Clinical Trials

2. Introductions

Exercise 1

What do you know about clinical trials?
Choose what you think is the most important statement regarding clinical trials.

Statements:

• Clinical trials enable the widespread use of proven therapies.
• Clinical trials are the only evidence needed for drugs to succeed.
• Clinical trials are the most rigorous way of evaluating a therapy while minimizing bias.
• Clinical trials are the most useful data to assess the safety of new drugs

Answers:
Clinical trials enable the widespread use of proven therapies.
[Not really. While clinical trials demonstrate the efficacy of a new therapy- marketing and appropriate pricing enable widespread use of a new therapy.]

Clinical trials are the only evidence needed for drugs to succeed.
[Not really. While clinical trials are crucial to demonstrate the efficacy of a new therapy, cost effectiveness and safety data are critical to the success of a new therapy. These are often proven using economic modeling in each national economy and conducting multinational safety registries of real world use of new therapies outside a clinical trial setting.]

Clinical trials are the most rigorous way of evaluating a therapy while minimizing bias.
[Yes! This is the main purpose of a clinical trial. Clinical trials attempt to measure the effect of a therapy on a disease compared to control treatment, balancing all other factors between the two subgroups of a study population so as to minimize the bias of any other factors.]

Clinical trials are the most useful data to assess the safety of new drugs.
[Not really. Large post marketing registries often provide more safety information about the adverse effect profile of a new therapy than a clinical trial. In a clinical trial, the study population is carefully selected, often excluding more complex and older patients in whom drugs are more likely to cause adverse effects.]