Clinical Operations

How to think like a patient in clinical research ?

Put yourself in the patient’s shoes

As a clinical professional , you are involved in the clinical trial management in one way or another, one of your primary responsibilities are to take care of the patient’s safety and the data integrity .

In order for the clinical trial to be a success, subjects who meet the protocol requirements need to be included by the investigators, right?

Let’s say that the study is focused on oncology, which targets a patient population with an average age of around 65 years old ( median age of a cancer diagnosis is 66 years

Some questions that you may ask about this population are:

Why use a digital device to collect patient quality of life questionnaires ? How many patients are digital friendly ? How many patients will need a reminder for another login and password ? How many patients will complete the questionnaires alone, as it is usually required ?

Collection of quality of life data :

The objective is to collect quality of life data directly from the patients. What if 50% of this data is missing, is it worth the effort (and the costs) to even use a digital device for this patient population instead of a paper version ?
What if the digital data system is hacked ? ( true story)

As we should honestly consider that this patient population is quite fragile because of the burden of the disease itself ,and the stress from multiple appointments ( doctors, nurses, study coordinator, lab, radiologist….), treatments, long journeys etc. These are enough for the patient to handle

The question is :
If you were the patient involved in the study, do you think you would be able to complete all these questionnaires through a digital device, at each visit during the study ?

Now, imagine a study which involves pediatric subjects ( from ages 6 to 18) diagnosed with Diabetes type I who have to record their diet , their quality of life in a trial , using digital devices. This could be an asset , right ?
What if you put the patients’ shoes on sometimes, it could be an important factor in the success of the collection of the data ?

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