Programming issues in oncology trials

Programming issues in oncology trials

Oncology trials are complex and require a different approach to trials compared with many other therapeutic areas and can generate significant programming challenges.

Oncology can be associated with fast developing disease and short survival times. Due to the fact that many oncology trials are event-driven, the timelines and resources are regularly reviewed and updated. In earlier phase oncology trials, there are frequent data reviews to assess for safety and/or efficacy, which can present challenges in the planning and delivery of programming tasks. Standards programs are often developed so that they can be used across different studies, and re-used across multiple deliveries. This helps reducing the programming time on each study and therefore meeting the tight timelines specific to the oncology therapeutic area. Close collaboration between programmers, data managers and clinicians is required to ensure data issues are promptly resolved.

Clinical oncology trials are also more complex than those in other therapeutic area. The design is often more complicated, with additional data being collected such as quality of life questionnaires, genetic and biomarkers data. Analyses performed are often more specific to this therapeutic area. Therefore, the datasets can be quite complex and below are some examples of the biggest programming challenges.

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CRM in Phase 1 Oncology trials

Use of the Continual Reassessment Method (CRM) in phase 1 oncology trials

By Gareth James, Senior Statistician, PHASTAR

The purpose of a phase I clinical trial is to determine the recommended dose for further testing whilst minimising the number of patients used and preserving safety. Oncology trials are different to those for other indications as patients have metastatic disease and have exhausted other treatment options. It is therefore important to minimise allocation to toxic and sub-optimal doses.

The 3+3 method is the most common dose-escalation design, with over 96% of phase I studies using this method, but it is not statistically efficient as it does not use all available data to recommend the next dose level to allocate. Approximately 100 publications have demonstrated the advantages of using model based methods such as the CRM compared to the 3+3 method. This included reducing the number of patients allocated to toxic and sub-optimal doses, and identifying the true maximum tolerated dose (MTD) more frequently, which would reduce the likelihood of making a costly and potentially unsafe decision.

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Data Management

PHASTAR adds Data Management

By mutual agreement, PHASTAR are pleased to announce the acquisition of Exp-e-Data, an established provider of clinical data management services, to complement our current set of statistics, programming and medical writing offerings. PHASTAR and Exp-e-Data have successfully partnered on many projects for a number of years. Together, we can enhance the services to our customers due to the complementary nature of our companies, building on our shared philosophy, which is to ensure that the work we produce is of optimal quality: every project is supervised on methodology and utilises unique internal processes designed to ensure the highest standards.

The strong working relationships and team bonds forged between both companies over the years have led us to joining forces as a single company so we can grow in a seamless way whilst continuing to deliver a quality service that is ahead of our competitors.

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ASCO 2016

Highlights from this year's conference

The American Society of Clinical Oncology (ASCO) held its annual mega-conference in Chicago, IL this year. With more than 30,000 participants it is the largest international oncology conference. Every year the ASCO meeting takes the measure of the development in cancer research. This year was no exception. The volume of results was truly staggering. There were several important updates that have bearing on the direction of oncology therapeutics.  

Last year's revolutionary advance "Immunotherapy" had many important updates this year. Many of the presentations on Immunotherapy focused on combining Immunotherapies with other cancer treatments. Success of this approach varied but there were some successes particularly in inhibiting tumor growth. Several important updates to which tumors that are susceptible to an immunotherapeutic approach were presented. Genetic data from a range of tumor types pointed to bladder and bowel cancer as good targets although Dr Jedd Wolchock, from the Memorial Sloan Kettering Cancer Center in New York, cautioned during a high-profile immunotherapy session that the approach “is going to take some tinkering before we know what will work for each patient”.

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PHASTAR attending ASCO 2016 meeting

PHASTAR are attending the ASCO annual meeting, which brings together 30,000 oncology professionals from around the world. Educational sessions feature world-renowned faculty discussing state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.

Clinical studies in oncology have a variety of statistical issues that need to be considered in their design and analysis:

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