Independent expert committees have become increasingly frequent in clinical trials in the past decade. As the number of committees called upon in the context of any given trial increases, so does the complexity and cost of managing them and so does the risk of accidental unblinding of data, confidentiality breach or other compliance issues. Have you considered using a robust platform that integrates the necessary features to ensure compliance and ease of management? Here are five good reasons for doing so.
Steering Committee (SC), Data Monitoring Committee (DMC), Data Safety Monitoring Board (DSMB), Liver Safety Committee (LSC), Clinical Adjudication Committee (CAC)... the list is long and getting longer with time. Complex studies in unclear pathologies, complicated endpoints, non-specific adverse reactions and symptoms, adaptive study designs with multiple interim reviews and analyses often require a number of specialized committees with custom-set access to data and information. Here are five reasons why managing clinical trial committees through secure, compliant platforms is recommended.Reason 1: Clinical trials committee members have “day-jobs”. Experts are increasingly solicited to participate in different committees. However, they also have a main activity that in most cases is to take care of their patients. Spending time in sponsors’ clinical trial committees is viewed as an additional workload by most. A user-friendly, secure and compliant interface makes it easy for them to perform their part in clinical trials.
Reason 2: Data and information is confidential and/or blinded to the sponsor. One of the highest risks of managing external committees with different levels of blinding is accidental disclosure of blinded information to unauthorized persons. Ethical’s systems like eAdjudication® and eDSMB® embed role-based access permissions that prevent this from happening without the need for continuous attention.
Reason 3: With more committees come more costs. Using secure, compliant platforms that streamline workflows obviously saves time for all involved individuals. At the end of the day, all the added benefits save money for the sponsor. A secure, compliant platform that guarantees no hidden costs allows for transparent, comprehensive budget calculation and unpleasant surprises.
Reason 4: Many individuals involved are external to the sponsor. Because clinical trial committees are mainly composed of individuals external to the sponsor, easy access from outside the company firewall is necessary for smooth operations. While VPN access is always an option it is certainly not the simplest or the most reliable. Cloud-based systems have robust security built-in allowing secure, compliant, role-based access from any internet browser and make the work of externals easy and pleasant.
Reason 5: It all has to end up in the TMF. At the end of the study, all the documentation must be safely stored in the Trial Master File (TMF) in archival formats. Having to collate and verify documents from different systems is time-consuming and occurs at study closure, usually a time when attention has shifted to other topics. Making sure that the chosen platform, like eAdjudication® or eDSMB® has embedded functions for on-time archiving can save a lot of time and frustration.
In conclusion, when deciding on which systems to use for the management of independent expert committees, we advise to consider integrated cloud-based software with well documented compliance features, secure access, role-based security, friendly interface and most importantly, an agile support group that will listen to your needs and apply the necessary changes without delay. At Ethical, we give strong attention to both the structural and support elements in order to provide top quality service in clinical trial committee management.
eADJUDICATION®: COMPLIANT AND COST-EFFECTIVE ENDPOINT ADJUDICATION COMMITTEES MANAGEMENT
eAdjudication® offers such flexibility that the software configuration and support provision are tailored to exactly match your need.
