PMID- 38515987
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240323
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 11
DP  - 2024
TI  - Patient listening on social media for patient-focused drug development: a 
      synthesis of considerations from patients, industry and regulators.
PG  - 1274688
LID - 10.3389/fmed.2024.1274688 [doi]
LID - 1274688
AB  - 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.
CI  - Copyright (c) 2024 Cimiano, Collins, De Vuono, Escudier, Gottowik, Hartung, Leddin, 
      Neupane, Rodriguez-Esteban, Schmidt, Starke-Knausel, Voorhaar and Wieckowski.
FAU - Cimiano, Philipp
AU  - Cimiano P
AD  - Semalytix GmbH, Bielefeld, Germany.
AD  - CITEC, Bielefeld University, Bielefeld, Germany.
FAU - Collins, Ben
AU  - Collins B
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany.
FAU - De Vuono, Maria Carmela
AU  - De Vuono MC
AD  - Chiesi Farmaceutici SpA, Parma, Italy.
FAU - Escudier, Thierry
AU  - Escudier T
AD  - Pistoia Alliance, Wakefield, MA, United States.
FAU - Gottowik, Jurgen
AU  - Gottowik J
AD  - Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Hartung, Matthias
AU  - Hartung M
AD  - Semalytix GmbH, Bielefeld, Germany.
FAU - Leddin, Mathias
AU  - Leddin M
AD  - Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Neupane, Bikalpa
AU  - Neupane B
AD  - Takeda Pharmaceuticals Co., Ltd., Cambridge, MA, United States.
FAU - Rodriguez-Esteban, Raul
AU  - Rodriguez-Esteban R
AD  - Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Schmidt, Ana Lucia
AU  - Schmidt AL
AD  - Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Starke-Knausel, Cornelius
AU  - Starke-Knausel C
AD  - Semalytix GmbH, Bielefeld, Germany.
FAU - Voorhaar, Maarten
AU  - Voorhaar M
AD  - Boehringer Ingelheim International GmbH, Ingelheim, Germany.
FAU - Wieckowski, Krzysztof
AU  - Wieckowski K
AD  - SageFiber, Ustron, Poland.
LA  - eng
PT  - Journal Article
DEP - 20240306
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC10955474
OTO - NOTNLM
OT  - patient experience data
OT  - patient-focused drug development
OT  - real-world evidence
OT  - regulatory decision making
OT  - social media listening
COIS- PC, MH, and CS-K were employed by Semalytix GmbH. BC and MVo were employed by 
      Boehringer Ingelheim GmbH. MVu was employed by Chiesi Farmaceutici SpA. JG, ML, 
      RR-E, and AS were employed by F. Hoffmann-La Roche Ltd. BN was employed by Takeda 
      Pharmaceuticals. KW was employed by SageFiber and he is a consultant to 
      Boehringer Ingelheim International GmbH. The remaining author declares that the 
      research was conducted in the absence of any commercial or financial 
      relationships that could be construed as a potential conflict of interest.
EDAT- 2024/03/22 06:44
MHDA- 2024/03/22 06:45
PMCR- 2024/03/06
CRDT- 2024/03/22 04:03
PHST- 2023/08/08 00:00 [received]
PHST- 2024/02/12 00:00 [accepted]
PHST- 2024/03/22 06:45 [medline]
PHST- 2024/03/22 06:44 [pubmed]
PHST- 2024/03/22 04:03 [entrez]
PHST- 2024/03/06 00:00 [pmc-release]
AID - 10.3389/fmed.2024.1274688 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2024 Mar 6;11:1274688. doi: 10.3389/fmed.2024.1274688. 
      eCollection 2024.