Technologies

Technologies in Clinical Trials: Digitalized Clinical Research

Published: 02.21.2021

 

Digitalization is changing clinical research. New technologies make it possible to conduct studies from home. The potential of electronic data collection for patients and doctors is manifold. Read more about the use of new technologies here.

 

Wearables: New technologies as digital data sources

Many people know wearables as fitness bands from everyday life. However, the term covers a wide range of measuring devices that are worn on the body. In addition to microphones and motion sensors, the integrated biosensors are useful for clinical studies.

Data collection using wearables is versatile:

  • Respiratory activity

  • Temperature

  • Heartbeat

  • Blood oxygen

  • Glucose level

The more precise data collection becomes through digitalization, the more diverse the options for evaluating clinical studies become. The new technologies raise new questions and innovative solutions.

If the devices are linked to a smartphone, they send the data to the study database. There, the information can be combined with other clinical data.

The use of wearables shortens or replaces on-site examinations. If the data collected is available to the study physicians at all times, they are able to react more quickly to changes in the patient's state of health. This means that patients receive better care during the clinical trial.

 

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Patient Apps: Data collection at home

Regular discussions between patients and doctors are part of clinical trials. The doctor asks about the patient's state of health or the effect of the medication.

Digitalization is changing communication between doctor and patient. With the help of an app, patients keep an electronic patient diary, through which they receive questionnaires about the study and their state of health. Other queries and functions are also handled via the app, so important study processes can be carried out from home using a tablet or smartphone:

  • Clarification and information

  • Electronic signatures

  • Televisits

Patient apps are also suitable for clinical studies with independent medication adherence. Recording and improving medication adherence, i.e. the correct intake of medication, is crucial for the success of a therapy. Push notifications via the app remind patients to take their medication regularly and answer the questionnaires.

 

eCRF: Digital documentation in clinical trials

A web-based, electronic Case Report Form (eCRF) is a questionnaire specifically used for clinical trials. Study physicians use it to document patient visit data in accordance with the study protocol. In addition to basic and medical history data, adverse events are also recorded. However, the content of an eCRF is customized depending on the project.

The traditional paper questionnaire has been almost completely replaced by the web-based eCRF. Study physicians collect the data for clinical trials using a smartphone, tablet or PC. As these are automatically stored in a database, the data entry can be checked directly by the sponsor or the contract research organization (CRO).

Plausibility checks prevent incorrect entries, such as an incorrect date. This allows study physicians to avoid around 80 percent of manual reworking. Primarily due to their user-friendliness and considerable time savings, eCRFs have become widely accepted in clinical trials and are now a firmly established standard.

 

Artificial Intelligence: Increasing efficiency in clinical trials

In clinical research, digitalization is particularly evident in the use of artificial intelligence. AI plays a supporting role in many study processes:

  • Patient recruitment

  • Data collection and processing

  • Patient communication

Machine Learning algorithms enable AI to recognize complex correlations and apply the knowledge to work processes. The increased data integrity as well as cost and time savings make clinical studies more efficient.

 

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