Why A Cro Needs Healthy Volunteers?

By Author: Rajesh Kumar
Total Articles: 17
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Many studies are done on "healthy volunteers". But what exactly does this term mean? And why do a CRO needs healthy volunteers?


Despite the dazzling advances in research, we are still far from fully understood the anatomy and physiology of the normal human being. Research on healthy volunteers is valuable for advancing science, but also to provide a basis for the study of diseases.


On the other hand, some tests of drugs and medical devices are easier to implement in healthy volunteers, at least in the early phases (phase 1 for drug testing). The difficulty in this case is to what extent the results obtained in healthy volunteers will be extrapolated to the patient population to which the treatment is intended.


If one were limited to 100% healthy volunteers, with no history, no anatomical variant and no pathology (not even a cavity!), we would never find anyone! We must therefore understand the term "healthy volunteers" from the context of the study. If a person who suffers from skin allergies can be considered healthy for a neurophysiologic test, it will not be the same ...
... if the test of a cosmetic product.


All clinical research companies or the organizations conduct a medical examination for recruiting the volunteers. While this exam may be a simple questionnaire for testing medical imaging, it will be a blood test, an electrocardiogram and possibly some other tests for drug testing. These investigations aim to determine whether the volunteer meets the criteria for inclusion in the study and if it does not suffer from a disease he did not know.


Sometimes it is not easy for researchers to define the boundary between healthy volunteers and voluntary patients. "Normal" varies from one subject to another and even within a single individual. Compare your blood parameters in two blood samples to 15 days apart: most will be slightly different, but all two considered "normal." Compare the results with a friend in good health; they will be different, but equally normal. This is to reflect the intra-and inter-subject that is important to conduct a volunteer recruitment for each study and enroll a sufficiently large number of volunteers so that the sample is representative as possible of the population.


Other factors may also be considered in the recruitment of healthy subjects. For example, you should check if they are not taking regular medication that might interfere with the results of the study. Weight, smoking and alcohol are usually also the part of criteria. Before offering your participation in a study, pay attention to the details of the offer. If you have any questions, feel free to ask and discuss with the researchers.



Author recommends choosing a good CRO for the contribution in clinical trials service, clinical research or the drug testing.