Clinical Trial Start-Up Top 5 Challenges

Clinical Trials Services

An efficient clinical trial start-up is essential to the success of a multicenter clinical trial. Initiating a clinical trial is a time-consuming, complicated process involving several aspects that require proper planning and timely execution. Delays in clinical trial start-up often mean prolonging the overall study timelines, which can result in significant additional costs and may threaten the overall success of the trial.

Below are 5 main factors that often lead to longer clinical trial start-up timelines and should be considered proactively in order to begin a successful clinical trial.

Regulatory Submissions

Documents needed for a regulatory submission can be complex and require coordination from team members with different areas of expertise. Additionally, some countries have rigorous requirements for the content of submission documents and lengthy decision timelines. Although counterintuitive, it is beneficial to spend additional time at the outset to ensure the content and quality of the documents to be submitted. A well-crafted submission can lead to fewer reviewer questions and faster review times, thus ultimately shortening the start-up timeline.

Site Selection

Selecting a clinical site is one of the biggest challenges sponsors and CROs face during the start-up process. Prior to selecting a site, the sponsor or CRO performs a detailed assessment of the site’s research capabilities, including past clinical trial experience, staff workload, patient population, site facilities and equipment, and qualifications, to determine if the site would be a good fit to participate in the study. Likewise, the site staff considers the study requirements and performs a feasibility assessment of its own, to estimate the site’s potential enrollment performance and costs. Start-up timelines are usually tight, so sponsors and sites need to begin this process as early as possible in order to provide accurate comprehensive assessments. When site selection is rushed, it often yields inaccurate site information and overly optimistic enrollment projections.

Contracts and Budgets

Contract and budget negotiation between sites and sponsors can take a considerable amount of time. Inexperienced site staff, inadequate budget templates, and extended legal reviews can all delay study start-up. Hiring a contract research organization (CRO) with experience in site negotiations on behalf of sponsors can help expedite contract and budget negotiations. This is especially true if the CRO has utilized a site in the recent past, as they can refer to the previously negotiated contract and budget terms to significantly reduce the timeline for contract execution.

IRB Submissions

At the site level, IRB submission delays are related to the use of a local IRB. Evidence suggests that the use of a central IRB that oversees multiple sites at the same time significantly expedites the IRB approval process. Frequency of IRB meetings has a great influence on start-up timelines, and central IRB boards tend to meet more frequently and require shorter lead times to schedule review of a submission. IRB approval delays can also occur due to incomplete or inaccurate IRB submission documents, regardless if a local or central IRB is utilized. Essential documents for the IRB submission require careful review, as even minor errors can lead to significant delays in IRB approval. Timely IRB approval allows for earlier completion of required site training and the potential to begin subject enrollment sooner, which are key factors in the execution of a successful clinical trial.

Site Initiation

Selected sites are required to schedule clinical trial-specific staff training before patient enrollment can begin as sites need to be trained on the protocol requirements prior to patient recruitment. Inadequate site staff training can lead to improper participant enrollment, poor data and/or noncompliances. Also as part of site initiation and prior to patient enrollment, the sponsor must deliver the necessary clinical supplies. Interruptions in supply shipments can lead to significant delays in patient enrollment and the overall enrollment timeline, which can lead to increased overall costs.

The clinical trial start-up process is complex and requires early planning and frequent communication with the trial sites. The results from one recent study demonstrated that the use of a CRO decreased the amount of time for the administrative phases of the start-up process, specifically the contract and budget negotiation and IRB approval.¹

For information about how we can help you efficiently and effectively navigate clinical trial start-up, please contact us today at 855-463-1633 | askmed@medinstitute.com | medinstitute.com.

Reference:

1. Krafcik, B. M., Doros, G., & Malikova, M. A. (2017). A single center analysis of factors influencing study start-up timeline in clinical trials. Future science OA, 3(4), FSO223.

Also of interest: Early Feasibility Studies Top 6 Considerations, Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives, 5 Reasons your Clinical Trial has Poor Patient Enrollment and Retention