![]() Being mindful of the significant time and costs involved in the start up phase and assessing how each aspect of study design will affect start up activities can result in streamlined start up. However, it is for this very reason that SSU considerations should be included in study design, as overly complex study designs and protocols can be the cause of delays in the start up phase. Specific guidelines for study start up activities are generally left out because these tasks are deemed to be dependent on the study protocol. Design the study and protocol with the startup timeline in mindĬonventional clinical trial design often focuses on operations from recruitment onward. Accelerate the clinical trial start up timeline with these 5 study start up tips 1. Let’s take a look at some specific methods for optimizing SSU processes and streamlining clinical trial start up. Unfortunately, recruitment setbacks are a common problem faced by nearly 80% of clinical trials.,īeing aware of potential setbacks and understanding why they occur puts sponsors and researchers in a better position to plan their clinical trials effectively and mitigate the risk of SSU delays and/or their resultant consequences. Clinical trial design plays a significant role here, with more complex trials generally involving more time-consuming SIVs.įinally, the time necessary to wrap up SSU is also difficult to gauge because it depends on the eventual enrollment if insufficient participants are recruited, startup activities continue. The timeframe for site initiation visits (SIVs) can vary widely as it depends on the completion of prior tasks and involves monitors/other actors visiting sites to train staff on the trial protocol and ensuring that various actors have a complete understanding of the protocol and their responsibilities. Negotiations with sites can be streamlined by focusing on clarity and transparency in communications. Errors or missing information in regulatory submissions are common reasons for setbacks which can be avoided through proper review of documentation. There are numerous potential sources of delay in the clinical trial start up phase, particularly in negotiating CTAs with sites and submitting various documents for regulatory approval (with the FDA and IRBs). Surveys have suggested that start up cycle times have increased and that the majority of sponsors and CROs are somewhat or completely unsatisfied with their study start up processes. There may be overlap between the various start up, although there are certain steps such as submitting regulatory applications which must occur before or after other specific tasks are initiated or completed. While there is no prescriptive template for study start up timelines as each study is unique, the main activities do tend to follow a similar general timeline. Executing and negotiating Clinical Trial Agreements (CTAs) with sitesĬlinical trial start up timelines and delays.Executing Confidentiality Disclosure Agreements (CDAs) with trial sites.Identifying and contacting potential trial sites. ![]() Compiling and submitting IRB application and documentation for approval.Budgeting and creating feasibility reports. ![]()
0 Comments
Leave a Reply. |