Enhanced Risk Management in Decentralized Clinical Trials

Risk Mitigation in Decentralized Clinical Trials

I’ve been a surgeon for more than 30 years, specializing in maxillofacial surgery and dentistry. A big part of my philosophy is to expect the unexpected. Which is why I cannot stress the importance of risk mitigation enough. The safety of my patients and the safety of my team is always top of mind.

I partnered with DecisivEdge to bring to life a solution that could bring a higher level of risk management – a digital patient engagement platform that could be used by patients from the privacy and comfort of their own home. This ultimately delivers a more attentive and better-informed patient.

At the time, I was focused on its use in surgical practice and hospital operating room protocols. But I quickly found a place for the solution in the decentralized clinical trials (DCT) space as the need for effective risk management strategies that could literally cross jurisdictions and borders became even more pronounced.

In this blog post, I talk about the risks associated with DCTs and how 5thPort works to greatly minimize those risks, while drawing from my own experiences with the platform.


It’s important right off the bat to mention that the FDA encourages all clinical trials, regardless of the phase they are in (often before trial initiation), moves towards a systematic risk-based monitoring approach (National Library of Medicine). That is, they are able to have a strategic and well-documented plan when it comes to the detection of potential risks and the inclusion of a mitigation plan.

But decentralized or hybrid trials are another ball game altogether.

As Nicole Gray highlighted in her article in the Clinical Leader, the decentralized model can introduce new risks in addition to those found in traditional clinical trials. These include the geographical diversity of participants and the reliance on remote technologies for decision making, differences in jurisdictions etc.

The first step to identifying the unique risks with Decentralized Clinical Trials requires us to ask the question we hope doesn’t jinx everything – What could possibly go wrong?

  1. Breakdown in Communication
  2. Struggles with Documentation Management
  3. Inconsistencies with Data Quality
  4. Technological Challenges for Staff and Participants

1. Breakdown in Communication

Nicole talks about the most common risk associated with Decentralized Clinical Trials (DCT) – communication. “All parties need to communicate well… Failing to confirm all the details, no matter how minor they may seem at first glance… can result in surprise(s)…” Efficient collaboration across sponsors, sites and CROs ensures a shared understanding of not only study protocols, but also risk management strategies.

In Decentralized Clinical Trials, communication is a double-edged sword – towards participants, and then between staff members themselves.

Researchers get frustrated by the limited physical oversight of individual participants, which may sometimes increase the risk of non-compliance or protocol deviation. And between members of inter and intra departmental staff.

One of the key advantages of 5thPort is its ability to offer transparency. Take for instance our centralized dashboard – study teams can get real-time access to the progress, status and documentation of all sites connected with a particular study. This enhanced multi-site visibility allows for better monitoring of potential risks and timely interventions when needed.

In her article, Nicole highlights an interesting point; virtual visits, combined with quizzes… “can help mitigate the risk of a patient receiving and taking the incorrect drug, as well as ensuring a full understanding of how and when to take their drug.” This is exactly what 5thPort aims to do with our multimedia content, which combines video education and interactive elements like quizzes and teachback technology.

2. Struggles with Documentation Management

Maintaining up-to-date documentation is crucial in mitigating risks related to Decentralized Clinical Trials.

Sites still hold onto completing an entire trial with physical documents as they don’t trust they can rely on remote data collection, or on participants’ self-reporting. But we really do need to strive for an “out with the old, and in with the new” mentality when it pertains to documentation management.

With 5thPort, your participant engagement and eConsent documents are digital, so you can access it at any time during or after the trial for compliance and quality assurance purposes. Also, using the 5thPort digital platform, all forms are original digital source documents. You no longer need to rely on scanning and archiving paper documents.

One of the biggest struggles with documentation is using the most recent/approved versions of informed consent documents, educational materials and protocols. With physical papers, and with many eConsent systems – the manual task of updating information lies with the user. The chances of outdated, incorrect information, especially when it comes to audits, being disseminated are high.

Using the 5thPort platform across multiple sites you have audit quality document version control and no more lost, incomplete or altered documents. Additionally, both sponsor and CRO monitors can access all patient documents remotely in real time on a centralized dashboard.

5thPort provides robust version control capabilities, minimizing potential risks associated with misinformation or non-compliance. Study teams can ensure that participants have access to the latest and accurate information throughout the trial.

3. Inconsistencies with Data Quality

Manual data collection may sometimes risk exposure to inaccurate or incomplete data. The way to mitigate it is to include data validation checks and access to real-time auditing trails, which can easily identify inconsistencies.

5thPort’s system ensures consistency; standardized templates and modularity throughout the patient engagement workflow, helps with data integrity.

Our powerful One Touch Compliance™ report enables healthcare providers see actions taken on patient encounters by both staff and patients in real time. It generates audit and inspection reports that assist in meeting protocol and risk management requirements. In other words, each action is logged as a separate date and time-stamped event, so you have details on who made what changes to a document/protocol and when/where it was taken – enhancing and ensuring risk management requirements and all who viewed them.

4. Technological Challenges for Staff and Participants

A recent PPD poll reported that keeping up with technology/innovation rounded out the list of the top 3 reported challenges in clinical trials.

Staff may encounter technological difficulties in DCTs, such as program compatibility or learning to use new platforms which can impact their ability to effectively carry out their responsibilities. Similarly, participants can benefit from a platform having user-friendly features that helps them access educational materials, review and provide consent and communicate with study staff.

5thPort has been designed with a focus on ease of use for both study staff and participants. For study teams, the intuitive interface and streamlined workflows simplify the process of managing patient engagement, obtaining informed consent, and documenting interactions.

For participants, they can conveniently access educational materials, review and provide consent, and communicate with study staff from the comfort of their own homes.

This ease of use reduces the chances of errors or oversights, enhancing risk mitigation efforts.


Enhanced documentation for decentralized clinical trials with 5thPort

Four years ago, I deployed 5thPort in my own office’s off-site care protocols. I could almost immediately tell a difference – it was a more holistic level of risk management than ever before to patient education, treatment protocols, seamless remote informed consent and documentation.

The adoption and deployment of this new technology resulted in this 13,000-patient experiences/outcomes with impressive results.

Over this 4-year period, the DecisivEdge team and I measured a few interesting datapoints:

  1. 62% of patients completed their engagement workflow completely remotely.
  2. 94% of those patients gave the remote education and consenting experience the highest rating.
  3. Patients demonstrated an 84% comprehension rate of the multimedia education content presented.
  4. Notably, there wasn’t a single lost, incomplete or altered informed consent document.

These outcomes showcase the platform’s ability to provide the highest level of patient documentation, compliance with protocols and risk management.

Extending 5thPort’s applications into the decentralized clinical trials space was a move I was all too happy to make. The more I learned from my patients about their experiences in clinical trials, the clearer it became to me that enhanced patient engagement would benefit the clinical trials space as well.


In any clinical trial, all roads lead back to promoting patient/participant understanding of the trial, and that cannot be achieved if we overlook patient and staff clear and consistent communication. The key is consistency: if we establish, follow and maintain procedures and clinical trial protocols over a course of time, it can considerably reduce the risk involved.

Decentralized clinical trials (DCT) existed pre-2020, but its adoption was really only accelerated over the course of the pandemic. This doesn’t even scratch the surface of trial complexity only getting magnified because of COVID-19, which incidentally, was reported to be the second-most reported challenges by top executives in a poll by PPD. The entire clinical research community was in new territory, sometimes literally having studies that crossed borders. The need for transparency across clinical trials, especially those that dealt with interventions (drug and devices), came to the forefront.

It’s about time we raised the standard of risk management in all of them, especially considering that it’s one of the most heavily regulated industry. This article by Pharmaceutics says this about the already high-risk business of clinical trials:” The regulatory landscape has evolved with increased requirements for risk management plans, risk evaluation and minimization strategies.”

5thPort brings some of the highest levels of robust risk management to decentralized patient management. Its proven outcomes in my surgical practice can translate to remote clinical trial protocols for higher risk management objectives while ensuring efficient study operations and improved participant experiences.

5thPort offers benefits like transparency and visibility across studies, streamlined version control for updated documentation and ease of use for both study staff and participants. All of which, is pertinent to your risk management strategy.

Get in touch with us for more information about how 5thPort can enhance your DCTs enhanced risk management protocol in your next clinical trial.

Written by: Dr. Robert Berube – Co-founder 5thPort