Testimonials from california-based researchers

"My NIDA-funded, FDA-regulated two-year drug-drug interaction study of mirtazapine and methamphetamine was ready to enroll in December 2020. The protocol was submitted to RAPC that month, but the committee didn't meet until February 2021. The Committee did not provide a response until April 2021, with no concerns that would alter the study at all (they had questions about dose that suggested they had not read the protocol). We responded to the questions they raised, corrected punctuation, and finally received approval after a total 5-month delay, costing at least $150,000 in staffing, and consuming >20% of the total time allotted for the entire trial. This was a terrible waste of taxpayer resources and delayed access to a medication to treat addiction"

"Studies are expected to run quickly these days - often in just 12 months. All California sites were dropped from consideration for a national NIH trial of ketamine for methamphetamine use disorder because the RAPC would eat up 50% of the time allotted for the trial. No other regulator is so slow and wasteful of taxpayer resources - nor is any other regulator so useless."

" [RAP-C] changed submission criteria without notice following the submission deadline for a review date. We submitted a new application shortly before the submission deadline. Right before the review date for that deadline, RAP-C asked for new application requirements that we were not prepared for. However, those new requirements were not published online or mentioned in any other documentation at the time of our submission. We submitted proof that the requirements were not made public at the time of our submission deadline and requested that RAP-C review the application anyway. They did not respond and are still holding the application."

"In another example, we submitted an application for a new study a week or so before the submission deadline. Shortly before the meeting date, RAP-C reached out about our FDA approval letter, which was a "requirement". We looked back at their website and archived versions of the website, the FDA requirement had not been added until after the submission deadline without notice." 

"[RAP-C] is not transparent. They are not always responsive to questions. There is no published timeline for approval of protocol amendment requests, which leaves us unsure about when we can implement changes. No notice of meetings being cancelled, specifically for meetings that we have submitted applications for months ahead of time & after confirmation that our application had been assigned to that meeting for review. For example, we submitted a application for review in December, but they cancelled the meeting and didn't let us know."

"Our ability to participate in a study testing a promising innovative treatment for treatment resistant depression sponsored by a UK company (Beckley Psytech) is in jeopardy because recruitment has started in all states except California due to delay in approval by RAP-C."

"[After the] loss of a potential research center in Southern California funded by Compass Pathways, UK after they became frustrated by RAPC. The company decided to create its research center in another state."

"With regards to this aspect of the letter “….penalized California residents who may have benefited from early access to emerging treatments for mental health and substance use disorders..”.  I have been informed today about a suicide that was contributed to by a study being delayed by RAP-C review, according to next of Kin and executives of the study sponsor.  The person who told me is putting me in touch with next of kin."

Study name: 2 x 2 factorial, double-blind, randomized study of ‘set and setting’: a translational study in healthy volunteers (aka, 'S&S'). 

• FDA IND #: 157762 
• IRB #: 23-38706  
• IRB Reference #: 388387 
• IRB approval: Oct 16th 2023 

"The approximate cost of RAP-C review: $250K spent on current staff recruited in anticipation of study start. However, we're also held back from recruiting prospective staff due to desire not to burn more funds. However, recruitment of new staff is needed to make the study start feasible."

"Funders have backed out of funding the study to the amount of several $100K due to lack of progress and this can entirely be pinned on the RAP-C hold-up, as we are ready to begin otherwise. FDA IND and IRB are in place. We must get DEA approval only after RAP-C, however."

"This study was IRB approved in October. We're spending currently on staff that should be recruiting for the project when RAP-C approves it. We also need to plan recruitment of new staff for the anticipated and required ramp up in effort. Likely a number of potential funders have not backed this study and one formally dropped out of scheduled funding because of delays to its progress. Our progress is directly stymied because of the RAP-C hold-up."

"I am in favour of eliminating RAP-C entirely. It is redundant after FDA and IRB review."

"CTN-0110/MUR was submitted to FDA March 2022. FDA’s safe to proceed was issued on 5/13/2022. Protocol v4.0 submitted to IRB May 2022. IRB approval on 6/23/2022 (protocol v4.0)"

"RAP-C submission July 2022. RAP-C response required updates to the protocol. Fall 2022 embedded in protocol v6.0. RAP C response submitted w/protocol v6.1 Feb 2023. RAP-C approval for CA sites (AHS, UCLA) on 02/10/2023. Protocol amendment for RAP-C changes (v7.0) approved by IRB on 03/06/2023"

"I think it’s worth noting that protocol version 4.0 was approved by sIRB and accepted by FDA via IND application. Without RAP-C, this study could have started June/July 2022. With RAP-C, we received approval for California sites in February 2023, a significant time and resource delay."

"CTN protocol 094 submitted [to RAP-C] 11/12/2020. Received no response. Emailed them on 1/29/2021 and received a study number. The Executive Director had passed away. We received a response on 3/16/23 that our study was not needed to be reviewed because [the study] was about access and not medications."

"Extensive experience with excessive delays in research due to RAP-C review over decades. Latest example was delays in NIDA CTN 0110 (MURB) due to RAP-C review process ."

"Our research was delayed for over 9 months because our RAP-C contact person passed away. We were not notified, and then we had to re-apply because our application was lost."

 "[Our] studies of psychedelics [are being] held up by RAP-C."

"[RAP-C caused] 5-8 months delay on studies that would otherwise be able to go into the field, costing waste in staffing costs."

 "Committee has not met since October 2023, holding up[our] current studies."