The views expressed in the interview are solely of the individuals involved and do not represent the views of the associated organization.
Mike Kassin, MD, Florence Healthcare
John McAdams, Manager, Data and Safety Monitoring, UCSF Helen Diller Family Comprehensive Cancer Center
With increasing site workload and protocol complexities, questions arise around how to best allocate time, effort, and money in order to reduce redundant tasks and study start-up time while remaining audit-ready at all times. This interview explores how we seek to answer these questions through the transition to paperless and painless clinical trials.
What do you think of when you think “paperless clinical trials?”
- I think of efficiency and access, namely being able to find documents and know where they are at all times. One of my biggest concerns would be that important documents can easily get misplaced. I also think of enabling clinical trial team members with the ability to access any document no matter where they are located. With access though, you must have tight permissions for who can access these trial documents. As a comprehensive cancer center, if we are going to grow and continue to run more and more single site and multi-site trials, we need an electronic system to increase efficiency. I think this is the wave of the future. There are many cancer centers implementing the process currently. If you want to grow, an electronic system is essential.
What are your reservations and concerns regarding paperless trials?
- Concerns about how much upfront work is required to implement. Are there any glitches? Are there going to be unforeseen issues?
How do you think paperless trials will affect regulatory documentation?
- We have protocol project managers (PPM), and their job is to manage the regulatory documents which are currently a mixture of electronic and paper documents. As a large comprehensive center, we have trial sites spread out over different centers across our city. Future electronic processes will allow remote access for our PPMs and other clinical staff.
How do you think paperless trials will affect monitoring?
- We need study teams to be able to submit to the same repository where they access and download the necessary documents. For monitoring, we could then do source data verification if we share the repository with the participating sites in multi-center trials. Therefore, we need electronic systems because it is so much easier to monitor. For example, there is a Consortium Program that utilizes an electronic system by granting access for regulatory documents to 12 different comprehensive cancer centers around the country, which promotes better communication and ease of access to these important documents. Multi-center studies are so much more complex in general. A central regulatory repository will make managing clinical trials more efficient for coordinators and PPMs. The other sites can see certain documents based on permission and access in this system. It is much better to have documents stored electronically, allowing clinical staff ease of access to these documents. However, for this electronic world to work, integration with numerous trial systems is key.
How do SOPs affect paperless trials?
- SOPs must be compliant with HIPAA standards, as well as GCP and NCI requirements. Additionally it is important to be compliant with recent FDA electronic guidance. The goal is to be audit-ready. When the FDA or pharma teams audit our cancer center, invariably they want to review our guidance docs and SOPs. In our most recent FDA audit, the auditors specifically made sure that we were compliant with our policies and processes. One of my goals for audit prep is to not only ensure GCP and NCI requirements, but also that we are compliant with our own policies and processes. Regardless of how organized our cancer center is, having our files stored electronically will improve efficiency in preparing and providing these documents to the auditors. In turn, this will contribute to successful and compliant audits.
What workflows are important for paperless trials?
- In general, tracking of documents is critical. There are time frames in our policies that need to be adhered to, such as notifying the IRB, FDA, or sponsor of new risks. Having an electronic system will enable better tracking and documentation of these important notifications.
Is an increasing protocol complexity driving a need for paperless trials?
- Absolutely. It all really comes down to accessibility. Study teams need to be able to access all clinical trial documents electronically and remotely if they are on a separate clinical campus or in a meeting out of town. For example, to ensure timeliness, safety reports need to be stored in one place, and physicians need to be able to access this information regarding SAEs, new risks, etc., all which will be possible with an electronic system.