Ensuring exceptional service delivery for partners in academia

Alongside projects in the pharmaceutical industry, Frontier Science Scotland (FSS) has contributed to projects in academia since 2002. We’ve partnered with academic organisations across the world to provide services in data management, biostatistics, quality assurance and management, and more.

Academic projects usually involve investigators who work in academic or clinical settings to answer research questions.

“These investigators are typically clinicians who have recruited patients to the parent regulated industry study and have gotten permission to access the trial data to answer additional research questions,

Dr Shona Fielding, Head of Biostatistics at FSS.

With 20+ years in the sector – including research and senior lecturer positions at the University of Aberdeen – Shona leads the Biostatistics, which consists of 11 people and two sub-teams: ‘Statistics’ and ‘Programming’. They work in tandem to conduct statistical analyses for clinical trials, as well as other associated research projects.

Combined with the company culture and our deep-rooted experience, FSS partners benefit from the team’s extensive knowledge to provide worldwide expert statistical consultancy – ultimately leading to the delivery of high-quality datasets and statistical analyses.

A process for partners in academia

From aims and values to data collection methods, every client has specific needs for their research project. The agile FSS team amalgamates these with our rigorous research process to retain the quality standards our clients come to us for.

“For some projects, we liaise with the academic investigators to provide the data they need for them to take on the analysis. For others, we liaise with investigators regarding their needs for the project. Then, we undertake the statistical analysis for them, and then contribute to the write-up for journal publications,” says Shona.

“Some can be relatively straightforward statistical methods, others can be more challenging and may involve learning a new statistical technique.”

For research projects related to our sponsored regulated studies – including APHINITY, ALTTO and Neo-ALTTO – academic projects typically begin with an approval process overseen by an external partner, or multiple external partners, to maintain objectivity.

“Once approved, we begin discussions with the investigator,” says Shona.

Next steps change depending on the tasks required.

“If we are providing data only, we aim to do that within a month of agreeing on the required variables. If we are analysing, then I assign a statistician, and they take it forward with the investigators. They will agree on what needs to be done, the statistician will create a statistical analysis plan, consult with investigators and embark on the SAS programming needed for the project.”

Draft outputs – in the form of tables and graphs, for example – are created and shared through a secure portal with the client and relevant partners. From this, the investigator writes a conference abstract or journal submission; we help to review these and agree on the final steps.

A recipe for strong partnerships

Communication and timely responsiveness are the two key factors that Shona attributes to smooth collaborations with clients. Establishing strong communication from the start is essential.

For Shona, a recent project that encompasses this is APH017, which looked at the impact of age on the clinical outcomes within the APHINITY trial. Results from the trial, published in the Journal of National Cancer Institute, demonstrated that young age does not provide any prognostic value in determining outcomes for patients with HER2-positive breast cancer.

To maximise project efficacy, Shona and the lead investigator ensured robust communication throughout.

“We had some initial meetings to establish what was required and kept in communication over email, with additional calls as needed,” she says. “If I had questions, the lead investigator was quick to respond to help keep the project moving forward. And I aimed to do the same.”

Our customers benefit from our intricate familiarity with industry studies, thanks to our long-established experience in research analysis.

“We are best placed to help figure out which data are available for the project. We have the statistical knowledge and the client provides the clinical knowledge,” she says.

Do you have a project in academia?

Get in touch to discover how we can assist your project needs today.

Publications on Aphinity, ALlto and Neo-Allto trials

APHINITY | European Journal of Cancer (EJC)

APHINITY | European Journal of Cancer (EJC)

Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial

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APHINITY | AACR Cancer Research

APHINITY | AACR Cancer Research

Effect of young age at diagnosis on clinical outcomes and efficacy of anti-HER2 targeted therapy in patients with HER2-positive early breast cancer: Results from the APHINITY trial.

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The APHINITY Trial: Results of the Primary Analysis

The APHINITY Trial: Results of the Primary Analysis

An article published in the New England Journal of Medicine (NEJM) reports that pertuzumab, when added to chemotherapy and trastuzumab, significantly improved the rates of invasive-disease–free survival among patients with HER2-positive early breast cancer.

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The ALTTO Trial: Results of the Primary Analysis

The ALTTO Trial: Results of the Primary Analysis

An article in the JCO reports that adjuvant treatment that includes lapatinib did not significantly improve Disease-Free Survival compared with trastuzmab alone and added toxicity. One year of adjuvant trastuzumab remains standard of care.

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Frontier Science Scotland provides adaptable solutions across data management and biostatistics for clinical trials. To find out more, get in touch.

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