4 Major Pitfalls in Clinical Trial Design and How to Avoid Them

Studies show that 90% of the clinical trials in drug development fail despite the implementation of a successful Veristat clinical trial design. Clinical trials are expensive and suffer many difficulties, including patient retention and recruitment, trial planning challenges, and unexpected protocol changes. Here is a look at the major pitfalls that face clinical trials and how you can avoid them for a successful research study.

Formulating the wrong question for the study

One of the first things you need to do to come up with a successful trial is come up with the right research question. The process can be challenging, but getting the wrong question will often lead to bigger issues later in the trial. If the study question is not properly chosen, methodological difficulties can arise during the clinical trial planning and operational components. Therefore, researchers must identify the clinical problem being solved and find the right question to achieve it. There is often the temptation to ask several questions, but it is highly discouraged since different trial designs require different designs and sample sizes. It is, therefore, crucial to focus on the primary research question.

Not engaging patients in the early stages of the trial

One of the major challenges facing clinical trials includes patient recruitment and retention. Part of the problem is that researchers and sponsors do not engage the patients early in the trial design process. This means that the trial design might not fit the patient’s requirements. When you engage the patients early, your trial design is going to fit with the patient’s requirements. Early patient engagement will also improve the research design. Also, patients will have important insight into their conditions and help shape the strategy better. They are the only people who can tell you if you are truly achieving the right balance with the research and easing the burden of the disease.

Getting the wrong sample sizes

Since the sample sizes are important, getting the right number of participants will give researchers precise estimates and easily detect the difference between the current treatment. If the sample size is too small, the results might not be statistically significant. On the other hand, recruiting a larger sample size than needed may be costly and strain your trial resources significantly.

Making the trial design too complex

A complex trial design means that you will have a more complex protocol. Researchers are better served if they eliminate unnecessary complexity in the trials to obtain the necessary study data. Researchers can also make a trial complex by trying to get desirable data but not which is not essential. Clinical trials must be designed to ensure that the patients benefit from the treatments. This way, the trials are more streamlined and cost-effective. It is therefore important to ensure teamwork among the researchers to achieve a common goal.

While it is impossible to exhaust all the pitfalls in clinical trials, they are of major concern to the research teams and sponsors. Each challenge has its best way to resolve with the help of the research team.