Clinical trial research in focus: why do so many clinical trials fail in IPF?

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.

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

F1000Research ◽

10.12688/f1000research.55541.1 ◽

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.

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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

10.21203/rs.3.rs-84171/v1 ◽

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.

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Increasing the Participation of Women and Minority Populations in Clinical Trials

International Journal of Information Communication Technologies and Human Development ◽

10.4018/ijicthd.2016040102 ◽

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.

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

Digital Health ◽

10.1177/2055207618777676 ◽

2018 ◽

Vol 4 ◽

pp. 205520761877767 ◽

Cited By ~ 3

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.

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Increasing the Participation of Women and Minority Populations in Clinical Trials

Healthcare Ethics and Training ◽

10.4018/978-1-5225-2237-9.ch048 ◽

2017 ◽

pp. 1018-1028

Author(s):

Michelle Lee D'Abundo ◽

Saliha Akhtar ◽

Cynthia Israel

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Online Advertising ◽

Research Process ◽

Healthcare Industry ◽

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.

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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

Cost Effectiveness and Resource Allocation ◽

10.1186/s12962-021-00297-1 ◽

2021 ◽

Vol 19 (1) ◽

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 of increase in volume and proportion was 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. Conclusion The clinical research coordinators’ access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.

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Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

Frontiers in Medicine ◽

10.3389/fmed.2020.598038 ◽

2020 ◽

Vol 7 ◽

Author(s):

Hasan Hashem ◽

Mohammad Abufaraj ◽

Abdelghani Tbakhi ◽

Iyad Sultan

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Research ◽

Ethical Issues ◽

Clinical Trial Design ◽

Cost Effective ◽

Clinical Trial Research ◽

External Monitoring ◽

Treatment And Prevention ◽

Clinical Research Trials

The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.

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

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2004.tb01967.x ◽

2004 ◽

Vol 32 (4) ◽

pp. 613-625 ◽

Cited By ~ 2

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.

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The V-BRCH Project: building clinical trial research capacity for HIV and noncommunicable diseases in Nigeria

Health Research Policy and Systems ◽

10.1186/s12961-020-00656-z ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Muktar H. Aliyu ◽

Mahmoud U. Sani ◽

Donna J. Ingles ◽

Fatimah I. Tsiga-Ahmed ◽

Baba M. Musa ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Clinical Investigation ◽

Evidence Synthesis ◽

Research Capacity ◽

Noncommunicable Diseases ◽

Grant Writing ◽

Double Burden ◽

High Quality Research ◽

Clinical Trial Research

AbstractAntiretroviral therapy has turned HIV into a chronic condition, with morbidity from HIV-associated noncommunicable diseases (NCDs) becoming more common as HIV-infected individuals live longer. In Nigeria, the additional challenge of an under-capacitated health system highlights the need for skilled clinical investigators who can generate evidence to tackle the double burden of HIV and NCDs. The Vanderbilt-Nigeria Building Research Capacity in HIV and Non-communicable Diseases (V-BRCH) programme is a training platform to create a cohort of skilled Nigerian investigators with the capacity to lead independent clinical trial research focused on the intersection of HIV and NCDs. V-BRCH will solidify an atmosphere of continuous mentoring and skills acquisition for physician faculty at the Aminu Kano Teaching Hospital via short- and medium-term learning opportunities, paired mentoring arrangements, and mentored research projects. Trainees will attend an annual faculty enrichment programme in Nashville, in addition to on-site workshops in Nigeria on HIV-associated NCD epidemiology, clinical trials methodology, evidence synthesis, qualitative research methods, stakeholder engagement, knowledge translation, and grant writing. Research-oriented junior faculty will undergo focused training in clinical trials administration and regulatory oversight. Scholars will share best practices through mentoring panels, regular ‘Works in Progress’ meetings, and monthly career development seminars. Competitive seed grants will be provided to mentor–mentee teams to promote targeted in-country pilot studies focused on HIV-associated NCDs. For long-term training, physician scientists will be supported to undergo enhanced Master of Public Health (MPH) training at Bayero University in Nigeria and Master of Science in Clinical Investigation (MSCI) training at Vanderbilt. Short-term regional courses, staff development workshops, and MPH curriculum refinement will help to strengthen institutional capacity in HIV-associated NCD clinical trial research. V-BRCH will create a cohort of skilled Nigerian scientists who will be able to compete for independent funding and design and implement high quality research that will generate evidence to inform policy and practice and lead to improved outcomes for Nigerians impacted by HIV-associated NCDs.

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