Benefits of the paperless approach in clinical trials. Key trial indicators that are improving
The main trend in clinical trial development is the use of electronic data management (paperless approach). This applies to almost all components of a clinical trial. For example, eCRF and EDC systems are being introduced instead of paper CRFs, ePRO instead of patient’s paper diaries, and eConsent to replace consent forms.
There are many examples of these types of tools and most of them are already being actively implemented in projects. However, not all sponsors and CROs have switched to electronic systems yet. There is a number of reasons for this, for example, the higher cost of eSource compared to paper, difficulties in the initial stage of usage, etc.
So, in today's article, we will discuss whether the paperless approach is an effective alternative and which specific indicators of clinical trials it improves.
What does «paperless» mean in a clinical trial?
Electronic resources in clinical trials are introduced as a more convenient and effective alternative to paper ones. Initially, this took place in large-scale clinical trials (phase III and post-marketing). In these projects, the data volumes are large, and it was illogical to collect them on paper, then analyze and transfer them into a single database. In addition, monitoring and controlling study dynamics is also complicated. This led to numerous errors and delays, and, as a result, losses, and complication of the product’s entry into the market.
Therefore, to simplify and automate most of the processes, electronic systems were introduced. With their help, it is possible to conduct studies more efficiently, minimize errors during data collection and optimize clinical trial budgets.
This approach showed excellent results and made its way into less large-scale trials.
As a result, the eSource market began to grow rapidly. Vendors develop products for a variety of clinical trials, ranging from large-scale post-marketing projects to academic trials. Now, almost every clinical trial can be implemented into an electronic system.
Today, more than 75% of sponsors and CROs use electronic systems. Let’s discuss what this approach provides and what motivates more and more new companies to incorporate eSource into their work.
Better data quality
Improving the quality of clinical data is one of the most powerful arguments to confirm the effectiveness of electronic systems. This section describes the application of the EDC (Electronic Data Capture) system and eCRF. They help to collect clinical data inside the electronic system, immediately entering them into the database without using paper CRFs.
According to Scoremarketing , 50% of electronic systems’ users point out that better clinical data quality is one of the most significant benefits they get by working paperless.
Here are examples of electronic system tools that help companies to improve the quality of the data collected:
- Automatic CRF checks. These reveal erroneous data in real time and ask the doctor to correct them. It does not allow incorrect values to be entered into the database;
- Query. This function helps a remote monitor to mark dubious fields of eCRF and create relevant queries. The doctor receives these requests and checks or fixes the data;
Thus, the paperless approach helps to get more efficient data at the end of the trial, which simplifies the processing and helps to obtain reliable information about the effectiveness of the drug.
Increases efficiency of a clinical trial
The use of electronic systems drastically increases the overall effectiveness of the trial. Firstly, usage of these systems enables the study as a whole to run quicker, which was pointed out by 20% of respondents according to Scoremarketing .
The increase in the overall effectiveness of the study depends a lot on keeping up with the trial`s term.
To sum up, the paperless approach helps you to get better results in less time.
To illustrate this, let’s look at these examples:
- Increases the speed of the study. Electronic systems help to start a project several times faster, reducing preparation time. This is achieved through the use of electronic document management systems, which increase the speed of signing and coordinating all necessary activities. It also saves the time spent on the creation and delivery of paper-based CRFs, ICF, diaries, etc. Now, all of this is managed in electronic systems in a few weeks and immediately ready after validation.
- Reduces clinical trial delays. With the help of electronic systems, such as EDC and CTMS (Clinical Trial Management System), remote monitoring can be carried out effectively. This means that the dynamics of the project can be monitored remotely, without visiting the site. It helps to identify research delays and quickly fix the issues causing them. In our article, we wrote in detail about how exactly bottlenecks in clinical trials can be monitored using EDC systems.
Using electronic systems, the total cost of clinical trials can be significantly
reduced. This was noticed by 33% of users . Partially, this advantage relates to the
previous point, since an increase in research effectiveness reduces the number of
unplanned expenses. For example, reducing the number of delays avoids unexpected costs
and meets the research budget.
Also, budget optimization is achieved, as electronic systems can collect high-quality data immediately. Thus, it is unnecessary to spend a significant portion of funds for clarifying and re-checking information.
In some cases, the starting price of electronic systems may seem more expensive than testing on paper. However, bear in mind that this cost does not take into account the costs associated with paper-based trials: direct monitoring costs, travel, accommodation, resource-consuming data cleaning, and general trial prolongation. Using eSource helps to minimize such additional costs and, as a result, the total cost of the entire project is lower.
Increased audit and inspection readiness
Minimizing the use of paper documents simplifies interactions with regulators. In this case, all data and documents are collected in one place, on electronic media or in an electronic system. This way, it is easy to find and provide the necessary information for inspectors, which means that the company is almost always ready for inspection.
In the case of paper data, it can be difficult to find and collect all the necessary documents in time and organize and prepare them for verification. And in the case of electronic systems, collection and systematization are more reliable.
The paperless approach in clinical trials has many benefits, such as:
- improving data quality through the use of eCRF, automatic checks, and queries;
- increases research efficiency by reducing the likelihood of delays and issues during the project;
- reducing project costs by reducing the likelihood of unplanned expenses.
1). SCORR Marketing and Applied Clinical Trials. Paperless Clinical Trials Survey Report: https://www.scorrmarketing.com/resources/paperless-clinical-trials-survey-report/