Industry Sponsorship Research Articles

Clinical evaluation of marketed and non-marketed orthodontic products: are researchers now ahead of the times? A meta-epidemiological study

BackgroundThe advertisement and adoption of untested orthodontic products is common. This study aimed to provide an update regarding the prevalence of clinical trials in orthodontics evaluating commercially marketed products. Associations between marketed/non-marketed products and study characteristics such as direction of effect, declaration of conflict of interest and industry sponsorship were evaluated. In addition, within the marketed products associations between direction of effect and study characteristics were explored.Material and methodsElectronic searching of a single database (Medline via PubMed) was undertaken to identify Randomized controlled trials (RCTs) published over a 5-year period (1st January 2017 to 31st December 2021). Descriptive statistics and associations between trial characteristics were explored.Results196 RCTs were analysed. RCTs were frequently published in Angle Orthodontist (18.4%), American Journal of Orthodontics and Dentofacial Orthopedics (14.8%) and European Journal of Orthodontics (13.3%). 65.3% (128/196) of trials assessed marketed products after their introduction. The majority of trials assessed interventions to improve treatment efficiency (33.7%). Growth modification appliances were typically analysed in non-marketed compared to marketed products. An association between the type of product (marketed vs non-marketed) and both the declaration of conflict of interest and industry sponsorship was detected. For individual RCTs assessing marketed products either a positive effect (45.3%) or equivalence between interventions or between intervention and untreated control (47.7%) was evident. In 27% of these trials either no conflict of interest or industry funding was not clearly declared. Within the marketed products, no association between the direction of the effect and conflict of interest or funding was detected.ConclusionsThe analysis of marketed orthodontic products after their introduction is still common practice. To reduce research waste, collaboration prior to the licensing and marketing of orthodontic products between researchers, industry and manufacturers is recommended.

GRADE Notes 3: two approaches to assess industry sponsorship bias used by two Dutch guidelines organizations

ObjectiveOur objective is to develop a step-by-step approach for our institutes to evaluate the influence of the funding body 1. on risk of bias of an individual study and 2. on publication bias in reviews and meta-analyses for guidelines. Study Design and SettingMethodologists from guideline organizations in the Netherlands discussed the influence of the funding body in clinical trials researching interventions. Results were discussed in our organizations and presented at the Dutch GRADE Network. ResultsTwo step-by-step approaches were developed to guide methodologists from our institutes in assessing the influence of the funding body 1. on risk of bias of an individual study and 2. on publication bias in reviews and meta-analyses for guidelines. For risk of bias, the involvement of the funding body in the study is checked as well as the direction of the effect. For publication bias, the exploration by the authors is evaluated, and any difference between industry-funded and non-funded studies in effect is checked. Guiding questions were proposed. ConclusionThe step-by-step approaches make the evaluation of the influence of the funding body more objective and transparent in our institutes. The developed approaches will also be brought forward to the Grading of Recommendations Assessment, Development and Evaluation working group.

A review of clinical trials registered in India from 2008 to 2022 to describe the first-in-human trials.

This analysis was conducted to review the number, and describe the characteristics of first-in-human (FIH) Phase 1 clinical trials registered in India from 2008 to 2022. The data were extracted from the Clinical Trials Registry - India database for all FIH Phase 1 clinical trials registered between 2008 and 2022. Early-phase trials that were not FIH trials (e.g., pharmacokinetic studies and drug-drug interaction studies) were excluded from the study. A total of 1891 trials were retrieved and 220 were included in the analysis. Most of the investigational products were drugs (55%) followed by vaccines (38.2%). The most common therapeutic class of drugs was cancer chemotherapy (19.8%), followed by antimicrobial chemotherapy and endocrinology (18.2% each). The most common vaccine was the influenza vaccine (21.4%), followed by the measles-mumps-rubella vaccine (15.5%). The pharmaceutical industry was the predominant sponsor for most (91%) of the Phase 1 trials. Of the top five sites where most of the Phase 1 trials were conducted, three were private nonacademic centers (cumulatively 31%) and two were tertiary care medical colleges (cumulatively 9%). Phase 1 clinical trials seem to be conducted in India predominantly with industry sponsorship. There is a need to have an alternate ecosystem to take forward molecules that do not receive adequate attention from the industry and molecules that are of national health priority other than areas such as chemotherapy, antimicrobials, and endocrinology. The Indian Council of Medical Research is setting up Phase 1 clinical trial capacity for molecules that predominantly may arise from nonindustry channels.

Challenges in the Evaluation of Emerging Highly Specialised Technologies: Is There a Role for Living HTA?

There is currently deep uncertainty about the clinical benefits and cost effectiveness of highly specialised technologies (HSTs), like gene and cell therapies. These treatments are novel, typically have high upfront costs, the patient populations are small and heterogenous, there is minimal information on their long-term safety and effectiveness, and data are limited and often of poor quality. With the increasing number of these technologies and their high cost burden on governments and health care providers, policy makers are currently walking a decision tightrope. On the one hand, an unfavourable funding decision could potentially limit patient access to life-saving treatments, while on the other, a favourable decision could result in unsustainable budget impacts and perhaps poorer patient health outcomes. Health technology assessment (HTA) is meant to determine the value of a health technology in order to promote an equitable, efficient, and high-quality health system. However, standard HTA processes have failed to mitigate the deep uncertainties associated with these technologies. In this paper, we propose a Living HTA framework to address these challenges. This framework includes a one-off process for making explicit the societal values associated with HSTs. These would inform the decision-making approach, data collection and the development of disease-specific reference models to be used by industry sponsors as the basis for their submissions for public funding. Coverage with an evidence development mechanism is also proposed by which data can be collected in real time to update the reference model on a rolling basis, thereby allowing re-assessment of the clinical and cost effectiveness of individual HSTs. The HTA would be 'live' until the results indicate there is sufficient certainty for the funding decision to be confirmed, the price changed or the funding removed.

All that Glitters is Not Gold: Examining Cost Effectiveness Analyses in Radiation Oncology

Cost effectiveness analyses (CEA) provide data for health policy decisions in resource constrained environments. These are important in Radiation Oncology as infrastructure and delivery costs increase and indications expand. The purpose of this study was to systematically review methodologic quality and trends in CEAs involving radiotherapy (RT). A systematic review was performed on cost effectiveness/utility studies involving RT, querying PubMed and Embase from inception to September 2020. Non-English, reviews, abstracts and cost-only studies were excluded. Independent reviewers screened and abstracted study demographics, economic parameters and methodological details. After screening 1652 abstracts, 214 met criteria. The first publication was in 1995, and more than half (n = 113, 53%) were published after 2014. Author institutions were from North America (n = 128, 60%), Europe (n = 49, 23%) and Asia (n = 30, 14%) with most reporting in US$ (n = 143, 67%). A majority utilized a decision model (n = 164, 77%), healthcare payer perspective (n = 171, 80%) and a finite time horizon (n = 108, 50%). Publications spanned 96 unique journals, most commonly International Journal of Radiation and Oncological Biology and Physics (n = 35, 16%). Treatment intent was curative in 171 studies. Disease sites included breast (n = 34, 16%), genitourinary (n = 31, 14%), and gastrointestinal (n = 31, 14%). RT was mostly used as primary treatment (n = 144, 67%), followed by adjuvant (n = 70, 33%) and neoadjuvant (n = 10, 5%). Emerging topics included stereotactic RT (n = 45, 21%), immunotherapy (n = 6, 3%), oligometastasis (n = 4, 2%), and heavy particles (n = 23, 11%). RT was compared to other RT (n = 136, 64%), surgery (n = 43, 20%), drugs (n = 14, 7%) and observation (n = 31, 17%). Incomplete reporting was common. Missing elements included analysis perspective (n = 13, 6%), time horizon (n = 38, 18%), discounting of utilities (n = 71, 33%) or costs (n = 54, 25%), and willingness-to-pay threshold (n = 59, 28%). Furthermore, 27 studies did not perform sensitivity analyses, 36 did not evaluate incremental cost-effectiveness ratio and only 60 explicitly utilized recognized reporting guidelines. Conflict of interest statements were found in 63%, with sponsor statements in 59%; 25% were industry sponsors. Outcome parameters were obtained from primary (author institution/trial data) sources in 33%, including randomized trials (RCTs) (n = 20, 9%), retrospective data (n = 20, 9%) and population data (n = 9, 4%). The remainder utilized secondary sources including RCTs (n = 71, 33%), retrospective data (n = 35, 16%) or meta-analyses (n = 11, 5%). Outcomes included quality adjusted life years (n = 158, 74%), life-years (n = 30, 14%) or toxicity (n = 26,12%). 31% utilized author generated utilities; of literature derived only 49% were matched to disease and clinical context. While CEAs are increasingly common in RT, reporting and methodologic rigor must improve. Greater use of published guidelines will improve data quality for decision makers.

TimesUpPRS: A Social Media Movement for Promoting Diversity, Equity, and Inclusion in Plastic Surgery

Minority representation and promotion in medicine is lacking. Social media can facilitate change by raising awareness of biases, empowering others, and cultivating connections. The TimesUpPRS Instagram account was created in March 2020 to foster diversity, equity, and inclusion (DEI) in plastic surgery by celebrating surgeons of diverse identities and emphasizing the need to create safe, fair, and equitable workplaces. We aim to characterize its content, audience demographics, engagement, and impact. All TimesUpPRS posts published until March 2022 were reviewed for content analysis. Audience demographics were assessed through Instagram Insights. Engagement was assessed through likes, comments, and posts tagging @TimesUpPRS. Three hundred fifty-five posts have been published, with 45.9% original content. These posts discuss representation or treatment of women (39.7%), Black (24.2%), Asian and Pacific Islander (14.4%), LGBTQ+ (12.7%), LatinX (6.5%), people of color overall (4.8%), first generation-low income (1.7%), and Native American (1.1%) individuals. 45.1% aimed to raise social awareness, 19.4% spotlighted plastic surgery figures, 16.3% highlighted research, and 5.6% advertised opportunities for community involvement. The mean (SE) number of hashtags utilized was 10.9 (0.6), with #ilooklikeasurgeon used most. There were 2052 followers, but 10,025 accounts reached. Of reached accounts, 66.8% were women, 71.8% were from the U.S., and 55% were aged 25 to 34. The mean (SE) number of likes and comments per post was 62.2 (3.4) and 2.6 (0.2). 85.0% of comments were supportive. Three hundred sixty-six posts tagged @TimesUpPRS. TimesUpPRS has also garnered industry and private sponsorship, inspired DEI programming, and collaborated with multiple other organizations. In 2 years, TimesUpPRS has generated 350+ posts and reached 10,000+ accounts. Content highlighted figures of diverse identities and cultivated high, positive engagement. Now with 20 content creators, TimesUpPRS will continue increasing content, expanding its audience, and fostering impactful discussion that helps shift the existing culture to one of inclusivity and equity.

Prevalence and implications of significance testing for baseline covariate imbalance in randomised cancer clinical trials: The Table 1 Fallacy

BackgroundThe ‘Table 1 Fallacy’ refers to the unsound use of significance testing for comparing the distributions of baseline variables between randomised groups to draw erroneous conclusions about balance or imbalance. We performed a cross-sectional study of the Table 1 Fallacy in phase III oncology trials. MethodsFrom ClinicalTrials.gov, 1877 randomised trials were screened. Multivariable logistic regressions evaluated predictors of the Table 1 Fallacy. ResultsA total of 765 randomised controlled trials involving 553,405 patients were analysed. The Table 1 Fallacy was observed in 25% of trials (188 of 765), with 3% of comparisons deemed significant (59 of 2353), approximating the typical 5% type I error assertion probability. Application of trial-level multiplicity corrections reduced the rate of significant findings to 0.3% (six of 2345 tests). Factors associated with lower odds of the Table 1 Fallacy included industry sponsorship (adjusted odds ratio [aOR] 0.29, 95% confidence interval [CI] 0.18–0.47; multiplicity-corrected P < 0.0001), larger trial size (≥795 versus <280 patients; aOR 0.32, 95% CI 0.19–0.53; multiplicity-corrected P = 0.0008), and publication in a European versus American journal (aOR 0.06, 95% CI 0.03–0.13; multiplicity-corrected P < 0.0001). ConclusionsThis study highlights the persistence of the Table 1 Fallacy in contemporary oncology randomised controlled trials, with one of every four trials testing for baseline differences after randomisation. Significance testing is a suboptimal method for identifying unsound randomisation procedures and may encourage misleading inferences. Journal-level enforcement is a possible strategy to help mitigate this fallacy.

480 The Quality of Reporting Inflammatory Bowel Disease Randomized Control Trials: A Systematic Review

Abstract Aim Our objective was to perform a systemic evaluation of the risk of bias of randomized control trials’ (RCTs) reports published on IBD. Method We assessed the risk-of-bias using the Cochrane tool, as indicators for poor methodology or subsequently poor reporting. We focused on assessing the risk-of -bias pertaining to appropriate sequence generation, allocation concealment, blinding, incomplete outcome data reporting and other bias. We systematically selected, with dual independent judgements, all studies published on IBD with no time limits and assessed the methodological quality of included studies again using independent dual ratings, with disagreement solved through a third author. Results 563 full texts were included after selection and review. When excluding blinding, 103 papers exhibited low risk of bias in all reporting domains, none of which were publications. RCTs published in journals with higher IF were associated with an overall reduced rate of being at high risks. However, only 6% of full RCT publications in journals with IF greater than 10, published in the past 5 years, were free of bias. The trend over time is towards improved reporting in all areas. Trials published by larger author teams, in full-text form and by industry and public sponsorship were positively correlated with lower risk of bias. Only allocation concealment showed a statistically significant improvement with time (p = 0.037). Conclusions These findings are consistent with those of other specialties in the literature. Whilst this may represent poor reporting instead of poor quality, it leaves readers and future secondary researchers with significant questions regarding such key issues.

Consent document translation expense hinders inclusive clinical trial enrolment.

Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1-3. As these patients often have limited English proficiency4-7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient's primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

Crate consolidation and standardization using lean manufacturing systems

This project was sponsored by a world-class leader in agriculture and construction equipment for nearly 200 years, hereafter referred to as Industrial Sponsor. The Sponsor’s five main brands consist of farm machinery, agriculture equipment, tractors, and various types of construction equipment. The machinery supplied by the Industrial Sponsor varies from tractors, harvesters, seeders, fertilizers, and field cultivators. For this project, a senior design team was assigned to work with the disc harrow product group at the Industrial Sponsor facility. The project scope had 3 problems: a) a large variety of crates which resulted in high pack-out times and material costs, b) an inefficient standard crate packing process due to an unorganized inventory storage area, and c) an incorrect number of parts packed in standard crates relative to the sales order. To address these problems, a variety of data sources, analysis tools, and experimental designs were employed to understand the current state, identify the risks and issues, improve the processes, and develop recommendations. Furthermore, simulations were conducted to determine the increase in efficiency based on the proposed inventory storage area. A reorganization of inventory and the use of the spaghetti diagram improved travel distance efficiency by 88 % for stationary crates and 98 % for moving crates. Yamazumi's analysis showed an improvement of 31 % in efficiency among experienced workers, compared to 0 % for new hires. The future state with a stationary crate showed an increase in efficiency of 76 % due to a significant reduction in walking distance, and the future state with a moving crate showed an increase of 86 %. In order to reduce recurring shipping errors, Kanban cards and poka-yoke systems were recommended. In addition to the variation of crates, the team identified other areas for improvement within the standard crate area, such as safety issues. This was accomplished by conducting a safety risk assessment. Finally, an implementation plan was developed to summarize and explain the process that the Industrial Sponsor would implement to fix existing inefficiencies in its crate packing operations.

ACM Conference on Recommender Systems September 18--22, 2023 at Singapore

ACM Conference on Recommender Systems (RecSys) is the premier international forum for the presentation of new research results, systems and techniques in the broad field of recommender systems. RecSys 2023 will be held in Singapore and will bring together the major international research groups working on recommender systems, along with many of the world's leading companies active in e-commerce and other adjacent domains. It is a SIGCHI-sponsored conference, that will attract also several leading industry sponsors. The proceedings will be published by ACM as part of the ACM Digital Library.

Assessment of Conflicts of Interest in the Transcarotid Artery Revascularization Literature

IntroductionTo systematically review the accuracy of self-reported conflicts of interest (COIs) among transcarotid artery revascularization (TCAR) studies and evaluate factors associated with increased discrepancies. Materials and methodsA literature search identified all TCAR-related studies with at least one American author published between January 2017 and December 2020. Industry payments from Silk Road Medical, Inc. were collected using the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior (24-mo period). Risk factors for COI discrepancy were evaluated at both the study and author level. ResultsA total of 79 studies (472 authors) were identified. Sixty four studies (81%) had at least one author who received payments from Silk Road Medical, Inc. Fifty eight (73%) studies had at least one author who received an undeclared payment. Consulting fees represented the majority of general payment subtype (60%). Authors who accurately disclosed payments received significantly higher median payments compared to authors who did not accurately disclose payments ($37,222 [interquartile range: $28,203-$132,589] versus $1748 [interquartile range $257-$35,041], P < 0.0001). Senior authors were significantly more likely to have a COI discrepancy compared to first authors (P = 0.0219). ConclusionsThe majority of TCAR-related studies did not accurately declare COI. A multivariate analysis demonstrated no effect of sponsorship on study recommendations or impact factor. This study highlights the need for increased efforts in accountability to improve the transparency of industry sponsorship, especially when consulting authors are reporting their results on patient outcomes.

Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials

Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30months after the completion date, the date the final participant was examined, allowing time for publication. Of 108 RCT (n=37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR=0.18, (95% CI 0.05-0.71), P=0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.

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.&#x0D; 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.

Discrepancies in Financial Conflicts of Interest in Robotic Cardiothoracic Surgery Studies

BackgroundIn academic surgery publications, self-reporting of conflicts of interest (COI) has often proved to be inaccurate. Here, we review the accuracy of COI disclosures for studies related to the use of robotic technology in cardiothoracic surgery and evaluate factors associated with increased discrepancies. MethodsA literature search identified robotic surgery–related studies with at least 1 American author published between January 2015 and December 2020 from 3 major American cardiothoracic surgery journals (The Journal of Thoracic and Cardiovascular Surgery, The Annals of Thoracic Surgery, and Annals of Cardiothoracic Surgery). Industry payments from Intuitive Surgical (Intuitive) were collected with use of the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and the year prior (24-month period). ResultsA total of 144 studies (764 authors) were identified. At least 1 author of 112 studies (78%) had received payments from Intuitive. At least 1 author of 98 studies (68%) had received an undeclared payment from Intuitive. Authors who accurately disclosed payments received significantly higher median payments compared with authors who did not ($16,511 [interquartile range, $6389-$159,035] vs $1762 [interquartile range, $338-$7500]; P < .0001). Last authors were significantly more likely to have a COI discrepancy compared with middle and first authors (P = .018; P = .0015). ConclusionsMost studies investigating the use of robotic technology in cardiothoracic surgery did not accurately declare COI with Intuitive. This study highlights the need for improved accuracy of reporting industry sponsorship by publishing authors.

Are enrollment criteria for phase II and III clinical trials in acute myeloid leukemia arbitrarily restrictive?

6525 Background: Ethical clinical research requires fair subject selection and a favorable risk-benefit ratio. Enrollment criteria can unfairly exclude patients if they are not based in safety. There are few data regarding variability within criteria, which can also represent unfair exclusion, or for acute myeloid leukemia (AML). Methods: We assessed enrollment criteria use and variability for frontline phase II and III therapeutic AML trials from 2010-2019 listed on Clinicaltrials.gov. Drug safety profiles were obtained from protocols, publications, and FDA labels. FDA publications guided a standardized abstraction and coding process. Associations between criteria and safety profiles were identified using X2 and t-tests. Regression modeling identified differences in infectious disease (ID) exclusion by sponsor adjusted for trial phase, year, size, and safety profiles. Results: 190 trials were eligible; 159 (84%) were phase II and 32 (17%) phase III. Trials were sponsored by the National Institutes of Health (NIH; 50; 26%), industry (109; 57%), and academic investigators (AI; 108; 57%). Exclusions and variability are shown in the table. ID exclusions were for HIV (96; 51%) and hepatitis B (60; 32%) and C (64; 34%). Older adults were considered as over 60 (42 trials; 39%), 65 (23; 21%), 70 (13; 12%), or 75 years (18; 17%). There was no association between QTc limits and the use of QTc prolonging drugs (criteria presence p=0.2; mean 450 vs 474 ms, p=0.3) or renal function limits and nephrotoxic drugs (presence p=0.2; mean 1.65 vs 1.67 ULN, p=0.8). Hepatitis B and C exclusions were associated with the use of drugs linked to viral reactivation (OR 2.1 [95% CI 1.1,3.9], 2.0 [95% CI 1.1,3.7]). This was not the case for HIV (OR 1.2 [95% CI 0.7,2.2]). Industry sponsorship was independently associated with hepatitis B and C exclusion (OR 3.0 [95% CI 1.2,7.3], 3.3 [95% CI 1.4,4.7]) and AI sponsorship with HIV exclusion (OR 2.5 [95% CI 1.4,5.5]). Conclusions: There is substantial variability in enrollment criteria for AML clinical trials. Many criteria are related to risks, but some exclusions and variability are not clearly based in safety. Avoiding arbitrary exclusions will likely enhance trial representativeness and enrollment rates. [Table: see text]

Repetitive presentations of phase II and III trials involving systemic therapies in gastrointestinal (GI) malignancies at international meetings in the past few years.

e18638 Background: The American Society of Clinical Oncology (ASCO) and the European Society of Medical Oncology (ESMO) annual meetings as well as their GI dedicated meetings (ASCO GI and ESMO GI) have the premise to accept abstracts for oral presentations that have not been previously presented. Methods: We conducted a review of all 220 abstracts involving phase II or III trials of systemic therapies that have been presented orally from June 2019 to January 2023 at ASCO, ASCO GI, ESMO and ESMO GI meetings to evaluate the incidenceof repetitive presentations of the same trial in different meetings as well as their relationship to pharmaceutical industry sponsorship. ANOVA test was used to compare means between different groups and p values of ≤ 0.1 were considered significant. Results: Overall, 20,9% of accepted oral abstracts from phase II or III trials were replicated during the 4-year time frame. Of them, 39% were phase II, 61% phase III, 72% pharma sponsored, 39% included developing countries, and 59% were positive. The association of industry sponsorship and study positivity indicated a variation of up 3,55 appearances (p 0,017) in the number of times this research was orally presented. Conclusions: Our findings suggest that almost 20% of oral abstracts involving systemic therapies in GI cancers are presented more than once at relevant meetings, especially those with positive results and sponsored by pharma. Our study highlights the need for a more effective oral abstract selection system in oncology meetings.

Colorectal Cancer Clinical Trial Summit: Devising solutions and interventions.

e15603 Background: Only 5% of adult cancer patients enroll in cancer clinical trials; however, approximately 70% are willing to participate. The numerous gaps between patient willingness and trial participation rates suggest that enrollment in clinical trials can be challenging. The Colorectal Cancer Alliance Clinical Trial Think Tank Summit brought together multidisciplinary voices to propose solutions and tailor interventions to increase participation in colorectal cancer (CRC) clinical trials and save lives. Methods: An expert advisory committee supported the planning of the Summit by collating existing knowledge and best practices from across the field. The Alliance collected patient perspectives through interviews and aligned around three critical themes for change in CRC clinical trials. The Summit created a forum for thoughtful and strategic discussions with expert speakers and sessions to explore thematic solutions. Results: The advisory committee’s research activities and discussion identified strategic solutions across the following themes: 1. Marketing &amp; Messaging Trust in Clinical Trials; 2. Fostering Readiness for Community-Based Cancer Research, and 3. Clinical Trial Patient Navigation. There was consensus that cancer patients and the public need to be educated on the importance of clinical trial access and dispel myths about clinical trials. Messaging must be culturally competent, creating quality standards for trial awareness and participation for utilization in a marketing campaign.&amp;nbsp; Summit participants discussed barriers to clinical trial enrollment at the institutional, structural, provider, and patient levels. Collaborations with industry sponsors and partnering with community oncology programs are necessary for designing and conducting research serving the understudied and underserved. &amp;nbsp; Participants identified that navigators are crucial for decentralized clinical trials and are a key element for improving clinical trial efficiency and the patient experience. Developing and launching a centralized clinical trial navigator pilot program is necessary to ensure that navigators are knowledgeable about recruiting CRC clinical trials nationally. Conclusions: Clinical trials are essential to advancing new treatments. To extend clinical research into the community, standardized messaging is needed that dispels myths about clinical trials and highlights positive trial outcomes. By improving our overall messaging, collaboration, education, and access to resources, we can accelerate CRC clinical trial participation to improve outcomes and research answers.

Impact of COVID-19 pandemic mitigation strategies on industry and NCI cancer treatment trials.

1565 Background: The onset of the COVID-19 pandemic resulted in major disruptions in enrollment and conduct of cancer clinical trials. In response, regulators allowed modifications to traditional trial processes to enable clinical research and care to continue. The American Society of Clinical Oncology and Friends of Cancer Research established a task force to evaluate how sponsors perceived the impact of these mitigation strategies on data quality and overall trial conduct. Methods: The study used a survey and live interviews of industry and National Cancer Institute (NCI) cooperative group sponsors of cancer treatment trials. Sponsors with trials active in the United States from January 2015-May 2022 were eligible. We assessed perceived impacts of the pandemic on protocol deviations, types of mitigation strategies, trial closures, dropouts, adverse events (AEs), and data integrity. Descriptive statistics were used for survey data summaries. Key findings from semi-structured interviews were described by theme. Results: Of forty-one eligible sponsors, 20 (49%; 15/36 industry and 5/5 cooperative group) completed the survey; eleven (55%; 7/15 industry and 4/5 cooperative group) were interviewed. Sixty percent of sponsors reported large portfolios (&gt;10 trials) of phase II and/or phase III trials. The most widely adopted mitigation strategies were remote distribution of oral anticancer therapies (70%), remote consenting (65%), and remote symptom monitoring for AEs (65%). The proportion of sponsors reporting a “substantial” increase in protocol deviations compared to the pre-pandemic period dropped from 42% in the initial wave (March-April 2020) to 16% thereafter. Sponsors primarily reported “no change” in trial drop-out rates (77%), the number of trials closed due to low accrual (90%), or rates of AEs (81%) at any point during the pandemic. Overall, most (83%) respondents reported the pandemic had “minimal” (14) or “no” impact (1) on data integrity. In interviews, many sponsors reported persistent time delays in data entry related to labor shortages at sites. Conclusions: This study represents the first systematic evaluation of clinical trial sponsors about the impact of the COVID-19 pandemic on the conduct of cancer clinical trials. Remote clinical trial conduct mitigation strategies were broadly adopted. Despite an observed increase in protocol deviations, most sponsors reported the pandemic had minimal or no impact on data integrity. The COVID-19 pandemic impacted how cancer clinical trials were performed and has likely accelerated a trend towards greater flexibility in trial conduct that was already emerging, with potential benefits of reduced burden and improved access for patients and sites . Future work is planned to further quantify the impact of the pandemic and trial mitigation strategies on the quality of trial data both overall and for historically underrepresented patient groups.

Evaluation of drug cost savings related to clinical trials from the perspective of a university hospital

ObjectivesClinical trials are an opportunity for patients to access innovative therapy, but patient inclusion in clinical trials can also result in cost savings for hospitals. Our objective was to evaluate...