Clinical trials are vital for the development of new treatments. The objective of clinical trials is to test whether a new drug or treatment is safe and effective. During the clinical trial process, it is essential that all aspects are carried out in an ethical and scientific manner, ensuring results can be reproduced elsewhere if needed. Clinical operations, or ClinOps, is a critical part of the equation.
What is ClinOps? In the simplest sense, ClinOps includes all activities that support clinical trials, from startup to close out. Establishing an experienced ClinOps team is vital. Project Managers (PM), Clinical Research Associates (CRAs), Data Managers (DM) and support staff are among the list of critical team members.
This overview outlines each aspect of ClinOps, including traditional roles within the ClinOps team, critical best practices, and other key aspects of project management in clinical trials.
Plan and Initiate the Clinical Trial Activities
The first step in ClinOps is planning. Ensuring team members are identified, setting timelines and expectations and identifying key study milestones are the first few steps during the planning process. If a project is mismanaged, delays can occur, often leading to additional costs for the sponsor.
Protocol training and ensuring all stakeholders understand the protocol and procedures is essential during study start up. The clinical trial protocol contains study drug information, background on the disease, inclusion/exclusion criteria for study subjects, type of data being captured and how the data will be analyzed. It is imperative that the study team is comfortable with the protocol and the design and is able to speak knowledgeably about the study objectives and procedures.
Identify Clinical Trial Sites and Investigators
To identify the clinical trial sites, you will need to look for places that have the resources and infrastructure necessary to conduct a clinical trial. Often, this includes facilities such as hospitals, medical centers, and professional healthcare offices.
Next, you need to determine whether these locations are appropriate for your study’s needs by evaluating their participation rate in past trials. Additionally, you need to factor in their overall ability to meet regulatory requirements.
The final step is finding investigators who are experienced with conducting trials, have the appropriate expertise, do not have any competing trials and are available for the trial based on the timeline.
After you have identified the ideal clinical sites for conducting your study and suitable team members, it’s time for them all to come together under one umbrella: You’ll want each site manager – a role that’s responsible for managing all aspects of a specific location – on board that’s participating in this project; they should be able to provide information on what they can offer both financially and logistically so that everything runs smoothly once recruitment begins.
Organize the Project Team According to the Study Needs
Every clinical trial has unique requirements, so it’s crucial to align the project team with the inherent needs of your study. In many cases, you’ll need the following, at a minimum:
- Project manager
- Study manager
- Clinical research associate (CRA)
- Quality control manager
Having an overarching project or trial manager in place creates a centralized point-of-contact and coordinator that will ensure all aspects of the project move forward in a controlled fashion. Generally, their skillsets need to contain exceptional organizational and communication skills, innovative and strategic thinking, budgeting expertise, and required technical knowledge within the lane of the clinical trial.
Train, Startup, and Manage Clinical Sites
With the right project team in place, it’s time to explore training, startup, and clinical study site management needs. Generally, this involves the creation of various protocols outlining requirements, expectations, and detailed timelines.
While every clinical trial is unique, these are typically the areas that need addressing:
- Establish a protocol for training clinical sites
- Establish a protocol for startup
- Establish a protocol for clinical trial site management
- Establish a protocol for closing down the site, addressing tasks like shutting down your employees’ access to systems and e-mail accounts
Within the startup phase, it’s wise to explicitly tap on the recruitment aspects of the equation. One analysis funded by the National Institutes of Health (NIH) and UK Medical Research Council (MRC) revealed that 45 percent of studies failed to hit the 80 percent threshold of their target sample size. Additionally, less than one-third ultimately achieved their target.
As for protocols for closing down the site, closure is typically planned in advance with enough lead time that you’re able to address any outstanding tasks before leaving. Make sure there are clear instructions from leadership about who will be responsible for closing out which aspects of the trial.
If possible, try to avoid having employees close things out themselves, as that can take them away from critical responsibilities and may lead to project delays.
Wrapping up contracts with vendors, suppliers, and contractors who were working with you at that location is also part of the equation. Similarly, having a plan for sending final invoices (if applicable), is essential.
Internal and External Stakeholder Management
ClinOps management is a critical component of trials and must be handled throughout the entire process. This includes internal and external stakeholder management.
Internal stakeholders are those who work within your company, while external stakeholders are those outside of your organization. Both groups have different expectations associated with their roles, including varying short-term versus long-term objectives, budget constraints, and technical expertise.
The main goal of managing both internal and external stakeholders is to ensure they all remain informed on issues related to the clinical trial. That ensures they can make informed decisions that align with the overall goals of your project.
Create definitive plans regarding updates and strategic communications, including a mix of time-based and milestone-triggered communications. Additionally, determine which communication channels are best for various types of information and specific stakeholders, clearly defining how they’ll be used and the reasoning behind those choices. That sets clear expectations within the broader plan, getting all involved on the same page.
Handle Compliance and Regulatory Issues
Clinical trials operations are highly regulated and subject to scrutiny from several agencies, including the FDA. As a result, ensuring compliance is crucial. Having a plan ensures there’s a path to success in this arena:
- Make sure the study is being conducted in accordance with applicable laws and regulations, such as those governing privacy, data protection, and informed consent.
- Review any reports of adverse events or other safety issues to determine whether they need to be reported to the appropriate authorities.
Manage All Fiscal Aspects of the Trial
The financial aspects of running clinical trials are often complex. As a result, it’s critical to outline the management of various parts of this equation in advance.
One area that needs defined processes is payments and reimbursements for study sites. Additionally, you’ll need to consider all other suppliers and vendors in the equation, allowing for improved budgeting, financial planning, and defined payment timelines.
Monitor and Follow Up with the Study Sites Throughout the Clinical Trial Process
To ensure that tasks are completed on time, you’ll need to monitor and follow up with the study sites throughout the clinical trial process. This is especially important for ClinOps, whose role is to:
- Monitor site performance and follow up with site managers if there are any issues
- Follow up with investigators to ensure they’re submitting data in a timely manner
- Follow up with study sites to ensure compliance with protocol requirements and regulatory guidelines
Perform Quality Assurance Activities
As you plan, you’ll want to ensure that quality assurance is part of the equation. Some of the steps are similar to those in the previous section, while others cover more requirements. Here’s an overview of tasks you’ll typically want to prepare for:
- Monitor clinical sites and investigators
- Ensure clinical trial data is accurate
- Ensure clinical trial participants are safe
- Ensure clinical trial sites are compliant with regulations and in good standing with the FDA (if applicable)
ClinOps are essential for any clinical trial. It involves everything from organizing the clinical trial to managing the patient list and monitoring participant data. It also includes planning for potential risks and providing support during the entire duration of trials. With ClinOps, staying on target is far easier, leading to better overall results.