Why paper should be your first choice for a medical device clinical trial
6 reasons to use paper in your clinical trial
You’ve been considering cloud EDC for your next clinical trial, but you are put off by the perceived challenges and costs of implementation and operation. You shudder at the thought of DIY EDC solutions like Clincapture or Medrio and don’t have the budget for Medidata.
For many early stage medtech startups, the first feasibility trial may involve only 1 or 2 sites and a relatively small number of patients. You would nominally assume that a paper CRF is cheaper and less trouble than cloud EDC.
So how can a smart CEO of an innovative medtech or drug startup make a smart decision for data management?
Let’s break down the pieces of a clinical trial and make a straw man for paper instead of cloud technology. We’ll let you be the judge.
The CRF – Case Report Form
A Case report form (CRF) is a specialized document for clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. While paper CRFs are still widely used, especially in smaller investigator-initiated studies, electronic CRFs (eCRFs) running on a cloud platform, delivered as SaaS, are gaining popularity due to the advantages they offer such as improved data quality, online query management and reporting on demand.
Objectives for CRF development
The key requirements for CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician.
Data should be organized in a format that facilitates and simplifies data analysis. Surprisingly enough many of the cloud EDC/ ECRF systems fall short on this side with the data extract to reporting being clumsy, slow and insecure, exposing sensitive IP and patient data on clinical operations staff Windows PC.
KISS in clinical trial design and how it impacts your bottom line
An important consideration in designing the CRF (whether or not it’s implemented in cloud EDC or not) is the number of data points that are collected. We believe that KISS – Keep It Simple Stupid principle holds here. Any good statistician (or physicist) will argue that the secret to proving a scientific hypothesis / clinical end point of your clinical trial is the sample size rather than the complexity of your CRF data model. Many articles have been written detailing how more data beats better algorithms.
But why does a simpler data model for your clinical trial yields the greatest return on your clinical trial investment? Having a big enough sample size allows the “data to speak for itself,” instead of relying on hundreds of irrelevant data points, unproven assumptions and weak correlations between demographics and clinical endpoints.
While you can invest a lot of time and money in protocol and CRF development, the smart alternative is to invest in online data collection, accessibility, and automated monitoring metrics which are more cost-effective and provide greater prediction accuracy. Conversely the temptation to collect a large amount of data points on subjects in the CRF will result in wasted resources in collecting and monitoring data that in many cases will never be used for analysis.
This article is an attempt to challenge (albeit satirically) some of the tacit assumptions that biomed executives make when they choose data management for their clinical trial.
Here are 6 reasons why you should stay with a paper CRF
Reason #1 is that you love paper. You love that touchy-feely thing of being able to hold on to a piece of paper and the security of knowing you have a hard copy that will never be lost. Large quantities of paper give you a feeling of power.
Reason #2 is paper quality. You rely on double-data entry to get it right the second time. You can read anyone’s handwriting, especially doctors at your site in Chicago. Monitoring multi-center trials with paper might be slow but you have the confidence of having hard copy and by the the time it arrives, you can take all the time you need to go over the paper in the convenience of your office.
Reason #3 is time. Let’s face it. You know that it takes time to get things right. All this fast moving cloud and mobile device stuff is for teenagers. Real men and women use hard copy and take the time to get it right. If its worth doing, its worth waiting for. Burning cash while you wait for paper to arrive is your investors’ problem, not yours. Let the founders worry about getting diluted on the next round of financing.
Reason #4 is money. Paper is cheaper than cloud EDC. Your clinical data management team can whip together an Access database application in no time or enable sites to enter data directly in Excel. Who cares how many trees and rainforests get destroyed? You are not going to pay Medrio $4000/month for a cloud solution when you can use paper.
Reason #5 is control. This is why you hired a CRO. It’s their problem to manage the paper, the data, the sites and the recruitment. You don’t want transparency to sites and subjects activity and compliance – better not to know. When its a piece of paper , 1 out of 100,000 pieces is just a needle in a haystack that no one will find. You feel comfortable knowing that your biostatistician has all your data on paper.
Reason #6 is tradition. This is the way your CRO and/or your biostatistician does it. If its on paper, its GCP compliant; if it’s in the cloud – who knows?
There is a lot of inertia and urban legend in the clinical trial industry but the 6 reasons above are 6 reasons for joining the folks who collect, monitor and manage clinical data in the cloud.
Ask us for a live demo and free price quotation to see how FlaskData.io can provide a highly cost-effective solution for your clinical trials using a fixed-price monthly subscription with unlimited users, sites and data.
Let us break some of your misconceptions.