TY - JOUR
T1 - Communication of anticancer drug benefits and related uncertainties to patients and clinicians
T2 - document analysis of regulated information on prescription drugs in Europe
AU - Davis, Courtney
AU - Wagner, Anita K.
AU - Salcher-Konrad, Maximilian
AU - Scowcroft, Henry
AU - Mintzes, Barbara
AU - Pokorny, Adrian M.J.
AU - Lew, Jianhui
AU - Naci, Huseyin
N1 - Funding Information:
Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/coi_disclosure.pdf and declare: This study was partly funded by Health Action International and the EU Commission’s Consumers, Health, Agriculture and Food Executive Agency (CHAFEA). CD reports membership of Health Action International (HAI), serving as HAI’s representative on the European Medicines Agency (EMA) Patient and Consumer Working Party (PCWP) and receiving reimbursement from EMA for attendance at PCWP meetings; AKW reports grants from the American Cancer Society outside the submitted work, and payment or honorariums from the University of Hong Kong; BM reports membership of HAI, L’Association Mieux Prescrire, and the Scientific and Education Committee of the Therapeutics Initiative (University of British Columbia), and reports serving as an expert witness for Health Canada during a legal case involving marketing of an unapproved drug product in Canada; JL reports grants from the non-profit organisation HAI to undertake data collection and analysis for the submitted work; HN reports grants from the Health Foundation, the National Institute for Health and Care Research, and UK Research and Innovation outside the submitted work, and consulting fees from the World Health Organization and Pharmaceutical Group of the European Union; HN also reports being an adviser to the Analysis section of The BMJ; the other authors declare no support from any organization for the submitted work; no financial relationships with any organisation that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.
Funding Information:
Funding: This study was partly funded by Health Action International and the EU Commission’s Consumers, Health, Agriculture and Food Executive Agency (CHAFEA). Health Action International had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.
Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023
Y1 - 2023
N2 - Objective: To evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe. Design: Document content analysis. Setting: European Medicines Agency. Participants: Anticancer drugs granted a first marketing authorisation by the European Medicines Agency, 2017-19. Main outcome measures: Whether written information on a product addressed patients' commonly asked questions about: who and what the drug is used for; how the drug was studied; types of drug benefit expected; and the extent of weak, uncertain, or missing evidence for drug benefits. Information on drug benefits in written sources for clinicians (summaries of product characteristics), patients (patient information leaflets), and the public (public summaries) was compared with information reported in regulatory assessment documents (European public assessment reports). Results: 29 anticancer drugs that received a first marketing authorisation for 32 separate cancer indications in 2017-19 were included. General information about the drug (including information on approved indications and how the drug works) was frequently reported across regulated information sources aimed at both clinicians and patients. Nearly all summaries of product characteristics communicated full information to clinicians about the number and design of the main studies, the control arm (if any), study sample size, and primary measures of drug benefit. None of the patient information leaflets communicated information to patients about how drugs were studied. 31 (97%) summaries of product characteristics and 25 (78%) public summaries contained information about drug benefits that was accurate and consistent with information in regulatory assessment documents. The presence or absence of evidence that a drug extended survival was reported in 23 (72%) summaries of product characteristics and four (13%) public summaries. None of the patient information leaflets communicated information about the drug benefits that patients might expect based on study findings. Scientific concerns about the reliability of evidence on drug benefits, which were raised by European regulatory assessors for almost all drugs in the study sample, were rarely communicated to clinicians, patients, or the public. Conclusions: The findings of this study highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians.
AB - Objective: To evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe. Design: Document content analysis. Setting: European Medicines Agency. Participants: Anticancer drugs granted a first marketing authorisation by the European Medicines Agency, 2017-19. Main outcome measures: Whether written information on a product addressed patients' commonly asked questions about: who and what the drug is used for; how the drug was studied; types of drug benefit expected; and the extent of weak, uncertain, or missing evidence for drug benefits. Information on drug benefits in written sources for clinicians (summaries of product characteristics), patients (patient information leaflets), and the public (public summaries) was compared with information reported in regulatory assessment documents (European public assessment reports). Results: 29 anticancer drugs that received a first marketing authorisation for 32 separate cancer indications in 2017-19 were included. General information about the drug (including information on approved indications and how the drug works) was frequently reported across regulated information sources aimed at both clinicians and patients. Nearly all summaries of product characteristics communicated full information to clinicians about the number and design of the main studies, the control arm (if any), study sample size, and primary measures of drug benefit. None of the patient information leaflets communicated information to patients about how drugs were studied. 31 (97%) summaries of product characteristics and 25 (78%) public summaries contained information about drug benefits that was accurate and consistent with information in regulatory assessment documents. The presence or absence of evidence that a drug extended survival was reported in 23 (72%) summaries of product characteristics and four (13%) public summaries. None of the patient information leaflets communicated information about the drug benefits that patients might expect based on study findings. Scientific concerns about the reliability of evidence on drug benefits, which were raised by European regulatory assessors for almost all drugs in the study sample, were rarely communicated to clinicians, patients, or the public. Conclusions: The findings of this study highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians.
UR - http://www.scopus.com/inward/record.url?scp=85151173194&partnerID=8YFLogxK
U2 - 10.1136/bmj-2022-073711
DO - 10.1136/bmj-2022-073711
M3 - Article
C2 - 36990506
AN - SCOPUS:85151173194
SN - 0959-8146
JO - BMJ
JF - BMJ
M1 - e073711
ER -
