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What are the best methods to ensure the validity of experimental results?

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Biotechnology is a field that relies on rigorous experimentation to generate new knowledge and applications. However, experimental results can be influenced by various sources of error, bias, or variation that can compromise their validity and reliability. How can you ensure that your biotech experiments are designed, conducted, and analyzed in a way that minimizes these threats and maximizes the confidence in your findings? Here are some best methods to follow.

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Dmitry Pliashkou

CEO BELGLOBALTRADE ? Agriculture, veterinary , pharma ??????????????? ? let's open new markets together
Dmytro B.

Bringing AI/ML, Cloud & Interoperable Integrations to HealthTech Innovation
álvaro López Zaplana

1 Define your research question and hypothesis

Before you start any biotech experiment, you need to have a clear and specific research question and hypothesis that guide your objectives and expectations. A research question is a statement that identifies the problem or gap that you want to address, while a hypothesis is a tentative answer or explanation that you want to test. Your research question and hypothesis should be based on a sound theoretical background, a review of existing literature, and a logical rationale. They should also be feasible, measurable, and testable with the available resources and methods.

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Dmitry Pliashkou

CEO BELGLOBALTRADE ? Agriculture, veterinary , pharma ??????????????? ? let's open new markets together
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It is very important in an experiment not to fall into the trap of expectation. Knowledge and preliminary assumptions can be very harmful and will affect the objectivity of the results.Bias and preliminary assumptions can be very harmful and will affect the objectivity of the results.... Non-subjective observation and evaluation of results is key in professional research.

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álvaro López Zaplana
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Obtén resultados similares en repeticiones experimentales (repite un experimento al menos 2-3 veces para validar que salen resultados similares). Otra vía es realizar pruebas científicas que te permitan validar un mismo resultado. Por ejemplo, si quieres cuantificar el ARN de un gen mediante rt-qpcr, puedes hacer dos parejas distintas de primers y ver si con ambas te sale la misma cantidad de ARN.

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Maria Remirez de Ganuza Monfort

Responsable de desarrollo de producto y regulatory affairs| Genetista vegetal y biotecnóloga
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Al definir tu pregunta de investigación, es crucial identificar con precisión el problema que deseas abordar en tu estudio. Esto te ayudará a enfocar tus esfuerzos en un área específica de interés y a establecer una base sólida para tu investigación. Además, es importante que tanto tu pregunta como tu hipótesis sean factibles, medibles y comprobables con los recursos y métodos disponibles. Esto asegurará que tus objetivos de investigación sean alcanzables y que puedas obtener resultados significativos y concluyentes.

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2 Choose an appropriate experimental design

Once you have your research question and hypothesis, you need to choose an appropriate experimental design that allows you to test your hypothesis and answer your question. An experimental design is a plan that specifies how you will manipulate the independent variables, measure the dependent variables, control the confounding variables, and assign the experimental units or subjects. There are different types of experimental designs, such as randomized, factorial, or blocked, that have different advantages and disadvantages depending on your research goals and constraints. You should choose an experimental design that maximizes the internal and external validity of your experiment, that is, the ability to draw causal inferences and generalize the results.

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Dmytro B.

Bringing AI/ML, Cloud & Interoperable Integrations to HealthTech Innovation
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Choosing a research design is like choosing tools for construction: you need to consider both theoretical appropriateness and practical feasibility. Randomized experiments are good for medicine, but may be awkward in the social sciences. It is also important to keep resources in mind - not all experiments are feasible with a limited budget.

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Maria Remirez de Ganuza Monfort

Responsable de desarrollo de producto y regulatory affairs| Genetista vegetal y biotecnóloga
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Una idea innovadora sería explorar la posibilidad de utilizar dise?os experimentales mixtos, que combinan elementos de diferentes tipos de dise?os para abordar preguntas de investigación complejas. Estos dise?os pueden ofrecer una mayor flexibilidad y permitir la exploración de múltiples variables independientes y dependientes. Además, considera la importancia de realizar un piloto o pre-experimento antes de comprometerte con un dise?o experimental específico. Esto te permitirá evaluar la viabilidad y efectividad del dise?o propuesto antes de invertir recursos significativos en su implementación.

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3 Follow good laboratory practices and protocols

When you conduct your biotech experiment, you need to follow good laboratory practices and protocols that ensure the quality and consistency of your procedures and data. Good laboratory practices and protocols are standards and guidelines that describe how to perform, document, and report your experiment in a systematic and ethical way. They include aspects such as safety, calibration, validation, maintenance, storage, sampling, labeling, recording, and reporting. By following good laboratory practices and protocols, you can reduce the risk of errors, accidents, contamination, or fraud that can invalidate your experiment.

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Gaurang Telang

| PhD Scholar in Biotechnology
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Ensure which guidelines are applicable to you from US FDA, EMA, OECD, ICMR, etc. Also refer to consortiums and consensus of your domain.

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Maria Remirez de Ganuza Monfort

Responsable de desarrollo de producto y regulatory affairs| Genetista vegetal y biotecnóloga
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Ser proactivo en la identificación y gestión de riesgos es fundamental para garantizar la integridad de los datos y la seguridad de todos los involucrados en el laboratorio. Esto incluye realizar evaluaciones de riesgos antes de cada experimento, identificando posibles puntos de fallo o fuentes de error, y desarrollando planes de contingencia para mitigar estos riesgos en caso de que ocurran.

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4 Apply appropriate statistical methods and tools

After you collect your data from your biotech experiment, you need to apply appropriate statistical methods and tools that allow you to analyze, interpret, and present your data in a meaningful and accurate way. Statistical methods and tools are techniques and software that help you to summarize, visualize, compare, test, and model your data. They include aspects such as descriptive statistics, graphs, hypothesis testing, confidence intervals, regression, and ANOVA. By applying appropriate statistical methods and tools, you can evaluate the significance, effect size, and direction of your results, as well as identify any outliers, assumptions, or limitations.

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Maria Remirez de Ganuza Monfort

Responsable de desarrollo de producto y regulatory affairs| Genetista vegetal y biotecnóloga
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Más allá de simplemente aplicar métodos y herramientas estadísticas a los datos recopilados, es importante también comprender la teoría detrás de estos métodos y cómo se aplican en el contexto específico de la biotecnología. Esto implica no solo utilizar el software estadístico para realizar análisis, sino también entender los fundamentos estadísticos subyacentes y cómo interpretar los resultados de manera adecuada.

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5 Replicate and validate your experiment

Finally, you need to replicate and validate your experiment to confirm and extend your results. Replication is the process of repeating your experiment under the same or similar conditions to verify the consistency and reliability of your results. Validation is the process of repeating your experiment under different or more realistic conditions to verify the applicability and generalizability of your results. By replicating and validating your experiment, you can increase the robustness, credibility, and usefulness of your results, as well as discover any new insights or challenges.

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Dr. Emil Kendziorra

Founder & CEO at Tomorrow Bio / Chairman Of The Board at EBF
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Replication is the key to validate experimental results. Do the experiments again, do them again with a different method, do them again in e.g. a different cell line or with a difference approach, have another lab repeat the experiments, etc. The more you repeat experiments while excluding potential confounders, the more certain you can be.

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Maria Remirez de Ganuza Monfort

Responsable de desarrollo de producto y regulatory affairs| Genetista vegetal y biotecnóloga
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La replicación y validación del experimento no solo son cruciales para confirmar los resultados, sino también para fomentar la transparencia y la reproducibilidad en la investigación científica. Una idea innovadora sería utilizar plataformas o repositorios en línea especializados en la publicación de datos y protocolos experimentales. Esto no solo permitiría a otros investigadores replicar fácilmente tu experimento, sino que también contribuiría a la construcción de una base de conocimientos sólida y accesible en el campo de la biotecnología.

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6 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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What are the best methods to ensure the validity of experimental results?

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1 Define your research question and hypothesis

2 Choose an appropriate experimental design

3 Follow good laboratory practices and protocols

4 Apply appropriate statistical methods and tools

5 Replicate and validate your experiment

6 Here’s what else to consider

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