Abraham Gutman, CEO, AG Mednet

It’s hard to believe that a global pandemic that has affected millions, and, so far, taken the lives of hundreds of thousands, could have any silver linings. After all, the loss of life alone is unfathomable in a time period where the majority believes that science, technology, and medicine can protect us to a much higher degree than where we find ourselves today. We have seen that the best solution to saving lives is based on a well understood epidemiological method that humans developed almost a century ago: quarantine. We have also seen how this necessary method has had a significant effect on businesses, especially those involving ongoing clinical trials, causing enormous hardships across the globe.

The conduct of a trial itself is mostly managed by CROs whose employees have for a very long time worked from home. These companies for years had the basic technology allowing them to exchange ideas and information, mostly through email, video conferencing, and good old telephone calls with their constituents, including site coordinators, investigators, internal colleagues, and KOLs. While not the most efficient, reliable, or trackable, these methods have been at the core of clinical trials, and we all have learned to live with them.

There is, however, one factor that we have not yet considered: clinical trial subjects; the reason the whole enterprise takes place. They are the source of all the answers regarding these grand experiments. Without subjects being physically available, there are no trials. Given that physical availability and quarantine are generally mutually exclusive, COVID019 has had a tremendous effect on the entire industry. Significant numbers of trial launches have been postponed, existing trials have slowed down appreciably, and sponsors and CROs found themselves in mostly uncharted territory.

As the pandemic continued and the stark reality of the current clinical landscape was revealed, many advocates urged for changes in the way we carry out these trials. The main buzzword making the rounds was virtual trials, which are generally understood to be the next generation of methodologies to enable the conduct of studies. These studies would increase the use of technology to provide subjects with the ability to participate without the current level of burden required to complete physical visits to investigator sites. These technologies include a variety of platforms and devices that enable remote processes such as wearable devices and video/telehealth. However, there still remains the challenge of delivering therapies to subjects. Infusions and injections do not lend themselves to virtualization, which is why virtual trials also require decentralization, enabling subjects to minimize travel time to the facilities charged with delivering their therapies.

Further, there is something other than the physically constrained manner in which we conduct trials that needs attention. For the last 15 years, we have developed capable systems to capture all the data necessary to determine whether the hypothesis set forth by the study is correct. Data capture systems abound and include EDC, CTMS, CDMS, IRT/RTSM, eCOA, ePRO, and eTMF, among others. These form-based systems help ensure that data is correctly gathered and validated, and that it can be accessed either directly or through reports in many flexible ways. Some of this data validation is enhanced by the ability to implement validation workflows that guide users (whether trial professionals or subjects) as they go along by calculating their entries in real time and presenting different fields depending on earlier inputs.

As an industry, we must think of ways in which collaborations can be codified to ensure that the data from all the various capture systems is made available at the proper time to the right individuals and in the appropriate context. Creating flexible people and system interaction tracks that can be laid and torn down on demand will allow us to be significantly more effective when the unexpected happens, while giving us both a roadmap and a history of our decision-making processes.

I believe that the post-pandemic clinical trial landscape will not be too different from the one we lived in at this time last year. The silver lining is the fact that our industry has shown resilience and demonstrated our shared commitment to improving patient care.

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Though the global pandemic that has affected millions, the industry has shown resilience and demonstrated a shared commitment to improving patient care. 

Silver Linings of Post-Pandemic Trial Disruption

The logistics involved in running a global image-intensive clinical trial are exceptionally complex. Just one submission error can cost up to seven weeks of trial delay, millions of sponsor dollars, and the potential loss of patient data. 

Why do we wait until an image reaches its final destination before we inspect it, reject it, send it back for correction or, worse, deem it “unevaluable”? 

Conducting an imaging trial is expensive, time-sensitive and risky. Providing investigator sites with the right tools to assemble and submit their clinical trial data, and ensuring that the quality and completeness of their work is automatically checked prior to submission greatly enhances the efficiency of the downstream process of converting this input into usable trial data by the imaging core labs (ICLs).
  
  The following tips show how, by advocating the use of the proper tools and a validated delivery platform for the submission of imaging data by the sites, a trial sponsor can mitigate the risk of error and ensure the highest level of quality for its data at the source.



  Investigators and site study coordinators participate in multiple trials from different sponsors requiring different types of submissions to various ICLs. This is akin to workingin a flexible manufacturing environment in which workers assemble one part today, and another tomorrow. As the requirements for the assemblies vary, the workflow to complete each assembly must vary as well. Workflow automation should guide study coordinators through the necessary steps for each particular trial submission, providing different tools that reflect the protocol-specific requirements of each.

The user interface should only present the tools required, in order, so that study coordinators follow every step properly.


The user interface must be consistent across all tools to reduce training requirements.


  The tools for each operation must have embedded in them quality control functionality which is constantly in the background checking for errors in data acquisition and data entry. If errors or inconsistencies within or across steps are detected, the tool should alert and guide the user to make the proper input.
  
  


  The right tools, presented in the most efficient order will help the study coordinator:
  • Enter the correct values in the deidentification process.
  • Replace without human intervention those tags for which constants for the site or trial can be used.
  • Pre-populate transmittal forms to ensure consistency.
  • Facilitate the inclusion of additional files or information to the submission.
• Perform automated checks, on-site, of protocol compliance. These may include anatomical completeness, contrast perfusion and proper series sequencing as required on a trial-by-trial basis.
• Identify if any data is outside protocol parameters to enable corrections for future submissions.


  The submission of medical image time points should be fully integrated with the rest of the trial information support systems so study coordinators don’t have to enter information about one subject twice. All submissions and their data should automatically update the systems at the ICL, CRO, and sponsor in real time.



  User-entered data should not be subjected to manual re-entry at the core lab/CRO. Since quality checks have occurred during the assembly of the submission, re-entry can introduce errors, data quality degradation, and loss of tracking ability back to the source.
  
  The key to lessening clinical trial delays is an environment where sites can be trusted to do the right thing, recognizing that although participating in clinical trials is an important part of their mission, their priority is caring for patients.
  
  This requires supplying them with proper tools that take into account a number of critical elements about “life at the site”—not just those that help get data to their ICLs faster. These require the least amount of training and help whoever is piecing the data together to complete their task as effortlessly as possible, while checking at every step that their final product is properly assembled.
  
  Give site coordinators the right tools, and trust that query rates will be drastically reduced.
  


Abraham Gutman, CEO, AG Mednet

Articles

Silver Linings of Post-Pandemic Trial Disruption

Six Tools for Decreasing Clinical Trial Delays