Technologies in Clinical Trials: Digitalized Clinical Research
Published: 02.21.2021
Digitalization is fundamentally transforming clinical research. Decentralized clinical trials (DCTs) use modern technologies to make digital clinical trials more efficient and patient-friendly. By using digital tools such as wearables, patient apps and electronic data capture, data can be collected and analyzed more precisely. Find out more about the opportunities and challenges of DCTs in clinical research.
Wearables: Digital data sources for decentralized clinical studie
Wearables play a central role in digital clinical trials. Many people know them as fitness wristbands from everyday life, but the term covers a wide range of measuring devices that can be worn on the body. In addition to microphones and motion sensors, integrated biosensors also enable the continuous collection of important health data for clinical studies.
- Respiratory activity
- Body temperature
- heart rate
- Blood oxygen level
- Glucose level
The seamless integration of this data into decentralized clinical trials enables a more precise analysis of drug effects. The more precise the data collection becomes through digitalization, the more diverse the options for evaluating clinical trials become. The new technologies offer innovative solutions for traditional challenges.
Connected to smartphones or tablets, wearables send the collected data directly to a central study database. This allows study physicians to react to changes in health at an early stage and provide optimal care for patients in digital clinical trials. Wearables also significantly reduce the need for on-site visits and facilitate long-term patient monitoring.
Patient apps: Digital interaction and data collection
Regular discussions between patients and doctors are an essential part of clinical studies. The doctor asks about the patient's state of health or the effect of medication.
Digitalization is changing communication between doctor and patient. In DCTs, apps enable participation in clinical trials regardless of location, improve patient loyalty and thus revolutionize communication between patients and study physicians. Mobile applications allow patients to fill out electronic questionnaires, document health data and communicate with the study team. Important functions of these apps include:
- Electronic declarations of consent
- Virtual rounds via video call
- Reminders to take medication
- Direct reporting of adverse events
These digital solutions improve patient adherence and increase the efficiency of decentralized clinical trials. They also reduce the need for on-site visits to study centers, which is particularly beneficial for patients in rural areas. The combination of patient apps with other digital technologies ensures seamless collection and management of clinical data.
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eCRF: Digital documentation in decentralized clinical trials
Electronic Case Report Forms (eCRFs) are indispensable in digital clinical trials. These web-based documentation systems replace traditional paper forms and enable structured recording of clinical data in real time. In addition to basic and medical history data from visits, study physicians document adverse events in accordance with the protocol. However, the content of an eCRF is customized depending on the project.
The advantages of eCRFs include:
- Automatic plausibility checks to avoid errors
- Direct storage in a database and review by the study team
- Reduced administrative effort through digital recording
- Improved data quality and security
By using eCRFs in decentralized clinical trials, study physicians and researchers save valuable time and at the same time significantly improve data quality. Automatic plausibility checks reduce errors and minimize post-processing effort by around 80 percent. At the same time, digital documentation facilitates compliance with regulatory requirements and enables efficient analysis of the collected data. Thanks also to their user-friendliness, eCRFs have become established in clinical trials and are now a firmly established standard.
Artificial intelligence: Increasing the efficiency of digital clinical trials
The use of artificial intelligence is revolutionizing digital clinical research. Through machine learning and automated algorithms, AI is optimizing various processes within DCTs, including
- Identification and recruitment of suitable patients for studies
- Analysis of large amounts of data in real time
- Automated patient communication
- Prediction of study outcomes
These technologies help to increase data integrity, reduce costs and make clinical research processes more efficient. The implementation of AI in digital clinical trials supports more precise and faster drug development. In addition, AI-generated patterns can identify and address potential safety risks at an early stage, further improving patient and data safety.
Regulatory requirements of DCTs
In order to successfully conduct digital clinical trials, regulatory requirements must be met. International and national health authorities set guidelines to ensure patient safety and the integrity of the data collected. The most important regulatory requirements include
- Compliance with Good Clinical Practice (GCP) guidelines
- EU data protection requirements such as the GDPR
- FDA and EMA requirements for digital data collection
Compliance with these regulations requires close cooperation between study centers, sponsors and regulatory authorities. At the same time, digital technologies must be continuously developed to meet the growing requirements in a DCT.
Future prospects in decentralized clinical research
The future of digital clinical trials will be characterized by further technological advances. Advanced data analysis, wearables, patient apps and the increasing use of telemedicine are just some of the developments that will continue to change clinical research. Companies and research institutions that adapt to these trends at an early stage can benefit from more efficient processes and greater patient loyalty.
Conclusion
Decentralized clinical trials represent a milestone in modern clinical research. Through the use of digital technologies such as wearables, patient apps, eCRFs and artificial intelligence, clinical trials are becoming more efficient, patient-friendly and data-driven. At the same time, regulatory requirements must be complied with and innovative technologies further developed. The continuous development of these digital solutions will have a lasting impact on the future of clinical research and contribute to more efficient drug development.
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