What is the ALS Research Collaborative (ARC)?
The ALS Research Collaborative (ARC) is an ambitious global initiative developed by the ALS Therapy Development Institute (ALS TDI). The goal of ARC is to better understand the underlying biology of ALS and to accelerate the discovery of treatments. The ARC Study collects natural history and biological data from people with ALS. This data is then made accessible to researchers worldwide through the ARC Data Commons, an innovative data-sharing platform powered by Google Cloud and Google’s Looker application.
What is a natural history study (and its role in ALS research)?
A natural history study is an ongoing, preplanned observational study intended to track the course of a disease. Its purpose is to identify demographic, genetic, environmental, and other variables that correlate with the disease’s development and outcomes. In ALS research, initiatives like ARC are crucial for accelerating our understanding of the disease and informing the development of new treatments.
Who is eligible to participate in the ARC ALS Research Study?
Anyone with an ALS diagnosis, anywhere in the world, is eligible to sign up and participate in the ARC Study. Asymptomatic carriers of a confirmed ALS-related genetic mutation are also eligible to enroll. You must be over the age of 18 and able to understand written English to join the study.
How do I enroll in the ARC Study?
People with ALS and asymptomatic carriers of ALS-related genetic mutations can enroll in the study by creating an account and answering a brief questionnaire at https://arc.als.net/.
Does it cost me anything to join the ARC Study?
There is no cost to participate in the ARC ALS research study. In addition, all data can be submitted remotely, so there are no associated travel costs.
What kinds of data will you collect through ARC?
All data submitted through the ARC Study are de-identified. You can choose what data you will submit and how often.
By signing up for the ARC Study, you may be asked for data related to:
- Personal background: Complete surveys on topics such as family history, geography, lifestyle, medical history, occupation, and your ALS experience.
- Electronic Health Records: You have the option to easily integrate your Electronic Health Records (EHRs) into the ARC Study. An EHR is an electronic version of a patient's history and care that is maintained by their medical provider over time.
- Speech Tracking: Record a few sample phrases each month to assess changes in your speech.
- Movement tracking: Participants who meet specific criteria* will be provided with accelerometers monthly to quantify movement.
- Sample collection: Participants who meet specific criteria* will be provided with an in-home blood kit or other types of sample collection kits.
- ALSFRS-R tracking: Complete an online ALSFRS-R** form once a month.
- Whole Genome Sequencing***: Participants who meet specific criteria* will be provided with genetic testing information.
Participants can choose which parts of the data they do not want to participate in and can contribute as much or as little data as they wish.
How is my ARC data used for ALS research?
Your ARC data is used to increase our understanding of ALS and accelerate effective treatments. ARC data is currently being used in research aimed at:.
- Developing innovative digital biomarkers for accurately tracking ALS progression.
- Identifying possible environmental and lifestyle risk factors for ALS.
- Inventing potential ALS treatments.
- Identify ALS subtypes to help expedite clinical trials
Who can see the data I submit through ARC?
ARC data is always private. The ARC clinical team will be able to see all of the information you submit, but when your data is viewed internally by anyone outside of the clinical team at ALS TDI or shared through the ARC data commons, it is “de-identified. This means that, while researchers may be able to see demographic information about you, such as your age, location, or race, they will not see your name or other personal information.
You may choose to share your personal data and progression charts from your dashboard with your doctor, but it will never be shared with anyone without your consent.
Can I participate in ARC if my ALS progression is advanced?
Anyone with ALS can participate in the ARC Study. While advanced progression may affect your ability to participate in particular aspects of the study, anyone with ALS is eligible to enroll and submit data.
What do I need to participate in the ARC Study?
To join the ARC ALS research study, you must be at least 18 years of age, must be able to participate in written English, and either have an ALS diagnosis or be an asymptomatic gene carrier. To register for the ARC Study, you will need a device with an internet connection capable of logging into our online portal. All participation can be completed remotely. For some aspects of participation, we might ask you to submit biological samples, record your voice over the phone, or wear accelerometers to track your movements, all of which will be done remotely as well. Participation in these programs is entirely voluntary.
Can I access the data I contribute to ARC?
Yes! ARC participants are provided with an online portal where they can view all the data they have submitted throughout their participation in the study.
What is the minimum amount of data that I can contribute?
The amount of data you choose to contribute to the ARC Study is entirely up to you. You might complete just a few surveys or submit only a handful of ALSFRS-r scores, or you could share a wider range of data over several months or even years. To maximize the impact of your contribution, submitting ALSFRS-r scores or other data for at least three consecutive months can be incredibly helpful to researchers. However, if that feels like too much, even providing one set of data at the time of enrollment is valuable for ALS research.
What if I want to stop or pause my participation in ARC?
The ARC Study requires no commitments from participants – you may pause or end your participation at any time. Similarly, if you have stopped submitting data, you may resume participation at any time.
Can I participate in the ARC Study if I have a family history of ALS but have not undergone genetic testing?
The ARC Study is seeking to enroll asymptomatic carriers of ALS-related genetic mutations. However, you must have already undergone genetic testing and confirmed that you are a carrier to enroll. We encourage those with family histories of the disease to seek out genetic testing if they are interested in participating.
Can I participate in ARC if I can’t speak or move?
Yes, there are various forms of data that you can still submit, including your electronic health records (EHRs), mood surveys, background surveys, and sample collection.
If I get selected for movement tracking, do I have to wear accelerometers the whole time?
We recommend that anyone selected to participate in movement tracking wear their accelerometers, at a minimum, during their guided exercises. Accelerometers can also be worn throughout the day for one week every month.
How does the ARC Study benefit me? How will it help others with ALS?
As an ARC participant, you are able to access a personalized portal showing your data, including your ALSFRS-r progression chart, movement data, mood data, and voice scoring data. You can use these metrics to track your progression and monitor if any interventions you try are having an effect.
Over time, this program has the potential to help others with ALS by sharing the deidentified data with ALS researchers all over the world, contributing to scientific breakthroughs in the ALS space.
Will I be notified if an independent researcher is looking for someone with my onset/symptoms for a trial?
We do not pass personal contact information from our ARC participants to researchers. However, if a researcher is interested in a subgroup of ALS, the ARC team may pass information on clinical trials to that group. If you are interested in learning more about clinical trials, you can check out the ALS Trial Navigator here.
Can I participate in other trials while enrolled in ARC?
Yes! There are no restrictions on enrolling in other studies or clinical trials. You are also welcome to take any treatments or supplements that you wish. Having access to your ARC data can even serve as a way of investigating whether any treatments you are using are influencing your progression.
I’ve heard of ALS TDI’s Precision Medicine Program (PMP). Is ARC related to this program?
The ARC Study is an evolution of the Precision Medicine Program (PMP), which was founded in 2014. All of the PMP’s data collection efforts are continuing under ARC, and all of the data collected by the program since 2014 is available to researchers as part of the ARC Data Commons.
Want to learn more about what it is like to participate in the ARC Study? You can watch our ALS Town Hall from August 2024 on the topic here.
To join the ARC Study, click here.