This time last year none of us imagined we were about to go through a…
Pursuit of a path from discovery to drug approval as quickly as possible is a clear objective for most biotech companies. Accelerating timelines, financial pressure, competition and current global healthcare events further drive the emphasis to move as quickly as possible into the clinic.
Congruent with this need for increased speed in an already fast-paced industry, the COVID-19 pandemic presents the necessity to quickly adapt to the new ‘abnormal’ reality of clinical research.
Challenges & Opportunities
The pandemic has brought many new challenges to our ability to run oncology clinical trials, and if ever there was a time to demonstrate the ability to adapt, and quickly, it is now!
Challenges always present new opportunities, and while the pandemic has exposed weaknesses in internal processes, reliance upon traditional methodologies, and leadership gaps. It has demonstrated a valuable capacity to leverage innovative technologies to rapidly implement creative ways to enable study personnel to continue providing data, and patients to continue to receive their study treatments.
As a result, the future of drug development could become more agile in action, patient-centric in design, and outcome-driven, perhaps even with changes that will better address rising costs of prescription drugs and eliminate waste.
What Does a Need for Increased Speed Mean for the Smaller Biotech?
As a smaller biotech Pamela Contag, cofounder and CEO, turns to a team of 5 experienced specialized CROs to provide the various levels of expertise her company needs for all the different stages of drug development. “If you’re a small biopharma trying to get more innovative therapies to the clinic with just the right amount of money — if there is such a thing — to get through Phase 1, seek smaller CROs that have really done it before,” she advises. “After all, smaller CROs can be just as impressive and move much more quickly. And I don’t get the sense that my project is in a long line with other projects or lost on someone’s desk awaiting action.”
Timeliness at the Best of Times and Especially in Crisis Management – COVID-19 Case-in-Point
Scimega is a strong player with very high pre-COVID performance, and has every intention to continue exceeding expectations. The current outbreak is not the first hurdle this niche Canadian oncology CRO has had to overcome throughout its 22 years of existence.
Based on performance during the COVID crisis Scimega’s sponsors, small to mid-size biotechs developing cutting edge oncology therapies, are quoted as being very impressed with Scimega and where Canada stands in comparison to other regions, including the U.S., and “especially during the COVID.”
A critical factor in Scimega’s ability to perform at a level that allows it to sustain its track record of excellent performance, even during the pandemic is timeliness in crisis management.
As a case-in-point Scimega’s tactics and actions were taken early on in the pandemic, which led to successfully resuming most study activities for their sponsors’ programs from the month of June, 2020 onward.
Scimega’s preemptive effort to assess and mitigate risks early on was key, as well as having long established connections with site managers /administrators and involvement of the Scimega workforce in identifying all possible solutions. Open and constant communication with the internal team and sponsors alike ensured everyone was up-to-date on current status for each study, and also knew the case-by-case contingency plans. This also contributed to introducing timely adjustments as the environment continually changed over time.
When the pandemic began in Canada, everything moved very quickly. In just under 1 week the country went from following the news and numbers in Europe to implementation of a very strict confinement policy. While the Scimega team routinely works with 50+ sites, when the lock down occurred 27 Canadian sites were in active study status; with patients under treatment, enrollment open and data analysis forthcoming, etc.
Scimega covers sites from coast-to-coast in Canada with a permanent workforce located in 2 provinces. So, travel restrictions imposed as part of the sudden lock down had a direct impact on several of the active sites and studies.
By the time the confinement was officially announced, Scimega had preemptively scheduled team calls and reached out to site administrators and managers. A timeliness that helped secure early discussions with key site staff of plans A, B, C, D and E. In truth, some site responses were slow in coming as everyone was uncertain how long confinement would last, so starting early was very helpful. In so doing, Scimega was able to share solutions across sites where applicable, to help those sites with fewer staff cope with the challenges everyone was facing.
Scimega constantly communicated clear direction to its internal team of oncology experts, and by inviting input on practical options everyone was engaged in finding solutions. Numerous suggestions were forthcoming from the Scimega field force, and involving everyone from all levels was truly helpful and kept team spirits high. Scimega CRAs and project managers, many of whom have prior site experience as coordinators, were a gold mine of possible solutions as they so well understand technical and policy restrictions/allowances of Scimega’s Canadian network of sites.
Handling Variable Impact at Sites
For one particular study enrolling patients in several heme cohorts located in 4 provinces the study agent, an oral drug, encountered a serious challenge. With the pandemic local pharmacies staff reduced their capacities and some could no longer dispatch the drug to study participants.
Undaunted Scimega first ensured the continuity of the study treatment and procedures. Not such a clear-cut endeavor as several providers typically available were now overwhelmed with the new demands.
Nevertheless, Scimega sourced suitable providers and quickly set-up agreements with them. No treatment was delayed nor missed and study procedures were carried-on on time.
Once this was taken care of, Scimega attacked the study data monitoring problem of 4 sites not set-up for remote monitoring. Options were proposed by Scimega based on knowledge of site capacities, and suitable solutions for each of the 4 sites were established. Only 1 led to slightly increased cost for the sponsor.
Scimega’s team worked around the clock to ensure study participants did not miss a treatment, and to ensure patient safety. The monitoring solutions implemented are durable and continue to be in effect as of August 2020. Two of the 4 sites continue not to allow monitoring onsite. Nonetheless the alternative working methods established permit Scimega’s team to perform monitoring activities despite the restrictions. SDV backlog was kept low at all 4 sites throughout, and was completely caught up by mid-July 2020.
This Niche Canadian Oncology CRO – Consistently Goes Above-and-Beyond
With 22 years unparalleled Canadian oncology experience Scimega Research has an optimal operations design critical to its ability to consistently go above-and-beyond for every one of your studies.
Contributed by: Julie Martin, Director, Clinical Operations