08 Apr Pharma and Biotech Phase I, II, III and IV Clinical Trials | Electronic Data Capture (EDC) as a useful tool
Pharmaceutical and Biotech Phase I, II, III and IV Clinical Trials | Electronic Data Capture (EDC) as a useful tool
Clinical validation plays an essential role in the pharma and biotech sector. Clinical trials involved in developing medicines are usually divided into four Clinical Trials Phases (Phase I, Phase II, Phase III, Phase IV). The pharma and biotech industries, as well as sponsors and contract research organizations (CROs), are increasingly using Electronic Data Capture (EDC) systems during clinical trials and patient registries. This blog explains for each clinical trial phase how an Electronic Data Capture (EDC) system can contribute as a useful tool. We also advise how to select the best Electronic Data Capture (EDC) system for your clinical trials.
What is an Electronic Data Capture (EDC)?
The traditional data collection on paper has been replaced by an Electronic Data Capture (EDC). With the use of such a system, clinical data can be collected, stored, and enriched in a safe and fast manner. There are several reasons to make the switch to an Electronic Data Capture (EDC):
- Minimizes making mistakes. With automated input fields, set validations, and set conditions, typing and placement errors are avoided.
- Saving physical storage space. A lot of unnecessary paperwork and documentation is saved by an online solution.
- Easy data sharing. Through an online system with different roles and rights, users (Role-Based Access Management) can easily and quickly access data. Anywhere in the world.• Helps users adopt an established method.
- Flexibility. Every study is different and has different rules and regulations, which is why EDC systems can also be set up in advance according to your wishes. In this way, the system will always fit any study.
Phase I Clinical Trials: Safety first
Phase I clinical trials often focus on finding the best dose of a new medicine with the fewest possible side effects. These studies are often applied in a clinic. The inclusion number is usually limited to 100 and consists mostly of healthy subjects. Doctors vary the dose across the inclusions to determine side effects. This is an attempt to achieve an optimal result, in which safety has been included as an important parameter. If the trial has shown that a medicine is safe, a phase II clinical trial will be entered.
Electronic Data Capture (EDC) for Phase I Clinical Trials
Building and executing Phase I clinical trials can be improved in terms of effectivity and efficiency by using an Electronic Data Capture (EDC) system. Questionnaires can be easily drawn up using study templates and a built-in library. Chapters in the questionnaires can be made recurring for each patient. This is easy for multiple measurement moments. The data can be collected and managed electronically in the Electronic Case Report Form (eCRF). We recommend paying attention to which strict regulations a specific Electronic Data Capture (EDC) complies with. The EDC system of Research Manager complies with Good Clinical Practice (GCP) compliance, ISO27001 information security, the NEN7510 standard, and 21 CFR Part 11. Also, 24/7 backups are made by our Dutch certified data centers.
Phase II Clinical Trials: The degree of effectiveness
Phase II clinical trials increase the safety and effectiveness of the medicine. The main difference of phase II clinical trials compared to a phase I clinical trial is that during phase II clinical trials a larger part of patients with a specific condition is involved. In addition to effectiveness, the correct dosage is also measured. If the medicine has successfully passed the phase II clinical trial, a phase III clinical trial will be set up.
Electronic Data Capture (EDC) for Phase II Clinical Trials
In addition to the benefits from phase I clinical trials, an Electronic Data Capture can also contribute to multicenter trials. Because an Electronic Data Capture (EDC) is web-based, it is possible to have multiple centers participate in a study; anywhere in the world.
Role-Based Access Management can be used to assign different roles per site. The environment of Electronic Data Capture (EDC) automatically adapts to the rights per role and participating site. This ensures high efficiency, but also a very safe environment where anonymous patient data can be collected.
It is also useful to pay attention to the presence of the functionality built-in notifications. Suspected Unexpected Serious Adverse Reaction (SUSAR) and Serious Adverse Event (SAE) can be created with this functionality. This is essential in the event of an adverse medical event in a patient or subject. When a notification is created for a specific patient, all involved roles (e.g. researchers, data managers) are automatically informed by e-mail.
Phase IV Clinical Trials: The most extensive phase
Phase III clinical trials are most extensive with a duration of several years and usually hundreds to thousands of patient inclusions. Long-term, but also rarer side effects are discovered. Subjects are given randomly choose the new drug, a standard treatment, or a placebo. This way, the effects can be properly monitored. If phase III has been completed, the drug will be used for the general population.
Electronic Data Capture (EDC) for Phase III Clinical Trials
A frequently used functionality within Electronic Data Capture is randomization. Multiple groups of test subjects can be compared with the randomization tool. It also contributes to blind practitioners.
Because of the high number of inclusions and multiple measurement moments during phase III clinical trials, sending out questionnaires is seen as a very convenient tool. We recommend choosing an Electronic Data Capture (EDC) that provides such functionality. We use Patient Self Service (PSS) in our EDC system. With this tool, questionnaires are sent automatically, based on the set schedule. Th-is responsive environment allows patients or test subjects to complete the questionnaires on any device (smartphone, tablet, laptop, computer). The results are automatically sent to the corresponding anonymized patient in the eCRF.
The Electronic Data Capture (EDC) of Research Manager also includes built-in inventory management. This provides the following benefits for phase III clinical trials:
- Management of dispensations, for example, medication. These can be linked to an anonymized patient;
- Stock can be entered in advance by the pharmacist.
- Double-blind spending of stock;
- Accurate stock management per location.
Phase IV Clinical Trials: Post-Marketing Surveillance (PMS) and Patient Registries
Once the medicine has been released on the market, long-term safety should be monitored. Market release happens on average after ten years. From that moment on phase IV clinical trials come into effect; the so-called post-marketing or surveillance trials. These trials often take place on a large scale. This is extremely important to keep optimizing the medicine.
Electronic Data Capture (EDC) for Phase IV Clinical Trials
In addition to the benefits during clinical trial phases I, II, and III collected clinical data in an eCRF should be enriched quickly and easily. We recommend checking whether the graphic elements are included in the EDC environment.
It is also relevant for data analysts to be able to easily import or export data to common file formats. Think of CSV, Excel, or SPSS.
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