Research sites are still asked to complete long feasibility questionnaires filled with information sponsors may already have. The answers often combine reusable facts, rough forecasts, and study-specific judgments in one document.

That creates more work without always producing better feasibility decisions.

A stronger approach uses existing data for questions that have already been answered, then asks sites only for current information that cannot be found elsewhere. The feasibility process becomes more focused on what matters now:

• Does the site have access to the right patients?
• Can those patients realistically be recruited?
• Does the site have the staff and capacity to conduct the study?
• Which protocol requirements may create problems?
• What support would make the study more practical?
• Is the investigator interested enough to prioritize it?

The feasibility questionnaire still has a role, but it should become shorter, more targeted, and part of a broader conversation with the site.

Why Do Traditional Feasibility Questionnaires Produce Weak Data?

Many questionnaires ask sites to provide a wide range of information, from investigator credentials and facility capabilities to estimated patient counts and expected enrollment rates.

The problem is that these questions do not all require the same kind of answer.

Some information changes rarely and can be stored for reuse. Other information changes quickly and requires a current response. Some questions ask for objective facts, while others require the site to make a prediction with limited information.

Combining these categories creates data that may look complete without being consistent or current. Sites may also interpret the same question differently, which makes responses difficult to compare.

A site might report the number of patients in its database, the number treated in the past year, or the number it believes could qualify. Each answer may be reasonable, but they do not mean the same thing.

Which Site Information Should Be Reused?

Research sites repeatedly provide the same basic information to different sponsors, CROs, and technology platforms.

Reusable information may include:

• Investigator qualifications and therapeutic experience
• Site location and contact information
• Facility and equipment capabilities
• Laboratory, pharmacy, and imaging resources
• Previous research experience
• Standard contracting and regulatory information
• Technology and connectivity capabilities
• Typical staff roles and organizational structure

This information should be maintained in a shared site profile and updated when something changes. It does not need to be recollected through every study questionnaire.

Reusing verified data gives sites more time to answer the questions that require current judgment. It also gives sponsors more consistent information across studies and reduces the chance that different versions of the same answer will circulate.

A reusable site profile will still need governance. Someone must confirm when the information was last reviewed, which fields require regular updates, and who is responsible for maintaining them.

What Can Only the Site Answer?

Some of the most important feasibility questions depend on current local knowledge.

A database may show that a site has performed well in an indication. It may not show that several coordinators recently left, the investigator is leading a competing study, or the relevant patient population has shifted to another care setting.

Sites are best positioned to explain:

• Current staffing and workload
• Investigator interest
• Competing studies
• Access to specific patient populations
• Active referral relationships
• Local treatment patterns
• Operational concerns with the protocol
• Expected startup constraints
• Support needed to conduct the study

These questions deserve more attention than information already available in a sponsor’s systems. They also benefit from direct dialogue because the strongest answer may require follow-up.

A checkbox can confirm that a capability exists. A conversation can show whether the site can use that capability under the conditions of the proposed study.

Why Are Site Patient Estimates So Difficult to Use?

Feasibility questionnaires often ask sites to estimate how many eligible patients they can recruit within a set period. These projections can influence site selection and country strategy, but they are frequently based on different methods.

One site may search an electronic health record. Another may rely on memory or recent clinical volume. A third may include patients referred from outside practices. Some estimates account for every major eligibility criterion, while others reflect only the diagnosis.

Patient availability also differs from patient recruitability. A patient may meet the clinical requirements but be unable or unwilling to manage the visits, procedures, travel, time commitment, or other demands of participation.

Sponsors can make site estimates more useful by defining the question clearly:

• What time period should the site review?
• Which eligibility criteria must be considered?
• Should the estimate include only patients currently under care?
• Are referral-network patients included?
• How many patients could be identified, screened, and enrolled?
• Which assumptions support the estimate?

These distinctions make the answer easier to interpret and compare with other evidence.

How Can Existing Data Improve the Questionnaire?

Sponsors already hold information that can reduce the number of questions sent to sites. Previous study performance, startup timelines, enrollment rates, retention, data quality, and protocol deviations can all provide relevant context.

Real-world data can add estimates of disease prevalence, treatment patterns, geographic distribution, and the effect of proposed eligibility criteria. Public registries can help identify competing trials and nearby research activity.

These sources should shape the questionnaire before it reaches the site. If historical data already shows strong experience in the indication, the sponsor can ask what has changed since the last study. If patient data suggests a much smaller population than the site projects, the follow-up can focus on referral sources or local factors that explain the difference.

The objective is to use available evidence to ask better questions. This reduces repetition and makes the site’s time more valuable.

What Role Can AI Play in Feasibility Questionnaires?

AI can bring together data from site profiles, historical studies, real-world sources, trial registries, and previous feasibility responses. It can identify missing information, flag conflicting answers, and suggest study-specific follow-up questions.

It can also tailor the questionnaire to the site. An experienced oncology center may receive different questions from a community practice conducting its first study in the indication. A site with current verified equipment records should not need to confirm every capability again.

AI can also compare site enrollment projections with historical performance and external patient estimates. A large difference does not necessarily mean the site is wrong. It creates a reason to ask how the estimate was developed.

Human review remains important. Context from the investigator, coordinator, or local health system may explain patterns that are not visible in structured data.

What Does a Better Feasibility Questionnaire Look Like?

A modern feasibility questionnaire should be built around decisions the study team needs to make.

A more focused process could include:

1. Prefill known information. Start with verified site data, previous performance, and relevant external evidence.
2. Ask the site to confirm changes. Give the site an opportunity to update staffing, capabilities, investigator status, and other reusable information.
3. Focus on the protocol. Ask about the eligibility criteria, procedures, visit schedule, technology, and operational demands specific to the study.
4. Separate patient counts from recruitment forecasts. Request the assumptions behind each estimate and define the population and time period clearly.
5. Include questions about current capacity. Account for competing studies, staff availability, and expected startup constraints.
6. Create a path for discussion. Use the written response to identify where direct follow-up will add value.

This approach may produce fewer answers, but those answers will be easier to interpret and more relevant to site selection.

How Can Direct Dialogue Improve Feasibility?

Questionnaires are useful for collecting structured information across many sites. They are less effective at explaining uncertainty, tradeoffs, and local context.

Direct conversations can reveal why a site expects a high screen-failure rate, which procedures patients may resist, or how referrals move through the local health system. They can also show whether the investigator has reviewed the protocol closely and whether the study fits the site’s priorities.

Dialogue should be targeted rather than added as another standard step for every site. Data and questionnaire responses can identify which sites and issues need deeper discussion.

This combination preserves the efficiency of structured data while making room for the context that feasibility decisions require.

How Does a Better Process Benefit Sites and Sponsors?

Sites spend less time repeating basic information and more time evaluating whether they can conduct the study. That creates space for more thoughtful feedback on recruitment, patient burden, workflow, and protocol execution.

Sponsors gain information that is easier to compare and more closely tied to current conditions. They can also identify potential problems earlier, before sites are selected and startup begins.

The change supports a better working relationship. Sites can see that their time and existing data are being respected, while sponsors receive clearer evidence for feasibility decisions.

From Data Collection to Decision Support

The traditional feasibility questionnaire tries to collect everything in one place. A stronger model separates reusable information, current operational conditions, and study-specific judgment.

Existing data can answer many questions before the site is contacted. A shorter questionnaire can then focus on what has changed, what the protocol requires, and what only the site knows. Direct dialogue can clarify the issues that matter most.

The future of feasibility is not questionnaire-free. It is a process in which every question has a clear purpose, every answer has enough context to be useful, and sites spend their time on information that can improve the study plan.

Continue the Conversation at SCOPE Summit Europe

Site selection, clinical trial feasibility, patient recruitment, and practical ways to improve sponsor-site collaboration will be important areas of discussion at SCOPE Summit Europe. Leaders from across clinical research will explore how better data and more focused site engagement can support stronger study planning and execution.

Learn more and register for SCOPE Summit Europe.