7/31/2023 0 Comments Clinical trial startup time![]() Without it, your trial will be risking delays or even potential failure. This means pre-identifying sites for receipt of the SFQ, employing efficient methods for the SFQ distribution and utilizing simple, easy-to-use, tracking tools to help monitor SFQ activity.Īs we can see from just the first four steps of a start-up phase, setting the right foundations and relationships is crucial. This stage is one of the longer steps in the start-up phase of clinical trials, but it can be made more efficient by establishing an effective strategy. This process lasts roughly four to six weeks. The purpose of conducting feasibility is to ensure that the site can meet the sponsor’s budget, timeline and other requirements when participating in the trial. The SFQ is typically sent in conjunction with a brief study synopsis and is highly dependent on the specific aspects of the trial at hand. Oftentimes, a Site Feasibility Questionnaire (SFQ) is used to collect this information. Next up, the sponsor goes through a process of evaluating the possibility of conducting a clinical trial at the sites. Transparent communication, established protocol and solid relationships between site, sponsor and CRO can help expedite this process. This stage is often very labor-intensive, as it requires constant contact and revisions between various stakeholders. Many stakeholders may be involved over multiple drafts leading to bottlenecks and roadblocks. This step is often subject to delays given the inherent issue of compliance and legal complexities – such as time spent negotiating terms of the CDA, which may take days or weeks. Essentially, a CDA – or a Confidentiality Disclosure Agreement – is a contract between the sponsor that limits the disclosure of confidential or proprietary information relating to the study. The next four to six weeks are spent executing CDAs with all sites and investigators involved in the clinical trial. Step 3: Execute the Confidentiality Disclosure Agreement (CDA) That’s why CROs normally have a dedicated project manager or clinical research assistant that keeps track of the lists of sites. If enrollment is lagging, the sponsor will need to quickly find a replacement site – which could mean ongoing maintenance of the response list. To complicate things even further, the sponsor (or CRO) might have to contact investigative sites at later stages of a clinical trial. Although this process seems simple, it can become complex, as spreadsheets require manual updates when responses from sites are received. Then, the sites’ responses will be tracked through spreadsheets. ![]() Normally, sites are contacted through typical communication methods – such as emails, phone calls, or even via fax. Either the sponsor or the CRO can be responsible for this stage. The next week – or two – are devoted to contacting sites that the sponsor gathered during the first step and assessing whether they are interested in participating in the study. Step 2: Contact Sites-Access Initial Interest CROs also maintain and update their information regularly, and often have a greater network of potential sites based on clinical trials performed with a broad range of partners. ![]() Where these obstacles arise, the right partnership with a qualified CRO can offer a wider breadth of data and overall competence. However, these internal databases may not be comprehensive enough to support larger studies and are prone to errors since they can be labor-intensive to maintain. The sponsors themselves will have a coherent internal database of sites that they’ve previously worked with. Generally, both the sponsors and the CROs understand how vital this first step is. Studies show that 11% of trials fail to enroll a single subject and 37% of trials are under-enrolled. However, identifying the right sites is easier said than done. While the duration is short, the goal of this crucial stage is to find and evaluate potential sites with the appropriate patient population for the study. The first step lasts roughly one to two weeks. This article will explore the first four steps to this phase in detail. In fact, 70% of clinical trials experience start-up delays due to improper execution.įor companies looking to streamline their process, it’s essential to gain a better understanding of the start-up phase – including its complexities and intricacies. ![]() However, if not carried out effectively, this phase of the trial can be delayed, costing time and money to all parties involved. It is essential to lay a strong foundation during the start-up phase, which involves conducting the necessary background work from subject recruitment to site selection, as this will affect the trial’s outcome. ![]()
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