Biostatistics
Biostatistics has been the pillar of all clinical trials for centuries. From protocol design to reporting and regulatory submission, M22 has been able to make use of the dedicated team and expert biostatistics resources to help our clients get the drug to the market in the most reliable and relatively efficient way through the following:
Study Design and Protocol Development
From phase I and II early-phase dose-finding safety and efficacy studies, PK/ PD to large multicenter phase II and III trials, M22 is ever ready to fully support and provide the best solution through expert biostatistical services to help with the design and clinical development of the protocol including the IND submission. From parallel arm trial, factorial, group sequential, cross over, adaptive, sequential parallel comparison and stepped wedge designs, M22 will consider the outcomes/endpoints line by line and make clarifications in line with the objectives, hypotheses among others for an optimal choice of a design, as well as the best choice of the most relevant and up-to-date statistical methodology for the analyses of the study endpoints. M22 expert Biostatisticians will provide adequate drilling on the limitations and trade-off regarding early stopping rules (O’Brien-Fleming, Pocock, Haybittle-Peto and Lan-DeMets) as well as the conditional power approaches based on the information fractions and make the best choice for your protocol if you consider stopping the trial early.
Sample Size/Power Calculations
During the planning stages of a clinical study, M22 will work with you to provide the optimal number of subjects and power that best reflect the design of your study. By taking all odds into account, M22 will run extensive simulations for precision analysis giving enough room for unforeseen circumstances at the interim if needed including sample size recalculation and alpha spending to ensure the trial is adequately powered throughout. The challenges with orphan and rare diseases are well handled by our expect Biostatisticians through the application of Bayesian methods.
Randomization Schemes/Treatment Allocations
Our expert Biostatisticians provide amazing services to help in the development of the randomization plans and the creation of the treatment allocation table to minimize the variability of the parameter of interest and avoid confounding from other factors using suitable software. Depending on the protocol requirements, any of the simple, block (sizes of 4 and 6), stratified as well as adaptive randomization can be used to ensure a perfect balance and bias reduction.
Statistical Analysis Plan (SAP)
Biostatisticians at M22 have led over hundreds of clinical trials including regulatory submissions to FDA-USA, Health Canada, NMPA-China, PMDA-Japan and EMA-EU. With amazing experience in writing SAPs, M22 is the ultimate solution for the best SAP including tables, listings and figure shells (TLFs), to meet the protocol requirements. M22 believe in the current and up-to-date statistical methods including regulatory guidance on multiplicity issues, control of interim alpha as well as subgroup analysis. M22 expert Biostatisticians have written SAPs in different areas such as meta-analysis, ISS/ISE analysis, interim analysis, final data analysis, post-hoc, PK/PD, manuscripts and DSMB for data and safety monitoring.
Data and Safety Monitoring Board (DSMB)
Biostatisticians at M22 have the relevant and expert knowledge, skills and amazing experience and involvement in Data and Safety Monitoring Board (DSMB) or Data and Safety Monitoring Committee (DSMC) meetings. M22 team will provide quality and relatively efficient services to assist the committee or board members do their job well throughout the trial by drafting the Charter, preparing open and closed reports from the blinded and un-blinded data, presenting the closed reports during the DSMB meetings, answering questions and making clarifications to the committee members, effective documentation of minutes and distribution through secured platforms.
Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
With the amazing experience and expertise from our Biostatistics team, your trial is fully supported to go through regulatory submission through the preparation of ISS and ISE. The M22 team is ever ready to prepare the SAP and TLFs for ISS/ISE, develop the data specification plan and implementation for the pooling of the safety and efficacy data across multiple studies and prepare the integrated safety and efficacy tables, listings, and figures. At the minimum, we help our clients to identify common related AEs and SAEs, subgroup related safety and efficacy profiles, validate secondary and exploratory outcomes, inconsistencies in estimates including sensitivity analysis across multiple studies.