With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
Optimizing the partnership between Sponsors and CROs can move the relationship from a tactical client/vendor operating model to a more strategic one. Where teams operate on a united front with shared goals, two-way communication and transparency, while promoting a culture of continuous improvement to establish a combined effort that can translate to increased resource productivity, cost savings, and ultimately, more successful studies.
Average patients per site per month enrollment rates for oncology clinical trials remained low at an average of 0.38 patients per site per month across all Phase I-III trials in 2018. While the annual cost of oncology medicines in the U.S. rose to $49.8 billion between 2012 to 2018 – an increase of $25.1 billion.
Phase I/II oncology clinical trials have success rates that remain at 30% (2016). While the number of subjects at the upper quartile of patient enrollment in oncology clinical trials for Phase III has declined sharply between 2013 to 2017, indicating a shift of trial burden to Phase I and Phase II trials
This along with the increasing body of evidence needed to clear new regulatory hurdles for market entry underscores why biopharma companies involved in oncology clinical research must continue to seek out new ways to improve efficiency of development.
What’s Different About a Specialized CRO/Sponsor Strategic Operating Model?
There are 3 key elements that differentiate a strategic focus for Sponsor relationships with their specialized CRO. As indicated above these include communication of clearly aligned expectations, a commitment to continuous improvement, conducted in an atmosphere of transparency and trust.
What Benefits Can Result from a Strategic Specialized CRO/Sponsor Relationship?
The depth of commitment to the effectiveness of the partnership by both parties characterized by the strategic model for the specialized CRO/Sponsor relationship creates value opportunities that surpass a transactional outsourcing model. This results in just some of the following benefits for the Sponsor.
- Faster feasibility
- Quicker start-ups
- Improved transaction processing
- Ongoing innovation and strategic input of expertise in clinical development planning & execution
- Fewer change orders and superior data quality due
- Strategic engagement of regulatory expert
So, What’s the Catch?
There are always challenges to deploying new ways of doing things. Key among them for the strategic specialized CRO outsourcing model is that this form of relationship places more responsibility and accountability on the specialized CRO.
In these models, the CRO accepts accountability to deliver to the agreed timelines and budget. The feasibility and planning process must include a very robust assessment of the protocol, development environment and projected site performance using historic performance metrics as well as a detailed study assessment to define the study deliverables. It is important that this process starts early in protocol development and that the CRO is committed to the objectives of the protocol and clinical development plan. (Perspectives in Clinical Research Journal)
Finding the right specialized oncology CRO capable of this level of performance to engage in a strategic relationship is the starting point for a Sponsor seeking to attain the considerable benefits this model can provide.
Your Specialized Oncology CRO as Strategic Advisor – Real World Evidence
An example of how an unwavering strategic focus of a specialized oncology CRO to deliver on its commitment to the Sponsor’s program is highlighted in the case study featured here.
The Challenge – Real World Evidence
Mid-way into study startup the Sponsor discovered that institutional biosafety approvals were required in addition to the usual ethics approval.
The majority of Sites selected for participation did not have existing biosafety committees in place. Start-up delays of over 8 months were anticipated. Truly a potential nightmare for this single-compound biotech.
The Solution – Real World Evidence
Given its stable, experienced teamwork and ability to identify, advise on, and implement enrollment strategies within the complex field of oncology clinical research this specialized oncology CRO was instrumental in getting biosafety committees up and running for this Sponsor by doing the following.
- Served as a strategic advisor to the Sponsor and worked to develop a solution and corresponding action plan to attain the required institutional biosafety approval within a 3-month period instead of the anticipated 8-month delay expected.
- Drafted study-specific biosafety procedures in compliance with applicable regulations and assisted each Site to begin the process with a working draft instead of starting from scratch.
- Shared tips and procedures from Sites more advanced in the biosafety committee process with Sites less advanced, to exponentially accelerate the process with results completed and already deemed acceptable.
- Counselled other regions in the study supported by the Sponsor’s other CROs by participating in several team meetings to expedite the set-up of biosafety committees in those regions (Europe, USA) by sharing how-tos and lessons learned through successes at Canadian sites.
Real World Evidence – Real Results
- Enrollment for this Sponsor’s oncology program closed 1 month early, and the program successfully advanced to Phase III.
- Many key Canadian Sites now have permanent in-house biosafety committees.
Your Specialized Oncology CRO as Strategic Advisor – Scimega Research
With 20 years unparalleled Canadian oncology experience Scimega Research has an overall SDV of 84.5% across all enrolling sites, at all times in 2018. With a 93% on-time site report delivery rate dispatched to Sponsors by our team in 2018, compared to the 60% industry average.
Scimega is a specialized oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies. We consistently deliver our services with a strategic focus on Sponsor program success with clinical trial start-up times 50% faster than the North American average, premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies.
These metrics and the case study featured above clearly reflect the caliber of combined skill and specialized expertise Sponsors can trust from Scimega to create value opportunities for their oncology clinical programs.
Contributed by: Julie Martin, Director, Clinical Operations