There are several steps involved in clinical trial research, but one that cannot be replaced is ‘site selection and feasibility‘. Site feasibility tells whether a clinical trial can be practically executed or not. It also highlights whether a clinical project can be ethically conducted or not.
Site selection ensures that the right sites are chosen, along with the patient population, infrastructure, and expertise to carry out the trial. As per a study, real-world data can come in handy in predicting research sites for a clinical trial.
In this article, we will discuss site selection and feasibility tools that researchers and pharma companies can use to conduct successful clinical trials. We will also delve into top considerations for site selection and feasibility in this article.
Top-Notch Site Selection and Feasibility Tools
Which tools will help you to make better clinical decisions for site selection and feasibility? With factors such as environment, disease prevalence, diversity, finance, and infrastructure impacting site selection, which tools will drive site feasibility and selection forward? Let’s have a look:
1. Mapping Software
Mapping software is one of the frequently used site selection and feasibility tools. Some of the popular mapping and GIS (Geographical Information System) tools are Google Maps, QGIS, and ArcGIS. Mapping software helps to identify differences in population density, disease prevalence, age distribution, ethnicity, race, poverty, and access to care.
GIS and geocoding tools of mapping software allow researchers to link patient and population locations to local demographics, and analyze these relationships. Mapping helps to explore public health and epidemiology. Plus, it helps to detect data on health workers, hospitals, and risk populations.
Here’s what mapping software has to offer:
- Understanding of morbidity and overall health of a population
- Gather health variables
- Look for local risks
- Analyze access to care and its utilization
- Inefficiencies and gaps in healthcare coverage
- Choosing locations for samples – hospitals, outpatient clinics
Data gathered from the mapping software can be used to identify the right site and check its feasibility for conducting clinical trials. One other thing to note is that mapping software creates charts and graphs of patient population, demographics, health risks, disease prevalence, and more of the desired location.
2. SWOT
What could be a better tool than SWOT to check site feasibility? This is one of the best ways to identify potential challenges that may hamper the clinical trials. Researchers can identify internal and external factors that may harm the project and tackle them with effective solutions. Some of the threats include a restricted timeline for clinical trials, a lack of technical expertise, limited infrastructure and resources, and a complex regulatory landscape.
Furthermore, use the SWOT technique to highlight the pros and cons of a site, as well as to explore the outcome and possible scenarios of the clinical trial project. This tool can also be used to compare different sites and choose the one that aligns with the clinical trial project’s objectives. For example, if there’s a clinical trial to check the impact of social media on the mental health of teenagers. So, the ideal site to conduct these trials would be schools. The mode of trial can be a questionnaire or survey.
3. Modeling and Simulation Tools
The next tool for site selection and feasibility analysis is using modeling and simulation tools. This will help to create a visual representation of the project and test it virtually. For instance, researchers can make use of artificial intelligence and predictive analytics to garner the possible outcome of a project.
Also, VR and AR technologies can help to understand drug interaction with humans. Modeling and simulation tools can help to evaluate the impact, performance, and feasibility of the clinical trial project. Researchers can also use these tools to simulate the behavior of patients to external entities such as emissions, excessive workouts, diet, water, lack of social media, etc.
4. Surveys
Surveys give direct results about the capabilities of a site. It helps to gain first-hand information about the site’s physical features such as equipment, drainage, patient population, experts, and technologies. Surveys also help to scrutinize possible opportunities in the trials and the byproduct of it.
Let’s not forget that surveys are a source to identify the right demographics, future trends of the clinical trial project, and possible outcomes of the trials. So, the researchers are braced for what’s to come next and what to expect.
Considerations for Site Selection and Feasibility
A good fit site not only increases the chances of successful clinical trial research but also increases the revenue of the sponsors – pharma companies and research institutes. So, to get the most out of clinical trials, here are the top considerations for site selection and feasibility.
1. Regulatory Compliance and Ethical Concerns
The clinical trial site must adhere to stringent regulatory standards to assure patient safety and data integrity. For example, FDA (US Food and Drug Administration) rules for novel drugs and medical devices.
Choosing sites with a history of regulatory compliance minimizes the risk of delays and protocol deviations. To tackle ethical concerns, adhere to GCP (Good Clinical Practice) guidelines, get consent from participants, and get approval from IRB (Institutional Review Board)
2. Selecting Patient Population
Select a site that has access to a diverse patient population. Feasibility assessments analyze the accessibility and availability of the target patient population at each site. Factors such as disease prevalence, demographics, and patient’s willingness to participate are evaluated.
Here are some of the additional questions to ask before finalizing the patient population:
- Does the site have access to the target patient population and does the clinical database already contain the patient group?
- How to recruit the desired patient population? Are there any creative methods to do so?
- Is the clinical trial attractive to patients and is there a USP to get them to participate?
- Is the research promoting a study that is known to people or is fairly new and may pose uncertainty?
- What is the percentage of the diverse population in the clinical trial?
During target population recruitment, ensure that the participants are well aware of the risks they’ll be undertaking. Get written consent before beginning with the trials. Ensure that all the necessary details are shared with the patients in advance, to avoid lawsuits in the future.
3. Checking Site Capabilities
Another consideration for site selection and feasibility is to check site conditions and its capabilities. Will this site work for the trial? Site evaluation involves checking on its infrastructure, expertise available to conduct the trial, and resources. Access to laboratories, specialized equipment, and medical resources determine the site’s capabilities.
Also, check the site’s readiness to conduct the study in advance. How soon can you start? Another aspect that determines the site’s capability is the timeline to start and end the trial. Are there any other clinical trials that may begin during the same time?
Additionally, check whether the site has a system to gather and record data. Checking regulatory compliance of the site is also a part of ensuring site feasibility and selection.
4. Potential Challenges of Site Selection and Feasibility
It is important to assess the patient population available to the site, as well as the site’s historical recruitment rates, to determine if any challenges may prevent you from achieving your enrollment goal. Factors such as geographical location, prevalence of disease, and competition with other trials can make it difficult to meet your recruitment goals. If you can anticipate these challenges, you can take proactive steps such as offering incentives or increasing your recruitment efforts.
Evaluate the site’s infrastructure, staff, and workload to determine if it can meet the requirements of the study. If the site is over-staffed, it can cause delays, issues with data integrity, and compromise the study’s success.
In clinical trials, regulatory compliance is a top priority. It is important to analyze the site’s history of regulatory compliance, experience with regulatory compliance, and the current regulatory environment within its location.
Budgetary constraints can affect site performance. It is essential to assess the site’s financial stability and be able to manage its study costs. Without financial stability, unexpected financial constraints can cause delays, and resource constraints, and may even lead to site closure, compromising the entire trial.
Summing Up
Mapping software, SWOT analysis, modeling and simulation tools, and surveys are top-notch site selection and feasibility tools that pharma companies and researchers can use to conduct clinical trials. However, before selecting these tools, you must be aware of the challenges during site selection. Plus, check whether the tools align with the regulatory compliance and ethical norms. As a researcher check site’s capabilities and have a thorough knowledge of the target patient population beforehand.
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