Remote Monitoring of Investigator-Held Documents
Across industries, companies are looking for new ways to reduce time, save money and make processes efficient. Even more so in the life sciences industry.
28 October 2014
Across industries, companies are looking for new ways to reduce time, save money and make processes more efficient. Even more so in the life sciences industry, due to big pharma’s failure to deliver innovation in their research and development laboratories, the scarcity of new blockbuster drugs, and increased pressure from competitors and generics.
One of the hottest topics in the last two years has been about shifting from traditional (interval-based) monitoring to risk-based monitoring. It’s no surprise the interest this has generated, since study monitoring costs for phase III studies account for 25-30 percent of the entire study budget and amounts to an annual spend of around $10 billion across the industry.
However, any examination of how to implement risk-based monitoring forces us to re-evaluate how we interact with the investigator sites — and there are areas that clearly need improvement.
A decade ago, we were in the early adoption phase of Electronic Data Capture (EDC). The majority of clinical data was collected using paper case report forms (CRFs). These needed to be sent to the sponsor or contract research organization (CRO), and recorded using double data entry. Today’s EDC systems look vastly different from early versions that mimicked paper CRFs. EDC adoption is now over 70 percent and surpasses 90 percent for Phase III trials — it is this data which currently enables most risk-based monitoring decisions.
Clinical data, however, is only worthwhile if we can be assured of its quality. Anyone who’s ever worked in this industry knows the importance of documentation in this regard. Indeed the high administrative burden associated with clinical trials is the largest factor for why over 55 percent of new sites drop out from our industry after only one to three studies.
Regulatory inspections are already focused on the clinical investigator (67.47 percent according to the EMA Annual report of the Good Clinical Practice Inspectors Working Group 2013) and the majority of their findings are document-related. Yet, while sponsors and CROs have invested millions in moving to electronic trial master files (eTMF) for study documentation, over 80 percent of site-based documentation is still completely paper-based today.
Unlike the old paper CRFs, we only review site-based documents during onsite visits. So for example, the data associated with a visit of a new subject cannot be guaranteed for inclusion in our datasets until a monitor has verified the associated source documents and completed the appropriate informed consent form correctly. Regardless of how quickly the data is captured, quality is only determined when the monitor next visits the site — and in fact over half of the monitor’s time spent onsite gets spent reviewing documents.
These monthly site visits cost the sponsor nearly $5,000 per day. So when you consider that the average study monitor spends 75 percent of their year on the road, one can appreciate how study monitoring can account for 40 percent of the revenue a CRO may expect to generate from managing a single study.
Moving away from interval-based monitoring to risked-based monitoring still requires the quality of the data to be checked, even if 100 percent of the source document verification is not performed — informed consent forms must still be reviewed, investigator site files must still be inspected.
Enabling remote monitoring means moving sites away from paper for all of their site-based documents — the segregation between sponsor and site must be maintained. Even when shared, sites must retain control over their content and ensure that patient confidentiality is respected. It is only with this level of security that remote monitoring can be conducted efficiently — without incurring compliance risks for the trial.
Providing study monitors this means to securely assess site-based documents remotely, allows them to check if a site has its files in order, or conduct source data verification before disrupting site staff. Sites can also monitor the status of their investigator site files and when the monitor visits the site. That way they know which documents might have a problem so they can make better use of their time with the site staff. Concerns can get dealt with faster and more time can be spent helping the site and knowledge-sharing.
The benefits of this shift in the allocation of time onsite cannot be underestimated. The monitor/clinical research co-coordinator relationship is one that can make or break a study; and the state of the monitor/study nurse relationship is vital to subject enrollment.
Andrew Mitchell is the director of strategy and product marketing for life sciences at Intralinks. Andrew has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions through his time with Covance, Relsys, Medidata and BioPharm Systems (Oracle Gold implementation partner). With a focus on Software as a Service, he has a strong belief in providing solutions that simplify and improve the user experience and the relevant subject matter expertise to ensure delivery of real benefits and enhanced compliance.