Clinical trial feasibility
Did you know that nearly 80% of clinical trials fail to meet their enrolment timelines, leading to significant delays and increased costs? By carrying out a clinical trial feasibility assessment, you can significantly increase your chances of meeting timelines and completing a trial within budget.
What is clinical trial feasibility?
Clinical trial feasibility is the assessment of whether a clinical trial can be conducted successfully and ethically within the scope of the protocol, on budget, within the specified time frame, and with the resources available.
It can also help determine if a trial is relevant to a particular patient population and can be recruited to protect participants from any unnecessary risks.
For the different clinical trial study phases and disease indications the feasibility assessment will differ.
The elements of clinical trial feasibility
Conducting a trial feasibility study involves several elements, each vital to determining whether a clinical trial should proceed.
Operational feasibility
Assesses whether the proposed clinical trial can be carried out in the current operational environment. Key considerations include:
Organisational strategic fit
- Does the trial fit with the organisation’s mission, vision and values?
- Is the organisation already participating in trials that compete for the same population?
- Are there sufficient organisational resources, such as staff, equipment, and facilities, dedicated to supporting clinical trials?
Patient population and recruitment
- Assess whether there are enough eligible participants who meet the trial criteria within a reasonable geographic area or clinical setting.
- Consider the barriers to achieving a trial’s participant recruitment target. For example, there may be competing studies that make recruitment more difficult. The inclusion and exclusion criteria of a clinical trial should also be taken into account, as there may be fewer eligible participants than expected.
- Consider whether there will be adequate representation from people from diverse backgrounds, such as vulnerable or traditionally underrepresented groups, and regional, rural and remote populations. If not, consider using the tele-trial model.
Staffing
- Consider the staff required to conduct the clinical trial. Do they have the appropriate qualifications and experience and time to undertake the clinical trial? If staff are to be recruited to the trial, will recruitment be able to be done in a timely manner that doesn’t affect the trial timeline or budget.
Facilities and capabilities
- Assess capability relating to drug storage, processing of biological samples, on-site pharmacy and access to scanners.
- Are these capabilities onsite or do they need to be procured?
- Are the health service departments supportive and, if required, do they have capacity to support the trial?
Data management and monitoring
- Evaluate the capability to collect, manage, and report trial data accurately, as well as ensuring adequate monitoring to maintain data quality and compliance with protocols.
Technical feasibility
Assesses whether the relevant technology and expertise are available to conduct the clinical trial.
Technology
- Assess the technology to be used, such as e-Case Report Forms (eCRF), and tools for randomisation. This will help to anticipate any problems and explore possible options to overcome any challenges.
Expertise
- Consider whether your team has the necessary skills and expertise to utilise the technology required. Additional training may be required.
- Consider if collaboration or partnership agreements are needed to support the teams contribution of diverse skill sets in the delivery of your trial.
- Are there relevant team members at the trial’s sites who have expertise to conduct activities relating to the trial?
Budget and timeline feasibility
Assesses whether the budget and timeline are appropriate.
Budget
- Assess if the clinical trial is financially viable to conduct the trial and whether it can be done within budget.
- Utilise a budget template tool to assist in calculating staffing costs, on costs and infrastructure charges.
Timeline
- Assess whether the trial can be completed within the specified timeline and budget, taking into account potential delays, resource constraints, and financial considerations.
- Utilise pilot data or previous recruitment examples, to give judgment on whether the timeline will be possible.
Regulatory and ethical feasibility
Assesses if the research complies with relevant laws and regulations.
Regulatory and ethical considerations
- Consult with the trial’s lead organisation’s governance office to determine the feasibility of obtaining regulatory approvals and Human Research Ethics Committee (HREC) clearance within the desired timeline.
- Consider if the trial site(s) has the ability operationally and facilities to comply with the protocol and investigator brochure or equivalent.
Including consumers in clinical trial feasibility
Including consumers in clinical trial feasibility is essential as it ensures the research is designed and conducted in a way that is relevant and practical from the participants’ perspective.
Here are several key reasons as to why consumers should be included in the early planning stage:
- Understanding patient interest: Engaging with potential participants allows researchers to gauge interest in the trial. This early interaction helps assess if there is sufficient enthusiasm within the target population to support enrollment.
- Identifying barriers to participation: Consumer feedback can reveal potential barriers that may affect trial participation, such as logistical challenges, time constraints, or concerns about trial procedures. Identifying these barriers early enables researchers to proactively address them.
- Assessing patient availability: Pre-trial engagement helps researchers understand the availability of potential participants. This insight is crucial for estimating recruitment timelines and determining the feasibility of meeting enrollment targets.
- Exploring patient preferences: By connecting with consumers, researchers can gather insights into patient preferences regarding study design, visit schedules, and communication methods. Aligning the trial structure with patient preferences enhances feasibility and improves participant satisfaction.
- Building relationships with stakeholders: Establishing relationships with consumer communities, patient advocacy groups, and healthcare providers before the trial fosters collaboration and support. These stakeholders can provide valuable input and assistance throughout the trial process.
- Tailoring recruitment strategies: Early engagement enables researchers to develop tailored recruitment strategies based on consumer feedback. This approach increases the effectiveness of recruitment efforts and optimises resource allocation.
- Enhancing protocol development: Consumer input before the trial aids in refining the study protocol. Researchers can incorporate valuable suggestions and address concerns raised by potential participants, resulting in a more robust and patient-centred trial design.
Engaging with consumers before initiating a clinical trial empowers researchers to gather essential insights that are crucial for assessing feasibility effectively. This proactive approach not only optimises trial planning but also enables researchers to anticipate and address potential challenges, ultimately laying a solid foundation for successful recruitment and execution of the trial.
Feasibility checklist and tools
A feasibility assessment tool helps assess whether or not a trial is feasible. There are a number of feasibility assessment tools which have already been developed:
- CT:IQ tri part Feasibility Assessment tool
- Feasibility Template – Study (for study-related considerations such as protocol, study phase, etc)
- Feasibility Template – Site (for site-related considerations such as staff, space, equipment)
- Feasibility Template – Sponsor (for sponsor-related considerations such as contact details, study vendors, and sponsor requirements)
- UCSF Clinical Trial Feasibility checklist form
- NSW South Western Sydney Local Health District
FAQs about clinical trial feasibility
Clinical trial feasibility is vital as it assists research teams whether or not to go ahead with a trial. It identifies risks of trial viability which can potentially be mitigated and increase the likelihood of the trials success.
Factors to be considered include organisational fit, patient population (availability and eligibility), site capabilities (expertise, facilities), logistical aspects (transportation, storage), regulatory requirements (approvals, ethics), operational considerations (data management, monitoring), and risk assessment.
Patient population assessment involves determining the number of eligible patients meeting study criteria within the target geographic area or clinical setting, often using patient databases, disease registries, or medical records.
Buse et al’s 2023 publication provides a framework for assessing site readiness. It recommends the following core assessment categories:
- research team
- Infrastructure
- study management
- data collection and management
- quality oversight
- ethics and safety.
Feasibility includes assessing regulatory approval processes, ethics committee requirements, and compliance with local laws governing clinical research.
Timelines and budget are estimated based on patient recruitment rates, site activation timelines, data collection and analysis needs, and resource allocation for study conduct.
Common challenges include difficulty in patient recruitment, limited site availability or expertise, regulatory delays, logistical constraints, and budget limitations.
Feasibility assessments provide critical insights that can influence study design, site selection, budget allocation, and timeline planning. Addressing feasibility issues early can optimise study execution and reduce risks of delays or failure.
Stakeholders may include clinical researchers, study sponsors, regulatory experts, ethics committee members, site investigators, and operational staff responsible for trial management.
