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. The time required to activate a trial is detrimental to the enrollment rate and, subsequently, the success of the 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.
Challenges of Clinical Trial Start-up
Although research-naive sites frequently encounter problems with trial start-up, experienced sites can also have difficulties starting a new trial. The most common challenges experienced by sites at start-up include:
- Incomplete clinical trial infrastructure
- Insufficient or frequent turnover of personnel
- Absence of protocols for the trial process
- Use of outdated operating procedures and lack of technology
- Need for adequate preparation to combat slow enrollment and start-up.
Clinical trial sites take time and effort to set up and activate. Despite all challenges, the process can be sped up with these eight tips.
8 Tips for Accelerating Clinical Trial Start-up
1. Assess site suitability
Carefully ensuring that the clinical site is suitable to the needs of the clinical trial is essential to decreasing obstacles in the future. 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. The site assessment should be comprehensive and done early to avoid delays.
2. Timely submission of regulatory documentation
Incomplete or delayed submission of regulatory documentation is one of the frequent causes of pauses in the clinical trial start-up process. Ensuring the regulatory documentation’s quality, completion, and timely submission can help maintain the trial timeline.
3. Early development of the clinical trial 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. The budget, staff training, and materials needed for the trial to start all depend on the details of the protocol. Careful planning of a detailed protocol created early can mitigate potential obstacles in those areas of the trial. If steps are missed out, or possible changes are not accounted for in the protocol, future amendments will require approval from the FDA and IRB before they can be implemented and may cause delays in the trial.
4. Comprehensive budget planning
Based on the protocol, a comprehensive budget needs to be created and approved by the site and sponsor before they can finalize the contract. Once the contract is signed, changes to the budget are unlikely to occur, leaving the clinical site to pick up any unforeseen costs.
5. Trial-specific training for staff
Although many sites have experience running clinical trials, training specific to the clinical trial must be scheduled early. This will ensure that the team is familiar with the protocol before the trial starts.
6. Vendor management
Agreements with vendors must be created early to ensure all materials are available before starting the trial. Delays in shipment or changes in availability can delay the start of the clinical trial and disrupt the recruitment process.
7. Implementation of technology
Digital technology can be harnessed to help with patient recruitment and enrollment through:
- Use of EHR systems to find patients who fit the eligibility criteria.
- Social media to reach other potential participants.
- Online platforms that participants can use to learn more about the trial, indicate interest on their own time, and provide eConsent, thereby improving their enrollment experience.
8. Partner with a Clinical Research Organization (CRO)
Clinical research organizations, also known as contract research organizations (CROs) like IQVIA, PPD, Medpace, and Vial, have the experience, technology, and expertise to set up and activate clinical sites. CROs can help assist sponsors, such as pharmaceutical, biotech, and medical device companies, in expediting the processes needed to start clinical sites, such as:
- Site selection, as most CROs have extensive site and PI networks they can choose from for the most appropriate fit.
- Budget creation and contract negotiations between sponsors and sites using previous agreements completed with sites.
- Training site staff through previously set up standard operating procedures that can be adapted to the trial.
- Patient recruitment through proprietary technology and platforms created to increase efficiency in the process.
- Completion and submission of regulatory documents through teams of experts who have a thorough understanding of the requirements.
- Efficient ethics approval processes through a central IRB with whom a relationship is already established instead of using local IRBs that tend to meet less frequently.
CROs can help by accelerating start-up, reducing costs, improving results, and bringing life-changing treatments to market faster.
Ready to Have Your Clinical Trials Activated within 30 Days?
Vial is a full-service, tech-enabled CRO that provides end-to-end support for all phases of clinical trials. A modern patient recruitment platform ensures accelerated enrollment, while expert teams in ClinOps, business development, and project management, use their experience to increase the efficiency of the startup process and have sites active within 30 days.
Vial also maintains a preferred site network built through the development of relationships with investigators who are leaders in their fields. By connecting these sites with sponsors, Vial is able to streamline the clinical trial start-up process further.
Let’s connect to start your clinical trials better, faster, and cheaper!
