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Research Principles @BIG

Intro text: 

By bringing together world class experts to collaborate on pioneering breast cancer research at the international level, BIG offers the guarantee to conduct innovative research, asking the most relevant scientific questions and designing the best clinical trials to serve patients’ needs.

BIG follows strict principles of research conduct that aim to eliminate bias from the research process and to maintain integrity vis-à-vis patients. This is the case both when BIG partners with pharmaceutical companies as well as when BIG works alone. BIG ensures that data collected is handled and analysed independently. Moreover, all BIG studies are governed by committees and policies embodying scientific independence and designed to safeguard patient interests at every step of the way.

When conducting, or participating in clinical trials or research programmes under the BIG umbrella, BIG Members agree to adhere to BIG’s Principles of Research Conduct.

BIG provides a platform for Member groups to:

combine resources and expertise to conduct research that will optimally serve patients

• establish clinical and translational research priorities

reduce the unnecessary duplication of efforts

• obtain credible study results more quickly

• develop models of collaboration with the industry that preserve scientific independence

This unique form of collaboration under the BIG umbrella offers a win-win situation for all the partners involved. Next to reducing costs and unnecessary duplication of efforts, it offers the possibility to discuss research issues with breast cancer opinion leaders from over 50 different research groups, spread over the 7 continents. The network also guarantees faster accrual, especially in niche patient populations and, thus, faster responses to the study questions.

Our collaborative approach ensures faster development of effective treatments, and ultimately better treatments and a higher likelihood of cures for patients. Together, we will find a cure.

BIG trials anticipate the future

BIG trials anticipate the future, collecting biospecimens for translational research to help us identify the treatments most suited to each individual patient. Translational research is conducted using biological samples (such as tumour tissue or blood) collected in the context of BIG trials from patients who have consented to their use, either for specific projects, or for yet undefined future research. The collected biological samples are maintained in qualified biorepositories, which in general are independent from the partners involved in running a specific clinical trial. At a specific point in time, these samples – as well as clinical and other data collected over the course of a trial – are made available to scientists from around the world, both from within and outside of the BIG network.

All translational research project proposals are carefully reviewed and prioritised by qualified experts and are approved by the steering committees of the respective trials. This process ensures the best use of precious biological materials and gives the best hope for rapid discoveries that can lead to better treatments for individual patients.

The BIG Biomaterials Inventory was created with support from the Breast Cancer Research Foundation (BCRF) / University of Michigan and aims to provide a detailed summary of which materials have been collected for translational research purposes in the context of BIG clinical trials. The inventory therefore serves as a resource for researchers who may wish to access such samples.