Good Publication Practice Research Articles

Do orthopaedics surgeons have any idea what predatory journals are?:(cross-sectional study)

ObjectiveThe legitimacy of published research confronts a real challenge posed by predatory journals. These journals not only distribute inadequately written articles but also undermine the prospects of acknowledgment and citation for high-quality content. It is essential, nevertheless, to differentiate between predatory journals and reputable open-access ones. A worldwide anti-predatory movement seeks to enhance awareness about such journals. Hence, our objective was to assess the awareness, attitudes, and practices of Sudanese orthopedic surgeons concerning both predatory and open-access publishing. MethodsConducted between January and April 2023, this cross-sectional electronic survey involved Sudanese orthopedic surgeons. The survey, comprising five domains to gauge knowledge, attitudes, and practices related to predatory and open-access publishing, was shared via the Sudanese Orthopedic Surgeons Association email distribution list among the 561 registered surgeons. The targeted sample size was 286. Categorical variables were reported using frequencies, while continuous variables were presented as medians and interquartile ranges. Nonparametric tests and ordinal regression were employed for inferential statistics. ResultsOf the 561 surgeons, 104 participants completed the questionnaire, resulting in a response rate of 18.5 %. Approximately 49% exhibited poor knowledge, with 56% unfamiliar with the term "predatory journals," and 74% unaware of Beall's list. Overall attitudes toward publication in open-access and predatory journals were neutral for 60% of participants, and only 26% demonstrated good overall publication practices. Higher knowledge scores positively correlated with attitude and practice scores. Ordinal regression analysis identified variables such as employment in university hospitals, higher academic rank, publication experience, and working in well-resourced countries as factors increasing the likelihood of higher knowledge, attitude, and practice scores. ConclusionThe majority of the study participants reported very low knowledge of predatory journals and their possible detrimental consequences on the integrity and quality of scientific publications. Therefore, educational efforts on the negative impact of predatory publication practices in orthopedics are needed.

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) 2022 Update: An Interview with Dikran Toroser

Dikran Toroser was educated in the UK and has a PhD in Biochemistry from Newcastle University in Newcastle upon Tyne. He did his post-doctoral research in the UK at the Cambridge lab on genetics and then moved to the US to work as a biochemist and researcher for the US Department of Agriculture (USDA). He has an extensive background in scientific publications as well as medical writing. He has led scientific publication teams involved with pre-clinical, clinical, and mature product studies and publications. Dikran is one of the founding faculty for the University of California San Diego medical writing certificate and a consulting director for the program. Active in professional organizations such as American Medical Writers Association (AMWA) and International Society for Medical Publication Professionals (ISMPP), Dikran most recently has been involved in compiling guidelines for the publication professionals, including the AMWA-EMWA-ISMPP joint position statement on the role of professional medical writers1 and GPP 2022, the latest 2022 update of Good Publication Practice (GPP) guidelines for company-sponsored biomedical research2.

Zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) withclaudin-18.2+ (CLDN18.2+) / HER2− locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Primary results from phase 3 SPOTLIGHT study

LBA292 Background: 1L treatment for pts with HER2−, mG/GEJ adenocarcinoma is typically chemotherapy and immunotherapy; an unmet need still exists. CLDN18.2 is expressed in normal gastric mucosa cells and retained in mG/GEJ tumor cells. In the FAST study, zolbetuximab, which targets CLDN18.2, prolonged survival of pts with LA unresectable or mG/GEJ adenocarcinoma when combined with chemotherapy. SPOTLIGHT (NCT03504397) is a phase 3 global, double-blind study comparing zolbetuximab + folinic acid, 5-FU, and oxaliplatin (mFOLFOX6) vs placebo + mFOLFOX6 as 1L treatment for pts with CLDN18.2+/ HER2−, LA unresectable or mG/GEJ adenocarcinoma. Methods: Previously untreated pts with CLDN18.2+ (moderate-to-strong membrane staining in ≥75% tumor cells by IHC)/HER2− LA unresectable or mG/GEJ adenocarcinoma were randomized 1:1 to zolbetuximab IV 800 mg/m2 (cycle [C] 1, day [D] 1) followed by 600 mg/m2 (C1D22, and every 3 weeks in later cycles) + mFOLFOX6 IV (D1, 15, 29) for four 42-day cycles vs placebo + mFOLFOX6; pts without PD continued for >4 cycles with zolbetuximab or placebo, + folinic acid and 5-FU at investigator’s discretion until PD or discontinuation criteria were met. The primary endpoint (EP) was PFS per RECIST v1.1 by IRC. Secondary EPs included OS, ORR, and safety. Differences in efficacy between treatment arms were tested by stratified log rank tests; OS was tested if PFS was significant. Results: Among 2735 pts screened, 565 pts were randomized 1:1 to zolbetuximab + mFOLFOX6 (N = 283) or placebo + mFOLFOX6 (N = 282). PFS was statistically significantly improved with zolbetuximab + mFOLFOX6 (median 10.61 vs 8.67 mo, HR 0.751, P=0.0066; Table). OS was also significantly improved (median 18.23 vs 15.54 mo, HR 0.750, P=0.0053, < 0.0135 as boundary; Table). ORR was similar between treatment arms. Most common TEAEs with zolbetuximab + mFOLFOX6 were nausea (82.4% vs 60.8% in zolbetuximab vs placebo arms), vomiting (67.4% vs 35.6%), and decreased appetite (47.0% vs 33.5%); the incidences of serious TEAEs were similar between both arms (44.8% vs 43.5%). Conclusions: Targeting CLDN18.2 with 1L zolbetuximab combined with mFOLFOX6 statistically significantly prolonged PFS and OS in pts with CLDN18.2+/ HER2−, LA unresectable or mG/GEJ adenocarcinoma. TEAEs were consistent with previous studies. Zolbetuximab + mFOLFOX6 may be a new option for these pts. Funding source: This study was funded by Astellas Pharma Inc. Medical writing support, conducted in accordance with Good Publication Practice (GPP 2022) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Ann Ferguson, PhD, of Oxford PharmaGenesis Inc., Newtown, PA, USA, and funded by Astellas Pharma Inc. Clinical trial information: NCT03504397 . [Table: see text]

Health care resource utilization and costs among individuals with vs without Huntington disease in a US population.

BACKGROUND: Quantifying the extent of health care resource utilization (HCRU) and costs associated with Huntington disease (HD) is vital for providers, decisionmakers, and payers to understand unmet treatment needs and to ensure limited resources can be used to benefit the maximum number of people with HD. OBJECTIVE: To quantify HCRU and costs for people with HD, overall and by disease stage, and compare these with non-HD controls. METHODS: This was a retrospective cohort study using administrative claims data from the IBM MarketScan Commercial, Multi-State Medicaid, and Medicare Supplemental Databases from January 1, 2009, to December 31, 2018. People with an HD claim between January 1, 2010, and December 31, 2017, were selected for this analysis and matched with non-HD controls for comparison. The HD cohort and the non-HD controls were exact matched on their follow-up duration and propensity score matched 1:4 to create the final analytical cohort. Index date was the first HD diagnosis for the HD cohort (proxy index date assigned to controls), and all individuals were required to have continuous enrollment for 12 or more months pre-index (baseline) and 3 or more months post-index. Proportions of all-cause HCRU (ie, outpatient visits, inpatient visits, emergency department visits, pharmacy fills, radiology visits, and physical/occupational therapy visits) in the 6-months post-index and HCRU counts and costs per patient per month (PPPM) over the entire follow-up were calculated for each cohort. RESULTS: A total of 2,473 individuals with HD and 9,522 matched non-HD controls were identified. HCRU in 6 months post-index was significantly greater in people with HD compared with non-HD controls for all health care service categories; P < 0.0001. The mean number of HCRU PPPM for all measured healthcare services was significantly higher in people with HD compared with non-HD controls (P < 0.001). Mean total costs (2018 USD PPPM) for the HD cohort ($2,260 [SD = $4,682]) were twice the total costs in the non-HD cohort ($1,056 [SD = $3,078]) (P < 0.0001) and were highest across all disease stages. CONCLUSIONS: This study provides current comprehensive HCRU and cost estimates in individuals with HD relative to those without the disease, thus demonstrating the high economic burden imposed by HD. DISCLOSURES: Dr Ta: Employment with Genentech (at time of study) and stock options with Roche; Dr To: Employment and stock options/dividends with Genentech; Dr Patel: Employment and stock options with Roche/Genentech; Dr Fuller: Employment with CHDI Management/CHDI Foundation; Mr Surinach: Employment with Genesis Research (which receives consulting fees from Genentech/Roche); Dr Abbass: Employment and stock options with Genentech; Dr Exuzides: Employment and stock options with Roche/Genentech; and Ms Luo: Employment with CHDI Management/CHDI Foundation. This study was funded by Genentech Inc. The authors thank Greg Rowe of Chrysalis Medical Communications for providing medical writing support, which was funded by F. Hoffmann-La Roche Ltd, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Publication integrity viewed from different perspectives

Publication and communication of research findings are important for the development of science, since future scientific work relies and builds on previous findings. However, this is not possible if researchers cannot trust the published work or if the principles of research integrity are not implemented in all phases of the research process, including the publication of research results (ALLEA 2017, NASEM 2017). This study aimed to explore authorship and publication practices across different disciplinary fields and to identify areas related to the publication of research findings that require improvements. We used a purposive sample strategy to recruit researchers from different disciplinary fields (humanities, social sciences, natural sciences, and medical sciences), different levels of seniority, and geographical locations. We conducted 30 focus groups with 174 researchers and other stakeholders from eight European countries (Belgium, Croatia, Denmark, Germany, Greece, Italy, Spain, and the Netherlands). The data will be analysed using the thematic analysis approach to develop a thematic map with themes and sub-themes. Currently, we are analysing the data using the NVivo software (QSR International). Some of the codes and sub-codes already identified are: 1) authorship distribution (authorship statement/plan; disciplinary field/country specifics and differences regarding authorship distribution/practices, ethical issues in authorship, handling authorship disputes); 2) authorship, publications, and academic career (stakeholders’ evaluation of authorship and publications); 3) research publication and dissemination (examples of good publication practices, examples of issues related to publication process); 4) peer review (good peer review practices, poor peer review practices); and 5) open science (perceptions on open science; open access, open data, open collaboration, and reproducible research).One possible limitation of our study, taking into account that publication practices differ significantly in different settings (countries, fields, etc.), could be that the knowledge obtained could not be generalised and applied globally, since we included participants from European countries alone. However, we believe that by including a large number of participants we managed to map publication practices in the European area and will be able to learn what should be improved and how to foster good publication practices by European researchers.

Promoting the quality and transparency of health research in China

Background and ObjectivesTo review the efforts and progress in promoting quality and transparency of health research in China and to discuss how to improve. MethodsWe focused on three different types of health research: clinical trials, systematic reviews, and clinical practice guidelines, and summarized China's progress from their registration, implementation, and reporting stages. ResultsIn the last 3 decades, China's major works include the following: 1) For registration, the trials and CPGs registries have been set up, and released policies to mandate registration and submission of protocols for trials. 2) For implementation, multiple clinical research and EBM centers have been established. The ResMan platform for data management has been created and required researchers to share results data. 3) For reporting, the Chinese EQUATOR Center has been set up. Translations and extensions of the CONSORT, PRISMA, and RIGHT have been published. 4) For traditional Chinese medicine (TCM), specific guidelines for the registration and reporting of TCM research have been developed. ConclusionChina has made progress in promoting research quality and transparency, especially in research registration and reporting. Nevertheless, more can be done in data management and sharing for research implementation, and good publication practices in TCM.

Accidental Flibanserin Ingestion in Children Causing Acute Respiratory and Central Nervous System Depression: What Health Care Professionals Need to Know.

Department of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine, Charlottesville, Virginia Department of Psychiatry, University of California, San Diego School of Medicine, San Diego, the Department of Psychiatry and Neuroscience, University of California, Riverside, Riverside, and the Neuroscience Education Institute, San Diego, California Guidelines for Letters. Letters posing a question or challenge to an article appearing in Obstetrics & Gynecology should be submitted within 8 weeks of the article’s publication online. Letters received after 8 weeks will rarely be considered. Letters should not exceed 350 words, including signatures and 5 references. Letters will be published at the discretion of the Editor. The Editor may send the letter to the authors of the original paper so their comments may be published simultaneously. The Editor reserves the right to edit and shorten letters. Letters should be submitted using the Obstetrics & Gynecology online submission and review system, Editorial Manager (http://ong.edmgr.com). Financial Disclosure Dr. Clayton has served as a consultant to AbbVie Inc., Brii Biosciences, Fabre-Kramer, Field Trip Health, Janssen Research & Development, LLC, Mind Cure Health, Ovoca Bio PLC, Praxis Precision Medicines, PureTech Health, S1 Biopharma, Sage Therapeutics, Takeda/Lundbeck, Vella Bioscience, Inc., and WCG MedAvante-ProPhase. She has received grants from Daré Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Inc., and Sage Therapeutics. She holds royalties/copyrights with Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire, and Guilford Publications. She holds shares/restricted stock units with Euthymics, Mediflix LLC, and S1 Biopharma. Dr. Stahl has served as a consultant to Acadia, Alkermes, Allergan, AbbVie, Axsome, Clearview, Eisai Pharmaceuticals, Gedeon Richter, Intra-Cellular Therapies, Karuna, Levo Therapeutics, Lundbeck, Merck, Neurocrine, Otsuka, Relmada, Sage Therapeutics, Sunovion, Supernus, Taliaz, Teva, Tris Pharma, and VistaGen. He holds options in Genomind, Lipidio, and Delix. He has served on speakers bureaus for Acadia, Lundbeck, Otsuka, Perrigo, Servier, Sunovion, and Teva, and he has received research and/or grant support from Acadia, Allergan/AbbVie, Avanir, Braeburn Pharmaceuticals, Eisai, Eli Lilly, Harmony Biosciences, Indivior, Intra-Cellular Therapies, Ironshore, Neurocrine, Otsuka, Pear Therapeutics, Sage, Shire, Sunovion, Supernus, and Torrent. Editorial support for this Letter to the Editor was performed by Kayt Scott, PhD, Sarah A. Laredo, PhD, and Lauren Hummel, BA, each of Arbor Scientia, supported by Sprout Pharmaceuticals, Inc., according to Good Publication Practices (GPP3). All opinions, conclusions, and data interpretation lie with the authors. The authors have served in the past as consultants to Sprout but received no payment for writing this letter. Support for logistics was provided by Sprout to the agency Arbor Scientia.

Patient perspectives on diagnosis and management of hidradenitis suppurativa: A web-based survey

Patient perspectives on diagnosis and management of hidradenitis suppurativa: A web-based survey

Annals for Educators - September 2022

Annals for Educators - September 2022

1779TiP Phase II clinical study evaluating the efficacy and safety of disitamab vedotin in patients (pts) with HER2-expressing urothelial carcinoma (RC48G001)

More than 212,000 deaths annually are related to bladder cancer worldwide (Sung 2021), with 5-year survival rates of <5% in metastatic urothelial carcinoma (UC) (Witjes 2021). Nearly half of all pts cannot tolerate standard cisplatin-based first line (1L) chemotherapy and opportunity still exists to improve outcomes in both 1L and later lines of therapy. Human epidermal growth factor receptor 2 (HER2) is overexpressed in multiple malignant tumors and overexpression of HER2 may be associated with poor outcomes in UC (Zhao 2015). No HER2-directed therapies are currently approved for locally advanced unresectable or metastatic UC (LA/mUC). Disitamab vedotin (DV; RC48-ADC) is an investigational antibody–drug conjugate (ADC) comprised of a HER2-directed monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a protease-cleavable linker. DV elicits antitumor activity through MMAE-directed cytotoxicity and bystander effect (Li 2020). DV is conditionally approved in LA/mUC and gastric cancer in China and was granted Breakthrough Therapy designation by the FDA for second-line treatment of HER2-expressing LA/mUC after platinum-containing chemotherapy. RC48G001 (NCT04879329) is a phase 2, multicohort, open-label, multicenter trial to evaluate DV in pts with HER2-expressing LA/mUC. Pts are enrolled in 2 cohorts defined by HER2 expression (by immunohistochemistry [IHC]) and gene amplification (by in situ hybridization [ISH]) by central laboratory: Cohort A (IHC 3+, or 2+ and ISH+) and Cohort B (IHC 2+ and ISH-, or IHC 1+). Eligible pts must have measurable disease per RECIST v1.1, ECOG Performance Status of 0 or 1, and must have received 1 or 2 lines of prior systemic therapy, including 1 line of platinum-containing chemotherapy. The primary endpoint is confirmed objective response rate (ORR) assessed by blinded independent central review. Secondary endpoints include ORR assessed by investigator, duration of response, progression-free survival, disease control rate, overall survival, safety, and pharmacokinetic parameters. Enrollment for cohorts A and B is ongoing in North America and EU, and planned in LATAM, APAC, and Israel. NCT04879329. Under guidance of the authors, assistance in medical writing was provided by Hanna Thomsen, PhD, of Seagen Inc. and was funded by Seagen Inc. in accordance with Good Publication Practice (GPP3) guidelines. Seagen Inc.

1261TiP CARMEN-GC01: Phase II, open-label, single-arm study of tusamitamab ravtansine in combination with ramucirumab in pretreated patients with gastric or gastroesophageal junction adenocarcinoma (GA/GEJA)

Tusamitamab ravtansine (tusa; SAR408701), an anti-carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) antibody conjugated to the potent cytotoxic antitubulin DM4, showed promising antitumor activity and was well tolerated in heavily pretreated patients (pts) with advanced non-small cell lung cancer (NSCLC) and high CEACAM5 expression (immunohistochemistry intensity ≥ 2+ in ≥ 50% of tumor cells). High CEACAM5 expression occurs in 30% of pts with gastric cancer (GC). Ramucirumab, an antibody antagonist of vascular endothelial growth factor receptor 2 (VEGFR2), combined with paclitaxel is a standard of care option for second-line (2L) treatment of GA or GEJA. Preclinical studies with tusa and a VEGFR2 antagonist have shown synergistic activity in gastric patient-derived xenografts, supporting clinical investigation of tusa in combination with ramucirumab. This combination may lead to improved 2L outcomes in pts with GC, with a better safety profile compared with that of paclitaxel plus ramucirumab. A phase II study (NCT04394624) of tusa in combination with ramucirumab is also ongoing in pts with NSCLC and high CEACAM5 expression. CARMEN-GC01 (NCT05071053) is a phase II, open-label, single-arm, multicenter, 2 part study to evaluate tusa combined with ramucirumab in pts pretreated for GA/GEJA with high CEACAM5-expressing tumors. Part 1 is a safety run-in, followed by a Part 2 expansion. Inclusion criteria include age ≥ 18, metastatic or locally advanced GA/GEJA, and ≥ 1 measurable lesion. Key exclusion criteria are untreated brain metastases, unresolved previous corneal disorders, concurrent anticancer therapy, and prior CEACAM5-targeted, DM1- or DM4-containing, anti-VEGF/VEGFR, or taxane treatment. The primary objectives are to confirm the recommended tusa loading dose in combination with ramucirumab (Part 1) and to assess the antitumor activity of tusa (Part 2). Secondary objectives include safety, duration of response, progression-free survival, disease control rate, pharmacokinetics, and immunogenicity. As of April 13, 2022, 22 sites in 6 countries are recruiting. EudraCT: 2021-001967-26; NCT05071053. Medical writing support was provided by Zeshan Mahmood, PharmD, and Elizabeth Strickland, PhD, inScience Communications (Philadelphia, PA). This work was performed in accordance with current Good Publication Practices and funded by Sanofi. Sanofi.

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.

P-156 MOUNTAINEER-02: Phase 2/3 study of tucatinib, trastuzumab, ramucirumab, and paclitaxel in previously treated HER2+ gastric or gastroesophageal junction adenocarcinoma: Trial in progress

Tucatinib (TUC), a highly selective HER2-directed tyrosine kinase inhibitor (TKI) approved in multiple regions for HER2+ metastatic breast cancer, is being developed as a novel therapy for patients with GI tumors including gastric or gastroesophageal junction adenocarcinoma (GEC). While trastuzumab (Tras) with chemotherapy is standard in the first-line setting for metastatic HER2+ GEC, no anti-HER2 therapy has demonstrated an OS benefit over chemotherapy as second-line therapy, possibly due to loss of HER2 expression following Tras-based therapy. In GEC xenograft models, dual targeting of HER2 with TUC and Tras showed superior activity to either agent alone. (Kulukian 2020) Interim results from the MOUNTAINEER study have shown promising activity for TUC and Tras for HER2+ mCRC.(Strickler 2019) The MOUNTAINEER-02 study (NCT04499924) is evaluating the efficacy and safety of TUC with Tras, ramucirumab (Ram), and paclitaxel (Pac) in patients with HER2+ GEC in the second-line setting. MOUNTAINEER-02 is a phase 2/3 study evaluating TUC + Tras with Ram and Pac. Eligible patients have locally-advanced unresectable or metastatic HER2+ GEC and have received a HER2-directed antibody and 1 prior line of therapy for advanced disease. Patients are ≥18 years of age; have an ECOG ≤1; and have had no prior exposure to Ram, an anti-HER2 or anti-EGFR TKI, HER2-directed antibody-drug conjugates, or taxanes ≤12 months before enrollment. Patients receive TUC 300 mg or placebo PO BID and Tras or placebo (IV on Days 1 and 15 of each 28-day cycle) in combination with Pac (IV on Days 1, 8, and 15) and Ram (IV on Days 1 and 15). The study includes an initial Pac-dose optimization stage because of the potential impact of TUC on Pac metabolism. The open-label phase 2 part determines the recommended dose of Pac (60 or 80 mg/m2) combined with TUC, Tras, and Ram in 6–18 patients and evaluates safety and activity of the regimen in Cohorts 2A and 2B (30 patients each). The randomized, double-blind, phase 3 part compares the efficacy and safety of TUC and Tras (Arm 3A, ∼235 patients) vs placebo (Arm 3B, ∼235 patients), both in combination with Ram and Pac, and evaluates activity of TUC with Ram and Pac (Arm 3C, ∼30 patients). The coprimary phase 3 endpoints are OS and PFS per investigator, and secondary endpoints include DOR, confirmed ORR, and DCR. Secondary objectives include patient-reported outcomes. HER2 status is determined by blood-based NGS assay or IHC/ISH assay of a tumor tissue sample (IHC3+ or IHC2+/ISH+) at screening. In Cohort 2A and phase 3, patients must be HER2+ by blood-based NGS. In Cohort 2B, patients must be HER2+ by biopsy but HER2 negative by blood-based NGS after progression in first-line or subsequent therapy. Disease assessments per RECIST v1.1 occur q6 weeks for 36 weeks, then q9 weeks. The pharmacokinetics of TUC, Pac, and their metabolites are evaluated in a subset of patients, including a cohort with gastrectomies. Enrollment in phase 2 is ongoing. NCT04499924. The authors thank Joseph Giaconia of MMS Holdings, Michigan, USA for providing medical writing support/editorial support, which was funded by Seagen Inc., Bothell, WA, USA in accordance with Good Publication Practice (GPP3) guidelines. Seagen Inc.

OP0023 A RANDOMIZED, DOUBLE-BLIND TRIAL COMPARING SECUKINUMAB 300 MG AND 150 MG AT WEEK 52 IN PATIENTS WITH ANKYLOSING SPONDYLITIS WHO DID NOT ACHIEVE INACTIVE DISEASE DURING AN INITIAL 16 WEEKS OF OPEN-LABEL TREATMENT WITH SECUKINUMAB 150 MG

OP0023 A RANDOMIZED, DOUBLE-BLIND TRIAL COMPARING SECUKINUMAB 300 MG AND 150 MG AT WEEK 52 IN PATIENTS WITH ANKYLOSING SPONDYLITIS WHO DID NOT ACHIEVE INACTIVE DISEASE DURING AN INITIAL 16 WEEKS OF OPEN-LABEL TREATMENT WITH SECUKINUMAB 150 MG

Development of a decision-support tool to quantify authorship contributions in clinical trial publications

Purpose: This study aimed to develop a decision-support tool to quantitatively determine authorship in clinical trial publications.Methods: The tool was developed in three phases: consolidation of authorship recommendations from the Good Publication Practice (GPP) and International Committee of Medical Journal Editors (ICMJE) guidelines, identifying and scoring attributes using a 5-point Likert scale or a dichotomous scale, and soliciting feedback from editors and researchers.Results: The authorship criteria stipulated by the ICMJE and GPP recommendations were categorized into 2 Modules. Criterion 1 and the related GPP recommendations formed Module 1 (sub-criteria: contribution to design, data generation, and interpretation), while Module 2 was based on criteria 2 to 4 and the related GPP recommendations (sub-criteria: contribution to manuscript preparation and approval). The two modules with relevant sub-criteria were then differentiated into attributes (n = 17 in Module 1, n = 12 in Module 2). An individual contributor can be scored for each sub-criterion by summing the related attribute values; the sum of sub-criteria scores constituted the module score (Module 1 score: 70 [contribution to conception or design of the study, 20; data acquisition, 7; data analysis, 27; interpretation of data, 16]; Module 2 score: 50 [content development, 27; content review, 18; accountability, 5]). The concept was integrated into Microsoft Excel with adequate formulae and macros. A threshold of 50% for each sub-criterion and each module, with an overall score of 65%, is predefined as qualifying for authorship.Conclusion: This authorship decision-support tool would be helpful for clinical trial sponsors to assess and provide authorship to deserving contributors.

Fraud and Deceit in Medical Research

Fraud and Deceit in Medical 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

AMWA, EMWA, and ISMPP Promote Ethical, Professional Medical Writing in JAMA Oncology Letter to the Editor

In March 2021, Del Paggio et al. published an article in JAMA Oncology that included disparaging comments about medical writers. American Medical Writers Association (AMWA) leaders, in partnership with representatives from the European Medical Writers Association (EMWA) and the International Society for Medical Publication Professionals (ISMPP), immediately and swiftly drafted and submitted a letter of response to this article, which was published on August 26, 2021, along with 2 other letters and the authors‘ response to all 3 letters. Del Paggio et al.’s article reported on multiple aspects of randomized clinical trials in oncology, including the use of professional medical writers. Specifically, the authors stated, “There is reason to be concerned that medical writers may unduly influence the interpretation of trials, … as it is unlikely that medical writers have a neutral effect on the clinical trial reporting.” Although we all share an understanding of the value of medical writers, it is imperative that we respond publicly to these attacks to safeguard the reputation of our profession. As highlighted in our letter, the use of our profession’s expertise improves accuracy, timeliness, and adherence to ethical conduct. Evidence from independent research on the benefits of working with medical writers was included in the response. The commitment of medical writers to adhere to Good Publication Practice (GPP3) guidelines and to ethical principles in scientific publishing as well as to the professional codes of conduct of their professional organizations was also identified as a significant benefit of working with professional medical writers.

Effectiveness of Sodium Zirconium Cyclosilicate in Hemodialysis Patients With Severe Hyperkalemia

Effectiveness of Sodium Zirconium Cyclosilicate in Hemodialysis Patients With Severe Hyperkalemia