This blog post is authored by Valérie André, Principal Research Scientist – Oncology European Statistics, Eli Lilly and Company, France
As many in research will attest, correlation is not causation so interpreting data must be done with discipline and care. In the era of big data, knowledge generation and sharing becomes that much more relevant. This is my challenge as a Clinical Statistician, working as part of the clinical development teams to design and interpret oncology clinical trials. Cancer is not a single disease, it is a set of diseases that despite sharing the common characteristic of uncontrolled growth of cells, needs a tailored approach to treatment. Therefore, design and interpretation of clinical trials is key to advance the science.
Lilly’s commitment from the lab to the bedside of advancing the quality of life for patients and their families living with cancer is stronger than ever. And I am part of this cycle inside Lilly. An important part of my job is to contribute to study designs, ensuring that proposed studies enable the development team to answer key scientific questions on investigational drugs - for example dose, safety and efficacy. We also analyse the clinical trial data and help the team to interpret the results. Our work aims to provide the right analyses and the best summary or visual representation of our clinical data to regulators and payers with the ultimate goal of helping cancer patients.
Oncology is a constantly changing field where treatment options are improving significantly. But many more leaps forward are needed if we hope to turn more cancers into curable diseases. For that to happen, statisticians are helping to find novel endpoints to evaluate the next generation of cancer therapies. Our goal is to turn data into knowledge that can then be used to advance the science and develop new medicines. This will not only help us to successfully take the medicines through the regulatory and HTA processes, making them available to patients around the world, but also to optimise safety and efficacy standards after they reach the patient and to learn from their experiences.
Behind every big discovery, every breakthrough, lies the relentless effort of a whole team. Statisticians help design a clinical trial to assess and capture the benefit of a molecule, and help the clinical development team translate figures into what hope has been created for - delivering a longer, better life with and after cancer.