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How can statisticians contribute to the development of new drugs?

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The development of new drugs is a complex and costly process that involves many disciplines, such as chemistry, biology, pharmacology, and clinical trials. However, one of the most crucial roles in this process is played by statisticians, who apply their mathematical and analytical skills to design, conduct, and interpret experiments and data. In this article, you will learn how statisticians contribute to the development of new drugs and what skills and qualifications they need to succeed in this field.

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1 Drug discovery

Statisticians are involved in the early stages of drug development, where they help identify potential targets and candidates for new drugs. They use various methods, such as bioinformatics, machine learning, and network analysis, to analyze large and complex datasets from genomic, proteomic, and metabolomic sources. They also help design and optimize screening and testing protocols, such as high-throughput assays, to evaluate the efficacy and safety of drug candidates.

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Marcelo Gamarra

Genetista | Bioinformatico | Analisis de variantes | ACMG | Freelance
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Bioinformatics is an important tool in the discovery of new drugs, especially in the evaluation of its molecular docking to its target. In this way, statistics contribute to the estimation of the most probable binding mode within a set of bindings and the interactions that occur most frequently between the drug and the target to which it is directed.

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2 Preclinical studies

Statisticians also play a key role in the preclinical studies, where they help assess the pharmacokinetic and pharmacodynamic properties of drug candidates in animal models. They help design and analyze experiments that measure the absorption, distribution, metabolism, and excretion of drugs, as well as their effects on various organs and systems. They also help evaluate the toxicity and adverse effects of drugs, using methods such as dose-response curves, survival analysis, and risk assessment.

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3 Clinical trials

Statisticians are essential in the clinical trials, where they help test the safety and effectiveness of drugs in human subjects. They help design and implement randomized controlled trials, using methods such as sample size calculation, randomization, blinding, and stratification. They also help monitor and analyze the data from the trials, using methods such as hypothesis testing, confidence intervals, and p-values. They also help report and communicate the results of the trials, using methods such as tables, graphs, and summaries.

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Shivashankar T.

Researcher | Medical Research | Statistics | Data Science | SAS | R | Python | Statistical Modeling | Data Visualizations | Clinical Trials | Leadership | SMIEEE | Subject Matter Expert
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Statisticians play a crucial role in drug development through their expertise in clinical trials. They contribute by designing robust randomized controlled trials, employing essential methodologies like sample size calculation and randomization. Their involvement ensures trial integrity, incorporating blinding and stratification to enhance data reliability. Throughout the process, statisticians meticulously monitor and analyze trial data using hypothesis testing, confidence intervals, and p-values. This rigorous analysis aids in drawing accurate conclusions about drug safety and efficacy. Moreover, statisticians contribute to transparent reporting, employing tables, graphs, and summaries to effectively communicate trial results.

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4 Regulatory affairs

Statisticians are also involved in the regulatory affairs, where they help prepare and submit the data and documents required by the authorities for the approval and marketing of drugs. They help ensure that the data and documents comply with the standards and guidelines of the regulatory agencies, such as the FDA and EMA. They also help respond to the queries and feedback from the regulators, using methods such as meta-analysis, sensitivity analysis, and subgroup analysis.

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5 Post-marketing surveillance

Statisticians are also part of the post-marketing surveillance, where they help monitor and evaluate the performance and safety of drugs in the real-world setting. They help collect and analyze data from various sources, such as electronic health records, registries, and pharmacovigilance systems. They also help detect and investigate any signals of adverse events, interactions, or effectiveness issues, using methods such as causal inference, pharmacoeconomics, and pharmacoepidemiology.

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6 Skills and qualifications

Statisticians who want to contribute to the development of new drugs need to have a strong background in mathematics, statistics, and programming. They also need to have a good knowledge of the drug development process, the relevant scientific fields, and the regulatory environment. They also need to have skills in communication, collaboration, and problem-solving, as they work with various stakeholders, such as scientists, clinicians, and regulators. Typically, statisticians who work in this field have a master's or a doctoral degree in statistics, biostatistics, or a related field, and some relevant experience in the industry or academia.

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Fεrδous Hossαin

Statistician @ Abbott | R&D, Biostatistics, Data Science
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Essentially calculus, linear algebra, probability, mathematical statistics, and some sense of epidemiology. Skills for drug discovery will become a conversation only if we can learn limit/derivatives before the central limit theorem, combination and permutation before the probability, and independence before the distribution. Programming will come as a package with all of it. With time and experience our communication, collaboration, research domain, and regulatory knowledge can be enlightened.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How can statisticians contribute to the development of new drugs?

1

2

3

4

5

6

7

1 Drug discovery

2 Preclinical studies

3 Clinical trials

4 Regulatory affairs

5 Post-marketing surveillance

6 Skills and qualifications

7 Here’s what else to consider

Statistics

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How can statisticians contribute to the development of new drugs?

1

2

3

4

5

6

7

1 Drug discovery

2 Preclinical studies

3 Clinical trials

4 Regulatory affairs

5 Post-marketing surveillance

6 Skills and qualifications

7 Here’s what else to consider

Statistics

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