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Closing the Gaps Left by Structured Data

The Case for RWE in Neurodegenerative Diseases

This article was inspired by content discussed in our webinar, Cutting Edge Conversations: Fighting Neurodegenerative Diseases.

Imagine treating a Parkinson’s Disease (PD) patient long before the event that puts them in the hospital. Or identifying an Alzheimer's Disease (AD) patient using caregiver feedback on behavioral symptoms, often forgotten and unreported by those who suffer from dementia. Real-world evidence (RWE) can make the hypothetical a reality.

RWE offers insights generated from real-world data (RWD) and analytics, which can be used to accelerate medical research and improve patient care. Once considered a bold new approach, RWE is growing recognition and acceptance by decision-makers across the life sciences ecosystem. The interest in RWE comes now not only from regulators like the U.S. Food and Drug Administration (FDA), payers, and health technology assessment (HTA) bodies.  Increasingly, biopharma companies seek to demonstrate their products' effectiveness in the real world, outside a randomized controlled trial (RCT) setting.

Currently, most life science (LS) companies rely on repositories of routinely collected RWD from claims and electronic medical records (EMR) to identify patients and the providers who treat them.

The information generated from claims data typically captures many patients but may be limited to short time frames and a shallow, incomplete view of patient care in the real world.
Structured EMR datasets have begun to provide some clinical value but lack information on patient characteristics and treatment decisions derived from provider-patient conversations (which can often only be found within the narrative text).

Seeing a comprehensive and continuous picture from blurry, truncated, and siloed data is nearly impossible for any disease. Building a complete picture is especially difficult for patients visiting multiple healthcare facilities – primary care doctors, specialists, supportive care, diagnostic laboratories, urgent care, and so on – an everyday reality for patients suffering from neurodegenerative diseases (ND). Moreover, the routinely-collected data may miss vital information about what happens between visits, an essential part of the story for the neurodegenerative population.  We may consider such information anecdotal and supportive in other diseases, however, this data missing in the context of ND can prevent researchers from:

  • Understanding the natural history of the disease, from the onset of the first symptoms to the diagnosis
  • Tracking disease progression and long-term outcomes, including changes in cognition, disability, or quality of life
  • Capturing symptom information in-between-visits, which can inform when and why a patient should switch therapies 
  • Leveraging patient- and care partner-reported outcomes (PRO/CRO) to understand the total burden of the disease

How can we overcome traditional data limitations to improve neurodegenerative research, treatment, and outcomes?

The therapeutic field of neurodegenerative diseases has been plagued with multiple failures across the industry.  FDA Commissioner Robert M. Califf recently called for “innovative approaches to better understand [neurodegenerative] diseases while also building on current scientific and research capabilities.” (FDA)

By working directly with consenting patients who contribute their medical data to research, LS companies could build the complete picture of a patient’s health across all providers - not just one care site or a specialist. The result? Relevant and reliable patient-centric data poised to support real-world evidence-generation programs.

Why neurodegeneration research needs real-world data

Patient-centric data is poised to support RWE generation programs through all development and launch stages. Today, while there are more RWD sources than ever, LS companies face the challenge of finding fit-for-use data that meet their specific needs.

The value of RWE—spanning clinical development, market access, reimbursement, surveillance, and sustained/expanded value demonstration—can be realized for all therapeutic areas; however, patient-centric RWD are especially conducive to accelerating neurodegeneration research.

First, there is more to the neurodegenerative story than what is captured by routinely collected data. Despite serving functional administrative purposes, these sources often miss critical information on what is covered in-clinic and  practical details between clinic visits. Moreover, we know that neuropathological change (or what is happening at the cellular level) does not always equate to clinical significance (or a noticeable effect on a patient’s daily life).  

Second, people experiencing neurodegenerative disease can experience various clinical symptoms and complications that require a range of care provided by different specialists. Accordingly, the RWD characterizing these complex care pathways spans many treatment sites and specialists. Bringing together data from separate, siloed sources begins with the patient—both in terms of the initial consent and the critical information that can only come from cognitive, functional, and patient-reported measures.

Third, for these neurodegenerative disorders, which are characterized by progressive degeneration, the role of the care partner is paramount. While most traditional RWD sources cannot integrate data beyond the individual patient, direct-to-patient channels are a novel exception that can extend to care partners. Not only does care partner data provide valuable information on patient outcomes, but it also helps to minimize the burden placed on patients to recall/document important events, experiences, or outcomes.  

PicnicHealth's patient-centric, patient-first approach results in an expansive capture of historical longitudinal data on the neurodegenerative patient’s journey, even years before diagnosis. By starting with patient consent, we’re empowering patients and care partners to own their data and contribute to research, while enabling long-term engagement prospectively through their treatment. We also know that not all patients with neurodegenerative diseases experience the same care journey. By capturing hundreds to thousands of unique patient journeys, researchers can derive valuable insights from analyzing the constellation of their clinical features. Patient-centric RWD collection means better data, and it’s changing the game for neurodegeneration evidence.    

Find out how PicnicHealth’s patient cohorts can help power your research. Contact us

Related articles

Webinar: Cutting Edge Conversations: Fighting Neurodegenerative Diseases

Infographic: Resolving challenges in data completeness with machines and humans

Article: Comparing PicnicHealth data with existing research databases

As Senior Evidence Strategy Manager at PicnicHealth, Evelyn Pyper is passionate about empowering patients to “make their data work for them” and informing research partners on how patient-centered data can advance their evidence generation goals. Her career in real world evidence (RWE) spans the public and private sector, and regional and global markets - most recently as Associate Director of Market Access at J&J Global Public Health. Evelyn is completing her DPhil in Evidence-Based Health Care at the University of Oxford, with a focus on digital health. Connect with Evelyn on LinkedIn.

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List the names of all the doctors, hospitals, and other facilities your loved one visits regularly, along with those they have visited in the past. Try to go back as far as you can, striving for at least the last 5-10 years, but do your best. Even if you can’t remember them all, having a strong baseline can help you quickly identify gaps in records.

Ensure You Have the Appropriate Legal Status

It is important to make sure that you are fully empowered to make decisions on behalf of your loved one with Alzheimer’s. Your relationship status with the patient may not be enough to legally give you access to your loved one's medical information. It is a good idea to talk to an expert about securing special legal status, such as Power of Attorney (POA), a legal document that allows an individual to name someone as their decision maker should they no longer be able to make decisions on their own.

Gather and Organize the Medical Records in One Place

It’s important to have all of your loved one’s medical records together in one spot. This makes it much easier for you and your loved one’s physicians to accurately map the patient’s medical journey and more easily share information between doctors. Fortunately, tools exist to make record management and access simple. A free resource like PicnicHealth helps you collect and organize all of this information. PicnicHealth’s intuitive timeline allows you to pinpoint data across the medical history, eliminating your need for keeping heavy binders filled with paper records or keeping track of multiple software portal logins.

Review the Medical Records to be an Informed Advocate

The better you understand your loved one's medical history, the better you can advocate on their behalf. Access and understanding of this information will help you to ask informed questions with physicians. Through regular communication backed by the data in the medical records, you can help your loved one’s care team develop a more successful care plan.

Learn more about PicnicHealth’s commitment to the Alzheimer’s community and the Alzheimer’s Association

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Learn more about PicnicHealth’s commitment to the Alzheimer’s community and the Alzheimer’s Association

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1

Build a support network.

If your loved one is in the early stages of Alzheimer’s, putting a support system together might not seem like priority #1. But it’s never too soon to build a network of people that you can turn to in times of need. Cultivate connections today with the people who can be there tomorrow, or whenever you might need a hand.

You may also want to connect with other Alzheimer’s caregivers through a support group, whether it meets in-person or online. In addition to the encouragement and empathy they provide, support groups can be a helpful source of tips, resources, and recommendations for navigating the world of Alzheimer’s.

2

Stay organized.

If your loved one is in the early stages of Alzheimer’s, putting a support system together might not seem like priority #1. But it’s never too soon to build a network of people that you can turn to in times of need. Cultivate connections today with the people who can be there tomorrow, or whenever you might need a hand.

You may also want to connect with other Alzheimer’s caregivers through a support group, whether it meets in-person or online. In addition to the encouragement and empathy they provide, support groups can be a helpful source of tips, resources, and recommendations for navigating the world of Alzheimer’s.

3

Plan for the future.

It isn’t always easy to look into the future with Alzheimer’s—but doing the legwork now will save you from stress later. If your loved one is in the early stages of illness, you can involve them in conversations about legal, financial, and long-term care planning decisions. Despite the difficulty of these topics, you’ll all feel empowered by facing them early, and you can move ahead with greater confidence.

4

Explore treatments and clinical trials.

It’s an exciting time for Alzheimer’s research, with new treatments in development and coming to market. Ask your loved one’s doctors about therapies they can try or clinical trials they can join. One easy way to participate in research is to sign up at PicnicHealth, which helps to advance Alzheimer’s science by sharing participants’ anonymous health data with some of the brightest minds in research.

5

Make time for self-care

It may seem self-centered to focus on self-care—but when you feel good, you can be a better caregiver. Whether it’s exercise, a mindfulness practice, a soak in the bath, or just time to rest when you need it, carve out those moments in the day when you can unwind, reset, and stay healthy mentally and physically. Think of it as building up your reserves of kindness, patience, and understanding—which can only benefit your loved one with Alzheimer’s. And don’t forget to keep a sense of humor along the way.

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25,966

patients onboarded to platform

1,427,368

medical visits processed

56,861

facilities provided medical records

255,101

healthcare providers

95+

research programs

12

published posters and manuscripts

10

partnerships withtop 30 pharma

New Research

Discover how PicnicHealth data powered medical research in 2021

Keeping Patients at the Center

This year, experts from PicnicHealth joined podcasts, webisodes, virtual summits and much more to speak to the importance of patient-centric approaches when building complete, deep real-world datasets.

LC-FAOD Odyssey: A Preliminary Analysis, presented at INFORM 2021

Data from real-world medical records:

(from 13 patients with LC-FAOD)

16 yrs old

Median age at enrollment

38% Female

15 providers / patient

7.5 years of data / patient

Data from patient-reported outcome (PRO) survey

(from 13 patients with LC-FAOD)

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patients onboarded across 19 conditions

2,719,618

medical visits processed

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Facilities provided medical records

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Change Champions onboarded

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Research programs

15+

published posters and manuscripts

14

partnerships with top 30 pharma

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