Investigator-Initiated research is exciting research.  It is attempting to answer questions asked by those at the coal face.  Who better than clinicians to know what problems face our patient day-to-day?

I have been involved with Investigator-Initiated research for over a decade and over that time, there are a number problems I see occur over and over.  All of them can be avoided by planning in the early stages of the project.

1. Trying to Do it All

Clinicians are extremely busy people and I am in awe of what they accomplish in 24 hours.  Trying to run a research project on top of everything else they have to do is Herculean.  Often they only realise this after about 6 months of trying to do it all themselves. Or with the help of a registrar, who is enthusiastic but just as busy and not as experienced.

Recruiting a research nurse or study coordinator upfront is ideal.  If you have one in your department already, most are usually happy to help out.  For larger projects, it may work out more cost effective to engage a coordinator to run the study for a fixed term.  Admin staff are a great resource and have the skills needed to help coordinate logistics, prepare HREC/Governance applications and keeping track of paperwork.

2. Not Writing a Protocol

It seems like a big undertaking but your protocol does not need to be fancy.  In fact, the simpler the better (if you do want a professional-looking protocol, there are lots of templates freely available on the internet such as here).  Some Ethics committees not insist on having a protocol before undertaking clinical research.  Even if they don’t, having all the information about the study in one document will make the project run more smoothly.  It is easier to explain the project to other staff or collaborators if you can email them a document with all the details.  It helps keep everyone on the same page and focused on the same endpoint.

Having a protocol makes analysing the data and writing the manuscript much easier.  Nothing is more time consuming than hunting through your emails looking for a conversation from two years ago as to why you chose this particular test over another.

3. Muddy Endpoints

If you build a clear endpoint, the data will come!  Or at least the data collected will inform the endpoint.  The endpoint should be SMART (specific, measurable, achievable, realistic and timely).  Otherwise, you are going to have a mess of data that is difficult to make sense of.  A good endpoint will assist with everything from planning the testing schedule to determining patient numbers to statistical analysis.

Side note: Objectives and endpoints are often confused.  The Objective is what you hope to achieve.  The Endpoint is how you know that you achieved it.  Both are required for a successful research project.

4. Too Many Objectives

It is reasonable to have some secondary, tertiary or even exploratory objectives built into your study.  It makes sense as undertaking a study is time consuming and expensive – you want to get as much out of the research study as possible.  However, if you have too many objectives, it can cause conflict with procedures to collect that data.  This can lead to incomplete or missing data and not enough information to answer any of your research questions.

Having a few clear, concise objectives that do not interfere with each other from the start of the project will give much more valuable information than trying to make the study a catch-all.

5. Unrealistic Timelines

Time is money even in the healthcare world.  Funding is limited so the longer a project takes the more it costs.  Research always takes longer than you expect.  I can count on one hand (or one finger to be more precise) the number of research projects I have been involved with that have been successfully completed earlier than expected.

Once a certain level of impetus is achieved, it becomes self-perpetuating.  People see patients on the study and they get excited about putting more patients on the study.  But getting the ball rolling can be hard.

Good planning can help with this.  Having a good protocol, engaging other department/service providers early in the process and having someone experienced with ethics/governance submissions helps get studies started quickly.   If you submit a robust application the first time, it is much easier to get approval quickly.  Trying to cut corners often has the opposite effect and ends up taking longer.


Affinity Clinical Research provides services such as protocol writing to Investigator-Initiated projects at a discounted rate.  We have experienced study coordinators that can assist with applications, patient recruitment and data management.  For more information, phone Business Development Manager, Krys Hiscock on 0422 550 279.



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