Every clinical trial should conceptually begin with the primary objective(s). If there is more than one, they should be few in number, clear, succinct and also detailed. This allows one to choose the most appropriate trial design to obtain the data necessary to study and evaluate them objectively. Indicate the specific endpoint, specific patient population, specific dose, specific length of time, the specific test and control groups, etc. These details in the primary objective will better enable you to design the optimal trial to evaluate that objective.

An objective stated as: "to study safety" or "to study efficacy" is not adequate and is incorrect as a meaningful objective. At the minimum, "safety" must be defined by each of the tests to be used.

While there is rarely any limit imposed on the number of secondary objectives in a protocol one should always consider if there are more than ten or so, if some of them can be relegated to subgroup analyses or tertiary objectives.

An objective is never expressed as: "To show that X" but as: "To evaluate whether X," because the former literally implies that the trial is set up to show a preconceived conclusion rather than to see how the data will turn out as one evaluates a scientific/medical question.