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The start-up phase is fundamental for any type of business, and pharmaceutical research is no exception. Clinical trials that get off to a good start are more likely to succeed. The start-up phase is a complicated, multi-faceted, and time-consuming period for any clinical study. Failures and incorrect actions at this stage can impact the overall study results. In this article we will walk you through the key steps of how to avoid such mistakes.
1. Identify the right countries and sites
Since many clinical trials are conducted globally, CROs and sponsors are looking to involve and evaluate the most eligible countries and the right investigative sites. However, finding suitable sites to conduct a study is one of the biggest challenges. If a patient needs a specific procedure or additional medications during screening or further on, such activities should be available/approved in the country where they are undergoing the treatment. Besides, sometimes issues with the site staff involved in the project could arise (work overload, unresponsive staff, lack of resources, and lack of motivation). For this reason, CROs and sponsors often use a combination of various methods to quickly find eligible sites for their clinical study:
- Estimation and analysis of a site’s capabilities for recruiting patients (therapeutic areas and indications, accessible populations and previous experience)
-Analysis of the ability of investigators to provide proper equipment and premises required for study procedures;
-Engagement of qualified staff and sufficient personnel to fulfill study needs, including sub-investigators, coordinators and data managers.
2. Conduct feasibility analysis
Feasibility analysis is the process of evaluating the possibility of conducting a particular clinical program in a particular region in terms of timelines, goals and cost. An in-depth and effective feasibility analysis lets you measure various business and trial parameters and predict the likelihood of your project’s success. Additionally, it helps foresee risks and form an action plan. While studies are complex and multifactorial, a standardized process for feasibility evaluation can be developed, and includes financial viability, available resources, past performance and ability to accrue, alignment with study timelines, current staffing and turnover, competing trials and populations. Development of a proactive and smart recruitment strategy is a cornerstone of thorough feasibility analysis.
3. Launch pre-study site visit, screening visit
Conducting pre-study visits is the final and most crucial step in selecting appropriate sites. These visits are especially vital in cases where the research team has had no prior experience with the site.
4. Initiate clinical trial agreement
The CTA is an agreement made between sponsors, CROs and sites, and can go by other names (contract, budget, or Investigator Commitment). This document aims to protect the interests of the parties involved. It is important to allocate an appropriate amount of time for discussing all critical points mentioned in it (delegation of responsibilities, obligations, allocation of risk and financial commitments). The better the parties understand each other’s perspectives, the greater the likelihood of successful and timely outcomes is.
5. Check regulatory documents and critical submissions
Putting together all the required documents is an important part of the start-up process, which ensures that sites are eligible to conduct a study. All documents can be divided into three categories: Federal/National Regulatory, Institutional Review Board (IRB)/Ethics Committee (EC) submissions and Standard Operating Procedure (SOP) requirements. Submission in many countries requires an extensive package of documents, which may include not only the essential documents, but also the specific ones (lists of equipment, additional documents for the investigational product, original letters to regulatory authorities etc.).
6. Initiate sites
The final step in the start-up process is to conduct site initiation visits, so that they can immediately start recruiting subjects. The purpose of such visits is to provide engaging and efficient training for PIs and staff. The CRO has to ensure understanding of the protocol, all procedures and Good Clinical Practice (GCP) requirements by clinical staff on all aspects of the protocol. Any misunderstanding is a factor in delaying study start-up progress or increasing timelines due to protocol deviations.
The start-up process sets a study up for ultimate success or failure. This essential step includes country and site selection, regulatory submissions, site activation, proactive planning and patient recruitment strategy, all of which can influence decisions and have a dramatic and positive impact on the conduct of the entire study. When considering an appropriate start-up plan, it is important to account for both real-world experience and performance data, and regulatory dependencies as part of the standard process.
OCT Clinical has been managing clinical trials in Europe for 17 years. The team has conducted more than 300 studies and has a solid grasp of all the nuances and subtleties of the process and will therefore be able to protect the interests of Sponsors, sites and patients. Among our core strengths are the ability to meet enrollment targets, streamline project management, and properly manage data to optimize research quality. Contact us to learn more or request a proposal.