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Q&A with Jeff Clark: Recent steps streamline clinical trials process

JeffClark

The appointment of Jeffrey Clark, MD (MGH) as medical director of Clinical Trials Operations at DF/HCC became official about two months ago, but the helm is hardly new to him. For over a decade, Clark has guided investigators through the clinical trials process, and beginning last year, he helped pilot a comprehensive effort to enhance and streamline clinical trial review, activation, and monitoring. Recently, he explained some of the improvements that the Operations group and the Office for the Protection of Research Subjects (OPRS) have been working on with Beverly Ginsburg-Cooper, MBA, administrator of DF/HCC, to help investigators better navigate the protocol process.

What changes have been made in the clinical trials review process that will benefit investigators?

First, we have added two Institutional Review Boards to panels A, B, C, and D. The new IRB-E is a rapid response panel that allows us to deal with acute issues as they arise. The new IRB-F is an addition to panel C and meets the weeks that panel C does not, so that we can increase capacity and reduce delays in continuing reviews of protocols, amendments, and serious adverse events.

Second, we have proposed three additions to Scientific Review Committees, which should be put in place over the next two to three months. The current SRC-1 meets every other week right now; the new SRC-2 will also meet every other week, giving us the same functional capacity as the IRB panels A and B, which review new protocols. SRC-2 will also improve the flow from SRC to IRB. Another new SRC panel will review only amendments. We receive many more amendments than we do protocols, so dealing with those in a rapid fashion is critical. Finally, we’re adding an SRC that will annually review the scientific progress of each clinical study to make sure it should continue. This SRC, which we’re combining with the accrual monitoring committee, will enhance our ongoing scientific evaluation of all the protocols in the clinical trials portfolio. It may also help us catch slow-accruing trials earlier so we can boost enrollment, if possible.

What’s happening with enhancements to IT systems for clinical research?

The most significant addition in information technology is InfoEd, the clinical trials system being implemented for OPRS, which will be phased in throughout 2008. It will track the progress of protocols, amendments, SAEs, and other forms submitted to OPRS, so that if a document is not moving along, we can deal with the problem sooner. InfoEd will markedly improve the quality and timeliness of whatever is being reviewed by different committees. Ultimately, the minutes of SRC and IRB meetings will be recorded in InfoEd, which will help investigators quickly determine where their protocols stand in the process.

We’re also upgrading the OncPro system, which provides online access to protocols, eligibility criteria, consent forms, and other documents. The upgrade will make the system more robust and allow investigators to access documents quickly. Then there’s the Electronic Data Capture system (EDC), which is gradually being rolled out one disease program at a time. EDC is a database for capturing and tracking the data for every patient on a study that DF/HCC investigators have initiated. We’re also exploring NCI’s caBIG [cancer Biomedical Informatics Grid, a set of tools for accessing and analyzing data] to see whether it has components that might replace some of our legacy systems, such as patient registration, or add new functionality, such as a calendar for subjects on studies.

Another key enhancement is the protocol template, a document now online that helps investigators write better protocols that should flow through the system faster. The template ensures that all information required for a clinical trial – such as treatment, drug formulation, SAE reporting, modifications, etc. – is included in the right place and worded consistently. The purpose of the template is to help standardize information, format, and language so that the protocol will be safer and easier to use in performing trials. The template should also reduce the number of corrections from reviewers and therefore speed up the approval process.

How are you planning to provide more educational opportunities for investigators?

The CItI System we use now provides basic training for those doing clinical research. But we want to engage investigators in a more meaningful way. Our goal is for every investigator and clinical research coordinator to understand why ethical and regulatory issues are important to good clinical practice in the conduct of trials. We’re developing a series of lectures and educational tools that we think will help.

What is the new multi-institutional trial program, and how will it help PIs?

PI-initiated multi-institutional trials are especially challenging because a significant percentage of patient accrual and management happens outside DF/HCC where we don’t have direct oversight. We’ve developed guidelines for investigators on how to run these trials and a template for writing the Data Safety Monitoring Plan (DSMP) for different sites. We’ve also established a consultation team that will review the DSMP to be sure it will produce high-quality data on a timely basis so that the trial can be done safely and at the highest scientific level. This program will greatly assist investigators in the design and performance of these studies.

What about plans to increase inter-institutional communications?

One of the things we need to do better is to tie back into the individual institutions – and not just to their oncology departments. If there are issues related to clinical trials in general that require institutional input, for example, we must be sure that the appropriate level of management of the hospital is aware of these issues. So we’re working to find better ways to communicate at that level so that we can promptly fix these types of problems when they arise.

You’re already a very busy physician, professor, and clinical researcher. Why did you take on this official responsibility?

On the one hand, it’s a pain in the neck, it’s hard work, and it takes a lot of time. But there are three reasons I do it. I believe very deeply that our institutions are excellent places for the care of cancer patients with wonderful investigators performing meaningful, high-caliber clinical research. I have an opportunity to help patients by facilitating this research, especially through improvements in information technology. And understanding what it’s like being a clinical researcher helps me find solutions that balance the need for scientific rigor and regulatory compliance with the need for user-friendly processes for the research community.

Lonnie Christiansen