[HTML][HTML] Defining patient engagement in research: results of a systematic review and analysis: report of the ISPOR patient-centered special interest group

RL Harrington, ML Hanna, EM Oehrlein, R Camp… - Value in Health, 2020 - Elsevier
Objectives Lack of clarity on the definition of “patient engagement” has been highlighted as
a barrier to fully implementing patient engagement in research. This study identified themes …

[HTML][HTML] Patient-reported outcome and observer-reported outcome assessment in rare disease clinical trials: an ISPOR COA emerging good practices task force report

K Benjamin, MK Vernon, DL Patrick, E Perfetto… - Value in Health, 2017 - Elsevier
Abstract Background Rare diseases (RDs) affect a small number of people within a
population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to …

Structure-function correlation and personalized 3D printed tablets using a quality by design (QbD) approach

J Zhang, R Thakkar, Y Zhang… - International Journal of …, 2020 - Elsevier
The current investigation aimed to manufacture and evaluate the structure–function
relationship of various 3D printed tablets by conjugating hot-melt extrusion (HME) and fused …

Defining patient centricity with patients for patients and caregivers: a collaborative endeavour

G Yeoman, P Furlong, M Seres, H Binder… - BMJ …, 2017 - innovations.bmj.com
Background Patient engagement is an essential aspect in the research/development of
biopharmaceutical products and disease management. Improving the lives of patients …

Using patient perspectives to inform better clinical trial design and conduct: current trends and future directions

SD Faulkner, F Somers, M Boudes, B Nafria… - Pharmaceutical …, 2023 - Springer
The approach to patient engagement (PE) in drug development has changed rapidly due to
many factors, including the complexity of innovative drugs and the need to demonstrate …

[HTML][HTML] Value to whom? The patient voice in the value discussion

EM Perfetto, EM Oehrlein, M Boutin, S Reid, E Gascho - Value in Health, 2017 - Elsevier
Background Professional societies and other organizations have recently taken a visible
role trying to define treatment value via value frameworks and assessments, providing payer …

Development of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT®) questionnaire: a new patient-reported outcome instrument for PAH

D McCollister, S Shaffer, DB Badesch, A Filusch… - Respiratory …, 2016 - Springer
Background Regulators and clinical experts increasingly recognize the importance of
incorporating patient-reported outcomes (PROs) in clinical studies of therapies for …

[HTML][HTML] DRAVET ENGAGE. Parent caregivers of children with Dravet syndrome: Perspectives, needs, and opportunities for clinical research

C Juandó-Prats, E James, DA Bilder, L McNair… - Epilepsy & Behavior, 2021 - Elsevier
Dravet syndrome (DS) is an intractable developmental and epileptic encephalopathy
significantly impacting affected children and their families. A novel, one-time, adeno …

Sustaining meaningful patient engagement across the lifecycle of medicines: a roadmap for action

M Cavaller-Bellaubi, SD Faulkner, B Teixeira… - … Innovation & Regulatory …, 2021 - Springer
Background There is increased recognition that incorporating patients' perspectives and
insights into the medicines development process results in better health outcomes and …

[图书][B] Pharmaceutical freedom: Why patients have a right to self-medicate

J Flanigan - 2017 - books.google.com
If a competent adult refuses medical treatment, physicians and public officials must respect
her decision. Coercive medical paternalism is a clear violation of the doctrine of informed …