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Re-Randomization Tests in Equivalence Trials: Can We Still Use Them?

Statistical Consultancy Team

Randomization is widely acknowledged to be one of the more, if not the most, important parts of a properly planned and designed clinical trial. Flaws at a randomization level might lead to systematic imbalances in the allocation of patients to treatment groups, ultimately resulting in a lack of control of the overall type I error (i.e.: the pre-specified α level used as a reference for hypothesis testing). Whilst generation of randomization lists based on ‘static’ algorithms (e.g. stratified algorithms) is a relatively easy and standard process that can be done using standard software, a new type of method, that we’ll refer to as ‘dynamic’ randomization, is also increasingly used. This requires more complex algorithms to be embedded in the Interactive Web Response System (IWRS) integrated with the study database. The reason for this is that whilst with common algorithms the list of treatment allocations is fully determined a priori, i.e.: before we know the characteristic of the subjects that will be randomized, dynamic methods generate the randomization list case-wise, that is only when a new patients come in, using minimization algorithms to make sure that the groups are balanced with respect to specific characteristics not only when all subjects have been recruited, but during the whole recruitment process.

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Topics: Phase I Studies, Phase 2 Studies, Phase 3 Studies, Phase 4 Studies, Re-Randomization, Equivalence Trial, Superiority Trial, Re-Randomization Test, Randomization

FDA Guidance for Human Gene Therapy for Hemophilia A & B

Statistical Consultancy Team

Having seen an increasing number of gene therapy approvals, the FDA has issued draft guidance1 to help the developers of human gene therapy (GT) products for the treatment of hemophilia A & B.  In this article we will be focusing our attention on what guidance has been provided about the design of human gene therapy clinical trials for hemophilia A & B, including what is needed to support an accelerated approval approach. 

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Topics: rare diseases, Clinical Trials, FDA, hemophilia, Statistical Consultancy, Phase I Studies, Phase 2 Studies, Phase 3 Studies, Phase 4 Studies, Regulatory Requirements, Clinical Study Design, Additional Monitoring

A Guide to Phase 1 Clinical Trial Designs

Statistical Consultancy Team

The primary aims of Phase 1 Clinical Trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound. Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug-drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Phase I Study Design, Clinical Trial Phases, Bioequivalence, Drug-drug Interaction, Bioavailability, Phase 3 Studies, Peadiatric Assessments

Integrated Summaries of Safety & Efficacy for Regulatory Submissions

Statistical Consultancy Team

Far from being simply a summary of individual results, a comprehensive and detailed summary allows companies to make informed decisions. Producing comprehensive integrated summaries of safety and efficacy is a critical stage of the submission life cycle. These need to be designed and planned carefully in advance to ensure informed decision-making and effectiveness at the regulatory interface. A focus on the approval and whole lifecycle of the product, and not just the submission, will influence the quality and direction of the content. Traceability is key in all respects of the creation of information, from data that leads to knowledgeable decisions and the ultimate wisdom that forms the label of a product.

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Topics: ISS/ISE, Integrated Summaries, Phase 2 Studies, Phase 3 Studies, Regulatory Requirements, FDA, Medical Writing, Statistics, Biostatistics Consulting

Electronic Data Capture Systems In Clinical Data Management: The myths and the reality

Clear Clinica

This post is a guest blog written by David Tashjian from Clear Clinica. The views and opinions in this post are not representative of Quanticate. By publishing Guest blog posts it does not imply Quanticate has a working relationship with any companies associated with a post and we are happy to receive guest blogs from any industry related company.

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Topics: Phase 3 Studies, Clinical Data Management, Electronic Data Capture, Paper-Based Studies, Case Report Form (CRF), Clinical Data Storage

The Different Phases of Clinical Trials

Medical Writing Team

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans.  These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years.  Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Pre-Clinical Study, Clinical Trial Phases, Phase 3 Studies, Phase 4 Studies, Phase 2 Studies

Comparing treatment response curves: a practical example in rheumatoid arthritis

Statistical Consultancy Team

Nowadays, more and more studies are being designed to collect information on treatment response at several time points during the treatment period of the study. Although the primary endpoint is often the comparison at the end of the study of the absolute response or of the change to baseline between study treatments, analyses involving intermediate time points in the assessment of treatment effects, e.g., repeated measures modeling, are now widely used.

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Topics: Programming R, SAS Programming, Therapeutic Areas, Biostatistics Consulting, Phase 3 Studies, Rheumatoid Arthritis (RA), PROC NLMIXED, PROC IML

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Statistical Consultancy Team

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

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