The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Choose Your Specialized CRO Partner Well
The global clinical trials market is expected to reach $69.8 billion US by 2027, exhibiting a 5.1% CAGR (compound annual growth rate) over the next seven years according to the recently published Clinical Trials Market Size, Share & Trends Analysis and Segment Forecasts report.
Navigating the selection process of service providers by Sponsors within an industry of this size and scope, with its vast offering of services critical to the business success of Sponsors and the health and welfare of patients, is not easy.
Nevertheless, it’s clear from the case example presented here that identifying and exploring the performance areas where the more focused niche CRO excels is an extremely important consideration, especially where new challenges need to be overcome with specialized expertise for areas such as oncology clinical research.
Meeting New Challenges as Opportunities
In light of the current COVID crisis this is more important than ever, particularly for the medium and smaller oncology biotechs seeking to keep their trials going while introducing the appropriate precautions, at a time when larger industry players may have paused trial activities.
Cancer patients continue to suffer from their condition during these uncertain times. Recognizing this, several health authorities are urging that research continue.
Sponsors developing cutting edge oncology compounds worried about trials not adequately enrolling can take heart. Especially since now is a good time for study start-up activities in Canada.
Amid the many closures clinical research is deemed essential in Canada, with research and legal staff at several Canadian sites available to work on new study start-ups. Choosing now to expand your study to the region means your trial expansion is ready to go when the world starts up once more.
The clinical trial case example below provides real world evidence of why it’s important not to overlook the specialized niche CRO when selecting the best option for your oncology clinical trial.
Real World Evidence with Real Results
Often upon realizing program timelines and targets aren’t being met, medium and smaller US oncology biotechs partner with Scimega to expand their trials to Canada, and in so doing find their trust well placed.
The Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies. Scimega SIV to Site activation is 8 calendar days across all programs in 2019. With Scimega Site activation to FPI 5.5 weeks across all programs.
Illustration of this excellent level of performance is highlighted in the following real-life case study of a Canadian expansion for a mid-size US biotech’s pivotal oncology P3 trial with a large number of patients.
The study design for this phase 3 solid tumor trial requires early patient catchment and considerable cross-department effort at Sites to execute effectively.
The level of cross functional team collaboration demanded by the study design is not readily implemented by Sites which typically work in silos for each of the particular functional responsibilities involved in the trial.
Anticipating this challenge imposed on Sites by the study design and proactively addressing it requires solid relationships with Sites, a deep understanding of how each Site functions, in conjunction with a specialized expertise in oncology clinical research. Thereby providing credible, legitimate solutions based in mutual understanding between this specialized niche CRO’s operations team and the different site functions needing to come together for the cross functional site study team.
To successfully implement the study design meant mapping the journey from point-to-point for each Site from one functional department to another, while emphasizing how exploiting the study design to meet a medical need could better serve patients.
This entailed mapping the patients’ journey from Dx to Sx and Tx, essentially devising a site-by-site customized patient catchment process with the development and implementation of cross-departmental communication workflows to enable effective study design implementation.
Further enhancing study design implementation led to exceptional rates of enrollment across all Canadian Sites. Undertaken with an analysis of key Sites experiencing marked accelerated enrollment, identification of root cause, and the sharing of this with other sites thereby boosted enrollment at all Canadian Sites for the study.
- Enrollment at Canadian Sites surpassed (237%)
- 92% of open Canadian Sites enrolled patients
- Sponsor requested additional Canadian Sites to further leverage the region’s success
- Study-wide sharing of Canadian patient catchment strategies
- This sharing improved other regions enrollment rate by 0.25 to 0.5 pt/mo/site
- Enrollment closed on time
- DB locked as planned
What Not to Overlook
This CRO works hard at working smarter every year for over two decades.
With inspection ready processes and key metrics performance that clearly reflects the caliber of combined skill and service, the Scimega team of oncology experts consistently delivers on its enrollment promises, and more-often-than-not surpasses them.
Contributed by: Julie Martin, Director, Clinical Operations
ASH Clinical News, March 29, 2020
Clinical Trials Market Size, Share & Trends Analysis and Segment Forecasts 2020-2027 report