A few weeks ago, we posted an article about the common reasons why studies don’t work out as originally planned. The first part of this series can be found here. In that post, we discussed how logistics, training and personnel can impact the performance and outcome of a study. In this three part series of articles, we will take a look at a total of 10 areas where problems can arise and present viable solutions for ensuring your organization does not get caught up with studies that won’t work.
In this article we will take a look at three more common reasons why studies fall flat.
Studies need patients to succeed. This means that ensuring you have a well thought out and organized recruitment strategy is crucial. Without one, a study can fail before it even gets off the ground. When creating the recruitment strategy for a study, there are two main areas where the first common problem is going forward with a poorly targeted enrollment campaign. This means that you are promoting your study in the wrong channels, with the wrong message, or both. An extreme example might be advertising a back pain study in a publication focusing on new technologies. You might have the perfect message, but the impact will be minimal because not enough people with back pain are reading the publication. To be successful you need to get in front of your target by advertising in publications people with back pain read.
Another commonly seen problem is running recruitment strategies that compete with other studies. This is a negative because it causes cannibalization within your organization. One study may do very well at the expense of another if they require patients with similar characteristics.
Another “problem area” revolves around the creation of inclusion and exclusion criteria. Trouble can arise when the criteria is too broad or too narrow. If the criteria is too broad, too many people fit the description of the ideal candidate and you end up screening too many patients who are not truly candidates for the study. If the criteria is too narrow you will have a harder time finding patients who fit the criteria and will make it difficult to fully, or even partially, enroll a study.
Maintaining patient safety during a clinical trial is paramount. Unfortunately, safety concerns can sometimes be a detriment to a study. For example, if the adverse event profile deters sites and patients, or if drugs are poorly tolerated by patients, especially if it is late in the trial.