Higher data security requirements
By means of new digital technologies, lengthy studies are becoming faster, more cost-effective and ultimately more successful. However, the question increasingly arises as to how the security of personal data can be ensured during the course of studies.
On average, it takes around ten to twelve years for a new drug to be approved. Clinical trials account for more than half of this time. These take place in three phases: First, the drug is tested on healthy volunteers, then on a small number of patients, and in phase three on a large group of patients in many different countries. Only when positive results are available from all three phases can a pharmaceutical company apply for approval of the drug.
Especially in phase three, clinical trials are complex and expensive. Companies have a hard time finding suitable participants, collecting high-quality data and evaluating it. In addition, patients often drop out during the course of a study because participation is too inconvenient for them or they feel poorly informed. All this means that results are often delayed and costs explode.
Digital technologies speed up clinical trials, make them more cost-effective, and make them easier to conduct for everyone involved. Pharmaceutical companies find it easier to plan a study precisely and find suitable candidates. With the help of wearables, sensors and smartphone apps, digital biomarkers can be continuously recorded in an automated way. This provides researchers with high-quality data that deliver valuable insights.
Technologization in different phases of virtual studies
One of the most important new technologies used for virtual clinical trials is Big Data Analytics. Consequently, data analytics are a crucial factor when it comes to reducing the costs of clinical trials: after all, the researchers of a trial usually only realize late that it is failing. So the earlier you identify problems, the better.
To ensure this, modern analysis techniques are needed to evaluate the huge amounts of data from digital biomarkers. Furthermore, with their help, the study design can be optimized. For example, the analysis of genomic data helps to define the pool of potential candidates as precisely as possible. By combining current real-world data with historical data, it also becomes possible to identify problems early on and take countermeasures before a lot of money is lost.
Quantum simulation technology also plays a special role in the development of new drugs. With the help of high-performance computers such as the Atos Quantum Learning Machine it is possible, for example, to simulate how various clinical pictures develop and what concomitant diseases there might be. Such simulations are carried out using huge, anonymized data sets. This helps researchers to better identify relationships between different diseases and understand how they influence therapy. These findings can then be incorporated into the design of a clinical trial.
Change makes clear data protection regulations indispensable
Clinical studies involve highly sensitive personal data that is subject to the GDPR, among other regulations. Companies must therefore ensure that the data they use does not allow any conclusions to be drawn about a specific person. This is usually ensured with techniques such as masking. In addition, high cybersecurity requirements must be met to protect the data from hacker attacks and theft.
The medical devices or wearables used on the patient side are also subject to strict guidelines and must be certified accordingly. In Europe, this is regulated by the MDR (Medical Device Regulation). Apps, on the other hand, fall into the new category of Software as a Medical Device (SaaMD). There are separate guidelines for them. Since phase three clinical trials are conducted in many different countries around the world, companies must take into account a large number of different regulations.
To master the numerous challenges associated with the introduction of virtual clinical trials, it is advisable to work with a specialized service provider. They provide the necessary technologies and support with digital services in all phases of the patient journey. This includes, for example, a web portal where interested parties can conveniently register for the study. It should be connected to a backend that can be used to coordinate and manage the pool of candidates. Chatbot services make it easier for patients to clarify important questions. In addition, clinics are given the opportunity to set up an online consultation.
The service provider can also take over the development of the app for the study, test it, validate it and install it on the relevant mobile devices. It takes care of managing the devices and shipping the study kits, including correct and secure documentation. This ensures that all participants receive their kits on time. It also provides a cloud platform with advanced data management and analytics capabilities. Data from the app as well as other sources flow together there and can be analyzed. A multilingual help desk is available around the clock for questions and problems.
You can read the detailed technical article in the print edition of SicherheitsForum from March 3, 2021.
Source: Atos
