Country Attractiveness for Conducting Clinical Trials – A Literature Review

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

BackgroundNovel methods to boost interest in scientific research careers among minority youth are largely unexplored. Social media offers a unique avenue toward influencing teen behavior and attitudes, and can therefore be utilized to stimulate interest in clinical research.ObjectiveThe aim of this study was to engage high-achieving minority youth enrolled in a science pipeline program to develop a targeted social media marketing campaign for boosting interest in clinical research careers among their peers.MethodsStudents enrolled in the Training Early Achievers for Careers in Health program conducted focus groups in their communities to inform themes that best promote clinical research. They then scripted, storyboarded, and filmed a short video to share on social media with a campaign hashtag. Additionally, each student enrolled peers from their social circle to be subjects of the study. Subjects were sent a Career Orientation Survey at baseline to assess preliminary interest in clinical research careers and again after the campaign to assess how they saw the video, their perceptions of the video, and interest in clinical research careers after watching the video. Subjects who did not see the video through the online campaign were invited to watch the video via a link on the postsurvey. Interest change scores were calculated using differences in Likert-scale responses to the question “how interested are you in a career in clinical research?” An ordinal logistic regression model was used to test the association between watching a peer-shared video, perception of entertainment, and interest change score controlling for underrepresented minorities in medicine status (Black, American Indian/Alaska Native, Native Hawaiian, or Pacific Islander), gender, and baseline interest in medical or clinical research careers.ResultsFrom 2014 to 2017, 325 subjects were enrolled as part of 4 distinct campaigns: #WhereScienceMeetsReality, #RedefiningResearch, #DoYourResearch, and #LifeWithoutResearch. Over half (n=180) of the subjects watched the video via the campaign, 227/295 (76.9%) found the video entertaining, and 92/325 (28.3%) demonstrated baseline interest in clinical research. The ordinal logistic regression model showed that subjects who viewed the video from a peer (odds ratio [OR] 1.56, 95% CI 1.00-2.44, P=.05) or found the video entertaining (OR 1.36, 95% CI 1.01-1.82, P=.04) had greater odds of increasing interest in a clinical research career. Subjects with a higher baseline interest in medicine (OR 1.55, 95% CI 1.28-1.87, P<.001) also had greater odds of increasing their interest in clinical research.ConclusionsThe spread of authentic and relevant peer-created messages via social media can increase interest in clinical research careers among diverse teens. Peer-driven social media campaigns should be explored as a way to effectively recruit minority youth into scientific research careers.

From the ASGT president

COVID 19 has brought race disparities to the forefront as part of a national dialogue and upset. Those of us that are people of color or do research in this space are not surprised. The reality is that despite the numerous reports and efforts that have so keenly highlighted race disparities and recommendations to address them, we have yet to truly move the needle to improve the health of black and brown people. Interestingly, COVID 19 has caused a national pivot among funding agencies to add research around COVID-19 to their current funding portfolios as enhancement awards or RFAs specific to the pandemic, quickly emerged requiring a rapid response. The value and need for this pivot given this monumental time in global health history is necessary. Yet to what extent are we thinking carefully and deliberately about the importance of diversity in our clinical research and trials to ensure our findings positively impact the populations who are hardest hit and carry the greatest burden of the disease, namely African Americans and other people of color. This a fundamental question and poses an opportunity for us to do something different than what has been our historical pattern. It is well documented that a lack of diverse participation in clinical research and trials is a national problem, where in most studies disproportionally engage white men and women more than any other race and ethnic group. For example, in a recent publication the authors found that 96% of prostate cancer research study participants are white men, in a disease in which black men have the highest incidence and mortality than any other race and ethnic group. National studies engage thousands of patients in clinical research, trials, registries and biobanks but on average have less than 20% of participants from underrepresented race and ethnic groups. This is a far cry from national representation of race and ethnic groups of color and has clear implications that in essence perpetuates the disparities we seek to reduce or eliminate. Lack of diversity in research participation limits our ability to accelerate research and improve population health more broadly. For example, it limits generalizability of findings from the development of effective therapeutics to dissemination and implementation of evidence-based methods to increase screening, treatment, and quality of care are critical, all critical points care points highlighted by COVID-19. It excludes or limits access to cutting edge and potentially life-saving therapies that may have the potential to ease the burden of disease and death for people of color. Essentially, access to clinical research and trials is a social justice and an equity issue and without deliberate and intentional diversity strategies being initiated as we develop and design studies, we are adding to the ongoing sickness and death or preventable diseases among people who are black and brown, this particularly true in the case of COVID 19, cancer and other chronic diseases. While diversity in clinical trials to improve population health and advance racial equity is critical, COVID 19 has presented added challenges and opportunities to address the lack of diversity in oncology clinical research, trials, and biobanking. The very nature of a pandemic requires rapid response, action with a heightened sense of urgency, and some would argue, fear of the unknown. Add these key factors to the well-known points that influence lack of diversity in clinical trials including race and ethnic minorities not being asked or informed about clinical trials, assumptions made by research teams that suggest implicit biases, lack of an overarching diversity strategy embedded in recruitment strategies, lack of accountability -despite the requirement to complete the minority enrollment table, and a paucity of authentic community and stakeholder partnerships that have the ability to build trust and bolster diversity in clinical research before, during and post the pandemic and across an array of diseases, the outcomes could seem dismal. However, addressing these key elements can yield invaluable outcomes, namely improved health and quality of life, preventing avoidable deaths, and equity. This presentation provides key recommendations to advance equity and move the needle in increasing diversity in oncology clinical research and trials, a national imperative. Citation Format: Nadine J. Barrett. The Compelling Imperative to Diversify Participation in Clinical Trials and Research [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr IA02.

Well-designed and performed pivotal trials are critical in providing the efficacy and safety of a new drug for regulatory approval. The success of clinical drug development relies on the ability of clinical trial leaders to design and conduct international clinical studies. Physicians can do good clinical practice quality trials by following the protocols accurately but may not be able to design a complicated trial or lead an international clinical trial team. Clinical trial leaders are rarely born but have to be trained and learn through clinical research experience. Academic centers and drug industries have identified this need and proactively designed programs to nurture the clinical trial leaders of tomorrow via multidisciplinary programs. Using Taiwan as an example, the government has set up a Center of Excellence for Clinical Trials and Research (CECTR) in four medical centers. These national CECTRs complete a nationwide clinical trial network; strengthen clinical trial and clinical research infrastructure; set up national clinical trial and translational research centers; provide education and training for clinical researchers, doctors, nurses, and pharmacists; and improve quality, capacity, capability, and results of clinical trials. They are among the best in the world. Major pharmaceutical companies sponsored 200 international clinical trials for New Drug Applications in Taiwan in 2007. Our clinical investigators showed their clinical trial leadership by chairing many international clinical trials in Asia and worldwide. A Clinical Trial Academy for the training of clinical research leaders in Asia-Pacific is held regularly at the National CECTR at National Taiwan University Hospital. In collaboration with distinguished speakers from the industry, academia, and the local regulatory agency, promising young physicians from Asia-Pacific are trained in practical small-group workshops. Topics selected included how to perform international investigator meetings, how to write principal investigator (PI)-initiated clinical trial protocols, the concept of new drug development from the perspective of industry, experience in the institutional review board review of investigational new drug protocols, and so on. These investments in human resources have been well reflected in the number of clinical trials performed in Taiwan. Other than Australia, Taiwan has the highest number of PI-initiated clinical trials in Asia. We believe a good clinical research environment can attract young physicians to develop careers in clinical research and become clinical trial leaders of tomorrow.

The Impact of COVID-19 on the State of Clinical and Laboratory Research Globally in Transplantation in May 2020.

A questionnaire survey was conducted to evaluate practical training and improve education on clinical trial and research. This survey was based on the results of questionnaire before and after the practical training undertaken by 240 pharmaceutical students (Kanto region; 1 university, Tokai region; 2 university, Kinki region; 9 university) at Mie University Hospital between 2011 and 2022. In the questionnaire before practical training, lectures in university (n=219, 91%) were the main source of information on clinical trials and research. Fifty-two students (22%) correctly answered the contents of phase 1-4 trials. As an occupation that can perform clinical research coordinator (CRC)'s work, only 7 students (3%) answered that "all medical and non-medical professionals" can perform the CRC's duties. Regarding the understanding of terms related to clinical trials and research, more than 90% of the students understood the meaning of "subjects," "informed consent," and "placebo" even before practical training. Otherwise, even after practical training, students' understanding of "reimbursement," "follow-up period," "audit," or "direct access" was less than 80%. Practical training improved the understanding of terms such as clinical trial (Wilcoxon signed-rank test, p<0.001), clinical research phase 1-4 trials (Wilcoxon signed-rank test, p<0.001), interest in clinical trials and research (McNemar-Bowker test, p<0.001), and understanding of CRC's work (McNemar-Bowker test, p<0.001). We will improve the content of practical training and bequeath the knowledge and importance of drug discovery and development to the next generation.

Ghostwriters, Data Manipulation and Dollar Diplomacy: How Drug Companies Pull the Strings in Clinical Research

<p indent="0mm">A clinical trial is a key step in the process of pharmaceutical research and development (R &amp; D). It is a key indicator of the innovative potential of the pharmaceutical industry. ClinicalTrials.gov shows that the average annual growth rate of the total number of clinical trials globally in the past decade (2012–2021) was 20.7%, mainly distributed in Europe and the United States, and the total number of clinical trials registered in China accounted for 6% of the world. According to the statistics of IQVIA Institute for Human Data Science, the global proportion of early-stage R &amp; D pipelines from China-headquartered companies increased from 1% in 2005 to 12% in 2020, which was still far behind that of European and American companies. Among 871 new active substances approved for marketing globally in the past two decades, 522 were for marketing in China, with the high number driven by regulatory acceleration mechanisms from National Medical Products Administration, such as breakthrough and orphan designations and priority reviews. Considering the gap in clinical research strength between China and developed countries such as Europe and the United States, the clinical trial research capacity and level should be improved to assist China in the R &amp; D of innovative drugs. According to the Registration and Information Disclosure Platform for Drug Clinical Studies and the clinical trial institution filing management information platform in China, in the last five years (2017–2021), the average annual growth rates of the total number of new drug clinical trial registration and clinical trial units in China reached 26.9% and 12.6%, respectively. However, clinical trial resources are mainly concentrated in major institutions, municipalities, or provincial capital cities in the eastern and central regions of China, with distributions becoming increasingly polarised. Under the background of China’s new medical reforms, the strategic direction of national political support is to motivate equitable access to high-quality clinical trial resources and cross-regional collaborative development of medical institutions by means of medical unions, national clinical medical research centres, Chinese national major projects for new drug innovation and so on. In the context of this background, clinical trial research unions (CTRUs) have been built in China. A CTRU is defined as a consortium formed by medical institutions, sponsors and third-party service institutions of various levels and functions, led by a national clinical medical research centre or clinical trial medical institutions undertaking major national science and technology projects or supporting projects of national key R &amp; D plans, radiating and driving the improvement of clinical trial research capacity in multiple regions. CTRUs develop a multi-level clinical research centre system and collaborative network by vertically and horizontally combining multi-level medical institutions, sponsors and third-party service institutions. All participants of CTRUs are crucial. The leading clinical trial research medical institution, as the core, is responsible for establishing institutional system standards in CTRUs, designing and leading high-quality multi-centre clinical trials, central ethics and personality training. The major clinical trial research medical institutions are responsible for implementing high-quality, multi-centre, complex and high-risk clinical trials. The other member institutions are responsible for implementing basic clinical trials. The sponsors, contract research organizations (CROs), site management organizations (SMOs) and other enterprises are responsible for funding, supporting and promoting the construction of a clinical trial centre system and collaborative network. The specific construction contents of CTRUs include building a clinical trial research resource sharing platform, homogenising clinical trial quality management, constructing a rapid clinical trial process platform, diversified multi-level and multi-form talent training, information interconnection, deepening strategic cooperation and designing and leading high-level trials. CTRUs have established the selection criteria and assessment exit mechanism and conducted work performance assessments from the dimensions of organisation and implementation, division of labour and cooperation, the connection of clinical trial resources from top to bottom, efficiency and benefit and sustainable development to ensure their good and sustainable development. Through CTRUs, we can achieve high-quality clinical trial resource sharing, improve the clinical trial research capability of member institutions, cultivate high-level skills, such as principal investigators (PIs), sub-investigators, institutional managers and clinical research coordinators (CRCs), and promote the development of clinical trials, economically and with high-quality. Through the trial operation with one member of CTRUs, it was found that the key points should be strengthened in deepening resource sharing, implementing central ethics review, interconnecting information platforms and leading high-quality clinical trials. The construction of CTRUs is an effective means for China’s clinical trial research to solve the current problems and change from a ‘follow-on pattern’ to leading high-level and high-quality international multi-centre trials. However, the construction of CTRUs is a complex systematic project. In addition to performing an excellent job in the top-level design and overall planning, CTRUs’ specific implementation process and measures need to be continuously explored in the practice process.

Volume 100: clinical investigations: where next?

Conflicts of interest, authorship, and disclosures in industry-related scientific publications: the tort bar and editorial oversight of medical journals.

A version of this paper was first delivered March 15, 2001 at a symposium on legal and ethical issues and conflicts of interest in clinical research at Widener University School of Law. It is intended for lawyers, physicians, clinical scientists, and others interested in human subject research. The article begins by stating broadly that there is a conflict of interest whenever researchers or an institution stand to benefit financially from the enrollment of patients in a clinical trial. The first part of the article offers a brief history of the protections offered to human subjects of research from the 1940s to the present, setting forth the premise that clinical research, although improved, still presents ethical problems and that conflicts of interest play a significant role. The second section looks at the doctor-patient relationship and the notion of informed consent, noting that the consent process for clinical trials is plagued by misconceptions and confusions on the part of patients. Regarding patients' awareness and understanding of conflicts of interest, the article points out that even if a researcher's conflict of interest were disclosed to patient-subjects, which such conflicts generally are not, most patient-subjects would not be able to reasonably assess the impact the conflict might have on subject enrollment or subsequent treatment. The third section focuses on the limitations of Institutional Review Boards, and the limits of institutional policies. The fourth section proposes some first steps to solve the conflict of interest problem, and asserts that until steps are taken to correct the current situation, clinical research will proceed in an ethically problematic atmosphere.

The unprecedented situation we are facing has strongly disrupted the clinical research rules. Nevertheless, for the scientific community, it may represent the opportunity to learn important lessons. The COVID-19 pandemic suggests that it is possible to alleviate redundancy in clinical trials, and while preserving the rigour of a study, can offer a new, less burdened and more inclusive vision of clinical research for the scientific community of tomorrow. This perspective article describes clinicians’ vision of how the pandemic could change the roles of clinical research. Since the beginning of the SARS-COV2 outbreak in Wuhan, more than 24 million people have been infected all around the world and more than 800 000 have died from the disease so far. In this scenario, Europe is facing one of the worst crises that our National Health Systems have ever encountered in the last 50 years. Six months after the first COVID-19 diagnosis, the lockdown is being eased in European countries and our lives are slowly adapting to ‘a new normality’. Providing care to immunocompromised patients with cancer during this pandemic has been extremely challenging and oncologists face many challenges in providing cancer care during the COVID-19 outbreak. Data from China reported that patients with cancer who are infected with COVID-19 are at 3.5 times the risk of requiring mechanical ventilation or intensive care unit (ICU) admission, compared with the general population.1 Additionally, the limitation of resources in outpatient settings, including administrative staff and specialists, has hindered the routine care of patients.2 National and international cancer societies published priority-driven guidelines for the management of oncohaematological patients on therapy during the COVID-19 pandemic and recommended considering treatment delays and modifications on a case-by-case basis, taking into account the characteristics of the patient and the disease.3 In addition to routine patient care, the imperative of …

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Time for D in R&amp;D?