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We are analyzing https://link.springer.com/article/10.1007/s12325-019-00920-x.

Title:
The Case for the Use of Patient and Caregiver Perception of Change Assessments in Rare Disease Clinical Trials: A Methodologic Overview | Advances in Therapy
Description:
Introduction The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome measures. Incorporating qualitative research into rare disease clinical trials may help sponsors, regulators, payers, and prescribers to better understand the real-world and patient-specific impact of a potential therapy. This paper provides a methodologic overview of the use of Patient and Caregiver Perception of Change (PPC and CPC) Assessments utilizing patient and caregiver video interviews to complement the data captured by traditional endpoints in rare disease clinical trials. Methods Incorporating qualitative patient and caregiver video interviews into clinical trials allows for the rigorous capture of patient experiences and caregiver observations. Interview guides informed by input from key stakeholders provide the opportunity to solicit structured feedback on experiences before, during, and after the clinical trial. Patients and caregivers can complete their video interviews in a study mobile application, and interview transcripts are analyzed by independent coders. Themes are summarized by the treatment group and individual patient, which adds context to the clinical outcome measures of how patients feel and function, as well as elucidates the degree of change that is meaningful to patients and caregivers. The qualitative results can be compared to the data captured in clinical trials to assess data concordance. Conclusion Capturing patient experience data with sufficient rigor allows it to contribute to the body of evidence utilized in regulatory, payer, and prescriber decision-making. Adding PPC and CPC Assessments to rare disease clinical trials offers an innovative and powerful way to tap into the unique insights of patients and their families to develop a fuller picture of the patient experience in the clinical trial. Funding Stealth BioTherapeutics Inc.
Website Age:
28 years and 1 months (reg. 1997-05-29).

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Link.springer.com utilizes WORDPRESS.

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🌠 Phenomenal Traffic: 5M - 10M visitors per month

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Keywords {🔍}

patients, patient, clinical, study, trial, rare, interviews, interview, disease, data, drug, article, pubmed, qualitative, trials, fda, outcome, caregivers, google, scholar, video, experience, treatment, development, internet, accessed, change, caregiver, research, meaningful, assessments, review, information, measures, diseases, central, application, population, drugs, mobile, evidence, important, assessment, conducted, captured, results, traditional, regulators, outcomes, orphan,

Topics {✒️}

org/sites/default/files/ghs-files/dur-miscellaneous/2011-01-19/guidelines-providing-public-comment-mainecare-dur-committee-1-18-11 gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhvisionandmission/ucm588577 /wp-content/uploads/2018/05/pro-label-database-fda-list-q1-2018 org/blog/2017/5/16/jett-foundations-patient-reported-outcome-report /2016/04/26/business/muscular-dystrophy-drug-fda-sarepta-eteplirsen org/static/meetings/immpact20/kovacs%20presentation org/wp-content/uploads/2017/12/pdf-inoutmedicaiddetermination org/wp-content/uploads/2016/10/s1_1_woodcock /ext/resources/files/2016/01/01-15-fda-eteplirsen org/sgp/crs/misc/r41983 gov/114/bills/hr34/bills-114hr34enr gov/newsevents/newsroom/pressannouncements/ucm544035 observer-reported outcome assessment gov/downloads/drugs/newsevents/ucm620707 cdrh patient-reported outcomes present-patient-centered-outcomes-report patient-focused drug development org/rare-diseases-facts-statistics/ mixed methods patient-reported outcomes gov/drugsatfda_docs/label/2008/021908s005lbl gov/drugsatfda_docs/nda/2000/20-989_evoxac_medr_p1 gov/drugsatfda_docs/nda/2017/208082orig1s000medr gov/drugsatfda_docs/nda/2015/206333orig1s000medr gov/drugsatfda_docs/nda/2009/125289_medr_p1 gov/drugsatfda_docs/nda/2009/022256s000_medr_p1 gov/drugsatfda_docs/nda/2008/021911s000_medr_p1 patient-reported symptom experiences gov/pmc/articles/pmc5600176/ patient-centered outcome measures idiopathic pulmonary fibrosis patient-reported outcome fda advisory committee fda-advisory-committee genetic disease-specific outcome measures providing public comment caregiver/observer interviews gov/diseases/pages/31/faqs regulatory decision-makers review clinical trial sites incorporating qualitative research rare disease patients—reflections /news-releases/jett-foundation randomized controlled trials integrating qualitative research duchenne muscular dystrophy clinical trial-derived evidence entire drug research web conferencing system

Questions {❓}

How to address the challenges of evaluating treatment benefits-risks in rare diseases?
Reimbursement of orphan drugs in Belgium: what (else) matters?
What is efficacy?

Schema {🗺️}

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         description:The traditional model of evaluating treatments based primarily on primary outcome measures has stumbled in its application to rare disease. Rare disease clinical trials face the methodological challenges of small, heterogeneous patient populations and relatively few validated, disease-specific outcome measures. Incorporating qualitative research into rare disease clinical trials may help sponsors, regulators, payers, and prescribers to better understand the real-world and patient-specific impact of a potential therapy. This paper provides a methodologic overview of the use of Patient and Caregiver Perception of Change (PPC and CPC) Assessments utilizing patient and caregiver video interviews to complement the data captured by traditional endpoints in rare disease clinical trials. Incorporating qualitative patient and caregiver video interviews into clinical trials allows for the rigorous capture of patient experiences and caregiver observations. Interview guides informed by input from key stakeholders provide the opportunity to solicit structured feedback on experiences before, during, and after the clinical trial. Patients and caregivers can complete their video interviews in a study mobile application, and interview transcripts are analyzed by independent coders. Themes are summarized by the treatment group and individual patient, which adds context to the clinical outcome measures of how patients feel and function, as well as elucidates the degree of change that is meaningful to patients and caregivers. The qualitative results can be compared to the data captured in clinical trials to assess data concordance. Capturing patient experience data with sufficient rigor allows it to contribute to the body of evidence utilized in regulatory, payer, and prescriber decision-making. Adding PPC and CPC Assessments to rare disease clinical trials offers an innovative and powerful way to tap into the unique insights of patients and their families to develop a fuller picture of the patient experience in the clinical trial. Stealth BioTherapeutics Inc.
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