DF/HCC Clinical Trials Infrastructure Update

January 28, 2020

Dear Colleagues

First, we hope everyone had a good holiday season and a happy new year!

We wanted to provide an update on the Dana Farber / Harvard Cancer Center clinical trial support system. As you know, over the summer, we launched iRIS, an online submission and review system. The goal of the change was to consolidate multiple processes from submission to activation in our clinical research into one application and to have more transparency where things were at in the movement of a protocol through the process. While we anticipated some bumps as you would with any new system, we concurrently had a much higher than anticipated turnover in the Office for Human Subjects Research, with > 50% of positions vacant soon after the launch of iRIS. As most people probably know and feel, this has led to delays in the review process. We are writing today to update everyone on progress to fix the process, plans for the next 6 – 12 months, and a request from all investigators and teams to help get us to a much better place, together.

Update on progress:

  • OHRS is almost fully staffed with only 4 remaining open positions 
  • OHRS is now staffed with 2 new Associate Directors, focusing on Clinical Trials and Social Behavioral research   
  • Engaging an outside recruiting firm to fill the Director of OHRS position (currently being managed by Nick Farley with consulting from Huron)
  • Engaged outside consulting company who are both training the new coordinators as well as conducting expediated reviews for submissions that do not require full board review
  • Trained 10 senior level volunteer study staff to work on administrative reviews and clearing the back log
  • Working with SRC and IRB chairs to improve timeliness of reviews and maximize production from each meeting, including working on adding 1-2 additional meetings for SRC reviews
  • While submission to activation timelines increased from average 113 days in July 2019 to 147 in December 2019, we are now seeing this leveling off and anticipate downward trend over the next few months. We are committed to reaching 90 days by Fall 2020
  • Launched new Secondary Use and Non-Human Subject Determination Applications in iRIS that allows for a single process to submit such requests
  • Have a new operational process in place in iRIS for the use of central IRB for clinical trials

Plans for the next 6-12 months:

  • With the engagement of the outside consulting company, we will revise the policies around what needs a full board or any SRC/IRB review to avoid filling the system with items that don’t require submissions or can be expedited
  • Working with SRC/IRB chairs to better harmonize reviews across committees
  • Determine which SRC and IRB committees require more members and adding proportionate representation across hospitals with a focus on allowing for remote participation that is still meaningful and engaging
  • Soliciting continuous feedback on iRIS to determine possible fixes to improve experience and ease-of-use for users
  • Increased educational experiences for investigators and study teams on iRIS, secondary use protocols, and clinical research issues
  • Improving the central IRB process to improve the experience and the ease with which teams engage central IRBs 
  • Evaluating issues that have delayed amendments from being promptly reviewed, and approaches to improve this going forward

How you can help:

  • Study teams and investigators should make sure submissions are accurate and complete
  • For Amendments: please carefully read the description of amendment changes and select all that may apply (eg. a change in accrual is a scientific change – if sent without that box checked, it will not route correctly). If a selection is missed, the submission may need to be withdrawn – this is an iRIS specific issue that we are working to fix but until that change occurs, it is very important to review amendment submissions carefully
  • SRC and IRB members can help by completing their reviews within iRIS in a timely manner and using the iRIS template for their reviews
  • Study teams should proactively reach out to Feasibility and Ancillary Reviewers to make sure their reviews are done in a timely fashion
  • Provide us feedback 

While metrics are important to the overall process and we are committed to getting to 90 days from submission to activation by this Fall, more important to us is that clinical investigators feel the process is user friendly, understandable, inclusive, and fair. DF/HCC is a leader in cancer clinical research and we need to maintain that status for our investigators, our institutions, and most importantly our patients.  

 

Thank you,

Jeffrey Meyerhardt, MD, MPH
Associate Director of Clinical Trials, Dana-Farber/Harvard Cancer Center

Jeffrey Clark, MD
Medical Director of Clinical Trials, Dana-Farber/Harvard Cancer Center

Drew Memmott
Associate Director for Administration, Dana-Farber/Harvard Cancer Center

Farah Daftary
Clinical Trials Operations, Dana-Farber/Harvard Cancer Center