Relations:
Excellent relationships with study coordinators at the site level are an ongoing primary objective for Scimega’s team of oncology experts, and is at the core of the company’s robust operational design. This type of commitment means site staff answer calls from Scimega even when sites are facing turbulence and low staffing challenges, to work together to identify win-win solutions early in the midst of crisis.
Never underestimate the value of a proactive, ongoing supportive communication approach with site staff over the long term, which is especially effective when timely clinical trial operation mitigating tactics and strategies become most critical.
Not pushing on non-urgent matters with sites, not coming off as demanding, or sending unnecessary or redundant communications as a matter of course is always a worthwhile collaborative operations strategy. This approach goes a long way in building trust with site staff over the long-term.
Staying honest and transparent with sites forges lasting trust links that can be maintained during crisis recovery, even as sites undergo major challenges to their ability to sustain clinical trial operations.
Low CRA Turnover:
No one appreciates a change in study partners, it places additional demands on everyone involved. Beyond the Sponsor and vendor teams, a low CRA turnover rate help keep site staff happy. When a change of CRA is necessary, involving the outgoing CRA and the site staff is key in promoting a smooth integration of the incoming CRA. Crisis or no crisis. In addition, achieving a low turnover rate requires optimal engagement from the internal team, and strong established retention and motivation initiatives for team members is critical to this outcome.
It’s a strategic advantage for the optimal robust operational design model to source CRAs locally. For Scimega having permanent locally-based CRAs and a very low turnover rate compared to the industry emerged as a key success factor in reducing the impact of the pandemic on site management functions while ensuring the highest quality standards in our service delivery. This strategic advantage was evidenced by only one single staff change in the whole of 2020.
2020 ‘New Normal’ Scimega Progress Summary:
In keeping with the targets shared with its Sponsors, the Scimega team continues to deliver consistent clinical trial start-up time 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies.
More than ever Drug Developers want access to sites that can deliver on their promises of rapid FPI (first patient in study) and patient enrollment milestones. They need a CRO with established site relationships in Canada who can provide accurate study feasibility and viability assessments.
Operational efficiency and communication are key as Sponsors demand clean, accurate data to meet deadlines and move projects forward quickly. Processes ensuring a high-quality standard and operation oversight of CRA activities and internal QA activities is the new gold standard. Even under circumstances imposed by the current pandemic steady and high enrollment rates thanks to the selection of the right sites, along with the Scimega team’s ability to engage oncologists and site teams at the highest level remain key to success.
With inspection ready processes and on point metrics performance that clearly reflects the caliber of combined skill and service the Scimega team of oncology experts consistently delivers, as this CRO works hard at working smarter every year for over two decades.
Contributed by: Julie Martin, CEO & co-Owner