The clinical trials sector is going through a challenging and delicate phase, that could lead to a slowdown in drug development in general.

In an attempt to limit damage, safeguard the validity of the data and protect the health of patients by guaranteeing their therapeutic continuity, several national regulatory authorities have issued directives that allow certain derogations to the standard procedures to be followed in conducting a clinical trial.

However, the contingent opportunity should lead all stakeholders, promoters, researchers, and patients not only to understand how to manage the current emergency. Further, how to concretely modify the operational processes of clinical trials so that, always in full respect of regulatory and privacy requirements, we can achieve those unavoidable goals like higher quality, shorter time, greater patients’ participation, and reduced costs.

 

Which are the essential GCPs principles to be fulfilled?

Once the required ethical-administrative approvals have been obtained, the study starts with the recruitment of patients and the execution of the procedures foreseen by the study protocol.  The promoter must ensure that the trial is adequately monitored by determining its scope and nature.

The purpose of trial monitoring  is to verify that:

(a) the rights and well-being of human subjects are protected,

(b) the reported trial data are accurate, complete and verifiable from the original source documents,

(c) the conduct of the study is in accordance with the currently approved protocol, GCPs, and applicable regulatory requirements.

The scope and nature of the monitoring shall be based on various considerations such as the objective, purpose, design, complexity, blindness, size, and end-points of the trial.

In addition, as specified in the Addendum GCPs E6 (R2) of June 2017, the sponsor should also develop a systematic and diversified approach to monitoring, based on the identification of study priorities and risks. The promoter may choose to implement the on-site monitoring, a combination of on-site monitoring and centralized/remote monitoring, or, if justified, centralized/remote monitoring only. Obviously, the rationale for the chosen monitoring strategy must be documented in the monitoring plan.

 

Is it possible to perform the activities of an on-site monitoring visit remotely?

Let’s immediately say that the answer to the question is: Yes.

Digital solutions such as the electronic site file (eISF) and digital platforms for the management of the investigational study drug (eDSM) make it easy to control both the study documents at site remotely and to make the drug accountability and to calculate the treatment compliance.

The procedure and technological solution for the remote source data verification, which must ensure compliance to both regulatory and privacy requirements, deserves a separate discussion.

In this regard, the Italian competent authority (AIFA) recommends that the solution adopted should comply with several requirements, including those listed below:

  1. use of advanced cryptography and security protocols in compliance with GDPR, with controlled access and audit trail of each activity,
  2. validation of the application according to GCPs standards
  3. guarantee that access to the database containing the patient’s identification data is allowed only and exclusively to the staff of the experimental center
  4. procedure for clear identification of personnel (study monitor) responsible for verification of original data

Genius rSDV: the Exom Group solution for a complete remote SDV

To overcome this critical issue, in line with its experience Exom Group has developed a multi-modular platform to perform, remotely, the same activities of the on-site monitoring visit, such as source data verification, drug accountability, and control of study site file.

In this way, the continuity of the complete monitoring activity is guaranteed as if it is carried out on-site. Even more, the advantage of not being conditioned by the need for a simultaneous presence of both monitor and investigator can fully be utilized. In addition, the time commitment of the center staff is reduced compared to that of an on-site monitoring visit. Ultimately the travel costs are eliminated.

Moreover, the integration of the rSDV with the risk detection & analytics algorithm (Genius RIDA) allows a simplified and centralized review of the risks detected by offering, through statistical models, an intuitive visualization of the data and the possibility to deepen them (e.g., by geography, center, patient or category), so that corrective actions can be taken  to minimize the problem and to prevent similar one in the future.

The feasibility, accuracy, and efficiency of remote source data verification  (rSDV) has been confirmed already in 2013 in a pilot study, published on Plos One. In five U.S. hospitals involved in two large NIH-sponsored multicenter studies,  the two methods of data monitoring have been compared. More than 99% of the data values were successfully monitored remotely.

 

How to stimulate and facilitate patient participation in clinical trials.

Never before, as in this period of a viral pandemic,  the problem of patient participation in clinical trials and hospital visits has been so important and serious.

The intent of each clinical trial should be to encourage the participation of as many patients as possible, making it easier and more comfortable to follow procedures and minimizing the need for visits to the clinical center.

Also, in this case, digital technology offers the appropriate solution.

Telemedicine applications based on familiar electronic devices, such as computers, tablets, and smartphones, can easily replace check-ups at the clinical site, allowing the patient to measure different parameters directly at home, thus avoiding the need to visit the center periodically. In addition, the possibility of being able to communicate at any time with the study doctor reassures the patient and increases both the participation in studies and retention.

Ultimately, the real-time analysis of Real World Data recorded at home helps to identify values and trends indicative of the evolution of the patient’s health status for the appropriate and timely medical-therapeutic interventions.

With its multichannel platform, Genius Rosa (validated, certified as a Class IIa medical device, as well as GDPR compliant, connected with an advanced analytics application), Exom Group offers a very competitive solution for the conduct of the so-called “Patient Centric” and “Real World Evidence” clinical trials.

 

Conclusions

As we have explained, today, multiple technological solutions allow the activation, conduct, and management of clinical trials in a complete digital mode. This approach prevents the occurrence of those problems we are facing today due to the impossibility for monitors and patients to go to clinical sites.

The hope is that promoters of the studies will not only consider this opportunity as a temporary solution to recover an emergency situation but that they will finally take the professional decision to enter the era of the digital modernization of clinical trials.

As always, Exom Group, through its expertise, experience, and innovative digital solutions, is ready to support those pharmaceutical companies and non-profit promoters who want to undertake a path of digital modernization of clinical research. Not only to ensure the proper and regular conduct of studies in any health, social, and economic scenario but also to enhance the centrality of patients and with an attention to time and cost.

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