A number of things can go wrong during respiratory clinical trials. Among other concerns, trial sponsors might find they don’t have enough patients enrolled by a key deadline, or that the study drug didn’t make it to the investigative site in time to randomize a patient.
But one thing you should never have to worry about is whether investigative sites are capable of capturing accurate and reliable spirometry data from trial patients during every site visit.
In this blog, we’ll review how to prevent site personnel from getting bogged down by spirometry equipment that gets in the way of high-quality data collection. And, we’ll present tips on what to look for to ensure technicians can coach patients in performing the required maneuvers effectively, leaving you with valid and reliable spirometry data every time!
In traditional respiratory trials, investigative site personnel are burdened by having to calibrate the spirometer for capturing patients’ PEF, FEV1 and other PFT measurements, which, if done incorrectly can impact data quality. Calibrating the device can take up to 15 minutes and requires technicians to maneuver a 3L pump, replace filters, and take additional time to clean the equipment after every use, which can be difficult given the design of many spirometers’ handles.
Additionally, site personnel have to roll a large, heavy cart between exam rooms, deal with multiple wires that can impact ease of use, and find a position for it that enables the patient to perform the test effectively.
In order to overcome these challenges, look for a spirometer that keeps the needs of site personnel and patients in mind. Investigative site personnel prefer spirometers that are:
- Pre-calibrated to save time
- Patient-friendly with a pneumotach sensor
- Cordless and compact, for freedom of movement during testing
Additionally, if the equipment comes with biometric fingerprint access for fast, secure login and is easy to clean, it further simplifies the testing process and fits into the technician’s daily workflow with ease.
Coaching for Better Patient Performance
Proper coaching is the key to precise, repeatable data, as patients often have challenges performing maneuvers. But, traditional spirometers, which aren’t designed for use in clinical trials, are cumbersome and don’t help the technician to focus on whether the patient is breathing into the equipment correctly. This often leads to poor patient performance, which results in data that is unacceptable for analysis.
To overcome this, look for spirometers that provide an intuitive touch screen and graphical interface to optimize the user experience and ensure the highest quality data are collected. Leverage technology that uses smart icons to deliver quality feedback in real-time so patients can be guided to proper testing maneuvers and adhere to the latest American Thoracic Society (ATS) and European Respiratory Society (ERS) standards.
These features culminate to simplify the testing process for site personnel, which enable them to focus more time on coaching the patient for optimal performance, and less time on the equipment.
Clinical trials that collect respiratory endpoints are among the most expensive to conduct and recruiting patients is increasingly difficult and costly. Therefore it’s vital that data from all patients actively contribute to the overall success of the study and development program.
Unfortunately, not all spirometers are built with the clinical trial user in mind. Most evolved for use in clinical trials after originating as healthcare devices and, a result, introduce more burdens to site personnel and patients and can get in the way of high-quality data collection.
Clinical trial sponsors should consider using a spirometer that is purpose-built for clinical development and uses the latest technology to deliver highly precise, research-grade data. Only then can they have confidence as they evaluate the efficacy and safety of novel medical treatments during clinical development.
Learn how ERT SpiroSphere leverages advanced technology to overcome traditional spirometry challenges and enables site personnel to stay focused on the patient, which ensures the collection of precise clinical trial data.
Mike Worth is a Product Manager at ERT.