Institutional Conflicts of Interest: Protecting Human Subjects, Scientific Integrity, and Institutional Accountability

2004 ◽  
Vol 32 (4) ◽  
pp. 613-625 ◽  
Author(s):  
Gordon DuVal
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Biomedical Research ◽  
Conflicts Of Interest ◽  
Human Subjects ◽  
Scientific Integrity ◽  
Clinical Trial Research ◽  
Institutional Accountability ◽  
The Social ◽  
Medical Advances

If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken.BackgroundIn the past two decades, the involvement of non-academic sponsors of biomedical research, particularly clinical trial research, has increased exponentially. The value of such sponsored research is difficult to ascertain. However, it is estimated that, between 1980 and 2003, overall research and development expenditures by US pharmaceutical companies increased from $2 billion to $33 billion and that, in 2001, clinical trial research expenditures in Canada totaled $800 million to $1 billion.The source of funding for biomedical research has shifted significantly from predominantly government and private foundations to industry. By 2002,70% of funding for clinical trials came from industry. These factors have affected the conduct of research, particularly clinical trial research, in a variety of ways.

The Use of Digital Clinical Trial Methods in the Evaluation of Digital Therapeutics: A Scoping Review (Preprint)

2019 ◽  
Author(s):  
Allison Hirsch ◽  
Mahip Grewal ◽  
Anthony James Martorell ◽  
Brian Michael Iacoviello
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Scoping Review ◽  
Digital Technologies ◽  
Good Clinical Practice ◽  
The United States ◽  
Clinical Trial Research ◽  
Digital Methods ◽  
Clinical Trial Methods

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

scholarly journals Clinical trial research on COVID-19 in Germany – a systematic analysis

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 913
Author(s):  
Julian Hirt ◽  
Abeelan Rasadurai ◽  
Matthias Briel ◽  
Pascal Düblin ◽  
Perrine Janiaud ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Agenda ◽  
Randomized Clinical Trials ◽  
Median Number ◽  
First Year ◽  
Industry Funding ◽  
Systematic Analysis ◽  
Clinical Trial Research ◽  
German Contribution

Background: In 2020, the COVID-19 pandemic led to an unprecedented volume of almost 3,000 clinical trials registered worldwide. We aimed to describe the COVID-19 clinical trial research agenda in Germany during the first year of the pandemic. Methods: We identified randomized clinical trials assessing interventions to treat or prevent COVID-19 that were registered in 2020 and recruited or planned to recruit participants in Germany. We requested recruitment information from trial investigators as of April 2021. Results: In 2020, 65 trials were completely (n=27) or partially (n=38) conducted in Germany. Most trials investigated interventions to treat COVID-19 (86.2%; 56/65), in hospitalized patients (67.7%; 44/65), with industry funding (53.8%; 35/65). Few trials were completed (21.5%; 14/65). Overall, 187,179 participants were planned to be recruited (20,696 in Germany), with a median number of 106 German participants per trial (IQR 40 to 345).  From the planned German participants, 13.4%  were recruited (median 15 per trial (IQR 0 to 44). Conclusions: The overall German contribution to the worldwide COVID-19 clinical trial research agenda was modest. Few trials delivered urgently needed evidence. Most trials did not meet recruitment goals. Evaluation and international comparison of the challenges for conducting clinical trials in Germany is needed.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

Increasing the Participation of Women and Minority Populations in Clinical Trials

2016 ◽  
Vol 8 (2) ◽  
pp. 16-25
Author(s):  
Michelle Lee D'Abundo ◽  
Saliha Akhtar ◽  
Cynthia Israel
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Online Advertising ◽  
Research Process ◽  
Minority Populations ◽  
Future Trends ◽  
Clinical Trial Research ◽  
Use Of Technology ◽  
Participation Of Women ◽  
Healthcare Interventions

Increasing the participation of women and minorities in clinical trials is a challenge for the healthcare industry. The lack of diversity in clinical trials prevents the tailoring of healthcare interventions specifically for women and minorities. The purpose of this paper is to explore how technology-oriented strategies can be applied in the clinical trial research process to increase the recruitment of women and minorities in clinical trials. An overview of clinical trials, the stakeholders, and current issues in diversifying recruitment are provided. In order to recruit diverse participant populations, the use of online advertising, social media, e-newsletters, tablets, smartphones, and apps are detailed. Lessons from previous use of technology in recruitment are outlined as well as future trends. With the support of clinical trial stakeholders, the current technology-oriented strategies available seem promising as methods for increasing the participation of women and minorities in clinical trials.

scholarly journals Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data

2018 ◽  
Vol 4 ◽  
pp. 205520761877767 ◽  
Author(s):  
Archana Tapuria ◽  
Philipp Bruland ◽  
Brendan Delaney ◽  
Dipak Kalra ◽  
Vasa Curcin
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Sample ◽  
Clinical Information ◽  
Research Database ◽  
Data Interoperability ◽  
Clinical Trial Research ◽  
Electronic Data Capture System ◽  
Data Elements ◽  
Cdisc Odm

Objectives Integrating Electronic Health Record (EHR) systems into the field of clinical trials still contains several challenges and obstacles. Heterogeneous standards and specifications are used to represent healthcare and clinical trial information. Therefore, this work investigates the mapping and data interoperability between healthcare and research standards: EN13606 used for the EHRs and the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used for clinical research. Methods Based on the specifications of CDISC ODM 1.3.2 and EN13606, a mapping between the structure and components of both standards has been performed. Archetype Definition Language (ADL) forms built with the EN13606 editor were transformed to ODM XML and reviewed. As a proof of concept, clinical sample data has been transformed into ODM and imported into an electronic data capture system. Reverse transformation from ODM to ADL has also been performed and finally reviewed concerning map-ability. Results The mapping between EN13606 and CDISC ODM shows the similarities and differences between the components and overall record structure of the two standards. An EN13606 archetype corresponds with a group of items within CDISC ODM. Transformations of element names, descriptions, different languages, datatypes, cardinality, optionality, units, value range and terminology codes are possible from EN13606 to CDISC ODM and vice versa. Conclusion It is feasible to map data elements between EN13606 and CDISC ODM and transformation of forms between ADL and ODM XML format is possible with only minor limitations. EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies. It is feasible to transform EHR data in the EN13606 form to ODM to transfer it into research database. The attempt to use EN13606 to build a study protocol (that was already built with CDISC ODM) also suggests the possibility of using EN13606 standard in place of CDISC ODM if needed to avoid transformations.

scholarly journals Lessons Learned in Clinical Trial Communication During an Ebola Outbreak: The Implementation of STRIVE

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S40-S47 ◽  
Author(s):  
Amy Callis ◽  
Victoria M Carter ◽  
Aparna Ramakrishnan ◽  
Alison P Albert ◽  
Lansana Conteh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Community Engagement ◽  
Information Needs ◽  
Human Subjects ◽  
Lessons Learned ◽  
Accurate Information ◽  
Community Acceptance ◽  
Institutional Review ◽  
The Impact

Abstract Communication contributed to 4 important aspects of the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE): recruiting participants, supporting Human Subjects Protection, building trust in the community to support the trial, and mitigating the impact of rumors and misinformation. Communication was particularly important because STRIVE was Sierra Leone’s first vaccine clinical trial and was implemented during a public health emergency. Communication efforts began months prior to trial launch, building awareness and support through sensitization sessions with stakeholders and community leaders. Community engagement activities continued throughout the trial to maintain relationships with leaders and stakeholders and disseminate accurate information, fostering trust in the trial. The communication team led recruitment with hundreds of information sessions for potential participants, facilitating the informed consent process. Communication efforts continued post-enrollment, supporting ongoing voluntary participation in the trial. Informal formative activities during the trial yielded insights on participants’ perceptions and information needs. While Centers for Disease Control and Prevention Institutional Review Board–approved activities and materials did not change, this flexible strategy allowed for responsive interactions with participants. The trial success and its community acceptance illustrated STRIVE’s successful communications efforts, owing in large part to this flexibility and commitment to community engagement. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Monitoring Twitter Conversations for Targeted Recruitment in Cancer Trials in LA County: Protocol for a Mixed-Methods Pilot Study (Preprint)

2018 ◽  
Author(s):  
Katja Reuter ◽  
Praveen Angyan ◽  
NamQuyen Le ◽  
Alicia MacLennan ◽  
Sarah Cole ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Social Media ◽  
Clinical Trials ◽  
Pilot Study ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Translational Science ◽  
The Social ◽  
Media Intervention ◽  
Twitter Users

BACKGROUND Insufficient recruitment of participants remains a critical roadblock to successful clinical research, in particular clinical trials. Social media (SM) provides new ways for connecting potential participants with research opportunities. Researchers suggested that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. OBJECTIVE The objective of this pilot study is to examine the feasibility and impact of using Twitter monitoring data (i.e., user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in LA County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. METHODS We will conduct a mixed-methods interrupted time series study design with a before and after SM recruitment intervention. Based on a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across six disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the USC Norris Comprehensive Cancer Center (USC Norris). We will monitor messages about the six cancer conditions posted by Twitter users in LA County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes include, first, feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials, which will be assessed using qualitative interviews and 4-point Likert scale, and calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of people who enrolled in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. RESULTS This study has been funded by the National Center for Advancing Translational Science (NCATS) through a Clinical and Translational Science Award (CTSA) award. Study approval was obtained from the Clinical Investigations Committee (CIC) at USC Norris and the Institutional Review Board (IRB) at USC. Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. CONCLUSIONS This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants center across six cancer disease types. We will shed light on the acceptance of the SM intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite, randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations.

scholarly journals Epidemiology of Adults AML in Nord-Pas De Calais and Picardy

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2281-2281
Author(s):  
Christophe Roumier ◽  
Céline Rodriguez ◽  
Cécile Frimat ◽  
Céline Berthon ◽  
Carole Delattre ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Molecular Biology ◽  
Median Survival ◽  
Conflicts Of Interest ◽  
Real Life ◽  
Npm1 Mutation ◽  
Demethylating Agent ◽  
Molecular Abnormalities

Abstract Introduction AML is a heterogeneous group of neoplasm according to leukemogenic mechanisms and has variable response to treatment. In addition to age and WBC count at diagnosis, cytogenetic and molecular abnormalities are key factors to assess prognosis. In this work, we evaluated the number of adult AML cases diagnosed between 2009 and 2012 in the French Nord Pas de Calais and Picardie regions (North of France). The aim of the study was the collection of epidemiology data, treatments proposed and their results in real life. Matérials and Methods The Nord Pas de Calais and Picardie observatory contains data of all adult patients (>18 years) with AML (>20% marrow blasts) diagnosed in the oncology and/or hematology departments of the following participating Hospitals: Amiens (A), Arras (Ar), Boulogne (B), Dunkerque (D), Lens (L), Lille (CHRU et CH St Vincent (Vi)), Roubaix (R) et Valenciennes (V), whose overall catchment population is close to 6 million inhabitants , allowing a population based registry. A disadvantage of registry data is that investigators cannot control data collection and quality. In our observatory, data were obtained from the declaration of all the participants centralized with a web access reporting data base. The declaration of patients in the database was made both by clinicians, cytogeneticists and molecular biologists. The following data were entered:, disease course, WBC counts, bone marrow blast %, cytogenetics, immunophenotype, molecular biology, treatment received, outcome. To optimize data quality, each kind of data was entered respectively by clinicians, cytogeneticists and molecular biologists. Data were cross validated and the follow up data were updated every years during follow-up of the patients. Data was collected as of October 2013 Results Between January 2009 and December 2012, 899 patients were enrolled in the observatory, respectively 185 (A), 33 (Ar), 43 (B), 66 (D), 85 (L), 197 (CHRU), 57 (Vi), 98 (R) and 135 (V). Median age was 67 years (range 17 to 97), 54% of patients were older than 65 years, M/F was 1.12 (425 female (47%) et 474 male (53%)). Cytogenetic studies were performed in 87% of the patients, immunophenotype in 57%, molecular biology screening for FLT3 and NPM1 mutation in 61%. Intent of treatment was conventional chemotherapy (CTi) 50%, demethylating agent (DMT) 18% and best supportive care (BSC) 32% + Low dose cytarabine (LDAC). The overall median survival was 269 days (624d < 65 y and 115d for > 65 y) (fig1). 15% of the patients (132pts) were included in a clinical trial (90 % <65 y and 10% >65 y). Median overall survival of the patients included in a clinical trial and aged <65y was 1121d vs 563d for patients not included in a clinical trial and aged <65y (p:ns). Of the 482 patients aged >65 y, MRC cytogenetic classification was unfavourable (139 pts; 29%), intermediate (209 pts; 43%), favourable (18 pts; 4%) and not done 116 pts (24%). Overall, in pts aged > 65, treatment was CTI 93 pts (19%), DMT 130 pts (27%), BSC 210 pts (44%), LDAC) 38 pts (8%), others 11 pts (2%). Among pts with unfavourable karyotype treatment was: Cti (14%), DMT (45%), LDAC (2%), BSC (38%) and others (1%). overall median survival in this unfavourable group was 222d with DMT vs 104d with LDAC vs 227d with CTI. In intermediate cytogenetics cases, treatment was Cti (24%), DMT (19%), LDAC (14%), BSC (42%) and other (1%), and median OS was 270d with DMT vs 189d with ARAC-LD vs 378d with Cti. Demethylating agent treatment results were different between MRC groups. In the intermediate MRC group of pts >65y, OS was better with CTI vs DMT (p:0.03), whereas in the unfavorable pts group aged >65y/o, DMT treatment seemed to be as effective than Cti (fig 2 and 3). Conclusion This registry study gives a real life idea of the therapeutic intent in AML patients, stressing in particular the small proportion of patients who can be included in clinical trials due to comorbidity and also the small number of available clinical trials in elderly patients, due to the current lack of promising drug apart from IC (among pts>65y/o only 13 pts have been included). Our observatory shows that in pts >65 y/o the intent of treatment should take account MRC classification, CTI being more effective that DMT or LDAC only in intermediate cases. Disclosures No relevant conflicts of interest to declare.

scholarly journals Recommendations for Supporting Prospective Study Registration in the Basic Experimental Studies in Humans And Alternative Procedures for Results Dissemination

2021 ◽  
Author(s):  
David Thomas Mellor ◽  
Nicole Pfeiffer
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Research Study ◽  
Human Subjects ◽  
Behavioral Outcomes ◽  
Experimental Studies ◽  
Basic Research ◽  
Health Related ◽  
Alternative Procedures ◽  
Definition Of

Recently, the NIH has modified the definition of clinical trial so that it applies to a much broader range of studies that previously were classified as clinical research but not specifically as trials. This definition, below, specifically includes research where behavioral outcomes are a focus of the study: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”With the addition of behavioral outcomes, many studies that previously would not have been “clinical trials” are now so classified. Research studies that meet both criteria for “clinical trial” and “basic research” are now referred to as basic experimental studies in humans (BESH). The purpose of this whitepaper is to analyze and investigate ways that existing infrastructure could be improved to support these new requirements in ways that benefit all stakeholders.

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