Doing the Groundwork before Designing a Trial

The principles

Recommendation 1: Before designing the trial, define the population at risk, the case and the impact of the potential target agent. 

Acute Respiratory Infections (ARIs) are usually benign self-limiting conditions, especially if caused by viruses. This characteristic should not make them attractive to the pharmaceutical industry or governments. 

However, they are very common, and they all present as a syndrome. This is an aggregate of signs (e.g. fever, measured by a physician) and symptoms (e.g. cough) with a sudden onset. The cause of the syndrome is not easily definable, as on average one third are caused by rhinovirus, one third by a mixed bag of agents, and one third are of unknown origin. There are n number of agents involved, often unknown, and in about 20% of cases, two or more agents are at work in the syndrome.

Their ubiquitous nature plays well in the hands of those selling the latest remedy, as it means huge numbers and even larger, if you want to prevent things. In theory, th…