On biostatistics and clinical trials

On Biostatistics and Clinical Trials

On Biostatistics and Clinical Trials

Statistics dates back centuries working with data collection, organizing and interpreting the data.

This was than today we can use statistics to prepare designs, interpreting relations and so on.

One of the new developments of statistics over the years has been biostatistics.

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On Biostatistics and Clinical Trials Biostatistics is the application of mathematical tools of statistics in the fields of medicine, biological experiments and collection followed by the analysis of the data of those experiments and interpreting a relation with the same 3

On Biostatistics and Clinical Trials Clinical trials are trials performed on real patients following a fixed protocol. These trials are used to test cancer therapies, the safety of new drugs and treating cardiovascular diseases in humans.

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On Biostatistics and Clinical Trials These trials help to identify the effectiveness of the drug in different phases which have been broken down in the trial. The clinical trial protocol follow a stating the type of people that may participate in the trials.

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There are 4 phases in clinical trials: ďƒź Phase 1 clinical trial: healthy people of about 20-30 are selected and the drug is administered to them to check the working and possible side effects the drug might have on the patients.

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There are 4 phases in clinical trials:

Phase 2 clinical trial: Around 100-300 people are used in this phase. This phase works more on the effectiveness of the drug. The aim is to obtain data on whether the drug is effective in diagnosing certain conditions in people or not..

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There are 4 phases in clinical trials:

Phase 3 clinical trial: The number of subjects is usually about 1000-3000 in this phase. It continues studying the safety and effectiveness of the drug but only this time with different populations and dosages.

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There are 4 phases in clinical trials: Phase 4 clinical trial: After getting approval from the FDA the drug is checked on diverse populations for safety and effectiveness.

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Steps in a clinical trial:

1. Explanation of the trial to the participant followed by gathering more information from the participant 2. Getting a consent form signed by the participant.

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Steps in a clinical trial: 3. Screening and checking the participant whether he/she qualifies for the test.

4. After selection, the participant is scheduled for a baseline visit (first visit). Here physical and cognitive tests are conducted.

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Steps in a clinical trial: 5. The next step is placing the participant in the control group.

6. Any issues or side effects faced by the participant should be reported to the researchers.

7. Regularly scheduled visits by the participants at the research centre so the researcher could evaluate 13

Helping in understanding the sample s ize The sample size is an important aspect of clinical

trials. This is where biostatics plays an important role. If the calculations are done incorrectly, the resulting sample may become quantitative research, which is unable to detect the correlation of the outcome variables and the

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Significance of the p-value:

How can you find whether your findings are significant or not, this is where p-value comes into play. The p-value helps in interpreting your hypothesis and correlate it with the results. If a pvalue of ≤ 0.05 is seen then there is strong evidence against the null hypothesis is rejected 15

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