Question

Should blinding randomization and having a control group be required for FDA approval studies?

250 words no plagiarism please

Answer 1

FDA approves only those drugs or other substances proved safe and effective for public use.The effectiveness and safety of newly detected drugs can be tested only through randomised controlled trials in various phases.While testing a food item,drug or a treatment modality, it's effect in various subjects ,representing various demographic subsets has to be checked.While checking this ,possibility of bias is very high, through blinding randomization and case control studies the reliability of the study results can be improved.

In blinding randomization the subject will be unaware about which drug or treatment they received,so there responses will be genuine and can be generalised to similar population.In case control studies the effectiveness of the intervention /therapy can be acknowledged by comparing the responses of the study group with control group.

The quantitative assessment of the drug can be achieved through randomised controlled trials,it can be done in various phases such as

- placebo concurrent control in which the effect of the drug is compared with an inactive preparation resembling the new one.

-Dose comparison control -uses two or more doses of the new drug in various study groups to find out the therapeutic dosage level.

-Active treatment concurrent control is another method in which the new treatment modality is compared with a known standardized treatment.

All the above assessments can be done through blinding randomization,this prevents the performance bias.In double blinding the subjects as well as the researcher are uncertain about which treatment given for which group.So the bias from both sides can be eliminated and thus reliability of the findings will be more.

The effective utilization of the sample can also be ensured through making the sample into various groups based on demographic variables ,and testing in each group will helps to generalised the finding to a large population which is required in FDA approval studies.

Retrospective evidence can also be assessed after the study to ensure the acceptance of study results.

It also ensure objective evidences for the effectiveness of the particular drug or therapy.Eventhough the control group doesn't receive active /new intervention ,they will be provided with standardized or established treatment.So the individual rights and safety can be assured and hence it can answer the legal issues.Hence the use of blinding randomization and having a control group is required successful completion of FDA approval studies.