Clinical trials are an essential aspect of medical research as they allow researchers to evaluate new treatments and procedures before they are made available to the public. However, starting a clinical trial is a complex process that requires careful planning and attention to detail. In this article, we will discuss seven critical steps sponsors must consider prior to starting a clinical trial!
Step 1 of Starting a Clinical Trial: Design the Protocol
The development of a well-written protocol is critical to achieving success before starting a clinical trial. The protocol is a comprehensive document that outlines the objectives, design, methodology, statistical analysis, and ethical considerations of the study. It also includes details on the study population, inclusion and exclusion criteria, and the interventions to be assessed.
Sponsors should develop their protocol with input from a multidisciplinary team of experts, including clinicians, statisticians, and regulatory experts, to ensure the clinical trial plan is feasible, ethical, and scientifically rigorous.
Step 2 of Clinical Trial Start-Up: Prepare Administrative Documents
Starting a clinical trial also requires several administrative steps in addition to designing key trial documents, such as the protocol, informed consent form, and investigator’s brochure. These include, but are not limited to, the following:
- Confirm that a confidential disclosure agreement (CDA) is in place prior to the release of any confidential or proprietary information related to your clinical trial.
- Facilitate contract preparation, in the case of outsourcing the clinical trial execution to benefit from a specialized contract research organization’s (CRO’s) expertise.
- Facilitate a clinical research study budget plan to ensure there are sufficient funds to conduct the trial as planned.
- Build the investigator site file, containing essential documents which permit evaluation of the conduct of a study and the quality of the data produced.
Step 3 of Clinical Trial Start-Up: Meet Regulatory Requirements
The regulatory requirements for clinical trials vary depending on the country and region in which the study is being conducted. In the United States, the Food and Drug Administration (FDA) regulates clinical trials, while in Europe, this function is carried out by the European Medicines Agency (EMA).
Regulatory compliance involves submitting the protocol and other necessary documents within a clinical trial application (CTA) to regulatory authorities, including the institutional review board (IRB), for review and obtaining approval before starting the study. These teams will review this application to ensure that the study is safe, ethical, and scientifically rigorous.
Among other objectives, the submission should describe the potential risks and benefits of participating in the study, and informed consent should be obtained from all participants before the study begins. The approval process may take several months, and there may be a need for revisions based on feedback from the regulatory review committees.
Biopharma and biotech companies must conduct their study in compliance with the International Council for Harmonisation (ICH) guidelines, which provide a framework for ethical and scientific standards for clinical trials around the world. Visit Vial CRO’s blog to learn more about navigating the regulatory submission process in various countries, including Canada, India, China, and Australia.
Step 4 of Clinical Trial Start-Up: Manage the Investigational Product
Investigational product management involves ensuring that the study interventions are safe and effective. This task includes obtaining the investigational product, storing it appropriately, and ensuring that it is administered according to the study protocol.
Clinical trial sponsors should obtain their investigational product from a reliable source and confirm that it meets the necessary quality standards, such as Good Manufacturing Practices (GMP). The product must be administered according to the study protocol, and its management should be closely monitored to ensure that the product is being used by site staff safely and effectively.
Step 5 of Clinical Trial Start-Up: Ensuring Quality Data Management
The next step of starting a clinical trial involves developing a robust data management plan (DMP), designing the database, and ensuring that the data is collected accurately and securely. Sponsors and their CROs must ensure that the DMP is developed before the study begins and that the database is designed to capture all necessary data outlined in the protocol.
The data should be collected and stored securely to ensure that it is not lost or compromised. A structured monitoring plan should also be set in place to ensure that the study is conducted according to the protocol, to identify and manage any risks to the study, and to maintain high data quality.
Step 6 of Clinical Trial Start-Up: Build a Comprehensive Recruitment Plan
Recruitment challenges are one of the most common obstacles sponsors and CROs face when conducting a clinical trial successfully. A key step prior to starting a clinical trial is building a comprehensive, multi-pronged recruitment plan. First, sponsors must have a thorough understanding of the target population.
The eligibility criteria for the study should be clearly defined, and the target population should be identified based on these criteria. It is also essential to understand the barriers that may prevent individuals from participating in the study, such as transportation, language, or cultural barriers.
Once the target population has been identified, the next step is to develop recruitment strategies, including:
- Advertising: Advertising the study through newspapers, radio, television, or social media platforms.
- Referrals: Asking healthcare providers or community organizations to refer potential participants to the study.
- Direct mail: Sending letters or brochures to individuals who meet the eligibility criteria.
- Outreach: Conducting outreach events in the community to inform potential participants about the study.
The recruitment plan should include a budget to account for costs associated with the recruitment strategies, such as advertising costs, outreach event costs, and personnel costs associated with recruitment. It is also essential to budget for participant compensation, which is often used to incentivize participation in the study.
Lastly, sponsors and CROs should monitor the recruitment progress regularly and adjust the recruitment strategies as needed to ensure that the study is completed within the designated timelines.
Tracking recruitment progress involves:
- Monitoring the number of participants who have been enrolled in the study.
- Identifying any barriers to recruitment and developing strategies to overcome these barriers.
- Communicating regularly with the recruitment team to ensure that the recruitment strategies are being implemented effectively.
- Documenting the recruitment process for reporting to the regulatory authorities and the IRB or Independent Ethics Committee (IEC).
Step 7 of Clinical Trial Start-Up: Start Site Selection Early
Once a sponsor’s clinical trial is approved by the applicable regulatory bodies, site selection can proceed. Although site initiation may not start right away, beginning the search for quality principal investigators (PIs) and clinical research sites early is one of the most important factors which determine the success of a clinical trial down the road.
Read this article to learn how to find which sites are the best fit for your clinical trial. Site selection involves identifying and evaluating potential sites based on the study protocol’s inclusion and exclusion criteria. It also involves assessing the site’s capacity to conduct the study, including the availability of resources, personnel, and equipment.
Vial: Streamlining Clinical Trial Start-Up
Vial is a next-generation, tech-first CRO delivering faster, more efficient trials at dramatically lower costs for biotech sponsors. By partnering with our experienced teams across nine therapeutic indications, we are empowering scientists to discover groundbreaking scientific innovations that help people live happier, healthier lives. We have built a global, full-service CRO powered by intuitive end-to-end technology with the expertise of innovators, engineers, and ClinOps leaders.
To learn more about how we can streamline your clinical trial start-up process, visit Vial CRO’s website and connect with a team member today!
