Three Common Mistakes in Clinical Trials

Clinical trials have evolved a great deal since they were first utilised in 1742. However, there are still areas in which those conducting medical research can seek to improve and further their skill sets. This article looks at three common issues that arise during these investigations and possible solutions.

Problem: Insubstantial Preparation

When setting out to answer a detailed question, the mistake that many researchers make is failing to thoroughly investigate whether someone else has already tried to answer the same question. The immediate and obvious issue with this oversight, is that a clinical trial that has already been performed could well be unproductive if it were to be completed again. The second issue is that even if previous trials were unsuccessful, a wealth of knowledge is still available following on from the initial trial and its subsequent findings.

Solution: In Depth Research

To achieve the most informed conclusion, most of the work for clinical trials should be completed well before the research commences. This preparation should always include a thorough investigation into similar medical inquiries. The groundwork should not stop there either, once comparable studies have been identified, they should then be examined with a fine-tooth comb for relevant findings.

Problem: Weak Link

The success of clinical studies hinges on the rigorousness of the researchers involved, especially in relation to long term trials. Ultimately, the outcomes of research programmes are as fallible as the humans involved in running them. When asked to concentrate fully on data sets with little to no difference between them for prolonged periods of time, a phenomenon known as directed attention fatigue can be induced involuntarily. As much as these individuals may want to provide faultless analysis of the results as they come through, there is very little they can do to avoid losing focus after processing results for a protracted length of time.

Solution: Regular Re-calibration

Whether working in-house developing and testing new drugs, or outsourcing to a clinical trial services provider, all researchers involved must be calibrated regularly to ensure consistency in measurement. This should involve enforcing regular breaks from research to ward off directed attention fatigue.

Additionally, there should be frequent evaluations by external personnel, who can sanity check the work completed and assess discipline levels presented by researchers. In either instance, it may be worth bringing in an independent body to ensure absolute neutrality.

Problem: Unspecified Criteria

A clinical trial must have rigorous admissions protocols to guarantee accurate and conclusive results. Most researchers will know this and have a very specific group of individuals in mind when planning a clinical trial study. Problems arise in this situation when criteria are not kept to, or if these are not outlined in the resulting literature concerning the study. In the first instance, this will play havoc when it comes to proving that an original hypothesis is correct, or when analysing why it was not. In the second instance, a lack of information regarding inclusion and exclusion criteria will scupper further studies by obstructing them from recreating the original core set up or measuring differences when working with a different control group.

Solution: Specific Detail

The solution to this is simple and only requires adherence to best practice clinical trial policy. This means outlining the group that will be tested in theory, sticking to this group in practice and detailing their inclusion and exclusion criteria clearly in the final study documents.

Although clinical trials are more advanced than ever, mistakes can still be made. These three solutions when adhered to, should solve common problems arising in research programmes today.