Feasibility: Can Your Site Run This Study?

Part of Clinical Research Coordinator (CRC) Training: Study Start-Up at the Site.

About 5 minutes. Free, in your language, no account needed.

Why this matters

The worst studies to work on are the ones a site should never have accepted. Enrollment targets that were never realistic, procedures the site cannot perform, a coordinator already running four trials.

Feasibility is where that is prevented. A sponsor asks whether your site can run a study. An honest answer protects your participants, your team and your site's reputation. An optimistic answer costs you two years.

What a feasibility questionnaire asks

Before selecting sites, a sponsor sends a feasibility questionnaire. It typically asks about:

• The size and characteristics of your patient population for this condition.
• How many participants you believe you could enroll, and over what period.
• The investigator's experience in the therapeutic area and in trials.
• Research staff numbers, experience and availability.
• Facilities and equipment, including storage for investigational product.
• Laboratory access and accreditation.
• Competing trials that would draw from the same patients.
• Experience with the electronic systems the study will use.
• Ethics committee arrangements and typical turnaround times.

The sponsor will check your answers. Overstated numbers are usually detected, and they damage trust before the study even starts.

Answering honestly

Base your enrollment estimate on data, not hope. Count how many patients with this condition your service actually saw last year. Apply the study's main eligibility criteria to that count. Then apply a realistic consent rate. The number you are left with is your estimate.

A useful discipline: write down the arithmetic. If you cannot show how you got to the number, the number is a guess.

Account for competing trials. Two studies recruiting from the same clinic do not enroll twice as many people. They split the same population, and the second one usually loses.

Be realistic about staff time. Ask who will do the work, on which days, and what they will stop doing. "We will manage" is the sentence that precedes most failed sites.

Say what you cannot do. If the protocol requires an assessment your site cannot perform, say so at the questionnaire stage. Sponsors can often arrange an alternative. They cannot arrange one after a participant has already missed it.

What the site should ask the sponsor

Feasibility runs both ways. Before your site agrees, get answers to these.

• What is the visit schedule, and how long is each visit for the participant and for staff?
• Which procedures are required, and does the site have to perform them itself?
• What are the eligibility criteria most likely to exclude our patients?
• What systems must the site use, and what training is provided?
• How is the investigational product supplied and stored, and who may dispense it?
• What is the payment structure, and does it cover screen failures?
• What is the expected enrollment window and total study duration?

The answers determine whether the study is workable at your site. Ask them before the enthusiasm sets in.

The pre-study visit

If your answers are promising, a representative of the sponsor or contract research organization will usually visit. This is called a pre-study visit or site qualification visit.

Expect them to:

• Interview the investigator, coordinators, pharmacy and laboratory staff.
• Tour the clinic, the storage areas, the laboratory and the archive.
• Look at how investigational product would be stored, including temperature control, monitoring and restricted access.
• Ask to see equipment calibration records.
• Review your standard operating procedures and staff qualifications.
• Ask how consent is normally taken and how adverse events are identified.

Prepare for it as you would for an inspection. Have your calibration records, SOPs, CVs and training records to hand. If something is missing, say so and say when it will be fixed, rather than looking for it while the visitor waits.

Honest self-assessment

Before your site says yes, four questions.

1. Do we have the patients? Not in principle. In the clinic, this year, after eligibility.
2. Do we have the people? With names, hours, and a named backup for every critical role.
3. Do we have the capability? Equipment, storage, laboratory access, systems, and the skills to use them.
4. Do we have the time? A protocol with 14 visits and 6-hour assessment days is a different commitment from one with 4 short visits.

If two of the four are weak, the honest answer is either no, or yes with a stated condition.

In practice

Vantis Pharma sends Northside Clinic a feasibility questionnaire for VT-201 and asks for an enrollment estimate.

Dr. Osei's first instinct is 60 participants. Nadia does the arithmetic instead. The practice saw about 900 patients with hypertension in the previous year. Applying the study's age range and the exclusion for a common co-existing condition leaves roughly 300. Of those, a realistic proportion will be reachable, interested and willing, and the practice already has one other trial recruiting from the same list.

Her estimate is 22 over twelve months. She writes down the arithmetic and sends it with the answer.

The sponsor selects the site. Two years later Northside has enrolled 25 and is described in the sponsor's internal summary as a reliable site. A neighboring practice that promised 70 enrolled 9 and was closed early.

The site that promises less and delivers is the site that gets asked again.

Key takeaways

• Feasibility protects the site as much as the sponsor, because a study a site cannot run damages participants, staff and reputation.
• Enrollment estimates should be arithmetic, not optimism: last year's real patient numbers, minus eligibility, times a realistic consent rate.
• Competing trials divide the same patient population rather than adding to it, and must be declared.
• Feasibility runs both ways, and the site should ask about visit burden, required procedures, systems, product handling and payment before agreeing.
• The pre-study visit should be prepared for like an inspection, with calibration records, SOPs, CVs and training records available.