Launching a clinical trial is important as completing it. Without the right foot forward, the trial could take longer than expected, spend more money and fail to get the expected outcomes. It is for these reasons that a clinical research organization like Veristat must ensure they carefully and professionally undertake all the needed tasks to kick-start the trail. This will involve tasks such as patient recruitment, site selection, framing of the trial design, and more. That said, in this post, we have compiled a guide on what to consider when starting a trail.
Mapping out your budget and timeline
Your budget will most likely affect your timeline as such; you should take time to carefully think it through. There are project bureaus available that can help you with the mapping out. These bureaus often do not respond as soon as possible which can seem like a barrier for clinical trials but they do this to ensure that your timelines and budget are realistic for your study. This verification can help you avoid future problems like financial constraints.
Create a compelling study.
Many clinical trials fail to accomplish their goals due to a lack of enough participants to measure the required effect size. To avoid this, understand the relationship between power, Type II error, and the effect scope to help you determine how many patients you’ll need. With software applications, you may simply determine the size of your sample and store the data size estimate to use throughout the trial methods section.
Patients are the backbone of a successful clinical trial. The exercise should be done in a timely and professional manner to reduce cases of patient dropout. This can be done physically or through online recruitment with an eConsent procedure. For less frequent procedures, it can be difficult to find and recruit patients because not every patient available will agree to take part in the trial. As such, create an effective patient recruitment plan to counter the chances of stopping the clinical trial due to inadequate patients.
The quality of your data is directly influenced by the sites you choose and how well they can carry out the intervention. These sites must be consistent with your study protocol and clinical research. As you define your site selection criteria, include factors such as; past trial performance, staff qualifications, patient access, facilities, and equipment. To avoid protocol deviations in your drug or medical device development study, consider the possibility of these sites carrying out interventions in different ways due to the use of different types of equipment.
Choose a method for data collection
You should think through how you will collect patient data and have the right systems and forums in place for this. These could be in form of paper or EDC. Depending on your study, you might have to use; Patient Reported Outcomes (PRO) for direct patient feedback or Case Report Forms (CRFs). As you choose these systems, have the patient in mind and ensure the chosen systems provide adequate information and safeguard patients’ privacy.
To achieve a successful trial, build the right foundation for it and use sustainable and safe procedures.