Centralized or Decentralized Clinical Trials? Exploring the Pros and Cons
The progression of medical knowledge and enhancement of patient care heavily depends on clinical trials. In recent times, spurred significantly by the onset of Covid-19, the discussion surrounding the conducting of centralized versus decentralized clinical trials (DCT) has gained momentum.
In this Insight, we explore the distinct advantages and challenges associated with each approach and highlight the solutions that Oximio can offer.
Centralized Clinical Trials
In centralized trials, patients often travel to a specific healthcare location for a face-to-face appointment with a doctor or clinician and data is manually collected at that time. Hosting a clinical trial at a centralized location means that studies can be undertaken in strictly controlled conditions promoting uniformity in data collection provided by standardized procedures. This strict control over study conditions enhances the reliability and consistency of the data collected, ensuring the integrity of the research.
Challenges of Centralized Trials
Unfortunately, some of the benefits of centralized clinical trials can be compounded by constraints and challenges.
- Geographical constraints can not only limit the participation of patients, but also the diversity of patients which can lead to underrepresentation of certain population demographics.
- Managing multiple sites and the travel expenses of patients can result in higher costs affecting the overall budget of a trial.
- The need for patients to travel to a specific location may lead to reduced participation due to the inconvenience, and patient retention may be affected as patientss drop out of the clinical trial.
Decentralized Clinical Trials
Decentralized clinical trials involve the conducting of studies remotely allowing patients to take part from the comfort of their own homes, or at local healthcare facilities. Leveraging digital technologies for data collection, decentralized clinical trials offer flexibility in study design and approach, enabling a more patient-centric approach. This has brought about many benefits including increased patient diversity, for example, the elderly, those on a lower income or living in a remote location and a wider ethnicity. This has led to better patient engagement and retention via remote monitoring and lower costs resulting from reduced site management, workloads and patient travel expenses.
The arrival of COVID-19 saw the acceleration of decentralized trials and the swift adoption of virtual communications between doctors and patients. This was made possible through modern advancements such as better online communication tools and platforms and combining these with digital health technologies (DHTs) such as portable activity trackers, blood pressure monitors, spirometers and sensory devices which can be wearable, ingestible or implantable. Logistics plays a key part in this with the direct delivery of research drugs, materials and devices direct to participant homes. The monitoring of data is possible without the need for in-person contact between the study team and patient.
According to Global Data, decentralized clinical trials have grown by 470% from 2012 to 2022.
Challenges of Decentralized Clinical Trials
Working at such a scale doesn’t come without its challenges. These can include:
- The need for vigorous data security and privacy solutions to safeguard sensitive information. Data quality may be compromised due to the diverse technologies being used which may introduce variability in data quality. This requires careful monitoring and validation.
With high volumes, data processing via apps and other platforms needs to be robust, reliable and with back-ups in place to accurately record large amounts of data.
- Implementing a decentralized approach can involve regulatory challenges and need to follow strict guidelines compliant with official requirements. These can vary by location and need to be carefully managed.
- The transportation of essential medication and ancillary supplies to and from a patient in specialist vehicles, sometimes requiring specific temperature control, by approved and experienced logistics partners.
The choice between a centralized or decentralized clinical trial will depend on the type of study being conducted, the target patient population and the available resources required to conduct the trial. Going forward we may see a hybrid approach combining the strengths of each option, utilising mobile health applications and wearables.
Sponsors will be looking for partners who can meet technological requirements and deliver fast, accurate and reliable results.
How Oximio can Support Centralized and Decentralized Clinical Trials
Oximio is able to support both centralized and decentralized clinical trials. With our own network of local offices, we have experienced staff with expert knowledge of current, regional requirements. Not only do they work within the required regulations, they shape them in manner which helps simplify and streamline processes, fostering an improved environment for decentralized clinical trials featuring adaptive designs and remote monitoring. Our patient focused services are the perfect fit for decentralized clinical trials, helping to improve retention and engagement throughout your trial.
Offering, complete end-to-end clinical trial logistic services, contact us today and find out how we can support your research.