Biostatistics for Non-Statisticians in Pharma and Medtech

Who will Benefit:

Following titles and departments who are involved with the statistical aspect of clinical trials, in order of bio-statistic’s will be benefited by attending this seminar:

• Departments: Clinical, Regulatory, R&D, Marketing
• Clinical Titles: Medical Director, Director of Clinical Affairs, VP Clinical, Clinical Manager, Clinical Department Manager, Clinical Project Manager, Clinical Staff, CRA (Clinical Research Associate), Study Coordinator
• Regulatory Titles: VP Regulatory Affairs, Manager of Regulatory Affairs, Regulatory Scientist
• R&D Titles: Director of R&D, VP R&D, R&D Project Manager, Engineers, Quality Engineer, Algorithm Developer

Attend this seminar to mitigate below risks:

Stat for device submissions for non-statisticians: Not being exposed to the information in this course is likely to lead to inefficient, and perhaps even erroneous, interactions with FDA. This can result in various difficulties such as:

• Being asked by FDA to meet harsher criteria than might have been needed, thus reducing Company’s chance for success
• Needing a much larger sample size than if the correct approach was used
• Specifying inefficient statistical analyses that reduce a trial’s chance for success (for example, running a clinical trial that does not deal efficiently with missing values)

Bio-statistics for non-statisticians: Not being conversant in statistics means that the staff member cannot understand basic concepts in clinical trials such as endpoint selection, trial sample size and trial length. Not knowing how to deal with these issues can cause a company a great deal of damage in terms of inefficient product development (costly in terms of both time and money), inefficient trial design, and erroneous interactions with statisticians. All these can lead to inefficient product development and regulatory submission and even failure:

• Almost everyone in the clinical, regulatory and R&D departments should be familiar to one degree or another with bio-statistics. It is the language of regulatory submissions, study design and accounts for much that is presented to FDA (and all regulators) in the clinical study report (CSR). The CSR is the final clinical trial document presented to FDA when submitting a product for approval. Company staff must be at least conversant in bio-statistics so that they can:
• Interact intelligently and efficiently with company statisticians, most of whom are subcontracted (i.e. not part of the organization)
• Be able to audit the statistician’s decisions
• Understand what competitors have done to demonstrate their product works to both regulator and the market
• Assist physicians, who are typically clinically oriented, to think in terms of the research needed for bringing a product to market

Efficient Design for non-statisticians:Designing inefficient trials will, at best, cause unnecessary costs in terms of both time and money and, at worst, produce study failure. Additionally, inefficient trial design can cause studies to be rejected by regulators and/or scientific journals. When the former is the case, product failure is almost ensured; when the latter, company’s marketing efforts will be greatly damaged.