In the current issue of ACRP's The Monitor, there is an interesting article regarding a different approach for monitoring federally-funded studies. In an effort to reduce cost and increase efficiency in regards to monitoring federally-funded studies, groups such as the Cardiovascular Cell Therapy Research Network (CCTRN) have been created. The CCTRN was established by the National Heart, Lung, and Blood Institute (NHLBI) with the goals to “develop, coordinate, and simultaneously conduct multiple collaborate trials testing the effects of cell therapy in cardiovascular disease”. The article states that there was a particular goal to assist in investigator-initiated studies.
With these goals in mind, the CCTRN set up several clinical centers throughout the U.S.(currently, there are seven), with each site including a principal investigator, fellow investigators, and research coordinators; in addition, the group has a main data coordinating center, which includes a principal investigator, project managers, clinical research monitors, and a safety team. The CCTRN is comprised of a network of physicians, scientists, and support staff that work together on clinical trials that focus on providing cell therapy to patients with cardiovascular diseases. Their trials are conducted at multiple participating centers, each of which specializes in studying treatments for heart diseases and stem cell therapies.
How has the CCTRN taken on the role of clinical monitoring? The ACRP article notes three differences between the industry model and the CCTRN model:
- Team building – focusing on communication and relationship-building between the clinical monitor and the study coordinator and site personnel, which includes both on-site and remote monitoring
- Involvement in protocol development – allows for in-depth knowledge of the protocol and product, which increases the effectiveness and efficiency of the monitor’s review of subject charts and eCRFs
- Resource allocation – includes timely and frequent review of outstanding queries, which is typically done remotely to reduce the time working on queries on-site; utilizing a process for prioritizing the scheduling monitoring visits, based on level of enrollment, endpoint data, and the number of forms requiring review
The CCTRN notes that their monitoring model forms “strong relationships with centers, collaboration of the entire study team, and communications across functional groups” which continue to allow their studies to run smoothly and efficiently. It seems as though this approach to monitoring is one that can benefit other areas of clinical research, if similar techniques are applied.
What are your thoughts on this monitoring model?
Photo Credit: Polygon Medical Animation