Reviewing and Updating the Statistical Analysis Plan and Creating Mock Shells as Part of the Phastar CARES Scheme

Phastar is providing pro-bono support to Medicines Development for Global Health (MDGH) as part of its Phastar CARES scheme. Phastar’s biometrics experts supported the statistical analysis plan (SAP) updates for two related studies on the treatment of onchocerciasis.

Study details

MDGH, a not for profit biopharmaceutical organization developing medicines for neglected diseases primarily affecting people living in poverty, is running two related studies examining the safety and efficacy of moxidectin as a treatment for onchocerciasis (also known as river blindness).

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‘Upskilling’ Your Workforce to Keep Pace with Change

Originally published in Applied Clinial Trials.

The DCT-driven evolution requires new levels of understanding and expertise.

With the transformation in the way data are generated, collected, and analyzed, clinical trials are evolving at a faster rate than ever before—along with the professional roles that support them.

It means that for those who are willing to develop the necessary new skillsets and mindsets, there are a wealth of opportunities on the horizon. In this article, we examine such synergies in this evolving clinical trial landscape, and explain why individuals in all roles need to continually build their understanding of this new paradigm. After all, it’s everyone’s responsibility to “upskill” the clinical research workforce.

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Super Models: How to Realise the Full Potential of Functional Service Provider Roles

Image of Elisa Mansfield, VP of FSP at Phastar

Originally published in PharmaTimes Magazine.

Sponsors are facing increasing costs, continued patient recruitment challenges, and huge changes in how clinical trial data is collected and monitored.

This is driving demand for more flexible approaches that deliver the ability to engage expert services when and where they are needed.

Sponsors are increasingly complementing the traditional full-service contract research organisation (CRO) model, for example, with the functional service provider (FSP) approach. In 2020, large biopharma companies’ use of FSP was growing at more than 13% a year.

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Data Monitoring and Complex Clinical Trials: Toward a Solution

Originally published in ACRP Clinical Researcher.

Complex trial designs may be more efficient than the traditional two-group model, but they also present important data monitoring challenges.

Standard one-size-fits-all approaches to evaluating accumulating data are not feasible when working with multiple variables, whether they be multiple endpoints, multiple treatments, or both. Ensuring a robust framework upon which to base stop/go calculations is essential to protecting participant safety whilst accelerating access to life-changing new treatments. The weight of responsibility carried by data monitoring committees (DMCs) is not insignificant, so it is important that these complexities are worked through.

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