Decentralized clinical trials: revolutionizing the way we conduct clinical research

The past year showed that remote work will outlive the pandemic. Clinical trials were no exception.

Previous clinical trial participants recall the hassle of traveling to a hospital or institute, undergoing numerous tests, and being away from their daily routine for extended periods.

With the advent of patient-centric decentralized clinical trials (DCTs), this could soon become a thing of the past.

What are decentralized clinical trials (DCTs)?

DCTs are a new approach to clinical research that allows conducting trials outside of traditional sites.

Instead, participants can enroll from the comfort of their homes, using remote monitoring technologies and digital tools.

DCTs are synonymous with patient-centricity. They present numerous benefits for participants and sponsors.

Advantages of DCTs

The clearest advantages for participants are convenience and accessibility. In a patient-centric setting, participants don’t have to travel to a clinic or hospital, saving them time and money.

With 85% of trials failing to recruit enough patients, such perks would lower the participation barrier for hesitant patients.

In trials requiring blood samples, DCTs can be conducted using remote blood collection kits. This advancement encourages enrollment and retention, especially from people with chronic needle anxiety.

Loop Medical conducted a field study in South Africa that highlighted the advantages of patient-centricity in blood collection.

Loop Medical’s remote blood collection device scored a 97.5% success rate in drawing an average of 1.12 ml blood – enabling testing for 20 biomarkers at once.

Out of the 297 samples collected, 99.8% were processed using Roche Cobas analyzers, and 91.4% of participants rated the experience as little to no pain (compared to 48.5% for venipuncture).

Convenience is not the only benefit of decentralization. The use of remote technologies allows for the recruitment of participants from a wider geographical area. This enhances the diversity of the group of participants, leading to more accurate data, more credible results, and a better understanding of the tested treatment or device.

DCTs can also reduce cost and time. There is no need for participants to travel to clinical trial sites and by using remote monitoring technologies,? the data collection and analysis processes are streamlined.

The result will be fast and efficient clinical trials with higher retention rates– a win-win for participants and sponsors.

Real-life examples

One example is the Parkinson's Progression Markers Initiative (PPMI). This international study aims at identifying biomarkers for Parkinson's disease progression.

Using decentralized studies and data collection methods such as wearable devices and digital tools, PPMI can monitor the participants' symptoms and track their disease progression in real-time.

This approach provides a more comprehensive understanding of Parkinson's disease and the potential for earlier diagnosis and more effective treatment.

Another example is the I-SPY 2 clinical trial for breast cancer.

I-SPY 2 uses an adaptive trial design and multi-center collaboration to quickly and efficiently identify the most promising treatments.

The trial framework allows for real-time evaluation of new drugs, and the decentralized approach increases patient access and diversity in the study population.

The goal of the I-SPY 2 trial is to accelerate the development of new treatments for breast cancer and improve patient outcomes and quality of life.

Challenges

The benefits are tempting. But before DCTs are fully endorsed, the industry has some challenges ahead.

Patient-centricity comes at the cost of having participants away from clinicians.

Therefore, one challenge is ensuring that patients have access to support and resources throughout the trial and receive any necessary medical intervention on time.

Additionally, there is a need for rigorous data security and accuracy measures to protect the sensitive information being collected and stored.

Participants in a remote trial may not be as closely monitored as they are in a traditional setting. This leaves room for bias in data collection, leading to inaccuracies and affecting the validity of the results.

Finally, some challenges are less obvious and require trial, error, and constant feedback from patients. One of the subtle challenges is keeping the process human.

Patients seem to look for a human connection more often than technical support during the trial. This points to a need to humanize DCTs and make sure there is a face on the other end of the screen.

Conclusion

Decentralized clinical trials are becoming increasingly popular. Despite the hurdles, they have the potential to revolutionize the way we conduct clinical research.

With technological advancement, low participation barriers, and reduced costs, we can expect to see more and more decentralized clinical trials in the future.

The successful examples of DCTs we’ve seen so far demonstrate the potential for this innovative approach to clinical research.

Patient-centricity can boost access to clinical trials and treatments and improve health outcomes worldwide.

Interested in a pilot using Loop Medical ’s painless, remote blood collection device? Contact Loop Medical today!