There are many advantages of having open source solutions available, particularly for industries where the main focus is not programming, but science. However, in clinical study evaluations there are just a very few open source programs available. Why? Where are the advantages? And what are the risks in our industry? This article will give you a short introduction and hopefully make you think about how we can go forward with open source.
Pinnacle21 Community as Open Source Example
The "Pinnacle21 Community" tool – starting as OpenCDISC Validator – is a good example for an
open source project. A great tool kit has been developed and used throughout the industry.
It quickly became very famous and is now an important standard tool which is strongly
recommended to use – and in case of PMDA even required.
As the popularity grew, more user requirements raised and funding has become more and more a
topic. An enterprise version had been developed to be able to scope with all challenges.
Nowadays Pinnacle21 is a very well running company. A blog about the history of OpenCDISC is
available on their website.
Despite this story of success there are many critics around this tool kit. But why? The focus
on commercializing the enterprise version seems to spoil the open source edition driving it
almost into a neglected project. An enterprise version can of course have additional
functionality, but missing out some core functionalities or even thinking about removing
options from the open version is difficult to handle. Fortunately, at least some important
functionality enhancements will be made available in the community version 3.0 which should
be released soon.
Pinnacle21 has a monopoly position here. A complete industry relies on this tool for
validation checks. Commercially it does not make sense to create a product in this area, as
the core functionality is available for free in the community version and the investment for
something similar would be much too high. Due to the license, a reuse is not possible. And
missing competitions always results in issues and critics.
So, what can our industry learn from this? First of all, open source projects have typically
to cope with issues regarding funding. Everyone likes to have tools available for free, but
somehow these must also be funded. And depending on the license you can either stimulate or
prevent competition. From the customers a competition is highly appreciated, but for service
providers these competitions mean risks and would normally better avoided.
Ways to go with Collaborations
First of all, the companies have to decide how open they would like to be. There exist many
open collaborations. Most of them driven by the PhUSE which is a community consisting of those
colleagues working in clinical study evaluations and related areas. The PhUSE provides
collaboration platforms for many working groups. One of those is specifically concentrating
on "Standard Analyses & Code Sharing".
Unfortunately, the results do not meet the high expectations in this area, yet.
On the other hand, there are of course close collaborations where something is developed with
just a few members. And finally, there are closed collaborations available with multiple
companies where things are shared just within the membership.
Ideally collaborations should be open to support the complete industry as well as academia.
Especially programs, tools and processes should be shared to be able to find best
collaborative solutions which enables transparency and standardization also in the
programming area of clinical study evaluations.
Why just few open sources?
What are the reasons why there are just a few open source programs and projects available?
The area of clinical study evaluations is a very specific area with high regulations and
long-term players on the marked. Typically, large companies have their own solutions
available. They do not have an advantage of giving this away. Tools do not only consist of
the programs itself, but also require documentation, training and validation. Who should
provide all the required information? Putting a tool online is likely not sufficient.
Why are there no engaged people putting things together for free like what we see in other
technological ecosystems? My guess is this is highly related to the purpose of clinical
study evaluations. Only companies – typically large Pharma companies – would benefit from
such open source projects. And as mentioned before, putting source and tools together for
clinical study evaluations is not sufficient. Looking into the life cycle of tools in this
area, in my experience less than 10% of the effort is going into the development part. The
remaining 90% serves documentation, validation and provision of training – not to mention
the important maintenance when updates are required or even bugs appear. There are hardly
many people volunteering to perform these 90% for free.
Funding to get Open Source
A possible solution could be funding projects which are made available as open source. The
question is whether companies see value in funding such projects and whether there are
companies or persons who will provide their tools and programs as open source.
The most important factor for companies funding open source is the benefit. What would they
gain? Or do they just have to pay so their competitors get the same solution for free? The
more funding companies are supporting a project, the less expensive it will be for each one
of them. But more stakeholders mean higher complexity as more communication and negotiation
The main advantage for the funding company would be that they are involved in defining the
project scope, content and direction. They are most likely the first testers and have direct
influence on the development. Furthermore, they could even decide which parts will be made
available as open source. Not necessarily everything needs to be made available. Extended
documentation, training and validation could be kept in the project and available just for
membership. Funders might even agree on a regular membership fee which could be made fixed
to ensure further development, availability for updates and questions – especially urgent
authority questions – at constant costs. In such a case competitors and academia could use
the programs and tools, but for extended services, they can join through membership.
When the programs and tools are made available completely free also for commercial content,
e.g. with the MIT license, then other companies could use this work and provide nice user
interface or combine the solution in their own tools. A monopoly could be avoided. Of
course, there is the risk that someone takes the programs and tools and create own services
like extended documentation, validation and so forth. But is this a really a risk or just an
opportunity? More competition means more solutions to choose from. Actually, this is
something we strongly need in our industry. Currently many areas have just too few or no
Starting Small, then Growing
There are many areas where solutions would be required in the clinical study evaluation area.
Starting with a huge project scope would by risky, but a small project could prove how
things are working and whether the benefits are worth the costs. So why not starting with a
small project which has the option to start small and grow huge? It can simply be performed
by a consultant which typically has no high costs.
I am currently planning such a project as a proof of concept, so if you are interested for
further information, please check out further details or get in touch with me.
Why does license matter?
The license behind open source projects is very important. In the pharmaceutical industry
many tasks are done by supporting specialized companies. As they have a commercial interest
in using these tools, a commercial usage should be granted. Ideally also other tools should
be allowed to be created based on open programs and tools. This is also only possible, when
commercial usage is allowed. For this the PhUSE source is published under the MIT license.
This should also be used for other open source projects.
Available Open Source on Github
Some companies provide already some tools and programs as open source in the field of
clinical study evaluations. Rho Inc. for example hosts some projects on github. Roche share some R Projects on their github and are probably planning for more. You can also find some
SAS macro repositories which use an open license for example this one from Scott Bass contains many useful SAS macros. If you
know other related open source projects, especially with the programming language SAS,
please mention them in the comments. R has quite a lot available, CRAN lists on this website many. I
also want to mention SASUnit as a validation
framework for SAS which uses the GNU license.
Funded open source with no license restrictions is a chance for our industry to have better
programs and tools available to build the ground for standardization in the programming
field. We do not want monopoly, but memberships could be integrated to support funding
If you have enough internal resources, join and support working groups. If not, think about
funding open projects. Collaboration is the best way going forward in supporting standard
programming and processing to be able to face the challenges of the future which needs
continuous update and change.
I’m happy to read your comments and suggestions on LinkedIn .
About the Author
Katja Glaß has more than 13 years experiences in SAS Macro Development and Maintenance in the
pharmaceutical industry mainly supporting Analysts, and has a broad knowledge about related
tasks and many other technologies. She is heavily involved in the PhUSE community where she
led the EU Connect conference in 2018. She recently founded Katja Glass Consulting, a new
start-up, hoping to support our industry to face the challenges of the future.
Please comment on LinkedIn .