Fundamentals Of Clinical Trials Research Articles

Design and Evaluation of a Clinical Investigator Training for Student-lead Prospective Multicentre Clinical Trials: a CHIR-Net SIGMA Research-based Learning Project

Scientific skills are not sufficiently taught during medical training, neither in medical school nor during postgraduate education. This results in a lack of clinician scientists. In order to counter this problem, the surgical study network (CHIR-Net) founded SIGMA (Student-initiated German Medical Audit). This paper describes the development, performance and evaluation of a Clinical Investigator Training (CIT) aiming to qualify students to autonomously conduct clinical trials. Based on the Kern cycle, a curriculum was developed, composed of three parts: online tutorials, a workshop and a follow-up period. The educational objectives were defined according to Bloom's taxonomy of knowledge. The learning objectives were based on the requirements of the "Network of Coordinating Centers for Clinical Trials" and the German Medical Association as well as content relevant to clinical studies. A wide range of educational instruments and assessments were used. By including all relevant professional groups involved in clinical trials, an interconnected working environment for students was generated. The increase in knowledge was assessed by a multiple-choice pre/post exam. The satisfaction of participants was analysed by a 5-point Likert scale, on which 5 indicated full approval. The first SIGMA CIT was realised in 2018; the workshop took place in Heidelberg in February. Thirty-two medical students from thirteen different centres participated. On average, 53.8 ± 8.3% of questions were answered correctly in the pre-test, compared with 71.2 ± 7.2% in the post-test (p < 0.0001). The maximal individual improvement was 30%; the lowest difference compared to the pre-test was 5%. Subjective evaluation results were positive with an average result of 4.63 ± 0.34 on a 5-point Likert scale. It is feasible to teach medical students the fundamentals of clinical trials. A compact Clinical Investigator Training using modern principles of teaching is able to prepare students for an autonomous performance of clinical trials.

3080 Ensuring Quality in Investigator-Initiated Clinical Trials through Monitoring Concepts Training

OBJECTIVES/SPECIFIC AIMS: Because clinical trial results are instrumental in the approval of a new drug or changes to the practice of medicine, ensuring the accuracy and validity of collected data is critical in the clinical trial process. This function, routinely carried out by clinical trial monitors in industry-sponsored trials, is often lacking in investigator-initiated trials (IITs) conducted in academia. To address this challenge, we have developed a self-study module that can be used to cross-train academic researchers in essential concepts and practical approaches to monitoring. Furthermore, we are applying a framework drawn from implementation science in the development and launch of this initiative. This framework, as used in other educational programs, is employed here to close the gap between initiative and practice, thereby effectively disseminating this training would improve the quality of clinical trials in academia. METHODS/STUDY POPULATION: This research project applied exploration, installation and implementation stages of the implementation science process by 1) exploring the need for a new initiative, 2) disseminating results, 3) engaging stakeholders, 4) creating standard operating procedures (SOPs) for installation and implementation, 5) studying user satisfaction and effectiveness, 6) addressing feedback and 7) conducting implementation. RESULTS/ANTICIPATED RESULTS: From literature review and internet searches we determined that although numerous GCP training resources exist, most are too broad and lack the practical approaches to meet the complex requirements of monitoring. Moreover, most of the offerings identified are costly or inaccessible. With only about 65% of IITs reported as being monitored (Figures 1 and 2), it appears that there is a clear need for training tools that are easily available to a broader audience. And because monitoring skills are substantially different from those associated with research coordination, it is not surprising that research professionals believed that they would need additional training to become proficient. To address this need, we began developing a monitoring module. We engaged key stakeholders from academia and industry to gain insights into their needs. The results indicated that although our training module was effective, supplementary information on the fundamentals of clinical trials should be included for those new to the field. After incorporating suggested changes and completing the module, we conducted user testing to determine if our module is ready to be broadly disseminated (Figures 3 and 4). Following positive feedback from the group, we are currently in the process of disseminating our module and studying its impact. DISCUSSION/SIGNIFICANCE OF IMPACT: IITs are instrumental in translating academic research into product development. Deficiencies in the quality control of these trials can lead to inadequacies in data accuracy and validity that could lead to significant delays in bringing innovative therapies to patients. Recent NIH policies require data and safety monitoring for all of the trials it supports. The latest addendum to ICH GCP, E6(R2), discusses a need for quality management across the clinical trial lifecycle. As we continue to disseminate and share information during the development of our self-study monitoring module, we are engaging key stakeholders from academia, government, and private institutions to understand and address quality challenges in conducting clinical trials. Finally, this research informs dissemination and implementation research, specifically for creating training for academic research professionals.

Why Study on a MOOC? The Motives of Students and Professionals

&lt;p class="3"&gt;Massive Open Online Courses have emerged as a popular mechanism for independent learners to acquire new knowledge and skills; however, the challenge of learning online without dedicated tutor support requires learners to self-motivate. This study explores the primary motivations reported by participants in two MOOCs: &lt;em&gt;Fundamentals of Clinical Trials &lt;/em&gt;and &lt;em&gt;Introduction to Data Science &lt;/em&gt;(n=970). Each MOOC drew a diverse cohort of participants ranging from professionals working in the field to students preparing to enter it. Across both MOOCs, a similar profile of primary motivations emerged, with respondents identifying the potential benefits to their current role, or future career, alongside more general responses reflecting casual interest in the topic or a simple desire to learn. Professionals were primarily motivated by current needs, describing how the course could fill gaps in their formal knowledge, broaden their skillset to increase their effectiveness at work, or enable them to innovate. Professionals also saw the benefit of MOOC study in preparing them for new roles and career progression. Students, meanwhile, used MOOC study to complement their other learning. It is clear that MOOC study represents a popular mechanism for professionals to address both current and future learning needs.&lt;/p&gt;

How health professionals regulate their learning in massive open online courses

Massive Open Online Courses (MOOCs) are typically designed around a self-guided format that assumes learners can regulate their own learning, rather than relying on tutor guidance. However, MOOCs attract a diverse spectrum of learners, who differ in their ability and motivation to manage their own learning. This study addresses the research question ‘How do professionals self-regulate their learning in a MOOC?’ The study examined the ‘Fundamentals of Clinical Trials’ MOOC offered by edX, and presents narrative descriptions of learning drawn from interviews with 35 course participants. The descriptions provide an insight into the goal-setting, self-efficacy, learning and task strategies, and help-seeking of professionals choosing to study this MOOC. Gaining an insight into how these self-regulatory processes are or are not enacted highlights potential opportunities for pedagogic and technical design of MOOCs.

Supporting professional learning in a massive open online course

&lt;p&gt;Professional learning, combining formal and on the job learning, is important for the development and maintenance of expertise in the modern workplace. To integrate formal and informal learning, professionals have to have good self-regulatory ability. Formal learning opportunities are opening up through massive open online courses (MOOCs), providing free and flexible access to formal education for millions of learners worldwide. MOOCs present a potentially useful mechanism for supporting and enabling professional learning, allowing opportunities to link formal and informal learning. However, there is limited understanding of their effectiveness as professional learning environments. Using self-regulated learning as a theoretical base, this study investigated the learning behaviours of health professionals within Fundamentals of Clinical Trials, a MOOC offered by edX. Thirty-five semi-structured interviews were conducted and analysed to explore how the design of this MOOC supported professional learning to occur. The study highlights a mismatch between learning intentions and learning behaviour of professional learners in this course. While the learners are motivated to participate by specific role challenges, their learning effort is ultimately focused on completing course tasks and assignments. The study found little evidence of professional learners routinely relating the course content to their job role or work tasks, and little impact of the course on practice. This study adds to the overall understanding of learning in MOOCs and provides additional empirical data to a nascent research field. The findings provide an insight into how professional learning could be integrated with formal, online learning. &lt;/p&gt;

Developing a World Class Clinical Trial Site

Developing a World Class Clinical Trial Site: A Step by Step Guide for Developing a Clinical Trial Site by P. K. Julka. 2011 Field Creation of a clinical trial site with a focus on drug development. Format Paperback and Kindle eBook available for purchase online. Audience Inexperienced clinical investigators. Purpose Overview of the clinical trial process from design to publication. Content This book is organized into 26 brief chapters that serve as a broad overview of the development of a clinical trial site. Important trial design and implementation concepts, such as review of ethical requirements, creation of standard operating procedures, composition of the study team, infrastructure requirements, and trial monitoring, are provided in pithy and easy-to-follow text. The flow charts and graphics included throughout the book are clear and mostly helpful, and each chapter concludes with several summary points. The last few chapters include templates for common documents, including clinical study reports and publications. Strengths The book is easy to navigate and covers many major topics of interest to novice clinical investigators. Limitations and Weaknesses Although the short book covers many topics that are useful for trial site initiation, the focus of book’s content is on drug discovery and development, with little guidance on other types of clinical trials. It is also primarily designed for inexperienced investigators and would not serve the needs of those investigators who have previously participated in clinical trials. In addition, subjects such as observational trials, implementation science, and investigator-initiated studies are not covered in this textbook. The book also appears biased toward the development of clinical trial sites in India, which may prove annoying to investigators from other locations. Finally, this edition has content unchanged from the 2009 book but has a new title and publication date. Competing Products • Friedman, Furberg, and DeMets. Fundamentals of Clinical Trials. 2010. • Liu and Davis. A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim. 2010. • Brody. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. 2011. • Meinert C. Clinical Trials: Design, Conduct and Analysis, 2nd ed. 2012. Funding Not reported.

Book Review: Fundamentals of Clinical Trials. 4th ed

Book Review: Fundamentals of Clinical Trials. 4th ed

Methodische Anforderungen an klinische Studien und ihre Interpretation

Clinical trials are performed to answer a large variety of questions. Of special relevance is their use in testing and estimating the benefit of medical interventions. Clinical trials are necessary for drugs, non-drug interventions, prevention and screening as well as diagnostic tests. The fundamentals of clinical trials are very old. Methods have been developed and improved during recent decades. This article describes essentials of modern clinical trial methodology.

The Clinical Development of Percutaneous Heart Valve Technology: A Position Statement of The Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI)

The Clinical Development of Percutaneous Heart Valve Technology: A Position Statement of The Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI)

The classics: a tribute to the fiftieth anniversary of the randomized clinical trial

In 1998 we celebrated the fiftieth anniversary of the first randomized clinical trial (RCT) [ 1 Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. 3 ed. St. Louis: Mosby, 1996. Google Scholar ]. Describing the plan and conduct of a controlled study on the effects of streptomycin in patients with tuberculosis (see below) the authors stated: “determination of whether a patient would be treated by streptomycin and bed rest or by bed rest alone was made by reference to a statistical series based on random sampling numbers drawn up for each sex and each centre by Professor Bradford Hill.” This and other randomized controlled clinical trials, some of them presented in this essay, gave origin to a revolutionary transformation in the standards of medical practice. This essay aims to honor the scientists who pioneered the development of methods for randomized clinical trials and the refinement of their application in practice.

Teaching clinical trials electronically

This article discusses the development, delivery and evaluation of an electronic extramural course, 'Fundamentals of Clinical Trials', a CME course designed to reach physicians and health care researchers without easy access to a local university. Ten week-long modules of instruction were developed.These were based on a graduate course in clinical trials, standard textbook topics and additional course materials specifically developed for the course. Questions and course topics were to be discussed by the students, and each participant was encouraged to present an actual or proposed clinical trial to the virtual class. Communication between students and tutors could be either 'one to one' or through a listserve, i.e. an automated mailing list available to all participants which copied and routed any message instantly to all participants. Ongoing evaluation of the course was accomplished by questions monitoring students' attitudes and needs, and a more extensive on-line questionnaire administered at the end of the course. Ten students from four countries were accepted onto the course. Half of the students contributed regularly and extensively, while the others tended to respond only when addressed directly.The students spent on average approximately 6 hours per week on the course. This differed little from regular classroom courses, but the students appreciated the ability to organize the course around their regular schedules.The students preferred topics that encouraged discussion and differing opinions. From the instructors' viewpoint, considerable time was required for course development and communication.This form of distance continuing medical education was preferred by all the students over regular correspondence courses, as it allowed for more immediacy and interaction.However, the time required for developing and teaching courses over the Internet should not be underestimated.

Fundamentals of Clinical Trials. (2nd ed.).

Fundamentals of Clinical Trials. (2nd ed.).

Book Reviews

Book reviewed in this article:NIH: An Account of Research in Its Laboratories and Clinics. DeWitt Stetten, Jr., and W. T. Carrigan (eds.).Epilepsie‐Bericht ′85. D. Janz, H. Penin, K. F. Scheidemann, and R. Thorbecke (eds.). Rheinland‐Verlag GmbH, Köln, 1985, 112 pages. Price: Gratis (papercover).The Citadel of the Senses and Other Essays. Macdonald Critchley.The Limbic System. Functional Organization and Clinical Disorders. Benjamin K. Doane and Kenneth E. Livingston (eds.).Epilepsy—Prejudice and Fact. Mogens Dam and Lennart Gram.Briefly Noted: GAB A and Mood Disorders. Experimental and Clinical Research. G. Bartholini, K. G. Lloyd, and P. L. Morselli (eds.).Briefly Noted: Positron Emission Tomography and Autoradiography. Principles and Applications for the Brain and Heart. Michael E. Phelps, John C. Mazziotta, and Heinrich R. Schelbert (eds.).Briefly Noted: Fundamentals of Clinical Trials. Second Edition. Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets.Briefly Noted: The Physiology of Excitable Cells. Alan D. Grinnell and William J. Moody, Jr. (eds).Briefly Noted: Sleep and Its Disorders. J. D. Parkes.Briefly Noted: Dynamics of Neurotransmitter Function. Israel Hanin (ed.).Briefly Noted: International Review of Neurobiology. Volume 27. John R. Smythies and Ronald J. Bradley (eds.).Briefly Noted: Benzodiazepine Recognition Site Ligands: Biochemistry and Pharmacology. Advances in Biochemical Psychopharmacology. Volume 38. Giovanni Biggio and E. Costa (eds.).

Fundamentals of Clinical Trials

The randomized clinical trial has become a significant career focus for an eclectic group of professionals, which includes physicians, epidemiologists, statisticians, computer specialists, compliance experts, nurse coordinators, and others. A society for clinical trials has evolved, which now has about 1500 members and publishes a quarterly journal. Courses in clinical trials are widely available, and several books have appeared to summarize the considerable practical experience and burgeoning methodological literature. Friedman and his collaborators brought out one of the first of these in 1981, which they have now updated. It is a well-written little book, which can be read in a day or so but could equally well serve as the basis for a semester course. The basic concepts underlying clinical trials are easily grasped, so most of the subject matter is accessible to the statistically unsophisticated reader. The authors have organized the book around a series of fundamental points, which

Fundamentals of Clinical Trials

Fundamentals of Clinical Trials