{"id":796,"date":"2020-03-11T15:05:15","date_gmt":"2020-03-11T15:05:15","guid":{"rendered":"https:\/\/www.almacgroup.com\/diagnostics\/?page_id=796"},"modified":"2023-02-24T10:56:07","modified_gmt":"2023-02-24T10:56:07","slug":"biostatistics","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/biostatistics\/","title":{"rendered":"Biostatistics"},"content":{"rendered":"\n

Biostatistics <\/h3>\n\n\n\n

The Biostatistics Team offer a rare combination of statistical and genetic expertise, providing clients with optimal strategies and solutions in the molecular diagnostics field.<\/strong>  Our biostatisticians are available from early stage assay design to late clinical assessment, and have excellent knowledge of the current regulatory recommendations and guidelines. <\/p>\n\n\n\n

Much more than a traditional group of analysts, our biostatistics team help ensure that the assay meets client\u2019s exact customised needs, that studies are designed to ensure success while minimising cost, and that the right analyses will be chosen to facilitate appropriate characterisation of the assay.<\/p>\n\n\n\n

To find out more on each of our biostatistical methodologies, select the appropriate drop-down below:<\/strong><\/p>\n\n\n\n

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Design – Early Clinical<\/strong><\/h4>\n\t\t\t\t\t\t
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Multivariate Statistical Learning<\/strong><\/p>\n

While it is always hoped that the trait of interest (e.g. response to drug) will be Mendelian, complex traits are much more common.\u00a0 We have extensive experience developing complex trait models using genetic and genomic data with techniques such as LASSO, classification approaches, and Bayesian regression (e.g. Bayesian LASSO). We will work with our clients to ensure that the most appropriate model is chosen and appropriately describe its expected performance.<\/p>\n

Semi-Quantitative Thresholds<\/strong><\/p>\n

While many diagnostic tests are quantitative in nature, there is often a need to define one or more thresholds and produce a qualitative output.\u00a0 We have experience assigning such thresholds using many approaches such as percentiles, orthogonal tests, and clinical data.\u00a0 We help our clients determine which approach is appropriate for their situation and work through the details, such as incorporating recruitment rate and sensitivity\/specificity costs.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t

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Design – Early + Late Clinical<\/strong><\/h4>\n\t\t\t\t\t\t
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Outlier Detection in qPCR Triplicates<\/strong><\/p>\n

While much statistical work has been devoted to outlier detection, this has primarily focused on \u201cbig data\u201d and multi-dimensional problems.\u00a0 When working with qPCR triplicates, we have the exact opposite problem\u2026how does one detect an outlier when only three data points are present?<\/em>\u00a0 Given that statistical test-based methods are inappropriate for such small sample sizes, we have developed a nearest-neighbour based approach that leverages our experience from running thousands of qPCR chips.<\/p>\n

Independent Verification Scripts<\/strong><\/p>\n

There are many activities that will increase the odds of accurate results, and one of the most basic and fruitful is having an independent operator verify the final output.\u00a0 We employ multiple levels of verification to meet the specific needs of our clients and utilize automated scripts to ensure highly accurate, fast, and reproducible results.<\/p>\n

Standardisation and Normalisation<\/strong><\/p>\n

Given that most RNA quantification techniques produce estimates of relative expression, standardization (and possibly normalization) is always necessary.\u00a0 We have extensive experience dealing with qPCR, NGS, and nanoString data and will help our clients understand the different options and choose the one most applicable for their situation.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t

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Early & Late Clinical<\/strong><\/h4>\n\t\t\t\t\t\t
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Study Design<\/strong><\/p>\n

Regardless of the quality of a diagnostic, a poor study design will do no more than ensure that time and money are wasted.\u00a0 We work with the client to quantify risks and ensure that the design is appropriate for the questions being asked.\u00a0 Then, we incorporate cost (actual processing cost, sample availability, etc.) to design a tailored study that has the best chance of succeeding and meeting the client\u2019s needs.<\/p>\n

Statistical Analysis Plans that Meet CLIA and \/or Regulatory Requirements<\/strong><\/p>\n

While guidance documents are helpful, they are rarely detailed enough or necessarily pertinent to diagnostic devices, especially ones that use emerging technologies like Next Generation Sequencing.\u00a0 Our statisticians have written dozens of statistical analysis plans that are compliant with CLIA and\/or regulatory requirements and we can help our customers make sure the appropriate factors are considered.<\/p>\n

Single \/ Dual Censoring<\/strong><\/p>\n

When dealing with quantitative or semi-quantitative assays, there is always a lower point when quantitation becomes unreliable.\u00a0 Such measurements are considered censored, but they still contain valuable information.\u00a0 We work with our clients to understand the information contained in such values and how to apply it so that sample failure rate is minimized while introducing no bias.<\/p>\n

Equivalency Designs<\/strong><\/p>\n

For many analytic validation studies, the goal is to demonstrate that a perturbation (sample input amount, potentially interfering substance, etc.) does not affect the measurement.\u00a0 Classical statistical tests, where the null hypothesis is that no difference exists, are inappropriate for such circumstances.\u00a0 Instead, equivalency tests should be used, and we can help our clients understand their interpretation as well as how to power the analysis and set appropriate acceptance criteria.<\/p>\n

Adaptive Sample Size Designs and Bayesian Analyses<\/strong><\/p>\n

For many studies, sufficient information is unavailable to reliably calculate the power for a classical statistical test.\u00a0 Adaptive sample size designs can be helpful in such situations since they allow the user to look at the data and decide if they should stop (since the answer, whether good or bad, is well supported probabilistically) or whether they are in an ambiguous state that requires more information.\u00a0 This, coupled with a Bayesian analysis, produces a very cost effective design that minimizes the number of samples while also lowering the risk of the study failing to due insufficient data.<\/p>\n

Censored mixed models<\/strong><\/p>\n

In many analytical validation studies, it is possible to obtain censored values.\u00a0 In such situations, it is inappropriate to \u201cremove\u201d such observations or impute values due to the bias this introduces.\u00a0 We work with our clients to implement censored mixed models to provide unbiased estimates that allow for standard acceptance criteria.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t

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Late Clinical<\/strong><\/h4>\n\t\t\t\t\t\t
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MC simulations for power estimation<\/strong><\/p>\n

Once a typical Phase III trial is ready to begin, there is usually plenty of information about how the diagnostic works.\u00a0 For certain outcomes, conducting power analyses is straightforward, but in other situations, the well-established deterministic methods do not incorporate all of the available information.\u00a0 In such instances, we can help develop Monte Carlo based simulations to provide the most accurate power and sample size estimates.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t

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Post Commercialisation<\/strong><\/h4>\n\t\t\t\t\t\t
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 <\/p>\n

Release of Reagents and Controls<\/strong><\/p>\n

Once an assay is validated and enters commercialisation, manufacturing and release of the assay components must occur. Biostatistics is involved with assessing the quality of reagents and controls prior to their release, to ensure quality. We are well versed in acceptance testing, which probabilistically ensures that the reagents and controls and suitable for release.<\/p>\n

Surveillance<\/strong><\/p>\n

Surveillance of an assay in the commercialised setting has always been a good idea, and now IVDR regulations mandate the procedure. Our biostatistics team are strong supporters of Statistical Process Control (SPC), which seeks to ensure that the assay is performing on target with minimal variability. We can help determine the best procedure, set limits, and interpret the resulting data.<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<\/div> \n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div> \n\t<\/div> \n<\/section>\n","protected":false},"excerpt":{"rendered":"

Biostatistics The Biostatistics Team offer a rare combination of statistical and genetic expertise, providing clients with optimal strategies and solutions in the molecular diagnostics field.  Our biostatisticians are available from early stage assay design to late clinical assessment, and have excellent knowledge of the current regulatory recommendations and guidelines.  Much more than a traditional group […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":30,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-796","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nBiostatistics - Diagnostic Services<\/title>\n<meta name=\"description\" content=\"The Biostatistics Team provide clients with optimal strategies and solutions in the molecular diagnostics field.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/biostatistics\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biostatistics\" \/>\n<meta property=\"og:description\" content=\"The Biostatistics Team provide clients with optimal strategies and solutions in the molecular diagnostics field.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/biostatistics\/\" \/>\n<meta property=\"og:site_name\" content=\"Diagnostic Services\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-24T10:56:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.almacgroup.com\/diagnostics\/wp-content\/uploads\/sites\/3\/2020\/11\/Almac_Logo-e1698941154737.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"100\" \/>\n\t<meta property=\"og:image:height\" content=\"52\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/biostatistics\/\",\"url\":\"https:\/\/www.almacgroup.com\/diagnostics\/supporting-services\/data-sciences\/biostatistics\/\",\"name\":\"Biostatistics - 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