Dataset Information

Strategy management in collaborative clinical research partnerships

ABSTRACT:

Purpose

Today's clinical trial partnerships frequently join multi-disciplinary investigators and stakeholders, from different countries and cultures, to conduct research with a broad array of goals. This diversity, while a strength, can also foster divergent views about priorities and what constitutes success, thereby posing challenges for management, operations, and evaluation. As a sponsor and partner in such collaborations, we seek to assist and support their development and implementation of sound research strategies, to optimize their efficiency, sustainability, and public health impact. This report describes our efforts using an adaptation of the well-established Kaplan-Norton strategy management paradigm, in our clinical trials setting. We share findings from our first test of the utility and acceptance of this approach for evaluating and managing research strategies in a collaborative clinical research partnership.

Results

Findings from pilot studies and our first implementation in an ongoing clinical research partnership in Liberia, provide initial support for our hypothesis that an adapted version of the Kaplan-Norton strategy management model can have use in this setting. With leadership from within the partnership, analysis artifacts were gathered, and assessments made using standardized tools. Practical feasibility, resonance of the findings with partners, and convergence with other empirical assessments lend initial support for the view that this approach holds promise for obtaining meaningful, useable results for assessing and improving clinical research management.

Conclusions and Implications

Engaged leadership, thoughtful timing to align with partnership planning cycles, support for the process, and an eye towards the collaboration's long-term goals appear important for developing model understanding and practice. Skepticism about evaluations, and unease at exposing weaknesses, may hinder the effort. Acceptance of findings and associated opportunities for improvement by group leadership, support a growing sense of validity. Next steps aim to test the approach in other partnerships, streamline the methodology for greater ease of use, and seek possible correlations of strategy management assessments with performance evaluation. There is hardly a better example than the COVID-19 pandemic, to spotlight the need for efficient and effective clinical research partnerships to address global health challenges. While heartened by the collaborative spirit driving the effort so far, we cannot let our enthusiasm lull us into thinking that nobility of purpose or an abundance of good will is sufficient. Careful monitoring and adjustment of clinical research strategy in response to changes (e.g., demographics, pathogen evolution, research acceptance, political and cultural environments) are vital to making the needed adjustments that can guide these programs toward successful outcomes. We hope that our work can raise awareness about the importance, relevance, and feasibility of sound strategy management in clinical research partnerships, especially during this time when there is so much at stake.

SUBMITTER: Kagan J

PROVIDER: S-EPMC8543383 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundDespite growing enthusiasm for co-production in healthcare services and research, research on co-production practices is lacking. Multiple frameworks, guidelines and principles are available but little empirical research is conducted on 'how to do' co-production of research to improve healthcare services. This paper brings together insights from UK-based collaborative research partnerships on leading co-production. Its aim is to inform practical guidance for new partnerships planning to facilitate the co-production of applied health research in the future.MethodsUsing an auto-ethnographic approach, experiential evidence was elicited through collective sense making from recorded conversations between the research team and senior leaders of five UK-based collaborative research partnerships. This approach applies a cultural analysis and interpretation of the leaders' behaviours, thoughts and experiences of co-production taking place in 2008-2018 and involving academics, health practitioners, policy makers and representatives of third sector organisations.ResultsThe findings highlight a variety of practices across CLAHRCs, whereby the intersection between the senior leaders' vision and local organisational context in which co-production occurs largely determines the nature of co-production process and outcomes. We identified four tensions in doing co-production: (1) idealistic, tokenistic vs realistic narratives, (2) power differences and (lack of) reciprocity, (3) excluding vs including language and communication, (4) individual motivation vs structural issues.ConclusionsThe tensions were productive in helping collaborative research partnerships to tailor co-production practices to their local needs and opportunities. Resulting variation in co-production practices across partnerships can therefore be seen as highly advantageous creative adaptation, which makes us question the utility of seeking a unified 'gold standard' of co-production. Strategic leadership is an important starting point for finding context-tailored solutions; however, development of more distributed forms of leadership over time is needed to facilitate co-production practices between partners. Facilitating structures for co-production can enable power sharing and boost capacity and capability building, resulting in more inclusive language and communication and, ultimately, more credible practices of co-production in research. We provide recommendations for creating more realistic narratives around co-production and facilitating power sharing between partners.

Project description:Background: There is a strong need to include training of research methods in training programs for physicians. International clinical research training programs (CRTP) that comprehensively introduce the methodology of clinical research and combined with practice should be a priority. However, few studies have reported a multimodal international CRTP that provides clinicians with an introduction to the quantitative and methodological principles of clinical research. Objective: This manuscript is intended to comprehensively describe the development process and the structure of this multimodal training program. Methods: The CRTP was comprised of three distinct, sequential learning components: part 1 - a six-week online eLearning self-study; part 2 - a series of three weekly interactive synchronous webinars conducted between Durham, North Carolina, USA and Beijing, China; and part 3 - a five-day in-person workshop held at Beijing Friendship Hospital, Capital Medical University (BFH-CMU). Self-assessment quiz scores and participation rates were used to evaluate effectiveness of the training program. Participants' demographic characteristics, research experience, satisfaction and feedback on the program were collected using questionnaires. Results: A total of 50 participants joined the CRTP. Forty-four participants (88%) completed the program satisfaction questionnaires. The average quiz score of the six eLearning units varied from 31% to 73%. Among the three components of the program, the online eLearning self-study was felt to be the most challenging. Thirty-nine (89%) of the surveyed respondents were satisfied with all components of the training program. Among the respondents, 43 (98%) felt the training was helpful in preparing them for future clinical research projects and expressed willingness to recommend the program to other colleagues. Conclusions: We established a multimodal international collaborative training program. The program demonstrated acceptable participation rates and high satisfaction among Chinese clinicians. It provides a model that may be used by others developing similar international clinical research training programs for physicians.

Project description:Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research.A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al.The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research.Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research.