MTEK Sciences is a bespoke global health research firm specializing in highly-efficient clinical study designs and biostatistical methods. They founded MTEK Sciences with the belief that true innovation is best fostered in a place where neither profits, political power nor pressure to publish is the key motivating factor. Their primary investigators and senior scientists have their roots in both academia and industry, and together with their researchers, make up a dedicated and proficient multi-disciplinary team.
Having been involved with over 200 trials and mega-cohort studies, they are passionate about removing the technical and bureaucratic inefficiencies that often exist in modern day clinical trials. They fundamentally believe most clinical trials should be of perpetual nature, recruiting patients to multiple arms, dropping treatments when evidence is firm enough to suggest non-superiority and adding new treatments naturally rather than having to set up a separate trial. They are passionate about innovating statistical methodology that facilitate such improvements to trials internally, or allow for better use of external data when planning and adapting clinical trials.
MTEK Sciences specializes in innovative and highly-efficient clinical study designs and biostatistical methods, providing such services as statistical simulations, interim analyses, and perpetual studies.
Highly Efficient Clinical Trial (HECT) design and simulations
Clinical trials are large investments. There is an important need to minimize costs, reduce the number of participants included, and arrive at a reliable answer as fast as possible. Preliminary statistical simulations can substantially help gauge the likelihood of success and failure with multiple candidate designs. Whether adaptive, group sequential, or conventional design; phase II, III, IV, seamless or perpetual; their team of clinical epidemiologists and biostatisticians can help ensure a better likelihood of achieving an answer quickly and minimizing your investment for your clinical trial. They call this Highly Efficient Clinical Trials (HECT) and believe it represents a paradigm shift in clinical trials.
Clinical trial independent interim analysis
Clinical trials with interim analyses commonly require an independent third party to run interim analyses that will objectively inform the data safety monitoring board (DSMB). With a wealth of experience in design and analysis of clinical trials, they understand what outputs are required at interim analysis for efficient interim decisions. Their primary investigators have sat on data safety monitoring boards over the years and represented clinical trials at major agencies including the US Food and Drug Administration (FDA), Canadian Agency for Health Technology & Assessment (CADTH), and the European Medicines Agency (EMA). They can help design the content and outputs of clinical trial interim analysis or perform the interim analysis as an independent third party.
Perpetual large-scale real-world studies
Like any clinical study, large-scale real-world studies, whether epidemiological cohort or nationwide surveys, require rigorous planning. Even more challenging is the widespread utilization of data from such studies (beyond simply confirming a few associations and producing a journal article). Having led many large-scale cohort studies around the world, their primary investigators specialize in ensuring a perpetual nature of large scale epidemiological studies, that is a dynamic structured data collection that ensures the feasibly most up-to-date evidence is always available to relevant decision-makers. In this setting, they work closely with stakeholders to continually ensure optimal uptake, whether via training, graphical user interfaces or optimization of performance indicators and analytic outputs.
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