How to decentralize clinical trials in three steps

Decentralizing clinical trials has lots of benefits. But many hesitate to implement DCT solutions in their own studies due to lack of experience and trust in new technologies or uncertainty about responsibilities. These three measures can help.

 

What are decentralized clinical trials?

Clinical trials are usually conducted in study centers such as hospitals or university clinics. Here, patients are interviewed, questionnaires are filled out or vital signs are taken. Visiting study centers is therefore obligatory for many patients.

In decentralized clinical trials, study centers are no longer the focal point of research projects. Data and information can be collected regardless of the location, for example through:

• Remote monitoring and collection of vital signs through measuring devices, such as a smartwatch that measures the pulse or a sleep tracker that monitors sleep

• Televisits in the form of video calls between investigators and patients

• Transmission of digital questionnaires to patients, instead of interviews on site

• Creation of a participant platform for patients to exchange information with the study staff and to collect additional data

• Social media channels and groups for communication between patients

The decentralized approach puts patients more in focus. The clinical trial is aligned with their needs. "Patient centricity" aims to make participating in study projects as easy as possible and gives patients a voice.

 

The advantages of decentralized clinical trials

Only in very few cases does it make sense to fully decentralize a study project. The reasons for this vary. Be it the lack of suitability of using wearables for the disease being studied or the requirement of the participants' local presence. Hybrid solutions, which involve the integration of individual digital methods, already bring significant benefits:

• Relevant data, collected in real time and directly from patients, for example through continuously worn wearables

• Greater patient diversity, as study participation is no longer bound to a specific location

• Increased patient participation and reduced drop-out rates in clinical trials due to easier and patient-centered processes

• More efficient workflows through integration of digital software solutions

 

Step 1: Consider current regulations and technologies

Clinical research is currently undergoing a strong digital transformation. Anyone planning for decentralized clinical trials should research and follow current successes and developments in this field. Proactive thinking is key:

• How can new technologies and services be used in clinical trials?

• What do new laws and regulations allow?

• Are there ideas from the project managers, staff or cooperation partners on how current clinical trials can be decentralized?

➨ Creating and maintaining a list of ideas from which project managers can draw is useful here.

 

Step 2: Consider the needs of all stakeholders

As technologies change, so do the needs of all those involved in studies. Patients are becoming more empowered, informing themselves about studies in advance and asking more specific questions. Meanwhile, the investigator team knows best what challenges decentralized procedures pose to their day-to-day work. Therefore, when building a strategy, one should put oneself in the position of all stakeholders and consider their wishes and concerns.

Questions that might arise:

• How much time do patients need to commit?

• Is there sufficient communication between the study team and patients? What opportunities are there for feedback?

• What established work processes are being replaced by new procedures?

• How much effort is required for the implementation of new decentralized work processes by the study center?

 

Step 3: Build trust in procedures

Long-established work processes are being replaced by new technologies and procedures. In order to avoid uncertainties and mistakes, all parties involved should therefore have confidence in the chosen procedures.

The following approaches build trust in new technologies:

• Train and educate the team and patients in the use of the new technology and software

• Define responsibilities clearly; everyone should know both their own and others' tasks

• Be available for questions and accept feedback

 

The challenge of interoperability: ensuring uniform data

One last tip: The integration of different technologies and services not only brings more data, but also different formats. However, the information collected can only be effectively analyzed and evaluated in a uniform format.

A possible solution: a central clinical data management system where all clinical trial data is brought together in one place using a unified interface. This transparency allows data to be managed, reconciled and interpreted in real time.

 

 

^{Text: Alcedis Redaktion}