Good Publication Practice Guidelines Research Articles

An Overview of the 2022 Update of Good Publication Practice (GPP) Guidelines: A Medical Writer’s Perspective

The Good Publication Practice (GPP) guidelines are a set of principles and recommendations pertaining to peer-reviewed or peer-orientated publications arising from research funded by or conducted in collaboration with industry sponsors, typically pharmaceutical, biotechnology, and medical device companies.
 This year marks the 20-year anniversary of the first GPP guidelines, which were published in 2003.1 These initial GPP guidelines were developed to promote transparency and to establish standards for publication practice used by pharmaceutical companies. Since then, GPP guidelines have undergone several updates to reflect changes within the publication field and to provide additional practical guidance on publication processes and procedures. These updates include GPP22 published in 2009 and GPP33 published in 2013. Good Practice for Conference Abstracts and Presentations (GPCAP)4 was published in 2019 to provide guidance specifically for congress abstract and presentations. The latest update of the GPP guidelines, the GPP 2022 update, was published in August 20225.

Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update.

These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.

A case of normal C1 esterase inhibitor hereditary angioedema successfully treated with berotralstat

A case of normal C1 esterase inhibitor hereditary angioedema successfully treated with berotralstat

Effectiveness of Sodium Zirconium Cyclosilicate in Hemodialysis Patients With Severe Hyperkalemia

Effectiveness of Sodium Zirconium Cyclosilicate in Hemodialysis Patients With Severe Hyperkalemia

131P - Cabozantinib in Asian patients with hepatocellular carcinoma and other solid tumours: Population pharmacokinetics analysis

BackgroundCabozantinib, an inhibitor of MET, AXL and VEGF receptors, was recently approved for the treatment of patients with advanced hepatocellular carcinoma (HCC) who had previously received sorafenib, based on findings of the CELESTIAL trial. We previously reported cabozantinib pharmacokinetics (PK) data based on 9 cabozantinib studies (N = 1534), Here, we report updated cabozantinib PK data in Asian and non-Asian ethnicities including patients with HCC. MethodsWe used data from ten cabozantinib studies that included healthy volunteers (HV) and patients with various cancer types (HCC, renal cell carcinoma, castration-resistant prostate cancer, medullary thyroid cancer [MTC], and glioblastoma multiforme). Studies pertinent to HCC were the CELESTIAL trial (NCT01908426) and the HCC cohort of a phase 2 trial (NCT00940225). The impact on PK parameters of selected covariates (age, weight, sex, race, cancer type, formulation, and liver dysfunction according to the National Cancer Institute Organ Dysfunction Working Group [NCI-ODWG]) was evaluated. Steady-state PK parameters were predicted for Asian and non-Asian patients. ResultsData from 2023 individuals were included (cancer patients, n = 1883; HV, n = 140), of whom 211 were of Asian ethnicity and 1812 of non-Asian ethnicity. MTC cancer type had the largest effect on cabozantinib PK parameters, with a 90% increase in apparent clearance (CL/F) relative to HV. Other cancer types, including HCC, and liver dysfunction per NCI-ODWG did not impact cabozantinib PK. However, because CELESTIAL excluded patients with Child-Pugh scores of B or C, results on patients with more compromised liver function are limited. A 24% decrease in CL/F was observed in females; Asian ethnicity, age, and weight had no clinically significant impact on cabozantinib clearance. ConclusionsMinimal cabozantinib PK and predicted exposure differences were observed across various cancer types except for MTC. The PK of cabozantinib was similar in individuals of Asian and non-Asian ethnicity. These findings are consistent with the major metabolic pathway of cabozantinib via cytochrome P450 3A4 which is not prone to genetic polymorphism. Editorial acknowledgementThe authors thank Isabelle Kaufmann, PhD of Oxford PharmaGenesis, Oxford, UK for providing medical writing support, which was sponsored by Ipsen, Abingdon, UK in accordance with Good Publication Practice guidelines. Legal entity responsible for the studyIpsen. FundingIpsen. DisclosureC-H. Hsu: Research grant/Funding (self): Ipsen; Honoraria (self): Ipsen. L. Nguyen: Full / Part-time employment: Exelixis. A-L. Cheng: Honoraria (self): Bayer; Honoraria (self): Eisai; Honoraria (self): Merck Sharp Dohme; Honoraria (self): Merck Serono; Honoraria (self): Novartis; Honoraria (self): Ono Pharmaceutical; Honoraria (self): Roche/Genentech; Honoraria (self): IQVIA. Advisory/Consultancy: Bayer Schering Pharma; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Eisai; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ono Pharmaceutical; Advisory/Consultancy: Exelixis; Advisory/Consultancy: Nucleix Ltd.; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: IQVIA. Speaker Bureau/Expert testimony: Bayer Yakuhin, Ltd.; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Ono Pharmaceutical; Speaker Bureau/Expert testimony: Amgen Taiwan. Travel/Accommodation/Expenses: Bayer Yakuhin, Ltd.; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Eisai; Travel/Accommodation/Expenses: Ono Pharmaceutical; Travel/Accommodation/Expenses: Roche/Genentech; Travel/Accommodation/Expenses: IQVIA. T.X.Q. Nguyen: Full / Part-time employment: Ipsen. K. Brendel: Full / Part-time employment: Ipsen. V. Aslanis: Full / Part-time employment: Ipsen. F. Benzaghou: Full / Part-time employment: Ipsen.

201P - Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer (nmCRPC) in the ARAMIS trial

Abstract Background Asymptomatic nmCRPC patients (pts) would benefit from treatments (Tx) that delay disease progression and maintain quality of life (QoL), with minimal Tx-related adverse events (AEs). In ARAMIS, darolutamide (DARO) prolonged metastasis-free survival vs placebo (PBO) (40 vs 18 months; HR 0.41; 95% CI 0.34–0.50; P Methods Pts were randomized to DARO 600 mg twice daily (n = 955) or PBO (n = 554), while androgen deprivation therapy continued in both arms. Secondary/exploratory endpoints included safety, time to cytotoxic chemotherapy, time to antineoplastic therapy, time to PSA progression, and QoL. Results DARO substantially delayed times to PSA progression (33 vs 7 months; HR 0.13; 95% CI 0.11–0.16; P 10% of pts. Discontinuation rates due to AEs were 8.9% with DARO and 8.7% with PBO. AEs noted with other androgen receptor inhibitors (including fracture, falls, seizures, hypertension and cognitive disorder) showed minimal or no difference in incidence between groups. DARO maintained QoL, and delayed the onset of pain and disease-related urinary symptoms compared with PBO. Conclusions DARO delays disease progression and subsequent Tx for metastatic castration-resistant prostate cancer vs PBO, maintaining QoL without increasing incidence of key AEs. Clinical trial identification NCT02200614. Editorial acknowledgement Medical writing support for the development of this abstract was provided by Lucy Smithers, PhD, and editorial support, including formatting, proofreading, and submission was provided by Beth King, both of Scion Medica, London, supported by Bayer according to Good Publication Practice guidelines. Legal entity responsible for the study Orion Corporation, Orion Pharma and Bayer AG. Funding Orion Corporation and Bayer AG. Disclosure J.S-T. Pang: Non-remunerated activity/ies, Writing support: Bayer. N. Shore: Advisory / Consultancy, Research grant / Funding (self): Ferring; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy, Research grant / Funding (self): Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Janssen; Advisory / Consultancy, Research grant / Funding (self): Dendreon; Advisory / Consultancy, Research grant / Funding (self): Tolmar; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Research grant / Funding (self): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self): Genentech/Roche; Advisory / Consultancy, Research grant / Funding (self): Myovant Sciences; Advisory / Consultancy, Research grant / Funding (self): Merck; Advisory / Consultancy, Research grant / Funding (self): BMS; Advisory / Consultancy, Research grant / Funding (self): Nymox. M.R. Smith: Honoraria (self): Amgen; Honoraria (self): Astellas; Honoraria (self): Bayer; Honoraria (self): Clovis; Honoraria (self): Gilead; Honoraria (self): Janssen; Honoraria (self): Lilly; Honoraria (self): Novartis; Honoraria (self): Pfizer. T.L. Tammela: Advisory / Consultancy, Research grant / Funding (self): Bayer; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (self): Lidds AB; Advisory / Consultancy, Research grant / Funding (self): Astellas. E. Vjaters: Research grant / Funding (self): Ipsen; Research grant / Funding (self): Bayer; Research grant / Funding (self): Janssen; Advisory / Consultancy, Research grant / Funding (self): Orion. M. Jievaltas: Honoraria (self): Bayer; Honoraria (self): Ipsen; Honoraria (self): Janssen. M. Luz: Advisory / Consultancy, Speaker Bureau / Expert testimony: Astellas; Advisory / Consultancy, Research grant / Funding (self): Janssen; Research grant / Funding (self): AstraZeneca; Travel / Accommodation / Expenses: Pfizer; Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Bayer; Research grant / Funding (self): Ferring; Speaker Bureau / Expert testimony: Sanofi. B. Alekseev: Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Bayer; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: AstraZeneca; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Astellas; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: BMS; Honoraria (self), Non-remunerated activity/ies: Ferring; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Janssen; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: MSD; Honoraria (self), Research grant / Funding (self), Non-remunerated activity/ies: Pfizer; Research grant / Funding (self), Non-remunerated activity/ies: Sanofi. I. Kuss: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bayer. M-A. Le Berre: Full / Part-time employment: Bayer Healthcare. A. Snapir: Full / Part-time employment: Orion Pharma. T. Sarapohja: Full / Part-time employment: Orion Corporation. K. Fizazi: Honoraria (self), Advisory / Consultancy: Astellas Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Honoraria (self): Merck; Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy: Sanofi; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy: Clovis Oncology; Advisory / Consultancy: Curevac; Advisory / Consultancy: ESSA; Advisory / Consultancy: Orion Pharma; Advisory / Consultancy: Roche/Genentech. All other authors have declared no conflicts of interest.

754P - Effect of second-line cabozantinib on health states for patients with advanced hepatocellular carcinoma (aHCC) after sorafenib: QTWiST analysis from the CELESTIAL study

754P - Effect of second-line cabozantinib on health states for patients with advanced hepatocellular carcinoma (aHCC) after sorafenib: QTWiST analysis from the CELESTIAL study

890P - Assessing the clinical relevance of drug-drug interactions (DDI) with darolutamide (DARO)

BackgroundDARO is an androgen receptor antagonist with a distinct molecular structure, which has demonstrated prolonged metastasis-free survival vs placebo (PBO) in the phase 3 ARAMIS study in non-metastatic castration-resistant prostate cancer patients. These typically older patients often receive multiple comedications. We assessed DDIs with DARO both in vitro and in clinical trial development. MethodsThe effects of induction and inhibition of transporters and CYP enzymes on DARO, and the effect of DARO on other comedications were studied in vitro and in several phase 1 trials using rifampicin (CYP3A4, P-gp inducer), itraconazole (ICZ; CYP3A4, P-gp inhibitor), rosuvastatin (BCRP, OATP1B1, OATP1B3 and OAT3 substrate), midazolam (CYP3A4 substrate) and dabigatran etexilate (P-gp substrate). The impact of comedication on DARO was investigated in a population pharmacokinetic (popPK) and covariate analysis of a subset of ARAMIS patients. The adverse event (AE) profile for comedication use between PBO and DARO was also analysed. ResultsConcomitant rifampicin led to a 3.5-fold decrease in DARO area under the curve (AUC) vs DARO alone. ICZ resulted in 1.8-fold increase in DARO AUC vs DARO alone. No significant effect of comedications that are CYP or P-gp inhibitors was identified in the popPK analysis; proton pump inhibitors did not significantly affect the PK of DARO. Effects of DARO on CYP inhibition in vitro were negligible and coadministration of midazolam or dabigatran showed no clinically relevant effects. Rosuvastatin AUC increased by 5.2-fold with DARO vs rosuvastatin alone, attributed mainly to BCRP inhibition. The incidence of AEs in ARAMIS was low; comedication use (98.7% in DARO, 98.0% in PBO arms) and AE profile were similar between study arms. ConclusionsDDIs with DARO and P-gp or CYP enzyme substrates, e.g. antithrombotics, calcium channel blockers or proton pump inhibitors, are not expected. Strong CYP3A4 inducers, e.g. rifampicin and carbamazepine, showed some interaction with DARO. Effects of CYP3A4 or P-gp inhibitors on DARO were not considered clinically relevant. DARO may increase the exposure of concomitant BCRP substrates, e.g. statins, although a safety and AE analysis from ARAMIS did not indicate any relevant impact of DARO. Clinical trial identificationNCT03237416, NCT03048110, NCT02671097, NCT02200614. Editorial acknowledgementMedical writing support: Lucy Smithers, PhD, and editorial support: Beth King, both of Scion Medica, London, supported by Bayer according to Good Publication Practice guidelines. Legal entity responsible for the studyBayer. FundingBayer and Orion Corporation. DisclosureC.R. Zurth: Full / Part-time employment: Bayer. K. Fizazi: Honoraria (self), Advisory / Consultancy: Merck, Sharp & Dohme; Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen; Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Astellas; Advisory / Consultancy: Orion; Advisory / Consultancy: CureVac; Advisory / Consultancy: Clovis. R. Fricke: Full / Part-time employment: Bayer. H. Gieschen: Full / Part-time employment: Bayer. K. Graudenz: Full / Part-time employment: Bayer. M. Koskinen: Full / Part-time employment: Orion Corporation. B.A. Ploeger: Full / Part-time employment: Bayer. O. Prien: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bayer. M.R. Smith: Advisory / Consultancy: Bayer; Advisory / Consultancy: Amgen; Advisory / Consultancy: Astellas; Advisory / Consultancy: Clovis; Advisory / Consultancy: Gilead; Honoraria (self): Hinova; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Eli Lilly; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Pfizer. T. Tammela: Honoraria (self), Research grant / Funding (institution): Bayer; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (institution): Lidds AB; Advisory / Consultancy, Research grant / Funding (institution): Astellas. N.D. Shore: Advisory / Consultancy, Research grant / Funding (self): Ferring; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Honoraria (self), Research grant / Funding (self): Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Janssen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Dendreon; Advisory / Consultancy, Research grant / Funding (self): Tolmar; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Astellas.

Good Practice for Conference Abstracts and Presentations: GPCAP

Research that has been sponsored by pharmaceutical, medical device and biotechnology companies is often presented at scientific and medical conferences. However, practices vary between organizations and it can be difficult to follow both individual conference requirements and good publication practice guidelines. Until now, no specific guidelines or recommendations have been available to describe best practice for conference presentations.This document was developed by a working group of publication professionals and uploaded to PeerJ Preprints for consultation prior to publication; an additional 67 medical societies, medical conference sites and conference companies were also asked to comment. The resulting recommendations aim to complement current good publication practice and authorship guidelines, outline the general principles of best practice for conference presentations and provide recommendations around authorship, contributorship, financial transparency, prior publication and copyright, to conference organizers, authors and industry professionals.While the authors of this document recognize that individual conference guidelines should be respected, they urge organizers to consider authorship criteria and data transparency when designing submission sites and setting parameters around word/character count and content for abstracts. It is also important to recognize that conference presentations have different limitations to full journal publications, for example, in the case of limited audiences that necessitate refocused abstracts, or where lead authors do not speak the local language, and these have been acknowledged accordingly. The authors also recognize the need for further clarity regarding copyright of previously published abstracts and have made recommendations to assist with best practice.By following Good Practice for Conference s and Presentations: GPCAP recommendations, industry professionals, authors and conference organizers will improve consistency, transparency and integrity of publications submitted to conferences worldwide.

75P - Cemiplimab, a human PD-1 monoclonal antibody, in patients (pts) with recurrent or metastatic cervical cancer: Interim data from phase I cohorts

Background: For pts who progress after first-line platinum based therapy for recurrent/metastatic cervical cancer, there are no therapies available that have been demonstrated to improve survival or quality of life. Cemiplimab (REGN2810), a human monoclonal antibody to PD-1, exhibited encouraging efficacy and acceptable tolerability in a phase 1 dose escalation study. The present report focuses on interim data from the phase 1 cervical cancer expansion cohorts (ECs) of cemiplimab as a monotherapy (EC 23) or in combination with hypofractionated radiotherapy (hfRT) (EC 24) (NCT02383212). Methods: Pts with recurrent or metastatic cervical cancer resistant to or intolerant of platinum and taxane doublet therapy received cemiplimab 3 mg/kg Q2W IV for up to 48 weeks, in ECs 23 and 24, and hfRT (9 Gy x 3 times/week given 1 week after first dose of cemiplimab) in EC 24. The co-primary objectives were to evaluate the safety, tolerability, and efficacy of cemiplimab monotherapy or in combination with hfRT. Tumour response assessments (in non-irradiated target lesions) were performed by RECIST 1.1 Q8W. Results: As of 1 Sept, 2017, these ECs were fully enrolled with 20 pts (EC 23, n = 10, EC 24, n = 10). Median (range) age was 55.0 (31–76) years (EC 23) and 51.5 (29–65) years (EC 24). ECOG performance status 1 vs. 0 was 60% vs. 40% and 80% vs. 20%, respectively, for EC 23 and EC 24. Investigator-assessed overall response rate (ORR; complete response [CR] + partial response [PR]) was 10.0% (0 CR and 1 PR) in each of EC 23 and EC 24. At the time of data cut-off, both responses were ongoing with durations of 3.7+ months. The most common treatment-emergent adverse events (TEAEs) of any grade were diarrhoea (40.0%), fatigue, hypokalaemia and pain in extremity (each 30.0%) in EC 23, and diarrhoea and urinary tract infection (each 30.0%) in EC 24. There was no grade ≥3 TEAE reported in > 1 patient in either cohort. Conclusions: Cemiplimab as monotherapy and in combination with hfRT demonstrated antitumour activity with an acceptable safety profile in pts with metastatic or recurrent cervical cancer. Cemiplimab monotherapy vs. chemotherapy in ≥ 2nd line cervical cancer is currently being evaluated in a global randomised phase 3 study (NCT03257267). Editorial acknowledgement: Medical writing support under the direction of the authors was provided by Emmanuel Ogunnowo, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publication Practice guidelines. Clinical trial identification: NCT02383212. Legal entity responsible for the study: Regeneron Pharmaceutical Inc. and Sanofi. Funding: Regeneron Pharmaceutical Inc. and Sanofi. Disclosure: D. Rischin: Research funding: Genentech/Roche, Merck, Amgen, Regeneron, Bristol-Myers Squibb. A. González-Martin: Consulting, advisory, speakers’ bureau, travel accommodation expenses: AstraZeneca, Tesaro, Roche, Pharmamar. J.Y. Hou: Consultant and fees: Foundation Medicine, Massive Bio, Inc. D. Cho: Consulting fees: Pfizer, BMS, Exelixis, Genentech, Prometheus. G. Falchook: Funding for trial for submitted work. S. Jabbour: Research funding grants: Merck, Nestle outside of the submitted work. K. Moore: KInstitutional consultancy (honorarium and ad board) fees: Tesaro, Genentech Roche, Clovis, AstraZeneca (for agents not involved in the SOLO-1 study), Immunogen, VBL Therapeutics, Janssen. M.G. Fury: Employee and shareholder: Regeneron Pharmaceuticals, Inc.; Patents, royalties, other intellectual property: Regeneron Pharmaceuticals, Inc. M. Feng: Employee and shareholder: Regeneron Pharmaceuticals, Inc., Bayer. J. Li: Employee and shareholder: Regeneron Pharmaceuticals, Inc., Novartis. I. Lowy: Employee, shareholder, fees for travel and accommodation expenses, leadership: Regeneron Pharmaceuticals, Inc. M. Mathias: Employee and shareholder: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.

71P - Phase I study of cemiplimab, a human monoclonal anti-PD-1, in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety data

Background: Cemiplimab (REGN2810) demonstrated a positive risk/benefit profile and produced antitumour activity in patients (pts) with advanced CSCC in the primary analysis, by independent central review, of a phase 1 CSCC expansion cohorts (ECs). We now report longer follow-up data from the CSCC ECs of the phase 1 study (NCT02383212). Methods: Pts with distantly metastatic or locally/regionally advanced CSCC who were not candidates for surgery were enrolled in ECs 7 and 8, respectively. All pts received cemiplimab 3 mg/kg by intravenous infusion over 30 minutes every 2 weeks for up to 48 weeks. Tumour measurements were performed every 8 weeks by RECIST 1.1 to determine overall response rate (ORR; complete response [CR] + partial response [PR]) according to intention to treat. The data cut-off date was Jan 20, 2018. Tumour response in this report was by investigator assessment. Results: A total of 26 pts were enrolled (21 M/5 F; 10 in EC 7, 16 in EC 8; median age: 72.5 years [range: 55–88]; ECOG performance status was 1 in 16 pts and 0 in 10 pts). Median duration of follow-up was 11.9 months (range: 1.1–18.2). Median duration of cemiplimab exposure was 36.0 weeks. The most common treatment-emergent adverse event (TEAE) of any grade was fatigue (26.9%). The only TEAEs of grade ≥3 that occurred in more than one pt were hypercalcaemia and skin infection (each 7.7%). ORR was 50.0% (95% CI: 29.9–70.1), with 2 CRs and 11 PRs; 5 patients had stable disease (SD), 6 had progressive disease, and 2 were not evaluable for response. Durable disease control rate (SD or response for ≥105 days) was 57.7% (95% CI: 36.9–76.6). The median time to response was 1.9 months (range: 1.7–7.5). The median duration of response has not been reached, and as of the data cut-off date, for pts with CR or PR, the observed duration of response exceeded 6 months in 9 pts and 12 months in 5 pts. Conclusions: The increasing duration of response in this analysis provides further evidence of a positive risk/benefit profile for cemiplimab in pts with advanced CSCC. Editorial acknowledgement: Medical writing support under the direction of the authors was provided by Emmanuel Ogunnowo, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publication Practice guidelines. Clinical trial identification: NCT02383212. Legal entity responsible for the study: Regeneron Pharmaceutical, Inc. and Sanofi. Funding: Regeneron Pharmaceutical, Inc. and Sanofi. Disclosure: T.K. Owonikoko: Fees for consulting or advisory role: Novartis, Celgene, Lilly, Sandoz, Abbvie, Eisai, G1 Therapeutics, Takeda, Seattle Genetics, Bristol-Myers Squibb, MedImmune. A.K. Salama: Fees for consulting or advisory and speakers’ bureau roles: Bristol-Myers. E. Calvo: Research funding: Boehringer Ingelheim, Roche/Genentech, BMS, Novartis, PsiOxus, Nanobiotix, Janssen, Abbvie, PharmaMar, PUMA, Sanofi, Lilly, Pfizer, Merck, Nektar, Amcure, Amgen, AstraZeneca, Principia, Bayer, CytomX, H3, Incyte, Kura, Loxo, Macrogenics, Menarini, Merck, Serono, Merus, Millenium, Rigontec, Tahio, TesaroReceipt; Honoraria or consultation fees: Novartis, Nanobiotix, Janssen-Cilag, PsiOxus Therapeutics, Seattle Genetics, Pierre Fabre, Boehringer Ingelheim, Cerulean Pharma, EUSA, Abbvie, Celgene; Speaker’s bureau fees: Novartis. N.S. Yee: Institutional research funding: Boston Biomedical Inc., Merck and Co. Inc., Pharmacyclics, Regeneron Pharmaceuticals Inc; Travel/accommodation expenses: Daiichi Sankyo, Foundation Medicine, Caris Life Sciences. D. Mahadevan: Speakers’ bureau and travel, accommodation expenses: Abbvie. J. Niu: Consulting or advisory role fees: Genentech, Biodesix, Paradigm, Ignyta, AstraZeneca and Teueda. K. Kal Mohan: Employee and shareholder of Regeneron Pharmaceuticals, Inc. J. Li: Employee and shareholder of Regeneron Pharmaceuticals, Inc. and Novartis. E. Stankevich: Employee of Regeneron Pharmaceuticals, Inc., a shareholder of Regeneron Pharmaceuticals, Inc., Celgene, Bristol-Myers Squibb, and Merck. M. Mathias: Shareholder and an employee of Regeneron Pharmaceuticals, Inc. I. Lowy: Employee, shareholder, fees for travel and accommodation expenses, leadership: Regeneron Pharmaceuticals, Inc. M.G. Fury: Employee and shareholder of Regeneron Pharmaceuticals, INC.; patents, royalties, other intellectual property: Regeneron Pharmaceuticals, Inc. H.M. Babiker: Honoraria: Bayer, Sirtex; Consulting or advisory role fees: Celgene, Endocyte. All other authors have declared no conflicts of interest.

Response to Vallance

Sir, In response to Dr Vallance's letter,1 we refute the implication that this article2 is an example of ‘medical ghostwriting'. Alpha-Plus Medical Communications acts in accordance with good publication practice guidelines (GPP2) as published in the BMJ,3 and confirms that there was no exception with this article. The authors provided direction, had full control of the editorial content, and accepted full responsibility for views and opinions as well as accuracy of the content.4 A clear and unambiguous statement regarding our involvement in this publication was included in the acknowledgements. In relation to Dr Vallance's claim that Alpha-Plus provides ‘complete medical communication services for all marketing needs', we would like to highlight that the source of this statement is an out-of-date and obsolete business listing from early 2009. We thank Dr Vallance for drawing our attention to this listing and have requested that it is removed at the earliest opportunity. Please refer your reader to our website (http://www.fishawack.com) for up-to-date and accurate information regarding our group of companies. As you will note on our website, publication activities are separate from other medical communications services. We would like to add that with regard to comments made about the appointment of Jo Jarvis, the conference in which Jo participated focused on how the industry should interact with different stakeholder groups (including physicians) in an ethically responsible manner and in compliance with the latest code of practice governing this area.

Authorship Policy of the Journal of Korean Medical Science

The Journal of Korean Medical Science (JKMS) follows the recommendations for authorship by the International Committee of Medical Journal Editors (ICMJE, 2008, www.icmje.org) and the Good Publication Practice Guidelines by the Korean Association of Medical Journal Editors (KAMJE, 2008, www.kamje.or.kr). The Uniform Requirements by the ICMJE recommends authorship as follows. credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3. Beyond the ICMJE recommendations, the KAMJE guidelines suggest that all authors should make a substantial intellectual contribution to the publication, the guidelines warn against authorship abuse, and list common types of abuse. Authorship is an important aspect of research publication, and all involved authors should agree whole contents of the document including authorship. Contributors should be differentiated from authors as recommended by the ICMJE. JKMS does not allow multiple corresponding authors for one article even when it is reporting on a multicenter study. Only one author should correspond with the editorial office and readers for one article. JKMS accepts notice of equal contribution for the first author when the study was clearly performed by co-first authors. However, the present issue of JKMS (Vol. 25 No. 5: 734-7) publishes one article which has two corresponding authors. The article, which is titled Optimal Waist Circumference Cutoff Values for Metabolic Syndrome Diagnostic Criteria in a Korean Rural Population, is published exceptionally because the authorship policy of JKMS has not been open declared yet. The authorship policy is declared open through this editorial and also at the homepage of JKMS, http://jkms.org. JKMS does not correct authorship after publication unless any mistake has been made by the editorial or publishing staff. Authorship may be changed before publication but after submission when an authorship correction is requested by all authors involved.

What Medical Writing Means To Me

This is a personal account based on many years experience as a medical writer. It considers aspects of medical writing with particular focus on the intellectual and ethical dilemmas it can raise. What makes medical writing both so interesting and so challenging is the fact that it often takes place at the border between different disciplines. For example, it straddles both science and art. Ethical issues also arise at the boundaries between academia and commerce. Until recently there have been few guidelines to help navigate such potentially dangerous territory. I have been privileged to be involved in developing two such guidelines and I describe how I hope the Good Publication Practice guidelines for pharmaceutical companies and the European Medical Writers Association guidelines may improve the practice of this fascinating profession, Medical Writing.

A concern that drug companies cannot ignore

A concern that drug companies cannot ignore

Raising the quality of publications: Now we have GPP!

AbstractUntil recently, few guidelines were available to assist companies in publishing their clinical trials and, compared to other phases of research, the quality of publications and the processes by which publications are developed have not received much scrutiny. However, guidelines on Good Publication Practice (GPP) for pharmaceutical companies have just been published. These aim to raise the quality of publications and to encourage ethical and responsible publication practices. The GPP guidelines were designed to be used alongside existing guidelines such as those from the International Committee of Medical Journal Editors (ICMJE) and the CONSORT statement. These, and other documents relevant to preparing publications, are reviewed and recommendations for ways in which companies might improve the quality of their publications are proposed. Copyright © 2003 John Wiley & Sons, Ltd.

Good publication practice for pharmaceutical companies

SUMMARYGuidelines on Good Publication Practice (GPP) for pharmaceutical companies are presented. The aim of the guidelines is to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. The guidelines cover companies' responsibility to endeavour to publish results of all studies, companies' relations with investigators, measures to prevent redundant or premature publication, methods to improve trial identification and the role of professional medical writers. Our aim in publishing the GPP guidelines, which are the first to be developed by and for those working on publications in the pharmaceutical industry, is to stimulate discussion between journals, investigators and trial sponsors and to provide guidance to those who seek it. We also hope that pharmaceutical companies and others involved in developing publications arising from sponsored clinical trials will endorse the guidelines.