Journalartikel - Artikel | 2024 | Peer reviewed

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators

Autor(en)

; Collins, Ben ; De Vuono, Maria Carmela ; Escudier, Thierry ; Gottowik, Jürgen ; Hartung, Matthias ; Leddin, Mathias ; Neupane, Bikalpa ; Rodriguez-Esteban, Raul ; Schmidt, Ana Lucia ; Starke-Knäusel, Cornelius ; Voorhaar, Maarten ; Wieckowski, Krzysztof

Normierter Zeitschriftentitel

Frontiers in medicine

DOI

10.3389/fmed.2024.1274688

PubMed-ID

38515987

URN

urn:nbn:de:0070-pub-29880526

URL

https://pub.uni-bielefeld.de/record/2988052

Web of Science-ID

001189751400001

Weitere Details

Sprache

englisch

Darstellungsform

Text

Band

Artikelnummer

1274688

Schlagwörter

patient experience data , patient-focused drug development , real-world evidence , regulatory decision making , social media listening

Link zum Volltext (intern)

https://pub.uni-bielefeld.de/record/2988052

DDC

610

Patients, life science industry and regulatory authorities are united in their goal to reduce the disease burden of patients by closing remaining unmet needs. Patients have, however, not always been systematically and consistently involved in the drug development process. Recognizing this gap, regulatory bodies worldwide have initiated patient-focused drug development (PFDD) initiatives to foster a more systematic involvement of patients in the drug development process and to ensure that outcomes measured in clinical trials are truly relevant to patients and represent significant improvements to their quality of life. As a source of real-world evidence (RWE), social media has been consistently shown to capture the first-hand, spontaneous and unfiltered disease and treatment experience of patients and is acknowledged as a valid method for generating patient experience data by the Food and Drug Administration (FDA). While social media listening (SML) methods are increasingly applied to many diseases and use cases, a significant piece of uncertainty remains on how evidence derived from social media can be used in the drug development process and how it can impact regulatory decision making, including legal and ethical aspects. In this policy paper, we review the perspectives of three key stakeholder groups on the role of SML in drug development, namely patients, life science companies and regulators. We also carry out a systematic review of current practices and use cases for SML and, in particular, highlight benefits and drawbacks for the use of SML as a way to identify unmet needs of patients. While we find that the stakeholders are strongly aligned regarding the potential of social media for PFDD, we identify key areas in which regulatory guidance is needed to reduce uncertainty regarding the impact of SML as a source of patient experience data that has impact on regulatory decision making.

Zitierstile

Cimiano P, Collins B, De Vuono MC, et al. Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators. Frontiers in Medicine. 2024;11: 1274688.

In die Zwischenablage einfügen

Cimiano, P., Collins, B., De Vuono, M. C., Escudier, T., Gottowik, J., Hartung, M., Leddin, M., et al. (2024). Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators. Frontiers in Medicine, 11, 1274688. https://doi.org/10.3389/fmed.2024.1274688

In die Zwischenablage einfügen

Cimiano, Philipp, Collins, Ben, De Vuono, Maria Carmela, Escudier, Thierry, Gottowik, Jürgen, Hartung, Matthias, Leddin, Mathias, et al. 2024. “Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators”. Frontiers in Medicine 11: 1274688.

In die Zwischenablage einfügen

Cimiano, P., Collins, B., De Vuono, M. C., Escudier, T., Gottowik, J., Hartung, M., Leddin, M., Neupane, B., Rodriguez-Esteban, R., Schmidt, A. L., et al. (2024). Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators. Frontiers in Medicine 11:1274688.

In die Zwischenablage einfügen

Cimiano, P., et al., 2024. Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators. Frontiers in Medicine, 11: 1274688.

In die Zwischenablage einfügen

P. Cimiano, et al., “Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators”, Frontiers in Medicine, vol. 11, 2024, : 1274688.

In die Zwischenablage einfügen

Cimiano, P., Collins, B., De Vuono, M.C., Escudier, T., Gottowik, J., Hartung, M., Leddin, M., Neupane, B., Rodriguez-Esteban, R., Schmidt, A.L., Starke-Knäusel, C., Voorhaar, M., Wieckowski, K.: Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators. Frontiers in Medicine. 11, : 1274688 (2024).

In die Zwischenablage einfügen

Cimiano, Philipp, Collins, Ben, De Vuono, Maria Carmela, Escudier, Thierry, Gottowik, Jürgen, Hartung, Matthias, Leddin, Mathias, Neupane, Bikalpa, Rodriguez-Esteban, Raul, Schmidt, Ana Lucia, Starke-Knäusel, Cornelius, Voorhaar, Maarten, and Wieckowski, Krzysztof. “Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators”. Frontiers in Medicine 11 (2024): 1274688.

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