Beyond The Feasibility Questionnaire: Rethinking Feasibility Assessments In Asia-Pacific Trials
In clinical trials, traditional feasibility is often assessed through a feasibility questionnaire means figuring out if a planned study can run, whether it’s practically possible, ethically sound, and likely to work at the specific site or within the region where it’s proposed.
Beyond the feasibility questionnaire, determining if a clinical trial will work is extremely important. Usually, people send out forms to different places to see if they can handle the study. That’s still helpful, but things are more complicated now, especially in the Asia-Pacific region. Since nowadays clinical trials are getting bigger and more complex, people running them need to think about more than just the basics. Stuff like local rules, culture, how good the site is, and what patients need all matter. This piece is about how figuring out if a trial is doable is changing in the Asia-Pacific region, why it’s so important, and how to make it better.
What is feasibility in clinical trials?
Feasibility in clinical trials evaluates a proposed study’s practicality and likelihood of successful and on-time completion. This feasibility assessment scrutinizes the achievability of key elements, including recruiting and retaining target participants, securing adequate resources (budget, trained staff, facilities, equipment), effectively executing the protocol, and meeting all regulatory and ethical requirements within the planned timeline. Ultimately, it determines if the study is realistic, sustainable, and capable of yielding valid, interpretable results, serving as a critical prerequisite to mitigate risks, avoid wasted resources, and protect participants.
Types of feasibility
- Protocol Feasibility: Can the study design be practically executed?
- Site Feasibility: Does the site have the right infrastructure, staff, and experience?
- Patient Feasibility: Are eligible patients available and accessible?
- Regulatory Feasibility: Are local approvals and timelines manageable?
- Operational Feasibility: Are logistics, vendors, and timelines aligned?
- Budgetary Feasibility: Is the trial financially viable at the site/region?
Software used in feasibility
- CTMS: for site tracking and trial management.
- Feasibility Platforms: for patient pool analysis.
- Survey Tools: for collecting site data.
- Site Databases: for identifying qualified investigators.
Feasibility is typically assessed during the planning phase of a trial and plays a pivotal role in site selection, protocol design, and overall study strategy.
Credevo offers a best-in-class, especially built feasibility tool that encompasses all the essential capabilities required for comprehensive site and PI evaluation.
To explore more about the feasibility of clinical trials, we invite you to read the article. click here.
Why is feasibility so important?
Feasibility assessments are not just administrative exercises; they are strategic tools that directly impact trial success.
Poor feasibility planning can lead to:
- Delayed site activation
- Low patient enrollment
- Protocol deviations
- Budget overruns
- Early site closures or trial discontinuation
Conversely, robust feasibility assessments can:
- Accelerate timelines
- Improve data quality
- Enhance regulatory compliance
- Strengthen sponsor-site relationships
- Ensure ethical and patient-centric trial conduct
- In short, feasibility is the bridge between protocol ambition and operational reality.
The limitations of traditional feasibility questionnaires
Despite their widespread use, traditional feasibility questionnaires often fall short in capturing the full picture. Common limitations include:
1. Static and generic feasibility questionnaire format
Most questionnaires are templated and fail to account for protocol-specific nuances or regional variations. They often ask broad questions like “How many patients with condition X have you treated in the past year?” without considering eligibility criteria, competing trials, or diagnostic access.
2. Self-reported data
Feasibility responses are typically self-reported by sites, which may lead to overestimation or underestimation of capabilities. Without validation, these responses can misguide site selection.
3. Lack of contextual insight
Questionnaires rarely explore cultural, socioeconomic, or healthcare system factors that influence recruitment and retention, especially in diverse APAC settings.
4. Limited engagement
Feasibility questionnaires are often transactional, with little opportunity for dialogue. Sites may feel like passive respondents rather than strategic partners.
Rethinking feasibility in the Asia-Pacific region
The APAC region presents unique opportunities and challenges for clinical trials. With its vast population, rising healthcare infrastructure, and growing investigator networks, APAC is increasingly attractive for global studies. However, its diversity demands a tailored approach to feasibility.
1. Country-specific regulatory intelligence
Feasibility must incorporate real-time knowledge of regulatory timelines, ethics committee processes, and import/export requirements. For example, timelines in South Korea may differ significantly from those in India or Indonesia. Understanding these nuances can prevent costly delays.
2. Cultural and language considerations
Patient engagement strategies must be culturally sensitive. In Japan, for instance, patients may prefer hospital-based care and value privacy, while in India, community outreach and family involvement may be more effective. Feasibility should assess not just numbers, but attitudes.
3. Healthcare system mapping
Feasibility should include an analysis of how patients access care. Are they treated in public hospitals, private clinics, or academic centers? What diagnostic tools are available? How are referrals managed? These insights help align protocol requirements with real-world practice.
4. Investigator motivation and bandwidth
Beyond experience, feasibility should explore the investigator’s interest, competing commitments, and long-term engagement potential. A motivated investigator with fewer competing trials may outperform a high-volume site with limited bandwidth.
5. Patient journey analysis
Understanding the patient journey from symptom onset to diagnosis to treatment can reveal bottlenecks and opportunities. For example, if genetic testing is required for eligibility, feasibility should assess access, cost, and turnaround time.
Innovative approaches to feasibility
To move beyond the questionnaire, sponsors and CROs are adopting innovative strategies:
1. Feasibility interviews and workshops
Engaging sites in structured interviews or feasibility workshops allows for deeper dialogue. These sessions can uncover hidden challenges, clarify protocol expectations, and foster collaboration.
2. Data-driven site selection
Leveraging real-world data (RWD), electronic health records (EHRs), and claims databases can validate patient availability and site performance. Predictive analytics can identify high-potential sites based on historical metrics.
3. Feasibility pilots
Running small-scale pilots or pre-screening campaigns can test recruitment assumptions before full-scale activation. This is especially useful for rare diseases or complex protocols.
4. Centralized feasibility platforms
Digital platforms that consolidate site profiles, regulatory intelligence, and feasibility metrics can streamline decision-making and reduce redundancy.
5. Patient and advocacy input
Involving patient advocacy groups in feasibility planning can provide insights into barriers, motivators, and communication strategies. This is particularly valuable in oncology, rare diseases, and pediatric trials.
Early engagement in a clinical trial
Early engagement in clinical trials involves proactively involving sites, investigators, stakeholders, regulatory and operational teams, and sometimes patients before formal study initiation to align expectations, build commitment, and identify potential challenges.
Key objectives
- Accelerating Site Activation
- Improving Enrollment Predictability
- Enhancing Protocol Understanding
- Strengthening Site Relationships
- Reducing Operational Risks
- Optimizing Resource Allocation And Boosting Data Quality
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Case example: Oncology trial in Southeast Asia
A global sponsor planning a Phase 3 ovarian cancer trial in the Southeast Asia region faced challenges in accurately estimating recruitment potential. Traditional feasibility questionnaires provided overly optimistic projections, yet previous trials had struggled in similar settings.
The results are presented below.
| Country | Avg. recruitment per site per month |
|---|---|
| India | -3 |
| Philippines | 4 |
| Thailand | 1 |
| Vietnam | 4 |
| South Korea | 2 |
| Russia | 4 |
By conducting feasibility interviews, mapping diagnostic access, and analyzing referral pathways, the sponsor discovered that many eligible patients were treated in non-trial centers or lacked timely biomarker testing. The protocol was revised to include centralized testing and patient navigation support, resulting in improved enrollment and reduced screen failure rates.
Conclusion for moving beyond the feasibility questionnaire
Feasibility is no longer a one-time task; it’s an ongoing dialogue between sponsors, CROs, investigators, and patients. In the Asia-Pacific region, where diversity is both a strength and a challenge, feasibility must evolve into a strategic, context-aware process.
By moving beyond the questionnaire and embracing data, dialogue, and design thinking, stakeholders can unlock the full potential of APAC trials. The goal is not just to find sites that “can” participate, but to build partnerships that “will” succeed ethically, efficiently, and impactfully.
Are you looking to go beyond the feasibility questionnaire to strengthen site selection and planning for your Asia-Pacific clinical trials?
If you’re looking to go beyond a basic feasibility questionnaire for your Asia-Pacific clinical trials, we can help. Our team strengthens site commitment and boosts enrollment through early engagement strategies. Fill out the form below to connect with us.