Electronic Data Capture (EDC) System for Academic Clinical Research
Academic clinical research plays a very important role in the development of new treatments and medicines, contributing significantly to the improvement of healthcare systems.
For decades, investigators and non-profit research groups have conducted clinical trials, post-authorization studies, and patient registries to investigate new therapies and drugs for a variety of diseases.
One of the pillars on which these clinical studies are developed are the electronic data capture (EDC) systems. In this respect, academic research is no exception and the sponsors of this type of studies need effective software tools adapted to their needs to manage clinical data in their projects.
Many software tools are currently used in clinical investigation, with electronic EDC platforms being one of the most fundamental.
In this article, we will explain in more detail the characteristics of academic clinical studies and in particular their specific needs with respect to EDC systems.
What Is Academic Clinical Research?
Academic clinical research can be defined as the type of clinical research that is not for profit or commercial purposes.
In other words, academic clinical research aims to contribute to the development of new therapies and medicines for the benefit of patients and science but is not commercially motivated.
Who Conducts Academic Clinical Studies?
Academic clinical studies are led by “academic sponsors”, also called “non-commercial sponsors”.
There are several examples of academic sponsors. Some of them are mentioned below:
- Independent researchers (e.g. PhDs)
- Scientific societies
- Medical associations
- Cooperative research groups
- Non-profit foundations
- Public hospitals and institutes
Although there are differences between the entities mentioned above, they all have something in common: they design and execute clinical studies with a medical and scientific (non-commercial) motivation.
What Types of Academic Clinical Studies Are There?
There are different types of academic clinical studies, including clinical trials, post-authorization observational studies, and registration studies.
First, academic clinical trials are prospective interventional studies in which a new drug —or a new combination of medicines— is tested in a specific patient population, usually to determine the safety and efficacy of the new treatment.
Secondly, in academic post-authorization observational studies, the safety and efficacy of drugs that have already been approved by regulatory authorities are observed, that is, they are drugs that have already been marketed and are being administered to patients in hospitals according to an authorized label, in line with standard clinical practice.
Finally, registry studies involve the creation of databases —usually web-based— of patients with specific characteristics. These types of clinical records are very useful for understanding the epidemiology —for example, incidence and prevalence— of a disease, and how it develops over time.
What Are the Specific Characteristics of Academic Studies?
Academic clinical research studies have particular characteristics that set them apart from other types of research.
These features are detailed in the following list:
- They are clinical studies that do not seek commercial profit (they are done for purely medical and scientific reasons).
- They are projects led by independent researchers or non-profit institutions (they are not led by biotechnology or pharmaceutical companies).
- In many cases —even if the sponsor is not commercial— the drugs and funding to run an academic study are provided by a biotech or pharmaceutical company.
- It is common for these types of projects to receive financial support from grants or public funding programmes.
Regarding the difficulties encountered in academic clinical studies, it is worth highlighting the statement in the article by Inmaculada Fuentes et al:
“Non-commercial clinical trials with medicinal products are often limited by the scarcity of financial resources and professionalization of clinical research activities. To partially address this problem, the new European Regulation on clinical trials has defined low-intervention clinical trials, subjecting them to less stringent rules than standard clinical trials. In addition, initiatives such as the European Clinical Research Network and funding from European funds such as Horizon2020 could be good opportunities for non-commercial research.” [1]
What Are the Data Management Needs of Academic Sponsors?
Academic clinical studies require data management software tools that are adapted to their specific characteristics.
Moreover, academic sponsors do not always have large budgets that allow them to acquire the electronic data capture systems typically used in this industry.
The budget of a non-commercial study can be limited, and sometimes this can be a challenge to obtain a sufficiently powerful EDC system in order to meet required regulations.
In fact, in some cases, there are still low-budget clinical studies that need to be conducted using paper case report forms (CRFs), due to the impossibility of using an EDC platform.
Of course, using paper-based CRFs brings added difficulties, reduced efficiency, and considerable additional effort in collecting, cleaning, and analyzing the data.
What Kind of EDC System Is Most Recommended for Academic Clinical Studies?
Today the market offers a wide range of electronic data capture systems, so academic sponsors should select the most suitable option for their type of study.
What type of EDC system is best suited for a non-profit clinical study? The following aspects must be considered:
- It must meet quality standards. An EDC system must always meet minimum quality requirements to guarantee data traceability and security. Academic studies are no exception to this need.
- Re-use. To get the most out of the investment, it is important that an electronic data capture system allows for easy reuse. That is, after a study has been conducted, the EDC software can be easily adapted for use in the next study without great effort.
- Ease of use. One of the most important features of an EDC system is that it is intuitive and easy to use. This is vital to make the work of researchers and their team of coordinators as easy as possible.
- An affordable price. Undoubtedly, price is an important factor when choosing an electronic data capture system. The cost of the EDC tool is a determining factor if it is a non-commercial study that involves many patients and lasts many months.
What Essential Requirements Must an EDC System Meet?
As mentioned above, an academic sponsor is not exempt from meeting the quality requirements demanded by international regulations.
Some of the essential requirements that electronic data capture (EDC) systems must meet are summarized below:
- Traceability. An EDC tool must allow full traceability of the data it hosts. The system must include an “audit trail” module that records the activity that takes place within the platform (record of the data entered, including user, time, values, etc.).
- Access control. The EDC system must have access control mechanisms and be able to detect unauthorized access attempts.
- Change control. Whenever data are modified, the EDC software must allow recording the reason why these data have been changed. This generates a history of modifications and preserves traceability.
- Calendar and internal clock. All activity on the EDC platform must be recorded in the system including the day and time of each action. This requires the system to have a properly functioning calendar and internal clock.
- Closing the database. At the end of a clinical study, there comes a time when the database must be closed so that no further changes are made. Therefore, an EDC system must allow the blocking of forms so that no user can make modifications or enter new data and the database can be closed.
- Backups. The backup system of the EDC software is absolutely essential to preserve and recover the information in the event of a serious incident or interruption in the operation of the tool.
Who Provides Electronic Data Capture (EDC) System Solutions?
Electronic data capture (EDC) systems are software tools developed by companies specialized in this type of application.
In the market, there are providers of EDC tools of different sizes, ranging from large international companies to smaller providers offering more affordable solutions.
Some of the best-known EDC vendors in the market include Medidata, Oracle, Medrio, Anju, Viedoc, XClinical and OpenClinica, among many others.
Despite that, it should be noted that implementing and maintaining an EDC system does not only involve purchasing software.
It is also necessary to define the specifications of the data forms required by the study protocol (what information will be collected and how). Furthermore, once the specifications are in place, it is time to implement, test, and validate the forms.
Put it differently, a clinical study requires data management specialists. Indeed, managing clinical data involves several other tasks, such as reviewing and cleaning the information and its subsequent analysis.
Klindat: An Ideal Solution for Academic Clinical Research
Klindat is an ideal EDC option for academic studies. It is a very easy to use software tool that complies with all international regulatory standards.
The Klindat software has been developed by a team with extensive experience in the field of clinical research and is perfectly adapted to the needs of clinical trials, post-authorization studies, and patient registries.
Another advantage of Klindat is its highly competitive pricing, which fits within the budgets of non-commercial sponsors. Klindat software can be used from 400 € per month, depending on the size of the study.
Conclusion
Academic clinical research plays an extremely important role in the advancement of new therapies. Academic clinical trial sponsors must conduct research with high quality standards, and this includes proper data management tools. An EDC system that meets international standards and can be obtained at an affordable price provides great advantages for these types of studies requiring low budgets.
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