Study feasibility assessments: do they really matter?

Posted on Aug 14, 2014 by Kelly Gleason in Research, Study Management

Unmet recruitment targets are costly and can have a negative impact on your site’s reputation. A robust study feasibility could help you set achievable recruitment targets- how many patients you can realistically recruit and manage on a study. A thorough study feasibility assessment could save you and the Sponsor a great deal of time, money and disappointment down the line.

The Sponsor will be interested in the overall study feasibility from a scientific, ethical and operational perspective. Is the study answering an important question? Is it ethically planned and thought through? Is the study do-able in a given geography (i.e. UK)?

In addressing study feasibility, the Sponsor will focus on such things as regulatory processes, the ethicality of the study design, the availability of the patient population, the experience and capacity of study teams and any operational challenges which may delay or restrict recruitment and management of participants on a trial.

In order to ensure sites are suitable to manage a study, the Sponsor may send the site a site feasibility assessment. Completion of this form is often delegated by the PI to the research nurse or practitioner (*do not forget to include this skill in your repertoire of research skills). If you aren’t new to an organisation and have experience of managing studies there, you likely have the knowledge necessary to do a study feasibility assessment, so carpe diem! Use this opportunity to expand your skill set and build relationships with other departments.

Here are some of the questions a feasibility assessment may ask:

What is the PI’s experience in clinical research? Does the PI have adequate time to dedicate to the study?

Do you have adequate staff and what is their experience in managing trials?

Have you met recruitment targets for other similar studies?

How many patients do you see a year that would be eligible? How many patients can you realistically recruit in six months? One year?

Do you have any competing studies?

What is your recruitment strategy? What challenges do you foresee?

Does the site have all the necessary equipment to adhere to the protocol? Can the organisation carry out all tests and procedures required in the protocol?

Are supporting departments staffed and equipped to adhere to the protocol i.e. pharmacy, pathology, imaging, tissue bank, ophthalmology etc?

Does pharmacy have adequate space and equipment to safely store and prepare the drug?

Can tissue bank or pathology prepare tissue samples as per protocol requirements?

Are there any training needs of staff involved in the study?

Do you have the right lab or sample preparation area to efficiently process and store samples as per protocol?

Are the labs accredited and do they have certificates to demonstrate this?

What archiving arrangements have been made?

When reviewing the Sponsor’s assessment of the site, you may simultaneously be identifying what you might need or do as a site to be able to deliver the demands of the study. This is a two way conversation and could be a great opportunity to help your organisation improve the service it offers.

Likewise, if you come across something in the protocol that looks like it will be impossible to deliver on, due to maybe service restrictions, ask if it is a necessary part of the trial. If it is a challenge for you it may be a challenge to other sites as well. It may also be a negotiable step in the protocol and removing it would still allow them to answer the research question. They may prefer to have you as a site than have the result you can’t deliver on.

Some things you might want to think about for yourselves as a site:

Are the timelines possible, can you safely do what the protocol is asking and would a patient be happy with these requests and timelines? Do you foresee any barriers to recruitment here?

If you have access to the budget, does it seem adequate? Has anything been over looked such as archiving costs?

What monitoring schedule and times have been agreed? (This is often costed by the hour so if they cost for 8 hours a month and your monitor needs to come for an entire day every two weeks, this will have costing implications so it is good to know what was decided in the beginning).

Will participants receive payment? If yes, how will they receive this payment? Could this be a barrier to recruitment?

Is there a set up fee to cover administrative duties required in setting up the trial?

What will your team need to carry out this trial? Will they have any training needs? Will they require access to equipment not used in their organisation? Equipment will sometimes be provided such as an ECG machine or a high-speed centrifuge, so don’t be shy to ask.

What will the Sponsor supply? What might you have to supply? Think lab kits, packaging material, CRF binders, lap tops, pharmacy essentials. Could you supply these if the Sponsor does not?

I’ve said it before but I’ll say it again, completing a site feasibility assessment is a great opportunity to:

develop your skills in clinical trial planning
create an open, honest dialogue with the Sponsor
establish clear expectations for both sides

When your team works on a study where the feasibility has been well carried out, you start to see the benefits of great planning and you realise these feasibility things…maybe they really do matter.

What are your experiences of carrying our feasibility assessments? What top tips can you offer to anyone taking on this task for the first time?

If you are new to clinical research and want to learn more about the day to day management of a clinical trials from Ethics submission to study close down, you might want to check out Clinical Research: Getting Started!