Sunday, April 16, 2017

How Does JDRF Decide What Research To Fund?


I've always been interested in how JDRF decides what research to fund. So I was lucky that while attending the recent Bay Area Diabetes Summit  [d1] I attended a talk by Dr. Aaron Kowalski the Chief Mission Officer of JDRF [d2].  After the talk, I was able to ask him how JDRF made those decisions. He did his best, in the few minutes we had, to describe the process too me.  Later on, we followed up with a phone call, which allowed him to answer more detailed questions about the process. This blog is my summary of the process.  As always, any mistakes in this blog posting are mine alone.

Who Is Involved

There are three main groups of people involved in deciding who JDRF will fund:
  • The Research Staff:  This is a group of about 15-20 JDRF employees, most of whom are Ph.Ds, or have other degrees in medicine or science.
  • The Research Committee: More than half of this committee is made up of members of JDRF Board of Directors.  The remaining members bring specific skills and experiences to the table.   There are 13 people on this committee, and they all have close connections to the world of type-1 diabetes: 11 have one or more children with type-1 diabetes, 2 have type-1 themselves, and 2 have spouses with type-1 diabetes.  The total is more than 13 because 2 people fall into more than one category.  Full list is below [d3].  
  • The Board of Directors: More formally, the International Board of Directors.  This group is listed here: http://www.jdrf.org/about/leadership/#board-of-directors.  This is the governing board of JDRF, and is also overwhelming composed of people directly impacted by type-1 diabetes (people with the disease, parents of people with the disease, spouses, grandparents, etc.)
Allocation Funds: Priority, Strategy, Budget

JDRF's research staff makes proposals to the Board of Directors about how to allocate research money and if specific areas of research should be funded or not.  The Board of Directors makes the final decisions about what areas should be funded, and how money should be allocated between areas.  For the last few years, money has been allocated into six basic areas, and the division between these areas is done by the Board: Restoration, Beta Cell Replacement, Artificial Pancreas, Glucose Control, Prevention, and Complications [d4].

For each year, the Board of Directors makes decisions about JDRF's priorities, strategy, and overall budget.  These decisions help guide the Research Staff throughout the year.  Also, as described below, the Board is sometimes asked about specific research when it is significantly different from what JDRF has funded in the past.

You can read more about JDRF's 2017 research priorities here:
http://grantcenter.jdrf.org/information-for-applicants/research-priority-areas/
But the seven priorities are:
  • Beta Cell Replacement
  • Beta Cell Regeneration and Survival
  • Beta Cell Autoantigen-Specific Immune Therapies
  • Prevention of Type 1 Diabetes
  • Artificial Pancreas Device Systems
  • Glucose Modulating Agents
  • Diabetic Kidney and Eye Complications Therapies
But I encourage you to read the whole document, because it includes a high level vision statement, but also more specific goals in each area for 2017.

Specific Research

There are two "paths" that individual research proposals can follow in order to get approval, which I will call the "normal path" and the "unusual path".

The normal path goes as follows:
  1. The researcher submits a summary of the research they want to do.  This is not a detailed proposal, but an overview.
  2. JDRF's research staff reviews this summary focusing on if it fits in with JDRF's priorities, strategies, and budget.  If it does, they ask the researcher for a detailed proposal.
  3. The researcher then submits the detailed proposal.  This contains all the details of what will be done, where it will be done, who will do it, how long it will take, how much money is needed, why it is important, and how it can push forward the goals of JDRF.
  4. The detailed proposal is then reviewed both internally and externally.  The internal review is done by JDRF's research staff.  The external review is done by multiple researchers who work in the field, but are not involved in this specific research.  There are usually three such reviewers and they sign non-conflict of interest statements.
  5. Assuming the internal and external reviewers both like the proposal, it next goes to the Research Committee.  The Research Committee must approve all grants over $500,000.  These grants are each discussed separately, and the committee members can vote yes, no, or request more information for any grant.  They meet about once a month to do this work.  Grants under that amount are approved by staff, but presented to the Research Committee.  That committee can review all documentation of the staff decision (i.e. external reviews, etc.) and can question any grant.
  6. There is a separate group of people, referred to as "Operations Staff" who are responsible for the grant after it has been approved.  In general, this group is not involved in the funding decisions.
The unusual path covers research projects where the research staff is unsure if the project is even the kind of project that JDRF would fund.  These are usually new types of research, especially those requesting a large amount of money.  In these cases, the staff member will sometimes present the project to the Research Committee, prior to reviewing it.  The goal of this early discussion is to decide if the research proposal should even be considered; if it is the sort of project that JDRF would ever fund (regardless of the merits of this particular project).  If the Research Committee decides it is, then it goes through the normal path; if the Research Committee decides it's not, then it doesn't move forward.

Dr. Kowalski  pointed out several strengths of the system: First, nothing can be done based on one person's actions.  Every funding decision involved the Research Committee and multiple external and internal reviews.  Second, everyone on the Research Committee is directly impacted by type-1 diabetes.  Third, everyone on the Board of Directors is also similarly impacted by type-1 diabetes. Points two and three, taken together mean that both the overall policy decisions, and the specific research approvals are in the hands of people who have type-1 diabetes, or who have children, a spouse, grandchildren, etc. who have type-1 diabetes.

Discussion

I'm sure many people will want more details than I've provided here (or different details), and I hope that JDRF will publish a detailed description of the funding process.  This blog includes every scrap of information that I know on the subject.

Dr. Kowalski and I spent some time discussing how to make JDRF more transparent, which we both agreed is important moving forward.  It's a trade off however, because money spent developing web pages which describe how decisions are made takes money away from research.  We both bemoaned the lack of a "funding dashboard", a web site where you could see at a glance a high level overview of where money had been spent.  I'm hopeful that JDRF will get this information on-line soon.

If you want a searchable database of all the research projects which JDRF funds, that is available here:
https://jdrf.smartsimple.us/ex/ex_viewreport.jsp?key=&token=@GgoITRgTeFtYRhpcSRxRQ1BXZ1x8GHFg
(Or, from the main JDRF page, select "Our Work" and then "Search Research Abstracts".)
This is a good resource to find out if JDRF funded a particular researcher or university.  However, it uses a few terms that non-researchers will not be familiar with [d6] and you can search for words only in titles, but not in the body of abstracts or proposals themselves.  It contains information on individual projects only, there is no summary data of any kind.

This information comes directly out of the "SmartSimple" software that JDRF uses to track grant applications, grants, etc, and I do think that is the long term key to providing transparency without spending a lot of money on it.  Since JDRF is already using software to manage their grant process, if that software can be configured to provide summary data to the public, it would provide transparency without the constant work of updating the web pages.

Dr. Kowalski and I also discussed another topic called "funding mechanisms".  These are pools of money allocated for specific types of researchers or specific types of research.  For example, there is a funding mechanism for young researchers (to encourage people to enter the field of type-1 diabetes research).  There is a funding mechanism for early patient research (to help bridge the gap from animal to human trials), for specific projects which JDRF is encouraging [d6], etc.  All of these funding mechanisms go through the same process described above.  You can read more about them here:
http://grantcenter.jdrf.org/information-for-applicants/grant-mechanism-descriptions/

The process described in this blog post does not cover JDRF's recently announced "Venture Philanthropy" fund.  That fund has a similar process (also with a Board of Directors and an Investment Committee).  If there is interest, I'll try to make contact with the director over there, and see if I can write up a similar blog for them.

Finally: I want to say that if you have a question about how JDRF does something, or why JDRF does something, then I encourage you to look on the JDRF web site.  If you can't find what you are looking for, then try searching on google.com and adding "site:jdrf.org" to your search.  This tells google to only return hits on JDRF's site.  You can also add "filetype:pdf" which will only find PDF documents.

Extra Discussion

[d1] The Bay Area Diabetes Summit was a great event.  It was organized by CarbDM, DYF, with help from many other organizations, and everyone did a wonderful job. These Summits happen once a year, and if you are in the area, I strongly recommend attending.  There is lots to learn.   More info here:
https://carbdm.org/events/bay-area-diabetes-summit/

[d2] Dr. Aaron Kowalski is JDRF's Chief Mission Officer.  He's worked for JDRF for 13 years.  Prior to being CMO he was Vice President of Research.  Prior to working at JDRF he earned a Ph.D. in molecular genetics from Rutgers University and the University of Medicine and Dentistry of New Jersey.  He was diagnosed with type-1 diabetes when he was 13 years old in 1984, and so has lived with this disease for a long time.  His brother also has type-1 diabetes (diagnosed in 1977).
https://www.linkedin.com/in/aaron-kowalski-3221a35/

[d3] The current members are: Steve Newman, Randy Anderson, Tom Chapman, Tim Clark, Maarten de Groot, Karen Jordan, Doug Lowenstein, Preetish Nijhawan, Carol Oxenreiter, David Panzirer, Lorraine Stiehl, Jerry Wisler, and Michael White.

[d4] Of course, everyone wants to know how much is spent on each area.  The most recent data I could find myself (and it took me over an hour to find it, and I had to use my best google-fu) was updated in March 2015, but I think it covers the year of 2014:
  • Restoration ($31m)            [Restoration of insulin production in people with type-1 diabetes.]
  • Encapsulation ($13m)        [Recently replaced by the broader "Beta Cell Replacement".]
  • Artificial Pancreas ($16m)
  • Glucose Control ($5m)       [This includes smart insulin.]
  • Prevention ($14m)
  • Complications ($13m)
  • Multi-category Programs ($9m)
Source: https://www.hlc.org/app/uploads/2014/05/2015-JDRF-Fact-Sheet.pdf
which is the most recent fact sheet that has this level of detail.  Note that the total here ($101m) does not exactly match the data from fiscal year 2014 tax forms ($98m).  The fiscal year ends in June. That might be a summation/rounding difference, or this data might be for calendar year 2014, or for the 12 months preceding March 2015, or I might have messed up the numbers in some way.  I'm a software engineer, not an accountant.

[d5] Especially the term "funding mechanism", which I describe below.

[d6] JDRF refers to these as RFAs (Requests For Applications), but another common name is RFPs (Requests For Proposals).  Instead of just sitting back and seeing what proposals come in, the funding organization makes a public request for a specific type of proposal.  JDRF does this on occasion. These proposals go through the same approval process as others. You can see a few recent examples here:
http://www.jdrf.org/wp-content/uploads/2012/12/FY16-Beta-Cell-Replacement-Retrievable-RFA.pdf
http://grantcenter.jdrf.org/wp-content/uploads/2016/12/FY17-Microbiome-RFA-2016.12.21-2.pdf


Joshua Levy
http://cureresearch4type1diabetes.blogspot.com 
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

5 comments:

Rick said...

Josh:

I think that Dr. Kowalski may be one of the true rock stars of our type 1 community. I am so pleased to see the interview.

I am so excited at the way JDRF takes care in spreading the resource. Of course, no one knows for sure what the ultimate answer will be (if there will be one answer). It seems to me that each approach has merits and drawbacks. So the full gambit seems to be the prudent way forward.

Matt Schmidt - Diabetes365.org said...

I think this is a question that a lot of people ask, a lot. So, thank you for breaking down the process and providing the community a little more insight into how these projects are funded. Would you mind if we linked to this article on our site https://www.diabetes365.org

Joshua Levy said...

Yes, you can link to the article from your site. --Joshua

Jared Madsen said...

Thank you for your time spent in collecting, organizing, and sharing this information. It is very interesting indeed, and gives me a lot more confidence in JDRF. Transparency like this goes a long way in building trust, and being new to the T1D scene (in the last few years) has given me reason to be selective about where to place it.

Unknown said...

Josh

Thanks for posting. What contributions does JDRF fund Canadian research sites as Stem cell
Or Islet cell transplants (Edmonton ,Bc,McGill ) I know Dr James Shapiro is a World Leader for a cure in Edmonton -islet/stem cells

We continue to hear a cure is on the way , many type 1 lead a stable & somewhat enjoayble life, not without some issues because all types1 & 2 will eventually have complications .

For a small percentage of type1 have different outcomes due to insulin shock or hypoglycemic unawareness or hypo unawareness & nothing to do with CONTROL which personally is a insult to a type 1 patient that's struggling .
Insulin has changed,Testing has changed. Administering insulin (pens,pumps)have changed but without 100% funding human based What will really change

I believe more funding needs to go to ore Human Based Research for a cure.
Thoughts!