Impatient series #1 – What patient organizations mean when they say they are doing research

When we could only look at symptoms, there were less diseases. Now that we can also look inside a cell and see specifically what went wrong, we are uncovering new diseases, thousands of them. This means that for a lot of people, the disease that they have or that their child has is quite new to science. So in the true spirit of impatient patients, some of those patients come together and start a patient organization.

Most patient organizations, no matter how small, start with the same mission: to raise awareness and funds for research in their disease. 

But what research are they doing? are they all starting in the same place? and do they all evolve to run the same type of research?

In my experience there are many types of strategy and approaches that patient groups take, in particular when they are starting. Although no two are the same, they do fall overall into some big types. To make things more complicated, what a patient organization funds in year 1 has often little to do with what they fund some years later. The field has evolved by then, the organization has evolved, the board members might be different… What a patient organization means when they say “we are doing research”, therefore, hides many different possibilities.

Here are some of the strategies that I’ve seen: 

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Type 1: We just need to exist

There is a tricky catch-22 situation where in order to raise funds (which you would hope to use for research) you have to already show you are a successful patient organization that funds research. Beyond friends and family, you will have to show most other donors where their money is going and how much of an impact it is making. Essentially: you need to be already funding research. 

Because of this, your first few projects are critical to show the world that your patient organization exists and that it funds research. The quality of what you fund is in fact secondary. In many cases the project(s) take place at a university located near the headquarters of the patient organization. This might get you into some local press release, provide you with a scientist to refer to when you need some interviews, and essentially get your ticket punched. Congratulations, you now have a patient organization that does research, and from there you can start building a more solid longer-term strategy.

Type 2: Marry a lab

The first researcher that approaches a patient group, in particular if it is a newly-described rare disease, sometimes goes on to become their official lab. As in the previous case, this often happens with organizations that are just starting off. For the next couple of years, the organization will raise funds to finance research at that main lab, which then becomes a referent in the field for that disease. These patient groups appear to be married to that initial lab.

Getting funding for academic research as an academic lab head is very hard. And if it is a new research area for that lab, it might be impossible. So, for some academic labs, receiving funding from those patient groups is the only way to advance their science during the first couple of years until they have generated enough data and publications about the new disease to be able to receive public funding. In a way, the patient group didn’t marry the lab, instead they adopted the lab until it was mature enough to become financially independent.

This is a good strategy when the patient group doesn’t have enough funds to finance multiple projects or labs and when the field is just starting. In this case, the patient group might choose to focus its resources on building a first solid lab, which will pretty much start building the entire research field. This is how some patient groups are doing research. 

This strategy, however, can backfire in many ways. One of such scenarios is when the patient group leadership comes to believe that they should not fund other labs because they owe to this initial lab some loyalty in return for their early support. It blurs the line between grantee and patient group and could lead to big conflicts among the patient group leaders. Another potential negative outcome is not having much to show for after supporting the same lab for several years. This happens when the lab learns to see the patient’s money as easy money and not dedicate enough efforts to the project to make an actual tangible progress, unlike they would do for regular external funding.

In short: it is a respectable strategy to adopt one lab and start building a field, but it must be done with a clear outcome in mind, which is agreeing with the lab that they should dedicate those early efforts towards generating compelling data to become financially independent from the patient group. It must to be bridge funding, and not funding for life.  

Type 3: Let the advisors decide

When patient organizations have enough funding to support multiple programs, they often choose to surround themselves with a handful of experts that will become their scientific and medical advisors. In many cases, they ask these advisors to tell them where to invest their research funds.

Often this is done by having an annual call for grant applications and then having the advisors and some external experts that they nominate evaluate the grants and rank them. Then the patient group will fund the top ranked proposals. This is how some patient groups are doing research.

One thing I don’t like about this strategy is that it is often bottom-up, with the external scientific community proposing what they would like to do and the patient group then picking the most scientifically excellent ones. I believe research funding should be more strategic and therefore more top-down, but there are ways to achieve a healthy balance.

My main concern with the advisors deciding where to invest is that in some cases a patient group ends up funding every year the same 4 or 5 labs, which happen to be the labs of their scientific and medical advisors and/or their close collaborators. If one can guess who your advisors are by seeing who you fund, you are an organization that has essentially followed the Type 2 strategy of marrying a lab. You simply have married you advisory board.

The debate inside these organizations after the first couple of years is usually the same: 

Board member 1: Why are we always funding these same labs? This endogamy of having the advisors finance their own labs is disturbing.

Board member 2: Well, we chose as advisors the leaders in the field, so it is only natural that we also finance the best research… which happens to be the one coming from their labs.

Board member 1: I am not comfortable with the conflict of interest of having the advisors decide where the funding should go after seeing that so much ends up in their own labs or their friends’.

Board member 2: What should we do then? Remove the leaders of the field from our advisory board? Or stop funding the best research out there?

And then board member 1 leaves the organization.

My recommendation, if you allow your advisors to also receive funding, is to ask them to guide you through what should be the main research priorities but then use external reviewers to score the grant applications that fit those priorities. Ask the advisors to pick the priorities, not the awards. I would also consider having a condition to be part of the advisory board, which is that your lab cannot receive funding from that organization. For good established labs that are indeed the best in the field this should not be a problem (see comment on previous sections about bridge funding).

As a side warning: if you are a scientist considering applying to one of the call for grants of a patient group, make sure you review where their funding is usually going. You might think it is an open call for grants, while in reality it is a closed group of advisors and their closest collaborators getting as much funding as they can out of a patient organization. We all know examples of this. 

Type 4: Owning the roadmap - the top-down approach

Anyone who has read the #ImpatientRevolution eBook knows that this is my preferred approach. Patient organizations cannot aspire to outfund NIH or their applicable national research funding body outside the US. What patient organizations can do with their research funds is to complement it, by identifying those areas that are essential for developing new medicines for their disease and that are currently not being pursued (or not fast enough). Then they would focus on those areas, ideally on setting up the basis so that good scientists can be attracted to those areas and bring more (non-patient) funding. This is how some patient groups are doing research.

I won´t extend on this strategy because the eBook covers much of it. But before wrapping up, here are some aspects of research funding strategy that I would like you to consider:

a) Bottom-up vs top-down

Do you want to collect external ideas and fund the best ones or do you want to analyze the field, identify the gaps and address those first?

Depending on your finances I recommend following a top-down strategy only, or a combination of both. For example:

  • Fund some projects that the organization has identified as a priority for the field. In those areas you identify what is needed and then go out and find the best lab or contract research organization to do that. This is probably the boring science, the type that no academic lab would propose in a call for grants because it is not conductive to exciting publications and promotions. It is, however, needed to develop cures.

  • At the same time, have your advisors identify where your priorities should be (for example biomarkers and a gene therapy with large capacity virus), and then have a call for grants on those topics. The call for grants would then be evaluated by a broader team, not just the advisors.

b) Projects vs enabling

I believe the greatest return on investment comes from generating the tools that will enable the scientists to then work in your disease and bring in their own external funding. For example, make sure that there is a good antibody, a good mouse model, iPSCs from patients, and that all of this open access. Make sure you have identified and helped set up clinical centers of excellence, and maybe some biomarker or outcome measure. Make sure there is a registry, or at the very list a way to reach out to families (a contact database). This toolbox serves both as a starter package and as a strategy to de-risk the field. With these things in place you will attract researchers and companies to your disease, and they will bring their own funding. They will also be many more than those that you could have directly funded yourself, so you would have mobilized much more funding to your disease than what you could have raised in decades.

Many of those efforts are the boring science, so you will only identify them if you do some top-down thinking and analysis. You should decide what percentage of your efforts and resources should be allocated to the boring science (enabling tools, de-risking the field), and what percentage will go to giving an opportunity to new exciting projects to develop. 

c) Organization aging and cycles

Young organizations and old organizations think differently. The first two strategies I covered, for example, are much more common in younger organizations. I would recommend you to revise your strategy every 3 years and see what is working for you and what is not working. Older organizations also tend to grow more complex, and are more likely to engage professional staff. 

I tend to work with patient organizations where the members of the organizations are parents of children with severe rare diseases. This has also helped me see another pattern, with parents of younger children being more optimistic and driven and investing in more high-risk projects, while parents of older children being more likely to make safer investments or to even move away from research and into care support programs. A parent of a 3-year old might want to invest in gene therapy, while the parent of a 13-year old might be more concerned with developing devices to assist with mobility issues, for example.

And add to this complexity the burnout factor. I´ve seen organizations that are centered around one person that can last many years, but those that rely on a group of core members can experience changes over time. I estimate a 3-5 year burnout time, before new members need to take over and continue the life or the organization.

Because of this, the same organization in year one is very different to the same organization in year seven. The members are different, the strategy is different, and what they mean when they say “we do research” is also different.

Let’s start an #ImpatientRevolution!

 Ana Mingorance, PhD