Why paper is not an option for your medical device clinical trial
November 5, 2018
This is a piece David wrote a couple of years ago originally entitled “Why you cannot afford to use paper in your first Phase I efficacy trial for your medical device”. David’s premise is that people do not like change.
People do not like change.
We have heard the axiom change is good all throughout our lives, but the fact remains that people, as basic animals, are hesitant to embrace change and take on new endeavors. Human beings are creatures of habit, and are more often than not content within their comfort zones, regardless if they are losing out on valuable experiences, money, etc.
Studies have even been conducted revealing how opposed to change we creatures of habit are. People will sacrifice the opportunity to enhance their quality of life because it may require a change to their routine, or learning new habits, and humans hate that.
In the clinical research industry, paper-based data capture methods have been used effectively, and for decades. Paper is the norm, and many a successful study have been conducted using this such method. While paper is the traditional, tried-and-true method for data capture and management (especially during Phase I efficacy trials of medical devices, which typically have smaller subject counts and shorter study durations), that does not mean it is the best method available, or that it is the most cost efficient.
In fact, the last point is no longer true whatsoever.
There are small CROs and clinical study sponsors that are so used to paper data capture for small medical device clinical trials, that they oppose the change to electronic data capture (EDC). However, while some early objections were valid in opposition of EDC for Phase I, they no longer ring true.
EDC has been implemented for clinical studies, particularly in later-stage trials such as Phase III studies with thousands of patients, for a little over 15 years. By now, many of the concerns regarding the ample paper vs EDC debate at any clinical study stage are now moot.
Today we are going to touch upon why one cannot afford to use paper for Phase I efficacy trials for medical devices, and will greatly benefit from the change to cloud EDC.
Time savings on amendments
During Phase I efficacy testing, pharmaceutical companies are getting their feet wet for the first time while developing a new drug. This is the stage with the highest level of patient risk, and EDC quickly thwarts paper-based systems in this realm.
Phase I experiences the most amendments to drug administration frequency, dosing, and amendments to trial need to always be compliant with the FDA’s 21 CFR Part 11. Vendor validated EDC systems are easily augmented to comply with changes to FDA regulations, and have measures in place within the software, to monitor and ensure that study SOPs are compliant every step of the way.
Paper simply cannot do that.
Also, amendments, whether at the hands of a regulatory agency or medical device company, tack on months of extended study time and costs. According to a study done by Tufts University, a single amendment using paper-based systems increases study time by an average of 2 months and costs the study over $400,000. The study also showed that on average, each study experiences 2.3 amendments to protocol.
The time savings, and thus cost savings, on amending SOPs is enormous for studies conducted using EDC, as the software and eCRFs can be augmented in the blink of an eye. Also, if further amendments are required down the study chain, they are made just as quickly.
Real-time data monitoring of cleaner, faster study data
Using EDC instead of paper affords clinicians and data monitors real-time access to data capture. Also, cloud EDC like Clear Clinica is mobile accessible, so all members of the study team can remotely access data using mobile devices like smartphones or tablets, the very second it is entered. This is especially valuable for Phase I trials, because these have the highest risk to study subjects, as they are the first in line to test the drugs.
Even though Phase I efficacy trials do not typically involve hundreds of subjects, adjustment to treatment protocol and dosing need to be made with as little delay possible. Patient safety is a top priority for clinical studies.
For studies using patient reported outcomes (ePRO), EDC wins over paper-based systems every time. When a patient enters data into the system, risk-based monitoring protocols within the software inform study teams whether or not a patient is at risk for harming their health if they proceed at the administered dose. This allows clinicians to make adjustments to dosage, or cease the subjects participation in the study, before their health is harmed if the dosage is too high or if grossly adverse effects are experienced by the patient.
Again, paper simply cannot perform in this manner for Phase I efficacy testing.
Further, using EDC for Phase I is smarter than paper regarding cleaner, error-free data. Human error occurs. Even the brightest of clinicians and data monitors will make a mistake when entering data, or miss an incomplete form. Especially being that Phase I is the first stage for drug testing, the cleaner data is from the get-go the smoother it will be for conducting Phase II and III of the trial.
The EDC system software can be set so that eCRF values are standardized, so that when data is captured and entered into the eCRF fields error notifications are displayed when data is outside of the field parameters. The same goes for submission of eCRFs that are incomplete. EDC systems like Clear Clinica are programmed according to data parameters set by sponsor or CRO staff for each trial’s needs. Also, once the eCRF parameters are set, they can be modified if needed according to amendments, but otherwise they remain uniform, saving time during the entire study cycle’s lifetime.
You cannot afford to not use EDC
Nobody will deny that the up-front costs of implementing cloud EDC for Phase I will cost more than a paper-based system. However, not doing so because of that reason is myopic and short-sighted. The safety, risk, time, and data quality savings are well worth the initial investment, as the system is not going to be used for only one study.
Down the road, after incorporating an EDC for Phase I, and using it for II and III, the money spent is quickly offset by the costs saved on time, IT personnel expenses (EDC vendors have support staff to solve whatever issues may arise), and data assurance, amongst others. The sooner you switch to EDC, the sooner future studies will save your CRO or sponsor organization money, and mitigate Phase I patient risks.