The way I'm used to assessing feasibility at the site level is to start by sending out a general interest email to potential principal investigators. I then email a feasibility questionnaire and a protocol to investigators who have expressed an interest in the study.

The questionnaire is fairly detailed and asks not only for information about numbers of potential patients within the allotted recruitment time scale, but also for information about the site resources, including clinical and IT equipment, staff availability and expertise, costs, recruitment resources (such as databases and access to patient interest groups), other trials in progress, and time scales for any necessary ethical and regulatory approvals.

I also make sure that the questionnaire emphasises the inclusion/exclusion criteria to ensure that potential investigators are fully aware of the study restrictions.

As regards achieving the recruitment targets, the answer is often 'yes' and sometimes 'no'. The complexity of the trial seems to be one of the most important factors    But the overall target tends to be met more often if I reduce the investigators' estimates by half to two thirds using criteria such as previous performance (if available) and previous trial experience. That way, a shortfall at some sites can often be overcome by asking other sites to recruit more patients.

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You do get the odd investigator who is obviously inexperienced and trying to get into clinical research. However, these are easily spotted from their answers on the questionnaires, which are quite detailed.

You have to bear in mind that there's a strong focus on doing clinical research here, and even experienced investigators are very keen to keep the research coming in.

Added to this, the experienced investigators are used to this approach because it's often used. Consequently, they tend to have the required information at their fingertips, and it's not a lot of work for them complete and return the questionnaires within the deadlines.

We reduce the figures the investigators give us because we want to make sure that the recruitment target is achieved on time, not because of the quality of the investigators.  Basically, we do this on the basis that it's better to give a conservative estimate that is achieved than make promises that aren't fulfilled.  After all, a study that runs over it's deadline can throw a whole development program off target with huge cost implications.

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This is the first posting for the discussion. Please add your comments below.

Following on from other discussion subjects brings me to post this new topic - which I have to say I do not know the answer to:

How do we do proper feasibility before starting a study.

CROs claim to do it when putting together proposals, but does anyone do it properly and more importantly does anyone's results of feasibility come true when they start the trial?

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I do not think it is at all common. It is usually done on a 'temptation' basis, i.e. a questionnaire that gets sites to complete usually in a biased way. They are effectively putting forward a sales pitch to the company doing the feasibility, how many sales pitches do you believe?

I am really interested by paid feasibility, how do you determine which sites to pay to do it?

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Is paid feasibility common?

Is this the difference between CRO and Pharma feasibility? Pharma have the time and resources to do it properly whereas CROs do it either as part of the bidding process or in a panic to find sites?

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A search of a database to identify individuals that meet a certain criteria

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I would think paid feasibility means doing a database trawl to identify how many patients the site has that would be eligible?

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I dont think so. When these is a fee attached, it makes a difference

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- Well designed feasibility questionnaire, to capture all basic information (Please note, most of the time these feasibility questionnaires are filled by site coordinator).

- The PI and team doesnt take much interest, as at this stage they are not sure whether the study will be awarded or not. In addition, top recruiters get feasibilities questionnares every day- Time constraints. This issue can be avoided by having paid feasibility questionnaires, where u get a time to speak with PI and discuss inclusion exclusion criteria, take time with site team and discuss infrastructure.

As pointed out, it should be done by someone experienced.

Kr,

Kapil Jhawar- Rxkapil@gmail.com

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I would always suggest doing it face to face or by phone and not by email or fax. Additionally let the senior staff do it as they know what they are looking for rather than the new starters/juniors who usually do it. The new starters can be over enthusiastic and underskilled to do it.

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Do you think that there could be some bias here - the investigators who reply to the questionnaires are the guys who have both the time and need to do the study? Might this explain why you have to reduce your estimates of recruitment by so much?

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What is a database trawl?

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