Successful clinical trials help in the development of treatments that are safe and effective. However, starting clinical trials is a complex and time-consuming process. And sometimes, things like choosing a site and turning on the process slow it down even more. Unfortunately, some of these factors are beyond the control of the involved parties. But if you know about these factors, you can spot them early and lessen their effects by getting the right clinical development consulting.
That said, let’s discuss these factors.
Site Selection and Activation
Site selection and activation are an important part of clinical trials. It entails identifying viable clinical trial sites and setting them which also includes at home clinical trials. As easy as it sounds, the process can be quite complex. This is because there are several key metrics used to gauge the viability of a site. These include its location, availability of appropriate patient population, the experience of the site staff, and its capacity and available resources. This means multiple sites have to be evaluated which can be time and resource-consuming. Once a site has been identified, there’s more to be done in training the available staff in case of skills deficiency, acquiring and setting up the needed equipment, and so on. All these lead to longer trial times.
Patients recruitment involves identifying and selecting the right candidates for the clinical trial. For a drug test to work, there must be enough appropriate participants from the start. Failure to achieve this can lead to longer timelines and the use of more resources in recruiting other patients. Like site selection, participant recruitment can be a complex process for several reasons. For one, if the patient population size is small, it will be difficult to recruit a sufficient number for the trial. Secondly, there is stiff competition from other studies that may be seeking to recruit the same patients, making it more difficult to recruit patients. Also, if patients don’t know about the trials or aren’t willing to take part, it can take longer to find people to take part. Patients may be weary of the trials due to the risks and inconveniences involved.
Regulatory Approval and Compliance
Regulatory approval involves obtaining approval and permission to conduct the clinical trial. The process can be lengthy as it requires a lot of documentation and intensive review to ensure the trials meets all the set regulations. This process can take anywhere from several months to years. Compliance involves adhering to the set clinical trial standards, guidelines, and regulations such as good clinical practice (GCP). Compliance is vital in maintaining the credibility and reliability of the trial and for maintaining the well-being of the participants. Failure to comply can lead to delays in the trials, nullification, endangering patients, and legal actions.
Clinical trials require finances. But coming up with and negotiating the right budget can take a long time for a number of reasons. These include the type of trial, the drug being tested, the location of the trial, and the number of sites involved. Trials with multiple sites will be costly as compared to a single site. This is without forgetting the associated costs of managing multiple sites. It is important to ensure all factors are put into consideration when coming up with the budget to avoid financial constraints.
Clinical trial timelines can be affected by factors such as budgeting, regulatory approval and compliance, site selection, and participant recruitment. Understanding these factors and how they influence the trial can help their negative impacts can be mitigated.