The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Study start-up is one the most time-intensive areas within clinical drug development, accounting for two thirds or more of total trial lifecycle times, and it is estimated that nearly 50% of the total time and capital expenditure during the drug development process is on conducting clinical research. Clearly then, start-up is an area with significant potential to positively impact clinical trials, especially as organizations ramp up for post COVID-19 trial starts. The results of a May 2020 survey of 100 clinical trial investigators reveals that 87% expect trial operations to normalize by early 2021.
The ‘new normal’ of business as usual is expected to evolve with a few key changes to clinical trials. Of those surveyed, 69% of Investigators expect more hybrid/virtual trial designs; 35% anticipate protocols will be leaner protocols with fewer endpoints; and 24% expect to see greater industry focus on patient burden. Although 44% of Investigators expect patient enrollment will become more difficult; at the same time, 69% believe a shift toward hybrid/virtual trial designs will increase patient interest in and access to clinical trials. Making recruitment within well-established site networks with significant, verifiable patient counts more important than ever.
Overall the global clinical trial market is growing at a robust pace that is expected to continue into 2025, with factors such as government initiatives in emerging economies for the promotion of drug discovery and continuous technological innovations expected to drive this growth. Phase III is likely to dominate the market, with Phase I expected to see fast and steady growth due to the increasing number of investigative new drug (IND) applications filed.
Worldwide sales for all oncology products are projected to exceed $230B annually by 2024. While, according to a study conducted by the MIT Sloan School of Management, the rate of clinical success, defined as the proportion of trials that result in approval of the drug/therapy under investigation, is estimated to be only 3% for investigational anti-cancer drugs, and 14% overall.
Prior to the pandemic oncology was seen to be both the largest and fastest growing therapeutic area in the clinical trials market, and based on the number of oncology clinical trials currently registered with clintrials.gov this trend holds, with a 6% increase over last year. With innovations in oncology precision medicine, 85% of the oncology market is focused on targeted therapies. In 2020 despite the ‘new normal’ COVID has brought about, there have been 42 FDA Novel Drug approvals so far, 14 of which are for cancer treatment.
While true in number these statistics are unlikely to reflect the full impact of the Covid-19 worldwide outbreak on trial start-up and conduct. With the outbreak, COVID-19 became front-and-center pushing back cancer and other illnesses for months. From an optimistic perspective, the global pandemic is anticipated to pave the way to modernize clinical trials. While at the same time, lags caused by the slowdowns in cancer treatment in worst hit regions during severe pandemic outbreaks increases the urgency for now getting oncology trials to the patients and to the physicians who are caring for them.
In the midst of all this upheaval the attributes Sponsors continue to seek from their clinical trial outsourcing partners remain the same. Quality and reliability are the number one and number two priorities.
Oncology Trial Launch Options – Think Canada First!
Close in geographic and demographic proximity to the U.S., Canada’s average annual number of cancer cases is projected to be 79% higher in 2028–2032 than it was in 2003–2007. While participation by Canadians in oncology clinical trials is 14%. Nearly triple the 5% participation rate in the U.S.
In addition, Canadian cancer patients are funneled through select oncology health centers across the country and will typically receive treatment at the same center throughout the evolution of their disease (1st, 2nd line, 3rd line, etc.). A factor that greatly aids in identification of possible oncology trial participants and in projecting enrollment rates.
And the number of physicians per population has increased in Canada over the past decade, and is expected to continue to increase for the next several years, ensuring a steady wave of new oncologist joining Canada’s research enthusiastic cancer health centers.
It is probably too soon to fully appreciate the impact of the COVID-19 outbreak on our industry, however, Canada has had the good fortune of seeing less disease. As this trend continues, the region is in an excellent position to contribute to oncology trial patient enrollment.
A number of new tools developed to cope with the new normal, and processes adjusted to ensure a high level of quality despite the changing environment were brought about in the region due to the pandemic. Some Canadian sites were early adopters of “new normal” strategies continue to implement them, remain ahead of the curve and are emerging as high performers during the long haul.
2020 in Retrospect – Real World Evidence of High Enrollment with Accelerated Site Activation for Oncology Clinical Trials
In keeping with the targets shared with its Sponsors, 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.
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 they expect 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. And of course, steady and high enrollments rates thanks to the selection of the right sites for your study design, and our team’s ability to engage oncologists and site teams at the highest level. Even under the current pandemic circumstances.
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, this CRO works hard at working smarter every year for over two decades.
Contributed by: Julie Martin, CEO
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Global Pandemic Paves Way to Modernize Clinical Trials. June 2020
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Opportunity in a Crisis: Demographic Inclusion in Clinical Trials. Oct 2020
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