Table 2.

Recommendations to develop sustainable locally led trial capacity in LMICs

Goal	Logic for change	Strategy	Implementation plan	Mechanism of change	Agent of change	Contextual relevance
Foster proresearch cultures	Encourages top-level investment and prioritisation of trials Encourages institutional staff and decision makers to support not hinder trials Increases pool of researchers willing and confident enough to conduct trials and reduces brain-drain	Explain trial and research methods and potential benefits for patients, institutions and individuals	Research and trial exposure in education and workplaces Engage and inspire through mentorship Access to training and knowledge resources Organise seminars and workshops	Increases awareness and desire to conduct trials and top-level buy-in and support for trials	Institutional level Research leaders International actors	Where negative research cultures or lack of interest in trials impedes operations and prevents investment Where skilled or junior staff show little inclination towards trial undertaking Where brain-drain problematic
		Provide opportunities for institutional staff to see trials conducted and practically get involved	Conduct trials in institutions and involve local staff Allow wider participation through exchange placements Seeing successful locally led trials most encouraging	Increases awareness and desire to conduct trials. Increases motivation and self-efficacy by reducing perception that trials are difficult	Research leaders
		Provide intrinsic and extrinsic incentives for employees to conduct or get involved in trials	Financial rewards and salaried time for research Research linked to career progression leading to better working conditions Provide rewards, appreciation and applauding research	Increases motivation to conduct trials	Macro and institutional level Research leaders
		Provide facilitative operational environment for trials	See section below	Increases motivation and self-efficacy to conduct trials by making trials more achievable	See section below
Develop trial leaders and staff	Human resources for research are essential for increasing trial conduct, either locally or foreign led Resolving key skills gaps is needed for researchers to gain funding and conduct trials Research leaders needed to conduct trials, foster proresearch cultures, provide training and mentorship, develop new research leaders and advocate for greater investment	Provide basic and advanced skills training. Focus on clinical trials and key skills gaps. Ensure regularity and sustainability. Best if locally applicable.	Increase research components in educational curricula Provide continuing education in workplaces Skills courses and workshops e-Learning and distance learning Fellowships and advanced degrees Use train-the-trainer models Use more applied teaching techniques	Improves knowledge, develops technical skills, reinforces motivation and increase self-efficacy	Macro and institutional level Research leaders International actors	Where extant expertise is insufficient to meet demand Where staff have key skills gaps that prevent or impede trials Where there are insufficient research leaders Where research leaders lack leadership capabilities
		Provide practical research experiences on trials. Locally-led trials and long-term foreign partnerships usually best.	Provide facilitative environment to encourage complete conduct of trials in institutions (see section below) Offer full involvement, responsibility and challenging work to local staff Provide mentorship and comprehensive training	Most effective technique for mastering technical skills and developing leadership capabilities. Increases motivation.	Research leaders Foreign collaborators
		Provide knowledge sharing and mentorship opportunities	Organise seminars and workshops Encourage teamwork and on-the-job knowledge sharing by developing leadership capabilities Coordinate mentoring relationships Use international networks if unavailable locally	Shares knowledge and provides support that increases knowledge, technical skills, motivation and self-efficacy	Institutional level Research leaders Colleagues International actors
		Provide open, easy access to knowledge resources	Provide libraries, computers and reliable internet Ensure access to HINARI and open-access journals Supply e-learning and offline research guidance	Supports independent learning that increases knowledge and motivation	Macro and institutional level International actors
Provide facilitative operational environment	Reduces barriers to trial conduct that increases self-efficacy and motivation to undertake trials Makes collaboration more attractive Encourages local and foreign-led research to be conducted through local institutions Facilitates trials of greater scope and quality and increases capacity development benefits that supports advocacy for greater investments	Provide funding for clinical trials that is sufficient to allow research of useful scope	Offer international grants exclusively for LMIC researchers National pilot grants for early researchers to gain experience and build portfolios so they can compete for international funding	Even modest grants can enable simple but important locally led trials. Improves chances of gaining more competitive funding.	Macro level International actors	Where trials are prevented due to operational barriers or material resource constraints Where operational barriers or material resources reduce the quality and scope of trials Where operational barriers or material resources prevent beneficial collaborations or capacity development
		Improve research governance and administration procedures and increase capacity to support research	Promote decision makers based on research experience Streamline procedures, update regulations and introduce greater accountability Early engagement between administrators and researchers Budget research services into grants	Speeds up trial operations and frees investigator’s time	Institutional level Research leaders
		Strengthen regulatory and ethical review capacity and procedures	Provide funding and training for review boards Ethics training for investigators Build monitoring capacity, develop legal framework and government backing for regulatory bodies	Ensures trials are safe and ethical, allows more ethically complex trials, speeds up trial operations	Macro and institutional level Research leaders
		Develop material resources and infrastructure	Provide sufficient building space with reliable services Provide advanced and basic laboratory equipment and supplies/maintenance Provide sufficient ICT access with reliable internet	Facilitates operations and enables trials with greater scope and quality	Macro and institutional level
		Support local collaborations among research producers and stakeholders, and encourage team working	Develop networking platforms to identify and bring together all local stakeholders Develop and use research leader skills to improve communication and team working	Leverages resources to reach a critical mass capable of self-sufficiently undertaking trials. Improves trial operations.	Macro and institutional Research leaders
		Encourage valuable foreign partnerships. Long-term partnerships most useful	Provide international networking platforms Ensure foreign collaborations have sufficient capacity to work within local institutions, without major investment Negotiate partnerships that have strong local leadership, are dedicated to capacity development and ideally conduct trials in local institutions	Enables more resource-intensive research and helps develop local capacities	Macro level Research leaders International actors Foreign collaborators
Ensure research is useful and has an impact	Trials must influence policy and have an impact on health outcomes for them to be considered valuable Useful and impactful trials develop and reinforce proresearch attitudes by showing benefits and returns on investments Increases credibility of locally led trials, which is needed for research leaders to advocate for further investment	Develop and implement clear research strategy to focus investments around research priorities	Develop and disseminate clear research strategy Focus local grant funding on key areas and make grants demand led Focus institutional investments on local departments and resources required to meet research goals	Ensures most efficient use of resources and builds an evidence base capable of informing policy changes	Macro level	Where trial evidence has limited use for policy or is not effectively disseminated Where research users lack capacity to translate research and implement policies Where poor communication and engagement impedes translation of evidence into policy
		Develop policy makers’ interest and capacity to demand and use research and implement policies	Foster proresearch cultures and attitudes (see section above) Provide training for policy makers to demand and use research Ensure resources available for policy implementation	Ensures research has an impact and improves patient care	Macro level
		Develop research producers interest and capacity to respond to research strategy, produce useful outputs and disseminate findings effectively	Provide a facilitative operational environment conducive to useful research (see section above) Develop research leaders who can effectively interact with these bodies (see section above) Provide training on research dissemination for publication and policy Ensure time and resources available for disseminating findings	Ensures research findings will be useful for policy and are effectively disseminated to influence policy	Macro and institutional level Research leaders
		Increase engagement between strategists, producers and users of research	Develop networking platforms to facilitate interaction between these stakeholders Engage early and regularly Dedicated liaisons may be helpful	Builds communication and trust between knowledge cycle actors that facilitate translation of research	Macro level Research leaders

LMICs, low-income and middle-income countries. ICT, Information Communication Technology.