As the use of hybrid and virtual trials grows, so does the number of technology solutions that allow for trial virtualisation.
These trials, increasingly referred to as Decentralised Clinical Trials (DCTs), rely heavily on technology. The key element of decentralised trials involves a seamless interaction of direct-to-patient services and new data management models and new processes. Companies like ObvioHealth (https://www.obviohealth.com/resources/decentralized-clinical-trials-a-comprehensive-synopsis) are making decentralised clinical trials more readily available to researchers.
This ensures a smooth delivery, minimises patient burden, and increases patient involvement.
In this post, we’ll discuss the key element of decentralised trials & how to conduct a successful remote trial.
Introduction to DCTs (Decentralized Clinical Trial)
FDA has defined DCTs as operational technology that is used to communicate with data collection and study participants. The FDA has made the difference between decentralised clinical trials and virtual trials, a computer-based model, and no real participants are used. Instead, model participants are used to assessing drug safety and efficacy during any preclinical phase.
Below are approaches that can be used to implement decentralised clinical trial
- Full DCT allows study participants to get a clinical trial at the comfort of the home or any other convenient place. Therefore, an electronic consent process will be utilised. All the investigational products will be transported to the participant’s location.
All health data will be collected and recorded in any convenient laboratory or home healthcare provider when using digital health technology. - The hybrid DCT has both decentralised trials and traditional clinical trials. It is one of the most common DCT types implemented in the market now. Hybrid DCT allows participant’s flexibility and still maintains subject data and safety integrity.
For example, a study will require patients to get their specific procedures or investigational products in a hospital setting. Therefore, participants will have to come to the centralised investigational site for study assessment.
One of the DCTs’ advantages is the fact that they take a participant-centric approach, unlike traditional clinical trials. Decentralised clinical trials can expand traditional clinical trial sites to reach more participants and those closer to their workplace or home.
Other benefits include:
- Reduced barrier to participants; hence increasing recruitment
- Additional data collection
- Trials can be carried out in a real-world setting
- Increase participant diversity
It can be overwhelming to choose when looking for a suitable decentralisation in clinical trial development, especially when there are different vendors.
Decentralised Clinical Trials
Clinical trials have remained to be one of the high-volume and complicated endeavours that involve several things, like:
- Testing drugs distribution
- Supply chain planning
- patient recruitment
Therefore, Life Science Company must show the safety and performance of a certain drug over a large population to be approved by FDA and prove drug efficacy. It is important to have clinical trial success on the demonstration and capture of high-quality data.
However, challenges increase in modern R&D organisations to balance this qualitative and quantitative mentality due to increasing patients’ centricity expectation.
How to Make the Clinical Trial More Convenient and Adaptable
The pressure biotech and pharmaceutical companies face concerning R&D is increasing every day. Adaptability is an imminent trend because life science industries are aggressively and strategically pursuing interesting areas such as individualised medicine.
Drug makers are serious about building necessary and important operationalised infrastructure for cell therapy. Therefore, the main challenge that life science organisations have is to transform R&D areas creatively to facilitate better delivery and increasing individual treatment.
Patient data collection methods and location will be important keys for a successful campaign. There is some incorporation of technology into healthcare delivery, like:
- Mobile health
- Wearables
- Telemedicine
However, the above solutions have not been fully integrated into clinical trials. Advanced technology has lead R&D leaders to explore decentralised clinical trials (DCTs). It involves a remote or patient-to-patient model. Therefore, patients’ data is collected partially or entirely in the natural environment or home on a more holistic basis.
Consideration When Implementing and Designing Decentralised Clinical Trails
There has been an increase in the use of decentralised clinical trials since the start of the COVID-19 pandemic. Therefore, the number of changes in clinical trials operation is increasing to find ways past the pandemic.
Clinical development activity outsourcing is a common phenomenon leading to additional complexity, time, cost, and inefficient models. Therefore, there is a need for agile clinical trials in the operating system that can provide easy access to patients and providers and orchestrate activity.
Some of the clear expectations and proactive strategies in the clinical trial operating system include:
- Patient centricity
- Taking traditional sites into consideration
- Involve the regulators
- A proactive strategy
- Use agile design
However, sponsors can face several challenges when it comes to decentralised clinical trials. Below are some examples.
- Time management
- Patient care continuity
- Getting a new tech vendor
- Searching for a specifically trained courier
- Processing and managing patent data (large volume)
- Patient attitude
- Technology failure
Parting Words
There is a need for a new clinical trial approach. Increasing decentralised trail elements is one of the best ways to put patients first and sharpen the policies and processes. With challenges come great and new opportunities! The use of a good ELN can greatly help a researcher conducting a clinical trial.