Subject: Re: Trial Power Date: Saturday, July 15, 2017 at 3:02:15 PM Paci?c Daylight Time From: Kevin Murphy To: Stein, Murray CC: Scott Matthews, Jain, Sonia Priority: High Murray thanks for the i?ve been traveling per your note below, and per Paul Holtzheimer?s recommendation, is there any reason to do a vs sham i like the scienti?c reasoning behind randomizing to standard, but Paul and a few others, seemed to think this wasn?t Also, re the sites, are you comfortable if we use the i can get access to that location at a fraction of the cost of VM RF On Jun 29,2017, at 3:20 PM, Stein, Murray wrote: Hi Kevin and Scott: I met with biostatistician Sonia Jain yesterday to get some preliminary advice about design and associated power for the trial we have been discussing. If we go with a two-arm study comparing to standard TMS, and power to detect a 20% standardized effect size difference between groups (which would be needed if trying to compare two ac?vetreatments), the requirement is for 197 subjects per group (294 total). For the same design powered to detect a 25% standardized effect size (which is getting unreasonably large) the requirement is for 126 subjects per group (252 total). Neither of these sample sizes are feasible. If we go with a three-arm study comparing to to sham which is probably the most appropriate design at this stage of knowledge with the primary endpoint being the comparison of each of the 2 active arms versus placebo, to detect a 40% effect size difference requires 60 subjects per group (180 total). This sample size is within the realm of feasibility with multiple site. Sonia wasn?t especially enthusiastic about an adaptive trial, but is happy to discuss this further. So those are the numbers. How would you like to proceed? (And will you want Sonia on-board formally as the study biostatistician?) Best, Murray Murray B. Stein MD, MPH Distinguished Professor of and Family Medicine Public Health Vice Chair for Clinical Research in UC San Diego Subject: (none) Date: Monday, June 5, 2017 at 8:14:13 PM Paci?c Daylight Time From: Dr. Kevin Murphy To: Matthews, Scott CC: Diana Shapiro scott, good seeing you hope you?re okay with taking the lead a little more re the PTSD de?nitely open to doing it at and/or our current feel free to coordinate our next meeting with Murray to discuss next steps tx Kevin T. Murphy, MD. Professor Vice Chair Department of Radiation Medicine Applied Sciences UC San Diego Director, Pediatric Radiation Oncology Program Rady Children?s Hospital 3960 Health Sciences Dr. #0865 La Jolla CA 92093-0865 email: website: Administrative Assistant: Robin Roberts (858) 822-7499 direct (858) 822?5568 fax r1roberts@ucsd.edu Subject: Fwd: funding for VA trial Date: From: To: Friday, August 5, 2016 at 7:05:36 PM Paci?c Daylight Time Kevin Murphy Jonathan Sherin, leahjacks@gmail.com Attachments: image003.png Fyi Sent from my iPhone Begin forwarded message: From: Maria Sittmann Date: August 5, 2016 at 4:57:21 PM PDT To: "Murphy, Kevin" Cc: Sherill David "r1roberts@ucsd.edu" Subject: RE: funding for VA trial Hello Dr. Murphy, Thank you for reaching out to VMRF. We are interested in discussing this with you further. Our Executive Assistant, Sherill David (858?552-7406) will set up a meeting for Wednesday afternoon (8/10) for us to learn more about this potential opportunity. I hope you are available. I will also invite Dr. Schulteis and Dr. Lang. You are welcome to ask others to attend if you wish as you mentioned Dr. Stein and Dr. Matthews in your email below. Also, after having read the information provided, I may reach out to you for additional information. Have a wonderful weekend. Best regards, Maria Maria Sittmann, MBA Executive Director/CEO 3350 La Jolla Village Drive San Diego, CA 92161 Direct Of?ce 858.642.3070 Fax 858.642.3499 msittmann@vmrf.org; Honoring Service with Science? From: Murphy, Kevin Sent: Friday, August 05, 2016 11:20 AM To: Maria Sittmann Subject: funding for VA trial Hi Maria, i will soon be in receipt of a large gift to my research account at UCSD. . .this money can be used for research for Veterans per the donor?s intent. . . .i have a protocol and interested physicians on the VA side (Murray Stein and Scott Matthews) to conduct a trial for PTSD and TBI, likely to be performed at the Aspire Center. I wanted to get in contact with you to discuss the appropriate logistics for a funding opportunity such as this. Please feel free to contact me directly on my cell 619 804 3359 thank you kevin Kevin T. Murphy, MD. Professor Vice Chair . Department of Radiation Medicine Applied Sciences UC San Diego Director, Pediatric Radiation Oncology Program Rady Children?s Hospital 3960 Health Sciences Dr. #0865 La Jolla CA 92093?0865 email: website: Administrative Assistant: Robin Roberts (858) 822?7499 direct (858) 822-5568 fax r1roberts@ucsd.edu