DECENTRALIZED MONITORING IN CLINICAL TRIALS


 INTRODUCTION

Decentralized clinical trials have the potential to improve accessibility, diversity, and retention in clinical trials by moving trial activities to participants homes and local surroundings. In this study, researchers conducted semi-structured interviews with 20 European regulators to identify regulatory challenges and opportunities for DCTs that were recognized by regulators include a reduced participation burden, which could facilitate the participation of underserved patients. Here regulators indicated that data collected in DCTs are expected to be more representative for the real world. Key challenges recognized by regulators for DCTs are concerns regarding investigator oversight and participants safety when physical examinations and face-to-face contact are limited.  To Facilitates future learning, hybrid clinical trials with both centralized and decentralized elements are proposed by the respondents. 


WHAT IS DECENTRALIZED MONITORING IN CLINICAL TRIALS                                        According to the FDA, decentralized clinical trials DCTs are defined as “The decentralization of clinical trial operations. Here technology is used to communicate with study participants and collect the data.”

                   



There are different words to describe the concept of decentralized trials,

  • Virtual

  • Home

  • Remote

  • Site less     

                                      


Whatever the term organization may choose, the goal is the same: making clinical trials easier for patients by reducing or eliminating the need to travel to specific sites. 


This approach has been shown to


  • Reduce drop-out rates                                               

  • Increase study

  • Effectiveness

  • Faster the marketing of life-altering drugs

  • saving sponsors in billions.


                          Decentralization doesn’t mean conducting trials in the absence of healthcare professionals. Nor it mean (in most cases) completely eliminating the need for any physical patient contact. Instead, it’s about looking at areas where technology and other novel solutions one can enable sponsors and CROs to take a hybrid approach to clinical trial design which provides an alternative to a site-anchored, inflexible system which often results in a high patient dropout rate.


It’s important to note that decentralized trials exist on a spectrum. If introducing a fully decentralised model where patients never have to set foot in a clinical site isn’t possible, it doesn’t mean the studies can’t or won’t benefit from incorporating some virtual or at-home elements. 

         

For example, a number of site visits can be replaced by an Healthcare personnel making a home visit, or with an app that facilitates data collection without needing patients to attend appointments/sites. 


MAIN BENEFITS OF DECENTRALIZED CLINICAL TRIALS


                                   


  • Accelerating patient recruitment 

  • Increasing participant diversity 

  • Gathering more applicable data sets 

  • Improved reliability and accuracy of data 

  • Easier reporting and analysis of results  



KEY CONSIDERATIONS FOR SUCCESSFULL DECENTRALIZED CLINICAL TRIALS


The most common areas for consideration when designing decentralized trials are:

  • Communication with patients

  • Smartphones 

  • Tablets

  • Facilitate data sharing


  • Travel reduction or elimination

  • Technology-enabled data collection 

  • Home healthcare


  • Transportation of medications, samples 

  • Specially-Trained courier transport

  • Collection of unused medications 

  • Deliver new medication


CORE TENETS OF DCTs :

  • Accessibility - One should use technology which can be easily used by participants and intuitive to learn. Technology is most effective in clinical trials when it fits seamlessly into patients’ daily routines and is accessible on devices they already have and which they are familiar with.


  • Simplicity -Tasks given to patients should be easy and simple. If it is too complex, leads to cause stress which also further impact the integrity of results as there is more chance of error. 


  • Reliability - One should make sure that the tools and processes have been thoroughly tested and aware of any potential pitfalls requiring mitigation. As the trial progresses, use patient feedback to continually improve processes and increase reliability.


CONCLUSION


          DCTs take advantage of modern technological solutions to extend the reach of clinical research to where patients live, facilitating remote collection of data reflective of the individual experience of patients in real world settings. By developing new capabilities to meet the technical and organizational needs of DCTs, researchers can help user in a new era of high-performance clinical research, one that is more inclusive and highly tuned to the diversity and unique needs of individual patients. And Yes, Decentralized monitoring in clinical trials is the future.


REFERENCES





Student Name: Sudham Pravallika

Student ID: 004/012023

Qualification: B. Pharmacy

e-Mail ID: pinkysudham2354@gmail.com

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