Summary from Annual Symposium of Clinical Outsourcing Strategies 2016, Brussels
PHASTAR attended the 4th Annual Symposium Of Clinical Outsourcing Strategies in Brussels on 20th to 21st October 2016. The conference provided an excellent platform for both pharma and small, medium or large CROs to assess the current challenges associated with Clinical Trial Outsourcing and Clinical Operations. The agenda covered various interesting topics such as Risk Based Monitoring, understanding regulatory requirements for the development of paediatric studies, providing businesses with realistic budgeting requirements for the outsourcing of clinical trials, solutions to help with site selection and monitoring and optimising successful long-term relationships with CRO providers.
Data Management Technologies and Directives
These are exciting times in Data Management. In recent years new technologies and directives have induced a subtle change in the role of a Data Manager. The raison dâ€™etre for Data Managers has always been the delivery of high quality data thereby ensuring the validity and integrity of the statistical results. With the advent of CDISC standards, EDC and ePRO and sponsors adopting a Risk- Based Monitoring approach, the role of the Data Manger as an interface with clinical and statistical programming teams has never been more crucial or diverse.
Data collection in accordance with CDASH initiatives means we have the tools to streamline our processes by standardising the definitions for the data that is collected over multiple studies facilitating easier transformation to SDTM for submissions. Working with the programming team on the challenges of implementing CDASH (it's by no means a one-size fits all solution) brings an understanding across roles) what's good for SDTM does not always fit the bill for good eCRF design and optimal data collection - or abide by the flow of the Protocol. In these situations, additional mapping may be needed to create the final SDTM compliant datasets. This essential understanding of the starting point to endpoint has promoted lively discussions and ensured all needs are met in the most efficient way.
SAS Art Competition 2016 - Open to all
Statistical issues in oncology trials
A key issue in assessing the efficacy of new drugs in oncology is getting the balance right between choosing a hard endpoint survival - and an endpoint that allows evidence to be assessed more quickly progression. Often discussions such as these are required after interactions with regulatory agencies. Progression free survival is used in many studies to assess whether drugs are providing benefit, but it comes with difficulties in analysis and interpretation. In any survival analysis (what we call any "time to-event" analysis), the statistician needs to decide on censoring â€“ patients who "run out" of data. One of the fundamental assumptions in survival analysis is that the censoring is unrelated to the survival times. If a treatment works then you'd hope for longer survival times in one treatment group. If more patients, or more of a certain type of patients, on one of the treatment groups are censored, then this assumption will not hold.
One of the main points of contention relates to handling patients who stop randomised therapy and start a new therapy while on the study. Should these patients be censored or not? There is a good chance that patients who are changing therapies are not doing well on their current therapy, either for safety or efficacy reasons. If the patient is censored, then the negative information about the treatment is ignored, and it's very likely that a bias will be introduced in the analysis, with resultant incorrect estimates of treatment effect. Recently, in a PhRMA sponsored study, it was found that anything other than a strict intent to treat analysis introduces bias. To avoid bias, patients should be followed up until progression, irrespective of whether they remain on the treatment being studied.