Curriculum Development of Human Clinical Trials for the Next Generation of PhD Students and Early Career Researchers in the Medical, Science, Pharmacy and Health Professions

Clinical trials are the way to market for all treatments. The clinical trials arena has changed over years, and patient safety has undoubtedly improved. But the environment in which trialists operate is highly regulated. This makes it daunting for PhD students and early career researchers and these enthusiastic future leaders may not be able to bring us the best therapies without adequate training. This is in line with the NIHR recommendations: 1.Increase flexibility and availability of clinical trials training, 2.Increase dissemination of opportunities for clinical trials training, 3.Explore linking trials training into the broader research pathway, 4.Consider key skills for different stages of clinical trials training, 5.Consider how research training awards can best prepare trainees for a career as a trials leader when developing recommendations into concrete proposals. The previous CONSCIOUS project enabled the undergraduates to develop knowledge of clinical trials. We then wished to deepen the understanding, address the above training needs, and provide participants with the skills to lead own trial. Our aim was to design a web-based, inclusive, and accessible curriculum for investigators of the future.

The purpose was to create a curriculum that would train the clinical trialists of the future and provide them with the skills to design, conduct, and manage clinical trials and report their findings to the highest standard. The curriculum, with worldwide access, was planned to meet the needs of our target groups - PhD students and early career researchers in the medical, science, pharmacy, and health professions. Objectives: 1.To design a clinical trial curriculum to provide target groups with the skills to design, conduct, and report on clinical trials in their disciplines 2.To provide transferable interdisciplinary training to target groups, focusing on leadership, scientific publishing, and teaching so they have the tools to become clinical trial leaders in their respective fields 3.To disseminate the finished curriculum widely and make this training available to as many people as possible worldwide 4.To standardize the clinical trials curriculum in Europe, to raise awareness of and disseminate the best practices in the field of clinical trials education 5.To reinforce the existing cooperation in clinical trials education in Europe by continuing and further strengthening the collaboration with ECRIN partners

The project had four main elements: designing and developing the training materials, conducting the pilot teaching, developing the training platform, and the project management. The aim of the project was to design a curriculum for the clinical trialists of the future, a curriculum enabling them to gain, develop, and train knowledge and skills on the conduct of clinical trials, including transferable interdisciplinary skills, like leadership, scientific publishing, and teaching. The curriculum was planned to be designed and finally was designed in chapters of study materials. Each chapter was planned and finally was prepared in two phases – the proposal of the content and main goals (the first phase; outlines) and the comprehensive content (the second phase; chapters). The consortium partners and the collaborating stakeholders reviewed all materials several times as planned in the proposal. The final versions of the materials were then published on the training platform and on the websites. The training platform as a place where to put together all the project materials and preserve the interactivity of the resources and tools (e.g., videos, hyperlinks to scientific articles, case reports, real-world problems, communication tools like discussion boards, and evaluation tools like quizzes) was another planned and finished activity in the CONSCIOUS II project. The training platform mediates self-learning remotely assisted by the project partners. The training platform is freely available here: https://consciousii.novaims.unl.pt/login/index.php. Besides the training platform, the training materials in the non-interactive, printable version (text content but still with pictures, schemas, infographics) are available on the project websites. Despite non-interactive and „old-school“, this format is still useful source of training and for some users even preferable. The printable versions of the training materials represent unplanned, extra results, but we consider them important for the broader distribution of the CONSCIOUS II project. On the websites, the training materials are organized into Modules; each module contains not only the training materials and the outlines but also the teaser video – a short interview introducing the author and the Module content, thus contributes to the participant's better understanding of who prepared the material, on the basis of what experience and with what aim. The teaser videos are another initially unplanned but finalized activity. Another activity included in the project was the pilot teaching/pilot course. This course was planned and finally conducted as „live, synchronous, online“ collaborative international online learning. The audience was planned to be, and finally was, PhD students and early career researchers in medicine, science, pharmacy, and other health-professionals fields. The number of participants strongly exceeded our expectations, but after some technical adjustments, we were able to open the course to anybody interested. We also found teachers among the participants who could see how to use the training materials in practice, blend the classroom, and conduct this kind of international online training. Each lesson of the pilot course was recorded as planned and the recording, placed on the training platform, can serve as complementary study material or as a teacher’s guide. Due to the success of the online pilot course, we decided to open another one run of the course, this time face-to-face in Brno in September 2024. This course represented an unplanned extra activity in the project. The project was led by Masaryk University. This leading organization established the Project Management Body responsible for the general management and direction of the CONSCIOUS II project (meetings typically conducted during the Transnational Project Meetings); the Steering Committee, which was responsible for solving issues inside the consortium (meetings scheduled as needed) and an Advisory Board which helped the produce quality results, direct the project to other opportunities, suggest reasonable dissemination pathways, and foster sustainability (meetings scheduled as needed). The leading organization also distributed the project results and related tasks among the partners (as planned, each project result had a responsible project partner), set and regularly updated the project working plan, and checked the timeliness, quality of the deliverables. The issues inside the consortium were successfully solved and finally did not negatively affect any of the project results. Regarding the content, attention was generally paid to the uniformity of the outputs (e.g., graphics, content, interconnection, elements included) and collaboration among partners. All the Transnational Project Meetings and Multiplier events were conducted (despite some time adjustments being necessary compared to the initial plan). The number of local and international participants at the Multiplier events met and exceeded the initial expectations. A special attention was paid to the dissemination and promotion of the CONSCIOUS II project and its results. As planned, the project websites and profiles on Facebook and LinkedIn were created and updated. Due to the wide dissemination of the pilot course and the number of people interested in participating in the pilot course, we obtained an extensive mailing list, which was used for the broad distribution of the newsletters twice a year. The project aims and later results were presented at a number of national and international conferences and meetings, in scientific journals, and disseminated to higher education institutions, other education institutions, pharmacological societies, governmental organizations, and via partner’s and ECRIN networks. Several informal agreements were reached regarding future collaboration and the use of the project materials. Masaryk University established a subject for PhD students based on the materials of this CONSCIOUS II project and prepares a micro-credential course for people outside of the university.

The project results were finished as initially planned: 1. PR1 - A freely available 9 lesson clinical trial curriculum (Life-cycle of the trial curriculum) for PhD students and early career researchers in medicine, science, pharmacy and health professions. Both deliverables of PR1 – D1.1 chapter outlines (9 outlines) and D1.2 training materials (9 chapters) is completed (repeatedly internally discussed, reviewed externally by ECRIN), uploaded to the training platform (PR4), used in the pilot course (PR3), revised, harmonized and interconnected with other chapters. Extra results in PR1 (originally not planned): each lesson is accompanied by a teaser video (to help to promote the materials), each lesson is available in the printable pdf format (some students prefer this “old school” format and we met their requirements). All chapters are formatted using the template to have the same visual design. One more chapter on Drug repurposing was prepared based on the ECRIN’s suggestion. Average extent: 27 pages (the “core content” is now accompanied by “additional content” in yellow boxes, and “exercises” in blue boxes). Average time requirements for core content: 1,3 hours. Average time requirements for additional content: 1 hour. Average time requirements for exercises: 1 hour. 2. PR2 – A freely available 3 lesson curriculum focused on Transferable interdisciplinary training, to provide skills to each participant to lead a clinical trial and lead a team in their respective disciplines. Both deliverables of PR2 – D2.1 chapter outlines (3 outlines) and D2.2 training materials (3 chapters) is completed (repeatedly internally discussed, reviewed by the ECRIN), uploaded to the training platform (PR4), used in the pilot course (PR3), revised, harmonized and interconnected with other chapters. The same extra results as in PR1 (teaser, pdf version) were prepared. Average extent: 28 pages. Average time requirements for core content: 3,3 hours. Average time requirements for additional content: 1,5 hour. Average time requirements for exercises: 0,5 hour. 3. PR3 - Pilot teaching - short summaries (D3.1) of all lessons were first completed (both pdf printable version and “clickable” version to support both electronic and paper dissemination strategies). The pilot course (D3.2) was conducted from January, 16 to April 2, 2024, all lessons were recorded, the video-recordings (D3.3) are available on the training platform (PR4). Extra result: Promotion material – leaflet. An introductory session was organized on January 9, 2024 to explain the concept of the pilot course (flipped classroom, individual preparation for the lesson, active approach to problem and case solving), to introduce the trainers, the participants to get familiar with the platform, materials, using Zoom (software used for these meetings). A certificate for the participants was designed and the conditions for releasing it were set. A 2-day face-to-face course was organized in September 2024 with more than 20 international participants as another run of the pilot course. 4. PR4 - A training platform was designed to have all materials in one place and in the interactive format and enable self-study or blended classroom format. The platform was designed based on the partners’ teaching experience, internally discussed, and reviewed before all materials were uploaded, harmonised in terms of design and debugged. (http://consciousii.novaims.unl.pt/login/index.php) All the developed materials are very flexible, easily accessible, easy to use, enable self-study, contain many references and interactive elements, support communication among participants. The materials were implemented into the existing curricula and several informal agreements on the repeated and future use of the materials were achieved across Europe. Thus, the CONSCIOUS II project contributed significantly to filling in the gaps in training identified by NIHR, and to standardizing the clinical trials curriculum in Europe. The CONSCIOUS II results were widely disseminated across Europe at various conferences and meetings. Moreover, the Multiplier events, pilot course and face-to-face courses enabled meeting and networking of the target population. It is probably too soon to see an increased number of investigator-initiated clinical trials. But we are sure that the training of the investigators of the future and their study teams and providing them with the tools on how to design, plan, conduct, manage, evaluate, and publish the results of their own research will help to produce a number of quality clinical trials