The trial could then continue without the placebo group. Unblinded data review by a data safety monitoring board with interim analysis of study results and safety issues is desirable. This is especially important for multicenter site studies. If a placebo is used in a study, the GW 572016 informed consent form must include all of the following information: The subjects must be informed that they may be given a placebo. A clear lay definition of the term ??placebo?? must be given to the subjects. The rationale for using a placebo must be explained to the subjects. If applicable, the subjects must be informed of any viable medical alternatives to being placed on placebo. The duration of time that a subject will be on a placebo, degree of discomfort, and potential effects of not receiving medication must all be explained.

Any consequences of delayed active treatment must be explained to the subjects. A statement in the risk section of the consent that the condition of the subject may worsen while on placebo should be included. A discussion in the benefits section that subjects who receive placebo will not receive the same benefit as those who receive active treatment if that treatment is effective should also be included. SUMMARY There are valid scientific and ethical considerations for using a control group in a clinical trial. Placebo-controlled trials are justifiable when they are supported by sound methodologic consideration and when their use does not expose research participants to excessive risk of harm.

Consideration should be given to the ??best-available therapy?? control groups in the evaluation of a new therapy or intervention Entinostat over an existing therapy. Investigators should bear in mind that one should not sacrifice the scientific merit of a trial to include the best-available therapy control group as long as the placebo control group poses little harm to the participants and, importantly, the trial offers potential benefit to the subjects. Footnotes Source of Support: Nil Conflict of Interest: None declared.

The objective of this survey was to seek opinion from clinical research professionals on their perceptions of ethical issues in clinical research in India. To achieve the same, a survey questionnaire was developed and mailed to about 500 clinical research professionals. A follow-up to receive the response was also done by way of mails/telephone calls.

The survey questionnaire covered 12 items which were: Listing the top three ethical selleck kinase inhibitor issues in the conduct of clinical trials in India. Readiness of the ECs on six parameters (rating on a scale of 1-10; 1 being non-competent and 10 being competent). Independence as the hallmark of EC functioning (rating on a scale of 1-10; 1 being non-independent and 10 being independent) and factors that posed barriers to independence.