Clinical trials from organizations like Veristat require investing in a lot of resources including time and capital. These are vital in ensuring you complete your research trial successfully. However, this doesn’t guarantee that your clinical trial will be a success. Nevertheless, the trial must be completed. Below are some of the factors that can help you complete your clinical trials fast.
In virtual clinical trials, it is paramount to record any protocol deviation. While the deviations may differ in some capacity, some CROs place no prioritization in their recording. However, deviations that may include biometrics, patient compliance, clinical outcomes, and dosing are primal to the clinical and safety endpoints and should be the starting point when recording.
Do some up-front risk assessment
Nothing is without risk. When it comes to clinical; trials, carrying out risk assessment without the proper data would be a waste of time. It is common to find clinical trial personnel predicting any potential risks with some hypothesis from previous trials; this is a grave mistake. As you start your trial, first collect the needed data then analyze the potential risks or threats that may arise from it.
Design the Data model
Clinical trials are sensitive procedures and require the touch of experts. More so in crucial areas such as designing an Electronic case report form (eCRF). This procedure should be done after the data model has been designed. When you hire a data modeling specialist, go for someone who is well vast in the procedure. You can easily pick a specialist based on their pay rate. An expert data modeling specialist may charge up to $500/hour since their work warrants that much. When the Ecrf is well designed it can provide you the abstract for your data model thus improving the speed of accessing data and its usability by study monitors, patients, and statisticians, and site coordinators.
Date and time
Clinical data is acquired on different timelines. One of the timelines is the study schedule; another is patient compliance, followed by adverse events and so on. One factor that most people tend to ignore is the several timelines a trial must take. The dates/time of the trial can be viewed in a triangle in which one side represents the site coordinator who collects the Electronic Data Capture (EDC). The other side represents the Clinical Trial Associate who monitors the data quality and CRC and performs SDV. The last side is the patient who is scheduled to visit the doctor at a certain time as stated by the coordinator. As you pay close attention to each time and date, do it with discipline. Start the trial early, go slow and soft then pick up the pace, maintaining the discipline equals improved speed throughout the clinical trial. This helps you to be prepared for what may come.
A clinical trial may not always be a success but for it to be completed, discipline must equal the speed, there should be risk assessment with data, time/dates must be observed and prioritization should be used in recording protocol deviation.