Types Of Funds Research Articles

A review of the potential use of melatonin in cancer treatment: Data analysis from Clinicaltrials.gov.

Melatonin's antioxidative and immune effects suggest potential in cancer therapy. This review assesses related clinical trials on ClinicalTrials.gov. All ClinicalTrials.gov trials registered up to January 17, 2024 were examined, focusing on trials that involved use of melatonin in cancer treatment. A 46 trials were summarized by their study status, study phase, study type, funder type and study results in the use of melatonin in cancer treatment. The examination of the research data revealed a collective count of 46 clinical trials enlisted on ClinicalTrials.gov, all focus around the utilization of melatonin in cancer treatment. Among these, 24 trials had reached completion, constituting 91.3% of the entire trials, while 5 trials were presently in the recruitment phase, making up 10.8% of the total. None of these trials had received approval for marketing yet. The majority focus of the analysis encompassed interventional studies, around 42 trials and representing 91.3% of the overall trials, thereby incorporating most enrolled patients. In contrast, observational studies are a smaller fraction, comprising 4 trials (8.6% of the total), with a correspondingly lower number of involved patients. Regarding funding sources, most registered studies secured funding from diverse entities such as individuals, universities, and organizations, constituting 95.6% of all trials. In comparison, a minority of studies received funding from the National Institutes of Health, comprising 5 trials and accounting for 10.8% of the total trials. The analysis of 46 clinical trials on melatonin's use in cancer treatment reveals a significant importance on interventional studies. Overall, these findings contribute to the evolving understanding of melatonin's role in cancer treatment.

The complexity of funding rare disease research: an IRDiRC assessment of the landscape

The complexity of the funding landscape for rare diseases (RD) research is due to many factors. Each type of funder has strategic goals guiding its investments. The International Rare Diseases Research Consortium (IRDiRC) convened RD experts to explore contributing factors and investment principles in RD funding. This report includes the Task Force’s findings. Similar to IRDiRC’s previous work on motivating factors for company investments in RD research, the current Task Force found that return on investment (ROI) was a guiding principle. However, within the broader RD funding landscape, the definition of ROI varied between types of funders. While they shared funding requirements (e.g., scientific quality, health economics), funders employed both major investment and venture-type instruments, demonstrating the ongoing need for flexibility in supporting RD funding. These observations warrant further analysis of the interactions and partnerships among all actors of RD research and the sustainability of RD research funding.

Who funds zombie firms: Banks or non-banks?

Analyses of zombie firms have emphasized the role of bank financing as the reason for zombie survival. This conclusion was made despite no comparative analysis of the sources of external finance for zombie firms. This paper provides the first analysis of that sort using Finnish data. Banks are not found to fund zombie firms by more than other types of funders when shares of the credit market are taken into account. Among different types of funding sources, only the relationship between equity funding and zombie status is found to be statistically significant. While bank funding is found to be associated with a longer zombie lifetime, equity funders are found to prolong zombie lifetime by greater extent than other sources. The choice of zombie definition - of which there are many in the literature - is not uncontentious and plays a role in determining the economic significance of coefficient estimates.

Comparing the Clinical Trial Characteristics of Industry-Funded Trials and Non Industry-Funded Trials.

We compared study characteristics of randomized controlled trials funded by industry (N=697) to those not funded by industry (N=835). RCTs published in high-impact journals are more likely to be blinded, more likely to include a placebo, and more likely to post trial results on ClinicalTrials.gov. Our findings emphasize the importance of evaluating the quality of an RCT based on its methodological rigor, not its funder type.

Posting of clinical trial results and other critical information from completed medicines trials on ClinicalTrials.gov.

Clinical trials transparency requires trial registration and the posting of results on a public register. US regulations also require the posting of protocols and statistical analysis plans (SAPs). For US Federal agency funded trials to be started on or after 21January2019, informed consent forms (ICFs) must also be posted. Posting these documents is not mandatory in other countries. We aimed to assess compliance with US regulations of trials conducted in the US or in other countries with respect to ICFs, protocols, SAPs, and results. This cross-sectional analysis (27April2023) comprised completed medicines trials to be started on or after 21January2019 registered on ClinicalTrials.gov. Trial data were registered by funder type (i.e., 'US federal agencies', industry, and 'all others') and development phase. Of 5,584 trials, 40% were conducted solely in the US. 47% and 12% of US and non-US trials had posted results. Some 40% of US trials had posted protocols and SAPs as did 9% of trials conducted in other countries. Only 10% (US) and 2% (other countries) of trials had posted ICFs. When the margin of the last 2 and 12 months after primary completion date were considered in the analysis, ICF posting rate did not change, but posting results increased to 64% for US trials. 'US Federal agencies' funded trials were significantly more likely to post ICFs than industry [OR 23.9 (12.5-45.7; <.001)] or 'all others' [OR 3.16 (1.79-5.56; <.001)]. Future interventions should be considered to encourage timely posting of trial results and information.

Unpublished completed obstetric randomized clinical trials registered at ClinicalTrials.gov: how big is this issue?

A portion of obstetrical randomized clinical trials (RCTs) registered at ClinicalTrials.gov are not published in peer-reviewed journals. To compare the characteristics of completed published versus unpublished randomized clinical trials in obstetrics registered on ClinicalTrials.gov, and to identify barriers to publication. This cross-sectional study queried ClinicalTrials.gov for all completed obstetrical randomized clinical trials registered between January 1, 2009, and December 31, 2018. For each completed obstetrical RCT, we abstracted the following registration fields from ClinicalTrials.gov: ClinicalTrials.gov identifier; recruitment status; trial start and completion dates; study results; type of intervention; study phase; enrollment size; funder type; location; and facilities. Calculated variables included time to completion. In May 2021, we used PubMed and Google Scholar to identify the publication status of completed trials, and we compared the characteristics of published vs. unpublished RCTs. The corresponding authors' email addresses for the unpublished studies were collected from ClinicalTrials.gov and departmental websites. Between September 2021- March 2022, authors of these completed but unpublished obstetrical RCTs were contacted and invited to respond to a survey examining perceptions of barriers to publication, responses of which were collected and presented as counts and percentages. Of the 647 obstetrical randomized clinical trials marked as completed on ClinicalTrials.gov, 378 (58%) were published, and 269 (42%) were unpublished. Unpublished trials were more likely to have an enrollment size of <50 participants (14.5% published, 25.3% unpublished; P < 0.001), and less likely to be conducted at multiple sites (25.4% vs. 17.5%; p < 0.02). The main barriers to publication reported in the survey by authors whose trials were not published included: lack of time (30%), change in employment or completion of training (25%), and results that were not of statistical significance (15%). Among the obstetrical randomized clinical trials registered and marked as completed on ClinicalTrials.gov, over 40% were unpublished. Unpublished trials were more likely to be smaller studies, conducted by researchers who reported experiencing a lack of time as the most common barrier to study publication.

Use of gender-neutral language in clinical trial protocols in select cancers.

1574 Background: Around 21% of Generation Z Americans self-identify as lesbian, gay, bisexual, transgender (LGBT), nearly double the proportion of millennials. Despite Affordable Care Act Section 1557 in 2020, transgender individuals continue to have poor access to quality cancer care, including clinical trials. The National Institutes of Health (NIH) recognizes that using gender-neutral language in healthcare is one of many ways to improve sexual and gender minorities (SGM) related health disparities. This study examines use of gender-neutral language in clinical trial protocols in select cancers. Methods: Data was collected from clinicaltrials.gov, a commonly used resource for patients and providers. Phase III clinical trials with all recruitment statuses in the US from 2017 to 2022 were included. Cancer types were limited to those with highest risk of using gender-biased language: breast, ovarian, endometrial, fallopian tube, cervical, prostate, testicular, and penile. For each trial, frequency of use of following terms was recorded by searching under study details section: male, female, she, her, he, his, him, man/men, woman/women, breastfeeding/nursing/lactating/pregnant mother or female or woman. Mean frequency was compared between 2017-19 and 2020-22 using Wilcoxon signed-rank test. Funder type, eligible sex, gender-based eligibility and gender eligibility description were also collected. Data were compared between 2017-19 (pre-1557) and 2020-22 (post-1557) using Fisher exact test. Results: 243 studies were included in the analysis; 130 were pre- and 113 were post-1557. 103/130 (80%) studies between 2017-19 and 78/113 (70%) between 2020-22 included at least one gender-biased term or “male/female” outside of eligible sex description ( p = 0.05), depicting a trend towards improvement; stronger improvement was noted in non-NIH funded studies versus NIH-funded studies. Mean frequency of gender-biased terms was higher in 2017-19 compared to 2020-22 (2.25 vs 1.88, p = 0.02). 27/130 studies (21%) between 2017-19 and 21/113 (19%) of studies between 2020-22 required gender-based eligibility ( p = 0.40). Amongst these, 100% of studies between 2017-19 and 95% of studies between 2020-22 either provided no description or used this clause incorrectly, commenting on sex assigned at birth and not gender identity. This indicates lack of awareness regarding difference between sex assigned at birth and gender identity. While it is evident to investigators during registration on clinicaltrials.gov that eligible sex refers to biological sex, it is not to anyone reviewing the trial for enrollment, resulting in implicit bias. Conclusions: Our study highlights the dire need to address SGM-related health disparities and brings attention towards paucity of gender-neutral language in clinical trial protocols. This step is critical in providing more inclusive care and capturing the rising population of LGBT individuals.

Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type

This study examines the dissemination of trial results by data source (ie, ClinicalTrials.gov and PubMed) and funder type (ie, industry and nonindustry).

Characterization of Informed Consent Forms Posted on ClinicalTrials.gov

This cross-sectional study examines available forms and posting trends of registered trials as well as the frequency of form posting by funder type for trials initiated since the revised Common Rule was implemented.

Use of connected digital products in clinical research following the COVID-19 pandemic: a comprehensive analysis of clinical trials

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late...

Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study

ObjectiveTo characterise and analyse the experiences of trial researchers of if and how conflicts of interest had unduly influenced clinical trials they had worked on, what management strategies they had...

Characteristics of COVID-19 clinical trials registered with ClinicalTrials.gov: cross-sectional analysis

ObjectivesTo characterise current COVID-19-related research activities.DesignCross-sectional analysis.SettingClinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19.Data sourcesClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1...

THE CLINICAL TRIALS LANDSCAPE IN TURKEY: AN EVALUATION OF THE CLINICALTRIALS.GOV DATABASE

Objective: Clinical trials are essential tools for improving scientific knowledge and public health. With this work, it is aimed to evaluate the clinical trials landscape in Turkey. Method: To evaluate the landscape of clinical trials in Turkey, all clinical trials registered on or before the date of 20.06.2019 in the ClinicalTrials.gov database were used. The registered clinical trials were filtered by study type, study phase, funder type, current status of clinical trials, and location. In addition, the number of clinical trials in Turkey was compared with some countries which were selected based on population and number of trials. Results: In Turkey, the total number of registered clinical trials was 3880. The majority of these trials (%79.4) were interventional studies. The majority of phase trials were phase III studies, of which the vast majority were sponsored by industry. The numbers of completed and currently participants recruiting trials were 2245 and 722, respectively. Not only in Turkey, but in all countries, the numbers of clinical trials with unknown status and phase studies without defined phases were higher in trials were not funded by industry. When the numbers of first registered clinical trials were evaluated between the years of 2009 and 2018, a considerable increase was seen. The number of clinical trials in Turkey was 5 or 6 fold less than in developed countries with a comparable population such as Germany, France, and United Kingdom. Conclusion: With this work, it was shown that the number of clinical trials in Turkey is still not as expected. In order to take its rightful place in the world, Turkey should continue to make improvements, use its potential and increase awareness in the field of clinical trials

Accountable and Thus Legitimate? A Comparative Study of Philanthropists

This article takes a comparative qualitative approach to explore the intertwined external accountability and legitimacy attempts of independently wealthy philanthropists. By comparing accountability forums and institutional logics stated by philanthropists, it is investigated to whom they are externally accountable and how they legitimate their controversial funding of public goods. The study compares the external accountability and legitimacy attempts of philanthropists with that of public agencies, corporations, and fundraising-dependent nonprofits. Empirically, this is a cross-sectional study of funders supporting human embryonic stem cell research in either California or Sweden. The study shows that it is through local isomorphism, rather than any specific accountability forum or institutional logic, that philanthropists are accountable and thus legitimate their giving. This is in contrast to other types of funders, which are more similar within each form when comparing accountability forums across societies, and more similar within societies in their usage of institutional logics, with certain patterned statements. In addition, philanthropists in both societies are more detached than any other type of funder as regards both specific patient populations and the general electorate. This finding raises questions on what philanthropists’ private funding for public purposes actually entails.

Trends in Crossover of Patients in Phase III Clinical Trials for Hematologic Malignancies

Background: The incorporation of crossover in randomized controlled trials is accepted as an ethical obligation, especially in cancer clinical trials. The more common type of crossover is unidirectional, which allows patients assigned to the control arm (either placebo or standard of care) to switch to the experimental arm. In contrast, bidirectional crossover includes the switching of patients from the experimental arm to the control arm. Integrating crossover into the initial study design may have advantages in patient recruitment, and incorporating crossover after initial positive results fulfills ethical requirements. However, crossover can also contribute to confounding major endpoints of studies, such as overall survival or the second progression-free survival interval. For this reason, it is important to investigate and identify potential trends of crossover in clinical trials testing novel therapies. The development of new treatments for hematologic malignancies is promising, and as such, makes these trials susceptible to crossover. Trends in crossover of clinical trials for hematologic malignancies have not yet been studied. Methods: Data about cancer clinical trials were extracted from clinicaltrials.gov. The search query was limited to completed phase III studies in adult populations. Location was limited to the United States. No date range or funder type was specified. The following search query was used: recruitment status: "completed;" age: "adult (18-64)," "older adult (65+);" sex: "all;" country: "United States;" study phase: "phase 3." These criteria were then applied in individual searches for clinical trials related each hematologic malignancy. The following terms were used in the "disease" search field: "acute lymphoid leukemia," "acute myeloid leukemia," "multiple myeloma," "lymphoma," "chronic myeloid leukemia," and "chronic lymphocytic leukemia." Repeat clinical trials obtained through separate searches were excluded. Studies were then excluded if they were not randomized controlled trials (RCTs) with the primary purpose of treatment, and if they did not test cancer-related interventions. Results: A total of 184 unique clinical trials were identified, of which 156 were RCTs with the primary purpose of treatment. Only 149 trials tested cancer-related drugs, biologicals, or procedures. Of those, 60 trials contained 2 experimental arms, and 89 trials contained 3 or more experimental arms. 6 of the 60 (10%) 2 arm trials permitted crossover, and 4 of the 89 (4.5%) 3+ arm trials permitted crossover, for a total of 10 trials with crossover. The start dates of these trials ranged from 2000-2012. 3 trials (30%) were bidirectional, and 7 (70%) were unidirectional. The identified clinical trials with crossover belonged to only 3 of the original 6 hematologic malignancies included in the original search query: multiple myeloma, lymphoma, and CML (Table 1). Conclusions: The proportion of identified clinical trials with crossover to those without is extremely small. Crossover in clinical trials studying hematologic malignancies does not appear to be a widespread practice. Multiple myeloma contains the most trials with crossover compared to other hematologic malignancies. Even though statistical approaches to mitigate confounding exist, crossover can still skew accurate reporting of the impact of experimental therapies on overall survival. Examining trends among the trials with crossover will hopefully lead to improved correction methods and better estimates of treatment benefit. Disclosures No relevant conflicts of interest to declare.

1638PD - Changing landscape of clinical cancer trials in Germany

BackgroundThe development of new therapeutic options for cancer patients due to a better understanding of tumor biology has profound effects on the design and conduct of modern clinical cancer research especially with respect to clinical trial design. Until recently, cancer drugs have been investigated in clinical trials for a definitive histological tumor type but this approach is slowly changing and recently drugs have been approved rather histology agnostic based on genomic alterations in various histological tumor types. Here we investigated the changes in the landscape of clinical cancer trials in Germany from 2000-2016. MethodsClinical trials gov database was queried in 2017 for interventional clinical cancer trials running in Germany with study start between 01/01/2000 and 31/12/2016. Data extracted from the database included the conditions, interventions, study phase, Sponsor/Collaborators, funder type, study design, outcome measures and number enrolled. ResultsOverall, 2977 trials matching the criteria were extracted. Number of studies heavily increased within the first decade from 32 studies in 2000 to 214 studies in 2010, remained thereafter relatively stable (with 260 in 2011, 243 in 2012, 236 in 2013, 252 in 2014, 274 in 2015 to 224 in 2016). There was a clear change in the study design over the years towards more trials with a placebo. Furthermore, the number of entities investigated within one clinical trial (from 1 tumor entity, 2-5 tumor entities, 6-10 tumor entities and >10 tumor entities (including clinical trials targeting events from various entities) increased over the years. With respect to sponsorship, there was an increase of industry-alone sponsorship over the years.Table: 1638PDTable: 1638PD2000 - 20042005 - 20092010 - 20142015 - 2016Maskingopen label78%75%73%77%single blind1%3%3%4%double blind12%20%18%12%quadruple1%2%6%6%Missing9%0%0%1%PlaceboPlacebo - no95%82%80%85%Placebo - yes5%18%20%15%Number of entities188%91%89%85%2 - 56%3%4%5%6 - 100%0%0%1%> 106%5%7%10%SponsorshipIndustrie alone43%68%65%64%other57%32%35%36% ConclusionsCancer clinical trials have changed with respect to trial design and sponsorship during the last decade to cope with recent development of new cancer therapeutics. Legal entity responsible for the studyCharité Universitätsmedizin Berlin. FundingHas not received any funding. DisclosureT. Füreder: Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Norvartis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Merck Darmstadt; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Sanofi; Honoraria (self), Honoraria (institution), Research grant / Funding (institution): Accord; Honoraria (institution), Research grant / Funding (institution): Celegene; Honoraria (institution), Research grant / Funding (institution): Ipsen; Honoraria (institution), Research grant / Funding (institution): Astellas; Non-remunerated activity/ies: President elect Austrian Head and Neck cancer society; Full / Part-time employment: Medical University of Vienna; Honoraria (institution): Johnson and Johnson ; Research grant / Funding (institution): Amgen. U. Keilholz: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Advisory / Consultancy: Serono; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD Oncology; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Pfizer; Honoraria (self), Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Speaker Bureau / Expert testimony: Glycotope GmbH. All other authors have declared no conflicts of interest.

Health Research Priority Setting: The Duties of Individual Funders

The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources.

Translating research into action: an international study of the role of research funders

BackgroundIt is widely accepted that research can lead to improved health outcomes. However, translating research into meaningful impacts in peoples’ lives requires actions that stretch well beyond those traditionally associated with knowledge creation. The research reported in this manuscript provides an international review of health research funders’ efforts to encourage this process of research uptake, application and scaling, often referred to as knowledge translation.MethodsWe conducted web-site review, document review and key informant interviews to investigate knowledge translation at 26 research funding agencies. The sample comprises the regions of Australia, Europe and North America, and a diverse range of funder types, including biomedical, clinical, multi-health domain, philanthropic, public and private organisations. The data builds on a 2008 study by the authors with the same international sample, which permitted longitudinal trend analysis.ResultsKnowledge translation is an objective of growing significance for funders across each region studied. However, there is no clear international consensus or standard on how funders might support knowledge translation. We found that approaches and mechanisms vary across region and funder type. Strategically tailored funding opportunities (grants) are the most prevalent modality of support. The most common funder-driven strategy for knowledge translation within these grants is the linking of researchers to research users. Funders could not to provide empirical evidence to support the majority of the knowledge translation activities they encourage or undertake.ConclusionsKnowledge translation at a research funder relies on context. Accordingly, we suggest that the diversity of approaches uncovered in our research is fitting. We argue that evaluation of funding agency efforts to promote and/or support knowledge translation should be prioritised and actioned. It is paradoxical that funders’ efforts to get evidence into practice are not themselves evidence based.

Rationalizing Science: A Comparative Study of Public, Industry, and Nonprofit Research Funders

In the context of more and more project-based research funding, commercialization and economic growth have increasingly become rationalized concepts that are used to demonstrate the centrality of science for societal development and prosperity. Following the world society tradition of organizational institutionalism, this paper probes the potential limits of the spread of such rationalized concepts among different types of research funders. Our comparative approach is particularly designed to study the role and position of nonprofit research funders (NPF), a comparison that is relevant as NPF could potentially be shielded from such rationalized pressures given their lack of profit gaining motives. By making a qualitative interview-based investigation we are able to describe how research funders rationalize their contributions to society at large, as well as their obligations to the researchers they fund. Four types of research funders are compared—independently wealthy philanthropists, fundraising dependent nonprofits, public agencies, and industry. We find that NPF, and especially philanthropists, are the least commercially geared type of funder, but that philanthropists also express least obligations to researchers funded. This is in sharp contrast to public research funders who, even more than industry, employ commercially geared rationalizations. We also find that both public and corporate funders express obligations to the researchers they fund. Our results indicate that there are limits to the spread of commercially tinted rationalizations among NPF, but that this does not necessarily mean an increased sense of obligations to the researchers funded, and by extension to the integrity of scientific pursuit.

Remarkable Funders: How Early-Late Backers and Mentors Affect Reward-Based Crowdfunding Campaigns

In recent years, the growth of the reward-based crowdfunding model has offered new opportunities to meet the funding requirements of start-ups. However, the achievement of the funding target is still a complex goal, given the existence of several information barriers between insiders (project proponents) and outsiders (backers) of a crowdfunding campaign. Within the framework of the information asymmetry and the theory of signals, this study aims to analyse the role of two kinds of previously un-investigated funders in determining the success of crowdfunding campaigns: early-late backers (who are placed at the beginning of the tail of the campaign) and mentors (who are represented by firms acting as more expert backers). The findings indicate that both types of funders are remarkably important for the success of a crowdfunding campaign.