Allergy and Asthma Research

 

Research can provide important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and healthcare costs and use. 

Allergy and asthma research leads to significant scientific discoveries, the development of new therapies, and an improvement in healthcare and public health. Research can have an enormous impact on human health and longevity. These improvements in health impact human lives, but also improve society and the economy. 4

How does the Allergy & Asthma Network support research?

We support research and conduct our own research as part of our core mission to reduce suffering and death due to asthma and allergic diseases. We are committed to educating patients about ways they can get involved in research and helping researchers recruit patients as advisors or participants in their research studies. 

We collaborate with researchers on clinical research, health services research, health economics and outcomes research, patient centered outcomes research, and other types of research.

Our research focus now plays a more significant role in advancing our mission by including the patient perspective into all types of research, including drug development  from pre-discovery to commercialization. Recent work in which we’ve been involved include clinical trials, investigator research initiatives, and patient and family focus groups. We have completed survey studies, hosted patient advisory boards, and developed an asthma patient research registry. 

We analyze and report on data from surveys and focus groups. We then serve as the voice of those with allergies, asthma and related conditions, and are able to articulate needs in an influential way with doctors, policymakers, decision makers and industry professionals.

Can I find out more about the research projects in which the Network has been involved?

We have been involved in a number of recent research projects. We work with researchers to incorporate the perspectives of asthma and allergy patients, including in drug trials  from Phase I to Phase IV.

Has the Allergy & Asthma Network been published in the clinical literature?

We are actively  involved in allergy and asthma research that is published in the clinical literature.  We also submit letters to the editor and other types of opinion pieces to medical journals and professional publications.

Photo looking over the shoulder of a patient having a conversation with a  doctor

In what ways are patients involved in allergy and asthma research?

Research in allergies and asthma has brought us some important historical discoveries, and the future seems limitless. 

Currently, the two main ways patients get involved in research are to:

  • Become a patient advisor to a research study 
  • Enroll in a research study as a study participant

How can patients get involved as a study participant?

Research often takes on many different forms, from qualitative market research to focus groups to rigorous, scientific drug development. Here are some of the ways patients can be a participant in a research study:

Contribute data to a patient registry

A registry collects patient information around a specific diagnosis or health condition.  This information can be used to track trends about the number of people with a disease, what treatments are being used, what patients may be eligible for a clinical trial or analyze specific management information.

Join Asthma 360
Participate in the COVID-19 Registry
Photo of a group of people talking

Participate in a focus group

When a researcher wants to understand a participant’s viewpoint or develop some data, they may convene a focus group.  This is a small group of participants, usually patients who gather (either online or in person) to discuss a specific topic or health concern allowing the researcher to analyze their information as a part of a research project.

Complete a research survey

When a researcher wants to understand a participant’s viewpoint or experiences, they may conduct a survey study to gather that data.  Patients are invited to take a survey, often online.  Researchers analyze and publish the data as a part of a research project.

Participate in a clinical trial

Clinical research trials study how effective a medical treatment is for treating a condition.  They not only advance scientific and medical knowledge, but also offer hope to patients and families. Participating in a clinical trial helps you take an active role in your own health, and you may be given access to new prevention strategies and treatments.

What are the different types of clinical trials?

  • Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may include medicines, vaccines, or lifestyle changes, among other things.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
  • Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
  • Natural history studies provide valuable information about how disease and health progress.

How can I find out more about clinical trials recruiting new patients?

National Institutes of Health – Clinical Research Trials and You
5 Myths About Participating In Clinical Trials 

Who sponsors clinical trials?

Clinical trial sponsors can include government agencies, healthcare providers, foundations or nonprofit organizations, pharmaceutical companies, insurance companies and medical device companies.

What is patient engagement in research?

Patient engagement in research and development is now viewed as critical to innovation and greater understanding of asthma and allergies. There is an increasing effort to incorporate the patient perspective, or patient voice, into health-related research, with the goals of addressing research questions that are important to patients and including outcomes of interest to patients.1 

Patient engagement in research involves active and meaningful collaboration between researchers and patients throughout all phases of a research project, including planning, data collection and analysis, and sharing of findings.

In some instances, the role of the patient advisor is served by individual or groups of patients, and in other instances, the patient advisor role is served by a patient advocacy group such as the Allergy  & Asthma Network.

What types of research studies involve patients as advisors?

Researchers of all types are involving patients in their research studies.  Advisors are used in patient centered outcomes research, investigative studies, survey studies, drug trials and others.

How can patients get involved as advisors?

Here are some of the ways patients serve in advisory roles:

Participate in an advisory board or patient family advisory council

An advisory board or advisory council is made up of a diverse group of people who can provide impartial guidance and objectivity to a research project. The advisory board or advisory council also provides a research project with key information and makes recommendations as appropriate. 

Participate as an individual advisor 

The role and responsibility as an individual advisor varies from project to project.

How do patients serve as advisors in the drug development process? 

Drug development from drug discovery to approval is a long and drawn-out process that takes years before a new drug receives Food and Drug Administration (FDA) approval and is available for patient use. 

Pharmaceutical companies now recognize the important role patient advisors and patient advocacy groups can serve to shape the drug development process to be more patient centered and lead to a faster drug development process and a more successful recruitment of patients into clinical trials.

Patients, and advocacy groups representing patients, are becoming increasingly involved in the drug development process for this reason.  

There are numerous ways for patients and patient advocacy groups to play an important role in shaping the drug development process and providing meaningful contributions and partnerships. These roles are separate and distinct from patients who are recruited as study participants.

The following are examples of how the Allergy & Asthma Network may be involved as a patient advocacy group partner in the drug development process.

chart showing the drug development timeline for medications in the U.S.

Prediscovery

    • Convene stakeholders to share ideas and research collaborations across disciplines, institutions, countries, and sectors
    • Employ the patients’ voice to help investigators identify unmet needs
    • Fund basic science and provide translational tools
    • Educate and motivate patients to participate and advocate for research
    • Advise National Institutes of Health (NIH)
    • Develop natural history database

Preclinical

  • Help define highest impact approaches for development
  • Engage in knowledge-exchange with KOL’s
  • Facilitate matchmaking among industry partners and research protocols
  • Collaborate with FDA regarding guidance, risk-benefit evaluation, participation in meetings

Phase I

  • Provide information on unmet needs and disease burden
  • Recruit participants promptly and effectively
  • Continue to educate and motivate patients and families
  • Support patient costs for the trial

Phase II & III

  • Continue support in Phase I
  • Assist sponsor in determining best trial design including identification of barriers
  • Provide input into patient-reported outcomes and quality of life instruments to be used
  • Renew patient-related materials (informed consent forms, educational materials)
  • Assist with recruitment and retention
  • Evaluate data and advise on relevancy
  • Assist in development of patient communication at conclusion of trial

FDA Review & Approval

  • Accompany sponsor to any FDA meetings
  • Provide patient representative to serve on FDA advisory committee
  • Provide testimony at FDA advisory committee or hearing

During Post-Approval

  • Work with sponsor and payers to obtain reimbursement
  • Advise sponsor of any gaps to address with post-marketing studies
  • Assist in post-marketing surveillance
  • Provide communications support and feedback from the patient community via social media, website, email and blogs

What is Patient Focused Drug Development?

Patient-focused drug development (PFDD) is an approach by the Food and Drug Administration (FDA)  to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. Patients are truly experts on what it is like to live with their condition. Therefore, patients are uniquely positioned to inform the understanding of the therapeutic context for drug development and evaluation.3

PFDD meetings are externally led by patient organizations.  In 2019, Allergy & Asthma Network was one of five patient organizations that held a More than Skin Deep PFDD meeting on Atopic Dermatitis. Patients participated in a full-day meeting with FDA leaders designed to capture the lived experience with atopic dermatitis and provide insights to the FDA that can be incorporated into the drug development process for atopic dermatitis.

How can I get involved as a patient advisor in research?

No matter what the form, Allergy & Asthma Network is committed to giving you an opportunity to lend your voice and serve as an Everyday Medical Hero. We can connect you with researchers who are seeking patient advisors in research. Please take our survey – patient advisors in research,  and we will follow up with you when an opportunity arises.

References:

  1. https://participatorymedicine.org/journal/evidence/research/2017/04/01/finding-the-patient-voice-in-research-activities-perspectives-of-patient-advisors-and-researchers/
  2. https://researchinvolvement.biomedcentral.com/articles/10.1186/s40900-018-0111-5
  3. https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development
  4. https://www.ncbi.nlm.nih.gov/books/NBK9571/