Minutes CTSpedia ARRA Supplement 2009-2011

August 1, 2011

Peter Bacchetti, Mary Banach, Laurel Beckett, Frank Harrell, Mat Soukup, Sally Thurston

New Award - August 1, 2011 - June 30, 2011 - Total Award Given

Laurel's grant administrator will be in touch with other grant administrators for the new award.

Final Report for Rochester Award

Mary has contacted the Education KFC to see how they would like to use our Education Materials. They will get back to us.

For the work done on CTSpedia, Mary has added listings to the CTSpedia Quarterly Report section (http://www.ctspedia.org/CTSpedia/ReportingCTSpedia). The section is only open to BERD Work Group members. There are 243 Research Topics with information. Not included in this 243 are 23 topics that need authors. They are marked in red on the Research Topics page and can be found on this page (http://www.ctspedia.org/do/jump?topic=CTSpedia.ResearchTopicsNeed). Links can be found on the Research Topics page and the Contribute page.

The Case Studies are in a separate topic area (http://www.ctspedia.org/CTSpedia/CRCaseStudies). There are some links to the Research Topics page but most links are within the Case Studies section. Erin Esp has also added 13 topics to the Research Topics. These are not linked to the Case Studies.

ENAR Spring Meeting

Laurel will be working with Frank, Sally, and Mat for abstracts for the ENAR Spring Meeting.

Access to Entire CDISC Datasets

Frank has noted that the CDISC datasets posted on CTSpedia are only a subset of the entire file. He would like to get access to the entire file and then post them in R on CTSpedia. Mat will send the letter giving us permission to access the data and send Mary the ZIP file for posting on CTSpedia.

Reproducible Research (RR)

Frank has hired a new coordinator for Reproducible Research. She will start in September. All members of the RR group will be required to upload a page onto CTSpedia.

Online Journal Presentations

Mary will look at webinar software, including Kahn Academy, and recommendations from the Sloan Consortium for Online Professional Education.

We would like to work with Liz Heitman, Nick Stennick, and others in research ethics in biostatistics practice for our first reading and meeting.

Our goal is to start early this fall.

Next Meeting, Monday, September 12, 1 PM PT

Due to the Labor Day Holiday our next meeting will be Monday, September 12th.

June 6, 2011

Peter Bacchetti, Mary Banach, Frank Harrell, Jeff Horner, Dale Plummer

New Funding

Iris said NIH is working on the Coordinating Center funding for Vanderbilt first. NIH needs to separate out any overlap in activities between the two projects. We need to let Iris know funding ending dates for the current grant.

Receiving More Feedback on CTSpedia

Jeff suggested that we use Tumblr as a blogging forum for CTSpedia. Mary will sign us up and incorporate it into the right menu bar. Mary is also a part of the BERD Watch staff and will be meeting with NIH Communications to see if there are ways of spreading the word about our activities. Chris Lindsell provided the list of BERD Success Stories. Mary will contact all the contributors to see if we can post their stories to CTSpedia.

Statistical Graphics Site Opening to the Public

The Statistical Graphics site will be opening to the public. They do need some help with coding some of the display graphs.

Forms for Macros and Graphs

Mary has re-designed the forms for the macros and graphs. You will now be able to look across all the different forms for SAS, R, and Stata codes.

Support for Other Groups

We will need to provide support to various groups. Chris Lindsell has received his JIT letter for the adaptive design work and will be putting materials on CTSpedia. As soon as Vanderbilt finishes their CTSA renewal, Paul Harris of REDCap will be working with Denise Babineau and with Felicity Enders to upload their materials to REDCap and CTSpedia. Babak Shahbaba from UC Irvine would like assistance in putting together his first biostatistics course for UC Irvine, School of Medicine. Shelley Hurwitz at Harvard and Liz Heitman at Vanderbilt would like to work with a group on ethics in statistical analysis.

Online Journal Club

Frank will initiate an online journal club on the CTSpedia. He has been participating in one on StatExchange. He thinks that it is great fun. He will present his ideas next Tuesday (June 14th) on Peter's call.

April 4, 2011

Peter Bacchetti, Mary Banach, Laurel Beckett, Frank Harrell, Jeff Horner, Dale Plummer, Ben Szilagyi Sally Thurston

Collaborations with PhUSE \x96 Introducing Ben Szilagyi

\x95 http://www.phuse.eu/Wiki.aspx

Ben showed us around the Pharmaceutical Users Software Exchange (PhUSE) site. Ben and Mary spoke at the DIA Computational Science Meeting. Many of the attendees wanted to know why CTSpedia and PhUSE were not collaborating. Ben and Mary thought that this was great idea. PhUSE needs feedback on software standards in clinical research. Sally pointed out that this endeavor fits well with the SAS Utilities being created at Rochester.

Ben is in Europe and our call was very late for him - so we excused Ben after promising to arrange a call earlier in the day to talk to the SAS Tools group about collaborations.

Report from the DIA Meeting

\x95 Progress on Statistical Graphics

Mat Soukup's session at the DIA Computational Science Meeting was well-received. There were both practical questions about collaborations on CTSpedia Statistical Graphics and also philosophical questions on working within a wiki. The audience, FDA and pharmaceutical company representatives, were very pleased to see the open and frank discussions between all parties. Some of the other sessions were not as well received because the data, e.g. PACE Initiative, cannot be shared with the public. Johns Hopkins and the FDA will produce reports on methodology and findings but they cannot open their data to the public.

\x95 Working on Code with Statistical Tools Group

Sally was looking over the Statistical Graphics work and realized that her group can provide SAS code for the graphics. We will have a meeting with Mat Soukup to discuss this work.

The only problem that we are currently encountering with the Statistical Graphics code is that all the CDISC data is in SAS Transport Files. The wiki cannot handle SAS Transport Files and so Mat has uploaded the CDISC files as CSV files. Mat says that this is working fine for his graphics. Frank said that we can re-shape the data and not lose as much of the functional capacity as compared to a CSV file. Mary is going to spend a few days at Vanderbilt and will look at how to re-shape the data.

Statistical Tools and Educational Materials:

\x95 Updating the materials Programmers at Rochester and UCSF will meet after April 15th (Rochester is moving on the 15th) to work on updates to the CTSpedia. The FDA lawyers have added a few disclaimers on the Statistical Graphics. We will review the disclaimers and see what is appropriate for our tools.

\x95 Reformatting On the Statistical Graphics site we have found that forms (with updates) and reports offer easier search and linking capacities. Unfortunately, we did not make as much use of these wiki tools on the rest of CTSpedia. We will review the Statistical Graphics work and determine what tools will be of assistance on the rest of the CTSpedia.

\x95 Naming Conventions Unfortunately, the wiki allows one to use the same name for attachments as long as it is on a different topic page. Currently, we have 12 attachments named "SAS example". We also have many attachments with very long names describing the materials included in the attachment. We will work on providing naming conventions and suggestions for all of our contributors.

Evaluations \x96

\x95 Statistical Graphics Rating Plugin For each of the Statistical Graphics we have added the rating plugin. We can add as many lines of ratings that we would like to see. Peter would also like to see a comment field. We need to see how that works on the plugin. We can attach this plugin to as many topic pages as we would like to see evaluated.

\x95 Topic Rating Plugin Jeff has also loaded the topic rating plugin. The downside to this plugin is that the administrator must list the name of the registered wiki user who will be using the topic rating. If this plugin was useful, we could set-up a file with all the CTSpedia registered users but we would not expect all users to rate every page - so this list would be quite overwhelming.

Other News

\x95 Adaptive Clinical Trial Design We met with Jim Ware, Chris Lindsell, and Jerry Schindler (Merck) about presenting Adaptive Clinical Trial Design materials on the CTSpedia. Chris has applied for a supplement studying adaptive clinical trials and will use the CTSpedia for the educational materials. Jerry is very involved in studying adaptive clinical trial design at the pharmaceutical companies. We will meet again to discuss whether this is a feasible collaboration.

\x95 Caren Heller from Public-Private Partnerships(PPP) KFC Chris Lindsell referred Caren to Mary. We are exploring CTSpedia/BERD initiatives partnering with the PPP for sustainable funding.

\x95 Updates Jerry Schindler suggested that Mary talk to Steve Wilson from the FDA about other initiatives. Steve thought that a place for good educational materials on new initiatives, e.g. adaptive clinical trial design and comparative effectiveness research, is needed. He suggested that Jerry get in touch with Sue Jane Wang and Bob O'Neill at the FDA.

January 10, 2011

Peter Bacchetti, Mary Banach, Laurel Beckett, Jeff Horner, Dale Plummer, Sally Thurston

Contributed Topic Session at JSM

We were invited to do a contributed topic session. We would need another presenter. Sally thinks that she could do this. We also would need abstracts from all presenters by February 1st. With the work that is needed for a supplemental application this is a very tight time frame.

We would like to make sure that we have a good structure for the CTSpedia before we need another presentation. Perhaps, it will be best to write an application for an Invited Session for 2012. The application will be due in June.

PI for Funding Proposal

Laurel is meeting with Lars about putting it in a fourth supplement at UC Davis. We will need a letter from Lars to Iris to obtain permission to submit a fourth supplement. It will also be good to get a letter of support from Jim Ware.

Structure of Proposals

Laurel sees the existence of two proposals.

The first would be bare bones support for CTSpedia through the Coordinating Center. We would leave this to Frank and the Vanderbilt proposal.

The second would be for one-year to work on the infrastructure on the CTSpedia - making it more user-friendly, better organized, and with a plan for sustainability. We would have three goals: 1) to expand and integrate the current materials, 2) work on tools, and 3) provide a platform and templates for adding new materials. We are particularly concerned with building partnerships and finding the best ways to develop and produce new materials and new initiatives. We need to expand our evaluation tools not only to look at our own projects but also to determine what works best for our stakeholders.

It will be important to differentiate between what should be on the CTSpedia versus what should be a link to other applications. As a wiki the CTSpedia is not equipped to host applications or provide this type of assistance to developers. We would like to provide links to new and important development projects but not host these projects.

The best fit for our proposal will be supplement #2. We will work closely with Frank to make sure that we are not putting in for redundant effort. It will be important to come up with a back-up plan if Vanderbilt is not chosen as the Coordinating Center.

We will focus on upgrading the current materials, developing evaluation tools, and provide more cross-links with the education groups.

December 15, 2010 - Discuss Funding Proposals

Peter Bacchetti, Mary Banach, Laurel Beckett, Frank Harrell, Jeff Horner, Dale Plummer

PI for Funding Proposal

Lars Berglund, PI UC Davis, has three other administrative supplements that he is submitting and cannot add CTSpedia to his supplements.

Proposal 1: Frank will check with Gordon Bernard, PI Vanderbilt, to see if he is interested in the CTSpedia as one of his three administrative supplements.

Proposal 2: Iris said that we could apply for a fourth supplement at UC Davis. Laurel will check with Lars after we hear from Frank. If we go this route, we will need to follow-up with Iris very shortly with a request to Bernard Talbot to allow a fourth submission from UC Davis.

Administrative Supplement

Iris suggested that we apply for Supplement #2, Supplement to support ongoing activities. We clearly fit in with this supplement but what are our plans for continuation? Iris did not feel that this needed to be a high priority in our submission.

Jim suggested #5, Collaborative projects that support Key Function projects. It is less money with a defined work project. Perhaps, we can also apply for #5 for education activities. We would not apply as PI for both supplements but have one institution apply as PI for one and another as PI for the second.

Laurel would like to see a long term plan that pays us modestly for maintaining the materials that people submit to the CTSpedia. Peter is concerned about that approach because too few people are working on the site as it is. He feels this would discourage potential contributors.

Other Funding

Mary needs to follow-up with Mat and the pharmaceutical companies about FDA or pharmaceutical funding for the project.

RFP from Booz Allen Hamilton

These appear to be geared toward Informatics folks.

Vanderbilt as CTSA Coordinating Center

Vanderbilt may become the CTSA Coordinating Center. In that case the CTSpedia belongs at Vanderbilt. Frank feels strongly that everyone needs to be on board with the proposal before going forward. The Coordinating Center would start the end of 2011. We would need some bridge funding until it started. If we had an administrative supplement, we would need to reduce the funding to the Coordinating Center for the first year to compensate for administrative supplement funding.

Increase the Number of Principals in CTSpedia

Besides our schools, we should consider Felicity Enders and Brad Pollock, who have both showed an interest in the CTSpedia. If we cannot get an administration supplement at one of our sites, perhaps they would be interested in joining us? At least we can get a Letter of Cooperation from Felicity and Brad.

November 1, 2010

Attendees

Peter Bacchetti, Mary Banach, Laurel Beckett, Frank Harrell, Deborah Nolan, Dale Plummer, Mat Soukup, Sally Thurston

PhUSE Meeting

Mat presented a summary of the Pharmaceutical Users Software Exchange (PhUSE) Meeting. Three individuals from Sally's group attended the meeting: Rui Chen, Kimberly Kaukeinen, and Arthur Watts. There was lots of jargon and discussion of best practices from the pharmaceutical standpoint. It was not applicable to our data. Mat will look at how best to provide meaningful collaborations between CTSpedia and the PhUSE group.

CTSpedia Programming Questions

Peter Bacchetti summarizes some of the issues that have come up on the CTSpedia. The instructions for tags is difficult to find because it is under "create new tag". Dale will check with Jeff to see if we can program another button after "view all tags" to see the instructions.

Peter would also like to see some voting mechanism or a way to capture point and counterpoint. Dale will look into this feature as a plug in.

Dale is not sure that there is an easy was to capture list of desired contributions except to list them on the topic page.

Google Analytics can only provide the names of contributions. It does not have a function to capture how many times someone has contributed to the site.

Reproducible Research

Deborah Nolan of UC Berkeley joined us for this discussion. She prefers XML to R - rather than Sweave to R. Although XML is more difficult and exacting, it provides superior documentation. Deborah will provide research case studies and teaching examples from her work for the CTSpedia. In the material that she will send us she will discuss the differences between using XML and Sweave for these tasks. Deborah finds that the ability to create hierarchies in XML is important in her work.

Sally suggested that we compare Sweave and xml by first giving sample code and output from both Sweave and xml to carry out the same tasks, namely to read in the same text file and do some simple graphics and analysis. We would show both the output and code for both. Secondly, since xml can do more things than Sweave, Sally suggested that Deb give some example code and output to demonstrate this. Deb liked Sally's suggestions and can help us with them.

October 4, 2010

Attendees

Peter Bacchetti, Mary Banach, Laurel Beckett, Frank Harrell, Jeff Horner, Dale Plummer

Reproducible Research

On our next call we will be discussing technical approaches to statistical computing with Deborah Nolan of UC Berkeley and Duncan Lang of UC Davis. Frank likes Sweave (LaTeX plus R) because there is a recent uptake in the community. It is a lean and mean way of getting material to R. Frank knows that Deborah and Duncan use XML but it appears to be a more expert approach.

Frank feels that our fear of computational methods have put us behind in the profession. We need to overcome this fear to improve teaching in our profession.

Laurel thinks that concrete examples with her ADNI database can provide illustrations and ways to adapt these computational approaches to our clinical research projects.

Other Updates

Jeff has installed tags on every page in the CTSpedia. As individuals add tags we will monitor the best organization for these tags.

Jeff has also installed the Embed plug in for Bibtek citations.

Dale has formatted the New Web Home for the CTSpedia. The CTSpedia web, BERD Consortia web, Educational Materials web, and Forum web will be accessed through this home page. The Statistical Graphics group will move their developmed materials from their private web to the CTSpedia web. Mat Soukup has contributed graphics and the CDISC datasets to the CTSpedia web. Mary will be moving all current materials to the new web home.

Three statisticians from Rochester attended the Pharmaceutical Users Software Exchange (PhUSE) Meeting in Boston. They will be reporting on projects where the SAS Macro group can contribute to PhUSE development work.

Next Meeting

Monday, November 1, 12:30 PT - 2:30 CT - 3:30 ET.

September 13, 2010

Attendees

Peter Bacchetti, Mary Banach, Frank Harrell, Jeff Horner, Dale Plummer, Mat Soukup, Sally Thurston

Updates on Funding Proposal

Sally found a few places where the wording on the budget does not agree with the proposal. Peter is still working on the Relative Risk materials and will re-write the description on the proposal to reflect plans for this site. We will write a short description of plans for working on Reproducible Research and Global Health. Laurel will combine these updates in the proposal.

Schedule for changes in Web Home

Dale has formatted the new Web Home for the CTSpedia. He will produce draft pages with different colors. Mary will start moving items to the new Web Home starting with some of Mat’s graphics. Until everything is moved and reviewed there will be a link to the new Web Home on the CTSpedia front page but we will not use it as the front page. Once all the material is moved, we will work on a schedule for evaluating the usability of the new materials.

Updates on Safety Graphics

The Safety Graphics groups are producing some great materials. Susan Dukes’ group is almost finished with a flow chart which describes the process of choosing a graphic.

Reproducible Research

It is very difficult to get our group together more than once a month. Laurel suggested that we use the monthly call to review new initiatives and projects. For the October 4th call we discuss a new initiative on Reproducible Research.

Due to space constraints with the VYEW software and a desire to have more inactive discussions we will start with our group plus Duncan Lang, Deborah Nolan, Chris Lindsell, and Jim Ware.

We picture that the audiences that we are trying to reach are: Teaching statistical computing or learning statistical computing, Users of Reproducible Research methodologies and tools. Non-methodologists who need to know Good Practices in Clinical Research.

We are planning on producing: Definition of terms, Definition of principles, Reports – examples of codes, Case-based materials, e.g. ADNI, and Webinars (in the future)

We know that we will begin with a discussion of using Sweave (R + LaTeX) versus XML templates for people to use as starting points. Deborah has many XML templates that she has been using.

August 16, 2010

Attendess

Peter Bacchetti, Mary Banach, Frank Harrell, Nancy Hills, Jeff Horner, Dale Plummer, Mat Soukup, Sally Thurston

Updates on Funding Proposal

Phillippa Savage at UC Davis is finishing the budget for the proposal. When Phillippa is finished, Laurel will send the proposal around for a final review and then onto Iris Obrams.

Teaching Stats in the Health Sciences (TSHS): Soliciting proposals for invited sessions for TSHS

Laurel is looking for volunteers to put together a session about the CTSpedia for next year’s JSM Meeting in August in Miami. Laurel would like to cover four areas: (1) General Overview, (2) Stat Graphics, (3) Ethics and other teaching tools (e.g. Case-Based Materials), and (4) Evaluations of the site. Laurel will tentatively mark down herself, Mat, Sally, Frank, and Mary as possible speakers.

Updates on Safety Graphics

Mat's group has uploaded lots of materials. They were having difficulty with the dataset files, which need to be uploaded as CSV files. People can send their files to Vanderbilt for uploading. A note has been placed on the CTSpedia main web and the Statistical Graphics web instructing individuals to contact Vanderbilt if they are having difficult uploading datasets.

JSM Meeting

Mat and Frank's session and Laurel’s roundtable at the JSM Meeting on the CTSpedia were well-attended with an overflow number of participants. There were excellent suggestions for re-doing the face and navigation on the CTSpedia as well as increasing exposure and letting other groups know about the service.

Global Health Collaboration

Global Health at UCSF is actually looking at two types of wikis. One is for administrative purposes – letting researchers know about materials that will need for working in each county. The other would include information on doing clinical research and would project from CTSpedia materials. Currently, Global Health at UCSF is the only Global Health group whose funding goes through CTSA. The other Global Health groups at CTSA sites have separate lines for their funding. We will discuss further

Programming Questions

Peter Bacchetti's Relative Risk site is still not working correctly. Jeff has edited the program and it should be working. We will check to see about the latest problems. We will add a page to the CTSpedia to report technical problems. Jeff can access the list and update his findings. Dale and Jeff will add the other plug-ins that are available for the foswiki.

Re-organizing CTSpedia

As mentioned above Laurel received a number of good suggestions for making the CTSpedia more accessible. Mary has sketched out a plan for new web home in a Word document (New_Web_Home_0813.doc). Everyone can go in and make changes to the document. Dale has set-up the skin structure in the Sandbox. One can also edit the document in the Sandbox (http://www.ctspedia.org/Sandbox/NewWebHome0811).

Frank suggested that we broaden the Professional Development category and call it Professional Environment. Within the Professional Environment category, we would include Protected Time and other discussion items.

It was suggested that one of the sites should be formatted like Research Ethics and it will include Research Integrity. Within Research Integrity we will have Reproducible Research. Rather than having a discussion of what constitutes Reproducible Research, we will provide a prescriptive set of information with Standards, Definitions, Methodology, etc. This site should be organized to provide information for the clinical researcher or PI, addressing some of the latest problems at Duke with their cancer research, at Berkeley with their genetic testing of freshmen students, and Global Health studies. Links would also be created with training materials for the residency projects and for the clinical research associates doing clinical trial projects at our institutions.

Laurel suggested that we schedule the activities for the re-organized site with a date for the draft, dates for the trial period, and a date for the final move.

CTSA Coordinating Center

Frank reported that NCRR is looking for a coordinating center to manage administrative functions for the CTSA sites. It is a $2 million project. Gordon Bernard is thinking of leading the effort through Vanderbilt. We will be able to expand our wiki work but we will need to separate out our BERD work from other wiki work and determine how to scale up the project. Frank will keep us posted.

July 12, 2010

Attendees

Peter Bacchetti, Mary Banach, Frank Harrell, Jeff Horner, Dale Plummer, Mat Soukup, Sally Thurston, Jim Ware

Limitations of Wiki Software

Dale pointed out that the main function of a wiki is for editing and displaying materials. It is not a programming platform in and of itself. There are better programming platforms available for specific applications.

Jeff pointed out that the wiki is a great tool for shared authorship of documents. Wiki mark-up language is simpler than HTML and it is a great tool in and of itself. The wiki is useful for database and applications that do not require extensive programming.

Currently, the materials that we have on the CTSpedia work well with wiki capabilities. It is good for the R-code and SAS macro work that we are doing. As we get into further development for the R-Apache work, Jeff will build the connections to the CTSpedia. Jeff helped build the java script and other connections to Peter Bacchetti’s Interpreting Results. In the future, it may be better to build the Interpreting Results pages in R. For the time being, we can use the Relative Risk programming as a template for other Interpreting Results pages. (The site is now working correctly. Jeff found a line of code missing and put it back into the script.)

Review CTSpedia Proposal

Iris could not make it to the call because Varmus’ swearing in ceremony was taking place at the same time. Mary, Sally, and Laurel will have a conference call with Iris to discuss the next draft of the CTSpedia Proposal.

Jeff and Dale will check to make sure that we have included all of their current work and their future proposals. Sally found formatting problems and suggested further expansion of the description of the current work that we are doing on the CTSpedia. Frank suggested that we check on plugins that are available for the wiki and add a description of these little applications to the proposal.

We discussed budget and funding issues for the new proposal. Peter is down for 0.05% funding but he does lots of work on the CTSpedia. We should increase his funding to 0.10% but he will not be available for that type of commitment for another year. We will discuss staggered funding with Iris because Mary will need funding soon where other commitments can wait for funding.

Update on Safety Graphics

Mat’s groups are enthusiastically using the wiki for their safety graphics. We will move some of the examples that Mat has put together to public view – so that everyone can see an example of the work that is going on.

Opening Educational Materials for Public View

Greg Stoddard;s Stata text book is now up under Educational Materials. He is teaching a class in August and one in the fall and he would like his students to be able to access the materials but he was told that the Educational Materials cannot be open to public view. No one else has heard that comment – so Mary will have Eric Vidal send an email out to the BERD mailing list saying that we are opening the materials to public view. Those individuals, who have sent us their materials, can contact Mary if they do not want their materials open to public view.

Suggestions for CTSpedia and Other BERD Collaborations

Jim's goal for BERD for this year is to scale up the educational materials available on the CTSpedia. Jim would like to see many more resources available to avoid all the one-on-one consultations that BERD members are doing. He likes Peter’s idea of being able to look up results interpretations and would like to see more resources of this type.

Jim also spoke to Jerry Schindler at Merck. Jerry would like to see the wiki used for a forum for industry, FDA, and academia for issues that are particularly important to biostatisticians working on clinical trials. Jerry would like to have workshops on adaptive design and non-inferiority analysis as part of the wiki. Dale suggested that we use the wiki in the way that it is designed as a tool that provides us a forum to discuss topics for brainstorming. Mary will follow-up with Jim and Jerry and then add a new section to the CTSpedia to address these ideas.

Action Items

June 7, 2010

Attendees

Peter Bacchetti, Mary Banach, Laurel Beckett, Frank Harrell, Jeff Horner, Iris Obrams, Dale Plummer, Mat Soukup, Sally Thurston, Jim Ware

Project Funding - Due June 30, 2010

Iris suggested that we submit a proposal to her for permanent funding for the CTSpedia. We need to address resources, personnel, and other needs. We also need to address scalability and the growth of the CTSpedia. What are the costs and time involved per planning year? We should format the proposal as we did the ARRA supplement. Mary will circulate the document for review and further suggestions.

Education - Case-based Materials

On a related topic Laurel discussed the need for a clinical research training unit for residents. Currently, residents have a heavy clinic schedule. They have little formal training in evidence-based medicine. Ninety percent of the residents do an EMR or chart review without a great deal of planning or emphasis on the final written product. Most of the mentoring falls on junior faculty and the amount of clinical research expertise of the mentor varies widely. We are currently looking at the last three years of resident's projects at UC Davis and will have that data available on the CTSpedia. Rosalie Dominik at UNC will be adding her data. CTSpedia contributors may add data to the Residency Projects topic in Educational Materials.

Sally brought up some questions that Frank had had about the current state of comparative effectiveness research. He felt that many of the studies that are currently called comparative effectiness research just go to the EMR, without looking at the limitations of the data, and then go on to publish their findings.

Laurel pointed out that this exactly the reason that we want to do a formal training program. We want to point out the limitations of the current records and how to approach the research in a statistically mindful manner.

Jim will connect us with a very gifted teacher at Harvard who is doing short (5-10 min) video vignettes from clinical research lecture. Peter pointed out that it is very important to keep the segments small. People do not have a long attention span. On CTSpedia we must keep the segments under 20 minutes because of size restrictions on uploaded data.

We asked Iris if this should be a separate proposal or just an additional segment of the CTSpedia? Iris felt that this is a stand alone proposal and will look at the best way to fund it.

Report from the Statistical Graphics Group

Mat said that the FDA-pharma statistical graphis group meetings are going very well. He has done a presentation on creating and editing a topic on the wiki. The participants are still digesting the current samples that we have put up and are thinking about the graphics that they wish to develop. Most of the members of the working groups have signed up to contribute to the Statistical Graphics web.

Protected Time

(See http://www.ctspedia.org/CTSpedia/ActivitiesBERD)

Frank would like us to develop a white paper on protected time for biostatisticians. We need to look at professional development and creating an optimal professional environment for our young biostatisticians. They are asked to work on many projects and at the same time keep up with the latest methodology.

Laurel pointed out that this exactly the reason that we want to do a formal training program. The EMRs can be useful for descriptive statistics and as a source of pilot data. However we need to make it clear what the limitations of EMRs are. Sally suggested that this latter discussion also be put on CTSpedia (perhaps in a different location).

The above hyperlink will bring you to the section of the CTSpedia where we will collect everyone's ideas and then put the ideas together for our white. Peter Bacchetti asked that we set up a Web Notify for any new materials on this site.

Improving Access and Visibility on the CTSpedia

Peter has done quite a bit of work on both P-Value Fallacy and Interpreting Results. He is still trying to find the best way to help investigators access his tables on meaningful and not meaningful statistical findings of relative risk. Ross Boylan, has designed a pull-down HTML menu under Interpreting Results (http://www.ctspedia.org/wiki/pub/CTSpedia/ResultsInterpretation/interpret.html). Ross will be leaving at the end of the month and we will work with Jeff and Dale to see if there is a better way of formating Peter's data for improved accessibility. (Sally also asked that we look at ways to let people know that this program is available.)

Dale and Jeff have set-up a report of CTSpedia usage on Google Analytics. If an individuals wants a report, you need to send Jeff your Google Docs login. (You need to sign up for a Google Docs account and then send Jeff your user name.) Mary will export the data on a monthly basis.

If there are any IT problems on CTSpedia, feel free to contact Jeff or Dale.

Online Journal

We are still not sure about interest in an online journal. We would develop the journal articles on the CTSpedia and then help the authors get published on COBRA or other forums. There is a DIA (Drug Information Agency) working group. the virtual journal. It is more of a journal club, presenting and reviewing published papers, than a forum for new publications. They have been very successful in getting DIA statisticians to participate in their monthly videoconferences. Jim will contact Jerry Schindler at Merck to discuss a possible collaboration with the DIA statisticians.