Criteria for volunteer selection for clinical trials

Published: 12th March 2012
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Selection of the right candidate for clinical trials and studies by any clinical research organization is one of the most critical parts of the overall methods executed for a successful study and effective results.



A scientific investigation for taking part into clinical trials must include:


Selection Criteria

Inclusion criteria are a group of conditions that must be met to take part in a clinical trial. That is the standard used to determine whether it is appropriate that a person be allowed to take part in a clinical trial. The most important criteria used to determine participation in a clinical trial include age, sex, type and stage of disease, treatment history and other medical conditions.


Exclusion Criteria

Conditions indicated that preclude the entry of candidates in a search even though they meet the criteria for inclusion. Exclusion criteria are the standards used to determine why a person cannot be allowed to take part in a clinical trial. The most important criteria used to determine whether it is appropriate that a person can be allowed to participate or not in a clinical trial include age, sex, type and stage of disease, history of treatment and other medical conditions.


These inclusion and exclusion criteria is always obeyed by every contract research organization in order to present the accurate results while employing the right methods for their clinical trials services or any other clinical research project.


Terms of Study

That is, double-blind study with inter-observer Kappa coefficient.


Study Groups and Monitoring


  • Random Samples (systematic random)

  • Sufficient number of patients in each group (and balanced).

  • They depend on the inclusion-exclusion criteria.




The Task Force


  • This is the group that one wants to study by comparing with the reference group, to determine the validity of a diagnostic test, a therapeutic technique or treatment.

  • All patients in the group must have exactly the same problem, the same lesions, the same symptoms, etc.


Control Group or Control


  • This is a group of healthy patient or a patient group with the same inclusion-exclusion factors: the reference group for comparison.

  • The sample number should match the study group.

  • In the study of a technical or validation of a diagnostic test, it is also manipulated.

  • It may be untreated or subjected to sham treatment (according to ethics) or other treatment.


Definition of the Placebo


  • A placebo is a treatment (surgery, therapy, chemical solution, sugar pill, etc...), which is administered as if it were a therapy, but has no therapeutic value other than the placebo effect.

  • Placebo etymologically means "shall please" in Latin.

  • This may be a drug prescribed or administered to please a patient, a medication without the active state and therefore devoid of specific pharmacological action.

  • A placebo may be pharmacologically inert placebo (pure) or contain substances that are only active in some circumstances but not in the patient who takes (eg, a vitamin B complex or ascorbic acid) (impure placebo).

  • In the clinical evaluation of drugs, CRO can include a group treated with placebos to differentiate the Pharma co-dynamic effects of specific psychological effects associated with therapeutic act or fluctuations own disease.




About Author

Better clinical data management or the clinical trials are possible only if the right candidates are chosen for the trials implementation.


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