Services from KJC Statistics

Protocol Development and Clinical Trial Design

While poor statistical analyses can often be salvaged by applying more appropriate methodology, poor clinical program and trial design can be a lot more damaging.   KJC Statistics will help and support you to get your clinical program and trial designs right first time to best meet the goals of your Target Product Profile.

Sample size and power

Ensuring clinical studies are correctly sized is essential to secure a conclusive result. Equally, studies that are oversized versus strategic intent can cost needlessly in both dollars and time.  KJC Statistics will work with you to strike the best balance between size, power and cost for you and your project.

Expert Statistical representation at regulatory authority meetings

With extensive experience representing statistical and drug development issues to regulatory authorities worldwide, including the US FDA, Japanese (MHLW), UK (MHRA), Canadian (Health Canada), German (BfArM), Sweden (MPA), Spanish (AEMPS), French (AFSSAPS), Dutch (MEB), Australian (TGA) and Swiss (SwissMedic), KJC Statistics can offer truly experienced support to help secure a successful regulatory interaction for your project.

Support preparing for FDA Advisory Committee meetings and EU Oral Explanations including statistical speaker & Q/A training

In addition to supporting health authority meetings, KJC Statistics has unique industry statistical experience in directly presenting critical data and scientific issues at multiple FDA Advisory Committee meetings as well as experience with MHLW Open Public Hearings and EU Oral hearings.   As part of supporting your project through these very challenging meetings, KJC Statistics can further offer critical speaker training and Q/A preparation to put you and your team in the best possible shape to succeed.

Statistical input to preparation of regulatory briefing materials

Careful and concise wording of regulatory background briefing materials and questions to the authorities is essential to get your ideas and proposals across and pave the way for productive face-to-face interactions. KJC Statistics has extensive experience writing, reviewing and shaping regulatory meeting briefing materials.

New drug regulatory dossier compilation and submissions

KJC Statistics has wide experience in providing statistical project leadership to the compilation and shaping of new product license dossiers for submission to FDA, EMA and worldwide. KJC Statistics can provide high calibre statistical input to deliver regulatory submission documentation of the highest scientific quality and persuasiveness.

Adaptive Trial Designs

Adaptive designs carry high expectations of delivering more efficient and effective drug development decision making.  However, these designs can sometimes be technically very complex and confusing to the non-statistician.  Consequently they require experienced handling, especially if employed in late stage development and decision making.  KJC Statistics has hands-on experience of practical adaptive trial design including successful interactions with FDA and other regulatory authorities on their use in supporting drug approval and labelling.  KJC Statistics can help de-mystify adaptive designs and construct the best adaptive design relative to your development goals and budget.

Efficient Phase II Trial Design For Decision Making

Phase II results are critical in the decision to proceed, or not, to further large scale Phase III investment.  A key focus of Phase II design and planning should therefore be effective decision making.  KJC Statistics can help guide you towards efficient Phase II designs for critical decision making.

Statistical Analysis Plans

Pre-defining your approach to clinical trial data summary and analysis is essential.  KJC statistics can assist you in preparing high quality SAPs for your clinical trials and trial programmes.

Statistical Data Analysis

KJC Statistics offers broad experience in clinical trial data analysis, from linear mixed effects modelling to survival analyses, meta-analyses, non-parametric methods and beyond.  Further, with increasing transparency and data availability, exploratory analysis methodologies are also offered.

Meta Analyses and Rare Event Meta-Analyses

Aggregation of data across trials is often necessary to better appreciate the true effect of treatment.  KJC Statistics has broad experience of meta-analyses and meta-analytic methodologies, including fixed and random effect approaches, risk difference and risk ratio approaches, exact methods and tricky rare event meta-analyses where there are often trials with no events.

Bayesian Data Analysis

Bayesian data analysis can be useful in many areas including, but not limited to, decision making, non-inferiority trial design and analysis, exploratory subset analyses, multi-regional trial analysis and rare event meta-analyses.  KJC Statistics can help guide you in terms of the opportunities for helpful Bayesian analyses in your project.

PK/PD Modelling

Understanding the relationship between exposure and effect is often crucial in determining the most appropriate dose to take forward into later stages of development.  KJC Statistics has experience with non-linear mixed effects PK-PD modelling to help you to better understand your data and dose-response.

Expert IDMC Statistician

KJC Statistics offers a high level of technical expertise and experience both as a Statistical Expert member and as Chairperson of multiple Independent Data Monitoring Committees.

Due Diligence of Critical Trial Data and Critique of Proposed Clinical Programme Design

In-licensing represents a major investment decision for your company.  Often timelines to make a deal are very tight, squeezing into a narrow window the time available to complete critical due-diligence activities.  KJC Statistics has deep experience of time pressured clinical due diligence assessment and what critical items to examine and stones to turn over in the limited time available.  In this way, KJC Statistics will help you and your company to make the right, fully informed decision to invest or not.

Statistical Expertise to Pharma and Biotech Equity Research Service Providers

Equity Research Service companies provide institutional investors with research into the likely performance of Pharma and Biotech equities. This work can benefit markedly from expert statistical input and insight into the design of critical, ongoing development programs and clinical trials. KJC statistics has rare-to-find experience in the provision of such support.

KJC statistics has experience as an Expert Witness in Patent Dispute cases, providing simple explanations of complex statistical issues to aid the Court in their deliberations.

Statistical Training Services

Dr. Kevin J Carroll is pleased to offer a range of practical, tailored training courses to statisticians and non-statisticians in a number of important areas including:

• Survival Analysis
• Practical Adaptive Design
  • Phase II/III dose selection design
  • Adaptive dose ranging design
  • Phase II/III sample size re-estimation design
  • Phase II/III patient sub-population selection design
  • Phase II/III futility design
• Practical Phase II trial design for decision making
• Interim analyses and Group Sequential Designs
• Independent Data Monitoring Committees
• Binary and Ordered categorical data analysis
• Clinical trials simulation
• Large ‘Outcomes’ trial design
• MCRT trial design and analysis
• Meta-analyses
• Sample sizing methodology
• Courses for non-statisticians such as global development leaders, physicians, medical communications scientist and project leaders are typically aimed towards an appreciation of statistical thinking and principles as applied to drug development and drug regulation rather than nuts-and-bolts statistics teaching.