NDLI: The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt

Content Provider	Springer Nature : BioMed Central
Author	Morel, Thomas Schroeder, Karlin Cleanthous, Sophie Andrejack, John Blavat, Geraldine Brooks, William Gosden, Lesley Siu, Carroll Ratcliffe, Natasha Slagle, Ashley F.
Abstract	Background In support of UCB pharmaceutical research programs, the aim of this research was to implement a novel process for patient involvement in a multidisciplinary research group to co-create a clinical outcome assessment strategy to accurately reflect the experience of people living with early-stage Parkinson’s. Patient experts were an integral part of the decision-making process for patient-reported outcome (PRO) research and instrument development. Methods In partnership with two patient organizations (Parkinson’s UK and the Parkinson’s Foundation), 6 patient experts were recruited into a multidisciplinary research group alongside clinical, patient engagement and involvement, regulatory science, and outcome measurement experts. The group was involved across two phases of research; the first phase identified what symptoms are cardinal to the experience of living with early-stage Parkinson’s and the second phase involved the development of PRO instruments to better assess the symptoms that are important to people living with early-stage Parkinson’s. Patient experts were important in performing a variety of roles, in particular, qualitative study protocol design, conceptual model development, and subsequent co-creation of two PRO instruments. Results Involving people with Parkinson’s in PRO research ensured that the expertise of these representatives from the Parkinson’s community shaped and drove the research; as such, PRO instruments were being developed with the patient at the forefront. Working with patient experts required considerable resource and time allocation for planning, communication, document development, and organizing meetings; however, their input enriched the development of PRO instruments and was vital in developing PRO instruments that are more meaningful for people with Parkinson’s and clinicians. Conclusions Conducting PRO research, in the context of clinical development involving pharmaceutical companies, requires balancing regulatory and scientific rigor with tight time constraints. Incorporating a multi-stakeholder perspective, which included patient experts as joint investigators, had a strong positive impact on our research, despite the logistical complexities of their involvement. Due to the input of patient experts, the innovative clinical outcome assessment strategy and the co-created novel PRO instruments were more relevant and holistic to the patient experience of early-stage Parkinson’s. Graphical abstract
Related Links	https://researchinvolvement.biomedcentral.com/counter/pdf/10.1186/s40900-023-00505-7.pdf
Ending Page	14
Page Count	14
Starting Page	1
File Format	HTM / HTML
ISSN	20567529
DOI	10.1186/s40900-023-00505-7
Journal	Research Involvement and Engagement
Issue Number	1
Volume Number	9
Language	English
Publisher	BioMed Central
Publisher Date	2023-10-24
Access Restriction	Open
Subject Keyword	Medicine Public Health Early-stage Parkinson’s Parkinson’s disease Patient-reported outcomes Patient expert Patient engagement Co-creation Patient and public involvement Patient-focused drug development Outcome measure Clinical outcome assessment PEIRS-22 Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Health Professions Health (social science)

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Patient Engagement in Research Scale (PEIRS-22): Danish translation, applicability, and user experiences

Correction to: The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt

Public involvement in health outcomes research: lessons learnt from the development of the recovering quality of life (ReQoL) measures

Co-creating a patient and public involvement and engagement ‘how to’ guide for researchers

The impact of patient involvement in research: a case study of the planning, conduct and dissemination of a clinical, controlled trial

Patient and public involvement and engagement in the development of innovative patient-centric early phase dose-finding trial designs

The technical expert/clinical user/patient panel (TECUPP): centering patient and family perspectives in patient-reported measure development

Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

Patient involvement in a qualitative meta-synthesis: lessons learnt

The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt

Similar Documents

Patient Engagement in Research Scale (PEIRS-22): Danish translation, applicability, and user experiences

Correction to: The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt

Public involvement in health outcomes research: lessons learnt from the development of the recovering quality of life (ReQoL) measures

Co-creating a patient and public involvement and engagement ‘how to’ guide for researchers

The impact of patient involvement in research: a case study of the planning, conduct and dissemination of a clinical, controlled trial

Patient and public involvement and engagement in the development of innovative patient-centric early phase dose-finding trial designs

The technical expert/clinical user/patient panel (TECUPP): centering patient and family perspectives in patient-reported measure development

Patient and public involvement prior to trial initiation: lessons learnt for rapid partnership in the COVID-19 era

Patient involvement in a qualitative meta-synthesis: lessons learnt

The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt