The budget, staff training, and materials needed for the trial to start all depend on the details of the protocol.

The clinical trial protocol guides the trial process as it contains the exact steps that must be taken for the trial to be conducted. Early development of the clinical trial protocol Ensuring the regulatory documentation’s quality, completion, and timely submission can help maintain the trial timeline. Incomplete or delayed submission of regulatory documentation is one of the frequent causes of pauses in the clinical trial start-up process. Timely submission of regulatory documentation The site assessment should be comprehensive and done early to avoid delays. This process involves understanding if the patient population, therapeutic area of the principal investigator (PI), staff research experience, site logistics, and site workload are a match for the trial.

Assess site suitabilityĬarefully ensuring that the clinical site is suitable to the needs of the clinical trial is essential to decreasing obstacles in the future. 8 Tips for Accelerating Clinical Trial Start-up 1. Despite all challenges, the process can be sped up with these eight tips. Need for adequate preparation to combat slow enrollment and start-up.Ĭlinical trial sites take time and effort to set up and activate.Use of outdated operating procedures and lack of technology.Absence of protocols for the trial process.Insufficient or frequent turnover of personnel.Incomplete clinical trial infrastructure.The most common challenges experienced by sites at start-up include: Challenges of Clinical Trial Start-upĪlthough research-naive sites frequently encounter problems with trial start-up, experienced sites can also have difficulties starting a new trial. Over 50% of clinical trials face start-up delays because of obstacles at various steps of the start-up process, including site selection, training, and activation. The time required to activate a trial is detrimental to the enrollment rate and, subsequently, the success of the trial. The clinical trial site start-up is a major part of the overall clinical trial process and can significantly influence the budget and the rest of the trial.

Clinical trial start up