Preregistration (science)

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(Redirected from Clinical trial registration)

Preregistration (science) is a process in the scientific method where researchers publicly declare their research design, including hypotheses, variables, and analysis plans, before conducting the study. This practice is intended to increase the transparency and reproducibility of scientific research.

History[edit | edit source]

The concept of preregistration in science has its roots in the clinical trials field, where it has been a requirement for many years. The Food and Drug Administration (FDA) in the United States, for example, has required the preregistration of clinical trials since 2007. The practice has since spread to other fields of research, including psychology, economics, and social sciences.

Purpose[edit | edit source]

The main purpose of preregistration is to prevent p-hacking and HARKing (Hypothesizing After the Results are Known), practices that can lead to false positive results and a lack of reproducibility in scientific research. By declaring their research plans in advance, researchers are held accountable for sticking to their planned analyses and not cherry-picking data or analyses to achieve significant results.

Process[edit | edit source]

Preregistration typically involves submitting a detailed research plan to a public registry before the study begins. This plan includes the study's hypotheses, the variables to be measured, the data collection methods, and the planned analyses. Once the study is complete, the researchers can then compare their initial plan with the actual study and explain any deviations.

Registries[edit | edit source]

There are several registries where researchers can preregister their studies, including the Open Science Framework (OSF), ClinicalTrials.gov, and the American Economic Association's registry for randomized controlled trials. These registries provide a public record of the study's original design and allow other researchers to replicate the study if desired.

Criticisms[edit | edit source]

While preregistration is generally seen as a positive step towards increasing transparency and reproducibility in science, it has also faced some criticisms. Some researchers argue that it stifles creativity and flexibility in research, while others worry that it may lead to an overemphasis on hypothesis testing at the expense of exploratory research.

See also[edit | edit source]

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Contributors: Prab R. Tumpati, MD