Last fall I initiated the Clinical Research Management Database to help me understand what factors are making it easier or harder for us to conduct clinical and translational research within the Johns Hopkins SOM and SON. As part of this process, we systematically selected a sample of recent IRB-approved protocols for more in-depth assessment. We have had nearly 300 responses to the survey (nearly a 75% response rate), and I appreciate the many comments from faculty. I thought you might be interested in some of the main findings from the survey:

• The Institutional Review Board (IRB): Faculty do not see the IRB as a substantial barrier. 86% of the faculty are extremely satisfied or satisfied with both the quality and efficiency of their IRB reviews. Only 12% were not satisfied with the eIRB application process.
• The Office of Research Administration (ORA): In about 30% of the protocols, PIs reported having to interact with the ORA. 66% were satisfied or extremely satisfied with the communication from the ORA office. For those who needed to use the ORA Support Services office dealing with the PRA (Prospective Reimbursement Analysis), 79% were satisfied or extremely satisfied with the quality and timeliness of their services.
• Biostatistical Support: Finding a biostatistician for protocols is one of the biggest burdens identified. Only 52% of the PIs reported being satisfied or extremely satisfied with finding high-quality biostatistical expertise. In contrast, satisfaction with finding a basic science or laboratory collaborator was over 90%.
• Locating Expertise: When we asked what was the most difficult type of expertise to identify for the particular protocol, biostatistical and database management were mentioned frequently in addition to several specific types of technical laboratory or imaging techniques.
• Financial Management: Financial management for the protocol was also a challenge. Only 61% were extremely satisfied or satisfied with the current process for financial management of their grants.
• The Collaborative Process: 94% of the PIs were very satisfied or satisfied with the collegiality and respect within the research team. This is another indicator of the collegial environment we are so proud of at Johns Hopkins.

There is much more data available from the survey that I will report in future communications. However, there is one more result from the survey data I would like to report.

• Overall, the vast majority of PIs thought the time they had spent getting the protocol approved was worthwhile. However, I am concerned that 19% of the PIs either reported they were not certain or indicated that the time spent in getting the protocol approved was not worth it. About 15% were not sure or certain they would not conduct a similar study in the future. As we track the success of these protocols we will report additional information.

What are we changing based on these results?

While I was pleased to see that the collaborative environment for research at Johns Hopkins continues, the need to provide more biostatistical and database support is clear. The shortage of biostatisticians is being felt both locally and nationally. I am working with Karen Bandeen-Roche, our new Chairman of the Department of Biostatistics, to create a better roadmap for how faculty can access the full range of biostatistical expertise that is needed. I am also pleased to report that we received an administrative supplement to the CTSA that will increase the number of trainees in the Master's level biostatistics program while integrating them into the Johns Hopkins Biostatistics Center.

If you have comments about biostatistical support or any other issue covered in this report, please share them in the comments section below.

Sincerely,

Daniel E. Ford, MD, MPH
Vice Dean for Clinical Investigation
Director, Institute for Clinical and Translational Resesarch