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newsnews24 THE TSWAKA STUDY The Tswaka Stdy A journey into an innovatve public–private–private researc partnersip Saskia JM Osendarp, Dominic Schofeld Global Alliance for Improved Nutrition (GAIN), > This report summarizes the key lessons learned and Geneva, Switzerland discusses what it takes to make such partnerships work. The key lessons appear on pp. 28–29. Maaike J Bruins DSM Nutritional Products, Basel, Switzerland This is a report on the learnings gathered by a unique partner- Leon GJ Frenken ship, consisting of two private-sector partners, one NGO and an Unilever R&D, Vlaardingen, the Netherlands academic partner, established to perform a complex study: the Tswaka Nutrition Intervention study. Jane Badham The study was a community-based randomized controlled JB Consultancy, Johannesburg, South Afica trial carried out in North West province, South Afica, on the efcacy of two small-quantity lipid-based complementary food Klaus Kraemer supplements provided to children aged 6–12 months. The Tswa- Sight and Life Foundation, Basel, Switzerland ka study – which means ‘mixing’ in the local Setswana language, referring to the fact that the supplement should be mixed into Cornelius M Smuts home-cooked food – was completed in 2015, and its results have Centre of Excellence for Nutrition, recently been published.1 North-West University, Potchefstroom, South Afica The journey embarked on in 2010 presented many challeng- es before it was successflly completed following eight years of efort. This report summarizes the key lessons learned and dis- Key messages cusses what it takes to make such partnerships work. We hope that our experiences and insights will be of value to others en- > This is a report on the learnings gathered by a partnership tering into partnerships in the nutrition space. In the end, our established to perform a complex study: the Tswaka Nutri- joint success came down to the three Ps: Personal relationships tion Intervention study. and trust, Perseverance and determination, and the Passion to make this project a success. > The study was a community-based randomized controlled trial carried out in North West province, South Africa, on the Inception: aligning motivations efcacy of two small-quantity lipid-based complementary to create a single concept food supplements provided to children aged 6–12 months. In 2010, an NGO (GAIN) and a private-sector partner (Unilever) joined forces as a Funding Consortium to facilitate a research > The Tswaka study was completed in 2015 and its results project investigating a novel fortifed complementary food sup- have been recently published.1 plement. For the detailed design and execution of the interven- tion study, it was decided that an Academic Research Partner would be selected via a call for proposals. SIGHT AND LIFE | VOL. 33(1) | 2019 25 Saskia Osendarp © One of the children participating in the Tswaka Study has her weight taken as part of the bimonthly anthropometric measurement process 26 THE TSWAKA STUDY The motivation for the study was diferent for each of the research team. Therefore, two contracts had to be aligned and partners in the Funding Consortium. While GAIN was interested agreed upon: one bilateral grant agreement between GAIN and in working with private-sector partners on product formulation the research team, and one trilateral agreement between GAIN and demonstration of the feasibility of a market-based approach, and the two private-sector partners (the Funding Consortium), Unilever was interested in testing the efcacy of such a product who each contributed one-third of the research costs. before considering an innovation project on the feasibility of a Issues concerning intellectual property (IP) rights for data market-based approach. and for products, as well as publication and dissemination Unilever wanted to collaborate with GAIN on this research clearance procedures, had to be discussed at senior manage- because GAIN was considered a trusted intermediary between ment level in all the partner organizations. The entire contract Unilever and the Academic Research Partner. Initial discussions negotiations took more than a year and were eventually con- between Unilever and GAIN, however, identifed a potential con- cluded in 2011. fict of interest if GAIN were to work on a study assessing the efcacy of a product fom just one private-sector partner. Preparation phase: managing risks and building trust To address this issue, a second private partner, DSM, was The preparation phase turned out to be the most delicate phase invited to join the partnership. DSM wished to demonstrate ef- of the entire process. There were no products ready yet, and fcacy for a similar product formulation that contained certain negotiations started between the two private-sector partners extra ingredients with additional benefts for growth and devel- with the aim of creating a single joint development process for opment. Despite their diferent motivations, the three partners the study products. A joint development process was thought to recognized the benefts of sharing their complementary exper- be benefcial because this would allow for blinding of the two tise as well as sharing the research costs within the famework intervention arms by having two products comparable in taste of an NGO/private-partner Funding Consortium. and appearance, albeit with diferent compositions. As product To align the diferent motivations into one achievable goal development and product ingredient formulations are among a acceptable to all three partners took some time. There were company’s most valued IP, it took some time for the two pri- discussions about the requisite levels of transparency and vate partners to agree on a joint development agreement (JDA). openness and about the dynamics driving the choices and de- When an issue occurred during the actual production of one of cisions required for a successfl partnership. To avoid potential the study products, however, the private-sector partners decid- complications and to keep the study to a manageable size and ed to terminate the JDA and to continue frther scale-up and acceptable cost levels, it was designed in such a way that the production independently of one another. sample size would not allow direct comparison between the two In March 2013, the acceptability study among mothers and products. children with the frst product samples started in South Afica. The acceptability study yielded positive results but also revealed “ The more organizatons you have to some mild side efects, assessed as being unrelated to the in- tervention products as such.3 Meanwhile, however, within the involve, the more important it is to private-sector partners, changes in leadership and company have regular, open communicaton”2 strategies had taken place, leading to a revised assessment of the potential reputational risk for all partners involved in this community-based trial among very young and vulnerable chil- While these initial discussions were still ongoing, and prior dren in a disadvantaged population. to DSM joining the partnership, GAIN and Unilever had already To better manage and control these risks, it was initially developed a call for proposals based on an initial concept note, decided to hire an independent monitor to remotely review and an independent expert committee was formed to select the the quality of the study execution. In addition, a Safety Moni- Academic Research Partner to perform the study. toring Board (SMB) was established to monitor adverse efects North-West University, South Afica, won the bid in partner- and identif any potential causal relationships to study par- ship with the South Afican Medical Research Council (‘the re- ticipation or test product. In addition, an independent study search team’) and started to work on a fll proposal, which had physician was hired to train and support the research team as to be adapted into a three-arm design when the second private and when needed. The study monitoring was frther upscaled partner, DSM, joined the Funding Consortium. by hiring an independent Contract Research Organization Simultaneously, contract negotiations had started. The idea (CRO) to ensure the quality and safety of the study by mon- was that GAIN would act as the ofcial study sponsor, and also itoring the implementation of the study on site and for data as an intermediary between the private-sector sponsors and the management on site. SIGHT AND LIFE | VOL. 33(1) | 2019 THE TSWAKA STUDY 27 There was a clear need to balance the risk exposure of all made in keeping the momentum fom the site visit with the parties involved. Whereas the private partners wished to imple- community and the feld workers. To keep the onsite research ment processes such as monitoring, a centralized database and team motivated, extra training opportunities were ofered by extensive medical supervision and reporting, the research team the fnding partners. wished to make sure that its credibility as an independent aca- demic team would not be jeopardized. “ The fac that there was a signed Having an intermediate party in the form of GAIN turned out to be critical, ensuring efective communication between the obligaton beteen the partners research team and the private-sector partners and coordinat- meant we had to move forward and ing negotiations about the changing needs of both the research team and the Funding Consortium. could not withdraw” In addition, a site visit by the Funding Consortium helped to provide a more realistic view of the circumstances at the study site and to improve understanding of the practical dilemmas The renewed confdence within the partnership allowed for the research team faced in day-to-day management of a com- more open discussions on the issues of sponsor involvement munity-driven study of this size in this setting. It also frther and authorship. The dilemma was whether the growing in- strengthened trust between the responsible individuals within volvement of the study sponsors in the various stages of study each of the partner organizations.

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