Among its various “souls”, IBSA’s R&D Scientific Affairs department also includes the Data Management & Statistics unit. As Sr. Data Management & Statistics Unit Manager, Arturo Lanzarotti is responsible for coordinating the data management and statistical analysis activities of the clinical studies conducted at IBSA. In this interview, he will give us an insight into his daily work and his role within the company.
Conversation with Arturo Lanzarotti, Sr. Data Management & Statistics Unit Manager at IBSA Group
WE COULD SAY THAT YOUR WORK REVOLVES AROUND CLINICAL STUDIES. CAN YOU TELL US MORE?
For a pharmaceutical company, clinical trials are essential to register new products and keep on the market those already commercialised (the so-called life cycle of products). In clinical studies, the statistical units on which the research is conducted are called clinical case histories, i.e. groups of patients or healthy volunteers who participate in the study with the aim of improving knowledge, therapies and treatments in the biomedical field. The clinical study – whose purpose is to investigate a planned set of objectives – is conducted according to a well-defined scheme, namely the study design.
There are two main types of study designs: the experimental study design (or “clinical trial”) and the observational investigation (or “survey”). The clinical trial requires a statistical plan programmed according to the experimental needs, so that its effects can be observed. In most cases, a clinical trial is adopted in studies aimed at testing a new drug or a new therapy on a particular group of subjects, i.e. patients suffering from a specific disease. In the survey, the researcher is a less active observer, who interferes as little as possible with the phenomena being recorded.
SO: RIGOROUS METHOD, IMPECCABLE ORGANISATION AND… CONSTANT DIGITISATION?
Definitely. The design and conduct of any study implies the need to examine and investigate important medical and clinical issues. In addition to this, clinical studies need to be based on a rigorous statistical methodology, in order for them to provide a clear, correct and quick answer to the research query. In the past, clinical trial data was collected in paper form, and our unit was responsible for entering such data into the system, in order to be able to manage and analyse it. Fortunately today, the “case report forms” used for clinical trials are almost exclusively in electronic format (eCRF). In my unit, we are responsible for the entire flow of data relating to clinical studies, from the design of the data collection form to the management of the data entered by doctors, up to the statistical analysis and the production of reports with the outcomes of the studies. A good percentage of these documents are an integral part of a drug registration dossier, whether it is a drug registered in Europe, in non-EU countries or in the USA.
IBSA’S PILLARS ARE PERSON, INNOVATION, QUALITY AND RESPONSIBILITY. WHICH OF THESE DO YOU FEEL CLOSEST TO YOUR DAILY ACTIVITIES?
The four pillars of IBSA represent values in which our work is fully reflected. In my opinion, the closest to the daily activities of our unit are Responsibility and Innovation. And I mention Responsibility first, since statistics are used to measure the effectiveness and safety of our drugs, and we are fully aware of the need to be rigorous and make the most of the work done by all our colleagues: from those who develop the drug to those from the R&D Scientific Affairs department, who follow the clinical trials with us. Also essential is then Innovation, because ours is a job that makes extensive use of digital tools: data management requires us to always stay up to date and to renew and revise the methods of data collection and analysis.
WHAT ARE THE NEXT CHALLENGES?
Data from clinical trials represent the heart of our activities. In the future, the centrality and quantity of data to be managed will grow even more. Data will increasingly be a value and an asset for our department; we must therefore be able to make it always and easily available and interpretable to all our R&D Scientific Affairs colleagues. Furthermore, I believe that the ability to interact with other company departments will be very important, exploiting also the potential of data other than that from the clinical studies.