Informe especial / Special report Pan American Journal

of Public Health

Technology transfer for the implementation

of a clinical trials network on drug abuse and
mental health treatment in Mexico
Viviana E. Horigian,1 Rodrigo A. Marín-Navarrete,2 Rosa E. Verdeja,1
Elizabeth Alonso,1 María A. Perez,1 José Fernández-Mondragón,2
Carlos Berlanga,2 María Elena Medina-Mora,2
and José Szapocznik1

Suggested citation Horigian VE, Marín-Navarrete RA, Verdeja RE, Alonso E, Perez MA, Fernández-Mondragón J, et al.
Technology transfer for the implementation of a clinical trials network on drug abuse and mental health
treatment in Mexico. Rev Panam Salud Publica. 2015;38(3):233–42.

ABSTRACT Low- and middle-income countries (LMIC) lack the research infrastructure and capacity to
conduct rigorous substance abuse and mental health effectiveness clinical trials to guide clini-
cal practice. A partnership between the Florida Node Alliance of the United States National
Drug Abuse Treatment Clinical Trials Network and the National Institute of Psychiatry in
Mexico was established in 2011 to improve substance abuse practice in Mexico. The purpose of
this partnership was to develop a Mexican national clinical trials network of substance abuse
researchers and providers capable of implementing effectiveness randomized clinical trials in
community-based settings. A technology transfer model was implemented and ran from
2011–2013. The Florida Node Alliance shared the “know how” for the development of the re-
search infrastructure to implement randomized clinical trials in community programs through
core and specific training modules, role-specific coaching, pairings, modeling, monitoring, and
feedback. The technology transfer process was bi-directional in nature in that it was informed
by feedback on feasibility and cultural appropriateness for the context in which practices were
implemented. The Institute, in turn, led the effort to create the national network of researchers
and practitioners in Mexico and the implementation of the first trial. A collaborative model of
technology transfer was useful in creating a Mexican researcher-provider network that is
capable of changing national practice in substance abuse research and treatment. Key consid-
erations for transnational technology transfer are presented.

Key words Technology transfer; clinical trials as topic; evidence-based practice; science and
technology information networks; substance-related disorders; mental health; health
services research, methods; Mexico.

1
Miller School of Medicine, University of Mia­ Evidence shows that in most fields in drug abuse treatment (5–10) led to the
mi, Department of Public Health Sciences,
Miami, Florida, United States of America. Send medicine, translation from research to establishment of the National Institute
correspondence to Viviana E. Horigian, email: practice can take considerable time (1–4). on Drug Abuse of the National Drug
[email protected] In the United States, this particular dis­ Abuse Treatment Clinical Trials Network
2
Instituto Nacional de Psiquiatría Ramón de La
Fuente, Mexico City, Mexico. connect between research and practice in (NIDA CTN) in 2000 (11). This network

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Special report Horigian et al. • Technology transfer for a clinical trials network in Mexico

brought together academic researchers of Mexico began opening 335 new pri­ Mexico to develop a researcher-provider
and community-based providers to de­ mary care centers for addictive disorders national clinical trials network that would
velop and execute rigorous clinical trials (Unidades de Especiales Medicas – Centros conduct randomized clinical trials of
of treatment interventions that fulfill de Atención Primaria para las Adicciones; drug abuse and mental health treatments
the practical needs of community-based UNEME- CAPAS). This offered a perfect in real-world, community-based settings;
drug abuse treatment programs. Engag­ opportunity to transfer to Mexico the (b) present the results of the technology
ing substance abuse treatment providers technology of the NIDA CTN (11–14) transfer; and (c) provide key consider­
in the research process in the NIDA CTN and create the first national clinical trials ations as a result of lessons learned in the
improved generalizability, acceptability, network for substance abuse and mental process.
adoption, and dissemination of research health treatment in Latin America.
results (12–14). To facilitate technology transfer, a MATERIALS AND METHODS
Adoption and implementation of evi­ partnership was developed between the
dence-based practices for drug abuse in University of Miami (Miami, Florida, The transfer of technology was sup­
real world treatment settings is a chal­ United States; a CTN-participating aca­dem­ ported by a bi-national collaborative ef­
lenge outside of the United States as ic institution) and the National Institute fort that involved the University of
well. In Mexico, as in other low- and of Psychiatry in the Ministry of Health Miami-based Florida Node Alliance of
middle-income countries (LMICs), this of Mexico, with the overarching goal of the NIDA CTN, hereafter referred to as
challenge is heightened by the lack of re­ improving substance abuse treatment in “the Node,” the National Institute of
search infrastructure and limited capaci­ Mexico. The goals of the partnership Psychiatry in Mexico, hereafter referred
ty for conducting rigorous studies to were to develop a national clinical trials to as “the Institute,” and several key
generate evidence on locally-effective network of substance abuse and mental players working within a facilitative con­
substance abuse and mental health treat­ health researchers and providers in text (Table 1).
ments that might inform the decision­ Mexico, and to develop and implement The adoption of the NIDA CTN model
making process in clinical practice (15, the first randomized clinical trial within was facilitated through a process re­
16). The need to bring evidence-based the newly-created network. ferred to as “technology transfer” (17,
interventions for drug abuse treatment The objectives of this paper were to: (a) 18). Technology transfer took place from
to community centers in Mexico gained describe the methodology for transfer­ 2011–2013 in two sequential, yet over­
urgency when, in 2010, the Government ring technology from the United States to lapping processes: the Node shared the

TABLE 1. Partners and stakeholders in the United States–Mexico technology transfer collaboration to create a clinical trials
network for substance abuse and mental health, 2011

Institution Role Description

Mérida Initiative and the United States Department of State Sponsor A binational cooperation program between Mexico and the United States
that includes support for the creation of Mexico’s first comprehensive
national demand reduction infrastructure.
The United States National Institute on Drug Abuse Treatment Model for the innovation United States research to practice network in the field of drug abuse
Clinical Trials Network (NIDA CTN) treatment.
Florida Node Alliance at the University of Miami Knowledge broker/ mentor One of the 13 centers that comprise the NIDA CTN,
experienced in conducting research with Hispanic and Spanish-only
speaking populations, with fully bilingual and bi-cultural team members
in areas of clinical trial development and implementation, design and
methodology, protocol development, quality monitoring, and trial
management.
Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz Mentee An institute within the Ministry of Health of Mexico that provides
(National Institute of Psychiatry Ramón de la Fuente Muñiz) leadership in epidemiological, psychosocial, clinical, and neuroscience
research, training, and services in the areas of substance abuse and
mental health.
Comisión Nacional Contra las Adicciones Stakeholder Federal commission within Mexico’s Ministry of Health with the mission
(National Center for the Prevention and Control of Addictions in Mexico) of promoting and protecting the health of Mexicans through the design
and implementation of national policies regarding research, prevention,
treatment and development of human resources for the control of
addictions.
Centro Nacional Contra las Adicciones Stakeholder Government office in charge of the planning and direction of the
(National Center for the Prevention and Control of Addictions in Mexico) nationwide newly created 335 primary, first-level care addiction
treatment centers, under the coordination of 32 national state councils
at the national level.
Centros de Integración Juvenil Stakeholder Non-profit organization and civic association founded in 1969 by the
(Youth Intergration Centers) Ministry of Health in collaboration with community boards. Comprised
of 115 treatment centers throughout the country dedicated to drug
demand reduction through the delivery of community-based substance
abuse prevention and treatment programs.

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Horigian et al. • Technology transfer for a clinical trials network in Mexico Special report

“know how” for the development of the guidelines (Table 2) were gleaned from operations calls, and site implementation
research infrastructure necessary to im­ the Node team’s experience over the last calls occurred weekly, and face-to-face
plement randomized clinical trials in 15 years in the US NIDA CTN. meetings were held periodically. In addi­
community treatment programs and the tion, informal communications between
methodology with which these trials The strategy the Node and the Institute occurred daily
would be implemented. The Institute, in or as needed via telephone, email, and
turn, led the national effort to create the The strategy for technology transfer in­ online audio/video-conferencing. Meet­
network of researchers and practitioners. volved a stage-wise acquisition of know­ ings served as an essential forum for
In collaboration with the Node, the Insti­ ledge in sequential, overlapping steps and providing recommendations, instruc­
tute selected and adapted the design of practical testing of the knowledge gained. tion, coaching, and feedback, as well as
the first trial that was implemented in These steps involved a progression from an opportunity to monitor the practices
the network and was responsible, under (a) developing the knowledge needed to and processes set forth. The Node and
the Node’s mentorship, for leading the create the network infrastructure and Institute teams identified implementa­
implementation of the trial (19). These building a knowledge base of clinical trial tion challenges in real-time and worked
processes were bi-directional in nature, concepts and practices to (b) developing/ together to develop solutions that were
that is, they were informed by feedback adapting a research protocol, and (c) feasible and sustainable.
on feasibility and cultural appropriate­ subsequently, implementing/managing
ness for the context in which they were the protocol at multiple sites within the The phases of implementation
implemented (Figure 1). newly-formed network. The steps were
overlapping in that the processes of creat­ The implementation of the “innova­
The innovation ing the network and developing and im­ tion” progressed through a continuum of
plementing the first trial were intertwined phases as illustrated in Figure 2. As de­
The innovation consisted of a set of and informed by each other. scribed in the implementation science
practices and guidelines, i.e., the “know The process of technology transfer was literature, the phases included: exposure,
how” for building and maintaining a supported by a structured communica­ adoption, (trial) implementation, and
network of scientists and treatment pro­ tions plan. The Node team and the lead­ routine practice (20–24).
viders with the goal of implementing ership at the Institute established regular
clinical trials for the treatment and pre­ meetings with specific objectives, which Exposure. In the exposure phase, the Di­
vention of drug abuse and mental health allowed the process of technology trans­ rector of the Institute explored and eval­
problems in Mexico. These practices and fer to unfold over time. Executive calls, uated the NIDA CTN as a model for im­
proving substance abuse practices in
Mexico.

Adoption. The adoption phase included

the laying the groundwork and building
FIGURE 1. The bidirectional process of technology transfer for
the development of a clinical trials network to improve sub- capacity and infrastructure at the Insti­
stance abuse and mental health treatment in Mexico, 2011–2013 tute. The Node and the Institute had col­
laborated previously in other contexts
and were able to build on existing trust
to develop a shared vision and objectives
for this effort.
Building the infrastructure at the Insti­
National Institute of Community
Florida  Node Alliance tute began with the creation of a special­
Psychiatry Treatment Centers
ized team, Unidad de Ensayos Clínicos (the
• Transferred and • Adapted and • Formed a
adapted the “know adopted the “know network committed
Clinical Trials Unit; UEC) composed of
how” for developing how” to working six cores: implementation; quality moni­
a national clinical • Developed the collaboratively with toring; intervention supervision and fi­
trials network for national clinical trials the mission of delity; data management; statistics; and
the implementation network improving substance
logistics and coordination. The structure
of randomized abuse treatment
• Developed and lead of this Unit mirrored existing operational
clinical trials for practice
the implementation cores at the Node. The Unit Director and
substance abuse • Implemented the
of the first clinical
treatment “know how” by core leaders were each assigned a specif­
trials in community
• Mentored on the treatment centers conducting the first ic member of the Node’s team for ongo­
designed and randomized clinical ing daily mentoring and support in their
implementation of trials in real world
rigorous clinical trials with in the network
respective areas of expertise. Role-specif­
ic coaching pairings allowed one-on-one
specialized attention, supported profes­
sional and technical development, facili­
tated joint problem-solving, and promot­
ed cross cultural understanding.
Bottom arrows represent feedback loops

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Special report Horigian et al. • Technology transfer for a clinical trials network in Mexico

TABLE 2. The Innovation—set of practices transferred from the United States to These included didactic instruction, expe­
Mexico for the implementation of rigorous clinical trials riential learning, modeling, coaching,
monitoring and feedback.
Set of practices
Development of a clinical trials network Implementation. The implementation
Partnership development phase entailed building the clinical trials
• Identification of potential partners
• Site visits network and the implementation of the
• Development of a general survey to assess agency/site capacity and needs first trial. The development of the Mexi­
• Development of institutional working agreements can Clinical Trials Network meant estab­
Infrastructure development lishing partnerships with other institu­
• Creation of a Network Coordinating Team (Clinical Trials Unit)
• Director tions and community treatment centers
• Implementation Coordinator to build the foundation of the network.
• Intervention Coordinator This included visits to community treat­
• Data Manager ment programs and involved the assess­
• Quality Monitoring Director
• Statistician ment of: characteristics of the patient
• Logistical Coordinator populations served, existing treatment
• Administrative Support and research capacities, openness to par­
• Acquisition of physical infrastructure for coordinating team and sites ticipating in randomized clinical trials,
• Allocation of physical spaces
• Technology (software, hardware, equipment) and program needs. These visits helped
Implementation of a clinical trial to consolidate relationships with the In­
Protocol development stitute’s founding partners in the net­
• Write up of protocol narrative work, the Youth Integration Centers
• Selection and adaptation of study-specific outcome measures
• Selection of sites to conduct the trial (Mexico City, Mexico), and the National
• Development of a study-specific site survey Center for the Prevention and Control of
• Site visits for study-specific site selection Addictions (Mexico City, Mexico). Visits
• Development of study-specific Informed Consent forms also helped to identify community treat­
• Submission of study documents for approval
Quality and regulatory monitoring ment programs that could carry out the
• Development of a study-specific Quality Monitoring plan first trial.
• Development of study-specific Quality Monitoring tools and report templates Critical to the technology transfer plan
• Identification of regulatory requirements for the study (for the coordinating center and the sites) was the selection of a clinical trial that
• Implementation of periodic on-site monitoring visits (site initiation, interim and close out visits)
Intervention would serve as the “task” around which
• Selection of the interventionists (e.g., randomly assigned or appointed) the network and its procedures would be
• Development of the intervention fidelity tools/process/medication compliance established and its capabilities built. The
• Training and certification on a manualized intervention goal was to select a trial that had been
• Intervention monitoring (fidelity)
Data management implemented previously in the NIDA
• Selection and acquisition of electronic data capture system compliant with international regulations CTN, could be readily adapted for im­
• Development of the Data Management Plan: Definition of data quality assurance procedures plementation, and that would be rele­
• Development of the Case Report Forms (CRFs) vant to the treatment needs in Mexico.
• Training and certification for system users
Implementation The Motivational Enhancement Therapy
• Development of Manual of Operations and Procedures and site-specific procedures for Spanish Speakers –CTN 0021 (MET-S)
• Establishment of staff training and certification requirements (25) trial was selected because it met
• Preparation and delivery of study-specific training these criteria and addressed the docu­
• Management and oversight of study implementation
• Weekly calls with sites mented clinical problem of poor treat­
• Tracking of site performance (e.g., weekly recruitment and retention reports) ment engagement and retention in out­
patient drug abuse treatment centers in
Mexico (26, 27).
The central activities of the imple­
mentation phase were the adaptation of
The next step in the adoption phase in­ a regulatory component and the impor­ the MET-S research protocol by the In­
cluded the delivery of core training mod­ tance of informed consent; quality moni­ stitute’s Clinical Trials Unit, and the im­
ules on clinical trial implementation and toring; and data management. plementation of the trial at three com­
management to the Institute. The core The instructional content delivered at munity treatment programs within the
training modules for the Clinical Trials each step included core concepts and new network. A multi-site randomized
Unit were delivered in Spanish by the “how to’s” followed by relevant activities clinical trial allowed the Clinical Trials
Node team via a series of face-to-face ses­ where new concepts could be immediately Unit team to apply their newly acquired
sions that spanned 3–4 days each. Mod­ applied with real-time feedback and sup­ knowledge and to test the infrastructure
ules and their corresponding practical port. The adaptation and conduct of a trial and systems developed. With support
assignments were organized around ma­ provided a rich and structured opportuni­ and monitoring from the Node, the
jor content areas: methodology and de­ ty to apply newly learned concepts and Clinical Trials Unit led and served as
sign of randomized clinical trials; Good practices. A number of different teaching the main coordinating center for the tri­
Clinical Practices (GCP), which included techniques were used with flexibility. al. It was responsible for all aspects of

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Horigian et al. • Technology transfer for a clinical trials network in Mexico Special report

FIGURE 2. Phases of technology transfer and implementation of a clinical trials network to

improve substance abuse and mental health treatment in Mexico – from exposure to sustain-
ability

Florida Node Alliance National Institute of Psychiatry

University of Miami (Mentors) Mexico (Mentee)

Exploration Director evaluates model

Exposure
to improve substance
abuse practice

Development of a collaborative
vision between the Node Development of a collaborative
and the Institute vision between the Node
Preparation
and the Institute

Establishment of a plan with clear Establishment of a plan

objectives: with clear objectives:
• Development of a Clinical • Development of a Clinical
Trials Network Trials Network
• Selection of a first Building infrastructure • Selection of a first
randomized clinical trial & capacity at the randomized clinical trial
Institute

Adoption
Establishment of a Establishment of a Clinical Trials
Identification of coaches for Research & Unit as a research/training Center
Clinical Trials Unit cores Implementation Team

Acquisition of skills through

Training and skills practical assignments
Delivery of core training modules building

Infrastructure and capacity

Space, equipment, needs assessment, and
Needs assessment and guidance and systems systems acquisitions
on system acquisition

Development of partnerships
Mentoring in relationship building Building the with Mexican treatment
and modeling of site visits institutions; site visits;

Implementation
Clinical Trials Network
needs assessments

Oversight of network and trial Adaptation and development of a

Implementation of the clinical trial (research protocol,
implementation; monitoring first randomized procedures, case report forms);
of progress clinical trial delivery of protocol-specific
training; implementation of trial

Implementation of the
Mentoring and oversight Protocol development and
second randomized
upon request implementation sustaining
Routine Practice

clinical trial
practices established
during the first trial
Sustainability of the
intervention (Motivational Regular supervision
ment Treatment) at the of intervention
Centers

trial management, including budget sustainability of the intervention at sites Ethics

and timeline planning, training of study after trial completion.
teams, development of study proce­ Study procedures were consistent
dures (Manuals of Operations), perfor­ with the ethical standards for protecting
mance and quality monitoring, and data Routine practice. The final phase in im­ human subjects and the Helsinki Decla­
management. The Node trained and plementing an innovation, as described in ration of 1975 (28), and were approved
certified therapists and clinical supervi­ the literature, is routine practice. Routine by the internal review boards/ethics
sors at each of the trial sites to build lo­ practice refers to the sustainability of the committees of all participating insti­
cal capacity on Motivational Enhance­ practices gained, described in the section tutions, where applicable. All trial
ment Therapy, and thereby facilitate the that follows. participants provided written, informed

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Special report Horigian et al. • Technology transfer for a clinical trials network in Mexico

consent. Safety events were identified The design and characteristics of this professionals (counselors, research assis­
and monitored for all study participants, trial, “Motivational Enhancement Treat­ tants, and clinic directors) through 47
according to a study-specific monitoring ment for outpatient treatment seekers training sessions.
plan. in Mexico,” can be found in Marin- As illustrated in Figure 2, the final step
Navarette (29). in instituting new practices/innovations
RESULTS The trial was implemented with out­ is moving from trial to routine practice.
standing performance, achieving its ran­ We defined routine practice as con­
The primary objectives of the technol­ domization target of 120 participants tinuously conducting rigorous research
ogy transfer collaboration were met. A across three outpatient sites ahead of based on the infrastructure and practices
Mexican national clinical trials network schedule, with a treatment exposure rate gained during the technology transfer
of substance abuse researchers and of 92%, and attendance of 93% and 95%, process. Results of the technology trans­
providers was established, and the first respectively, at the 2- and 4-month re­ fer and sustainment of the practices
randomized clinical trial was successful­ search follow-up visits. The Clinical Tri­ gained are pre­sented in Table 3 and are
ly completed within the new network. als Unit developed and implemented a summarized below.
Under the mentorship and coaching of study-specific Quality Assurance Plan
the Node, the Institute adapted and im­ that included on-site monitoring visits, Expansion of the Mexican Clinical
plemented the first trial in the Mexican written reports of findings, systematic Trials Network
Clinical Trials network at three outpa­ identification and reporting of protocol
tient community-based centers. The ob­ violations, and implementation of cor­ The Clinical Trials Unit has developed
jective of this trial was to compare the ef­ rective and preventive actions to address new partnerships using the infrastruc­
fectiveness of Motivational Enhancement all findings and violations. Moreover, ture created and the methodology ac­
Treatment (MET) versus Counseling as the trial provided training in research
quired, and has now expanded to in­
Usual in retaining substance users in methods, processes, and intervention to
clude an additional institution, the
treatment and reducing substance use. more than 143 community treatment
National University in Mexico, as well as
participating centers (i.e., centers over­
seen by state councils and non-govern­
mental organizations) with both out­
TABLE 3. Results of the technology transfer for the implementation of a clinical trials
network for substance abuse and mental health treatment in Mexico: sustaining the patient and residential settings. This
practices gained expansion was intended to broaden the
network’s reach to a wider population
Expansion of the Mexican Clinical Trials Network with substance abuse and mental health
• Six collaborative research agreements established with institutions in Mexico problems.
• Agreements permitted research implementation in 45 different clinical settings:
 • 9 outpatient addiction primary care centers New research projects
 • 36 mutual aid residential care centers (run by non-governmental organizations)
• 2 outpatient community treatment centers
• 1 hospital outpatient clinic The new partnerships have allowed
the implementation of research projects,
Implementation of new research projects
a

• REC 002: Online intervention for Substance Use Disorders (completed) beyond the initial three treatment centers
• REC 003: Co-Occurring Disorders and Validation Scales in residential facilities in Mexico (completed) of the trial, to 45 additional centers. This
• REC 004: An Examination of the Mexican Clinical Trials Network (in progress) new network has completed a second
 • A Qualitative Study on the Technology Transfer Collaboration
randomized clinical trial, an online inter­
 • Readiness to Adopt- and Adoption of Evidence Based Practices by centers of the Mexican Trials Network
• REC 005: Co-Occurring Disorders in people with disabilities in Mexico City (completed) vention, and a clinical measures valida­
• R EC 006: Co-Occurring Disorders and Neuropsychological conditions in inhalant dependent adults (under tion study—both within the expanded
development) network—and a study examining the
Improvement of research capacity at treatment centers process of technology transfer.
Total of 72 research training modules have been delivered to approximately 143 mental health professionals: Research trainings and protocol spe­
Overview of clinical trials
• Clinical assessment
cific trainings, including the use clinical
• Participant recruitment and retention strategies research methodology and procedures,
• Good clinical practices and ethics in research standardized measures, good clinical
Development for the delivery of evidence-based interventions practice, and ethics in research were de­
Specialized training/certification delivered to 27 mental health professionals in evidence-based interventions: livered to sites of the expanded network.
• Motivational Enhancement Treatment in Spanish (METS) - delivery and supervision In addition, specialized training and cer­
• ASSIST – Brief Intervention
• Online intervention for substance abuse and depression
tification on three evidence-based inter­
ventions (EBIs) were delivered for pro­
Dissemination of scientific findings
Research findings from network projects have been presented in: fessionals at participating treatment
• 7 invited lectures at international congresses and meetings centers.
• 9 research posters Scientific findings of the Mexican
• 3 papers in peer-reviewed journals ­Clinical Trials network have also been
• 1 book chapter
disseminated through several venues.
a
‘New’ means after the completion of the first trial. In collaboration with its partners, the

238 Rev Panam Salud Publica 38(3), 2015

Horigian et al. • Technology transfer for a clinical trials network in Mexico Special report

Network has presented its work at na­ though a standard practice in the Unit­ health and drug abuse treatment in Latin
tional and international conferences ed States, in other countries it may be America.
(30–38), in peer-reviewed journals (19, difficult or impossible to directly cover The strategy and process of developing
39–41), and a book chapter (15). time spent by staff on research activities the Mexican Clinical Trials network en­
with research funds. However, partners compasses several distinct components.
Keys to transnational technology can come up with alternative ways First, the shared vision for the technology
transfer to compensate staff for time devoted transfer was developed jointly and col­
to the research project, thus reward­ laboratively, rather than promoted pri­
There are key considerations for suc­ ing their dedication and ensuring marily by either the user or the knowl­
cessful transnational technology trans­ account­ability. edge broker. Second, in addition to a
fer. First, is the development of mutually Additionally, particular attention needs coaching team, each member of the team
agreed-upon goals and a work plan to to be given to the cultural norms of com­ had an assigned mentee, which allowed
guide the collaboration and ensure active munication. While much of the commu­ for specialized coaching on practice-based
investment and accountability by both nication can occur online or by phone, projects over time. Finally, the technology
parties. Second, a detailed needs-assess­ some cultures place a high value on face- transfer process was culturally informed,
ment is critical to identifying existing lo­ to-face contact. This should be consid­ reaching beyond typical adaptations for
cal infrastructure (personnel, systems, ered when planning critical collaborative EBIs (44, 45) by acknowledging and ad­
and expertise) on which to build, as well and problem-solving activities, as well as dressing the contextual and cultural ap­
as areas that will require full develop­ when celebrating successes and accom­ propriateness of each practice adopted.
ment. Third, a local team capable of plishments. Finally, trust, patience, hu­ The research-to-practice network cre­
leading the adoption and implementa­ mility, and flexibility are key ingredients ated, and most importantly, the local
tion of the innovation and sustaining it for a true working collaboration. team that led the network to develop and
into the future must be established. implement rigorous clinical trials in real
Fourth, the mentor team must be cultur­ DISCUSSION world settings, are capable of generating
ally informed, able to communicate ef­ evidence for treatments that are effective
fectively with the local team in a com­ This paper presents a technology and culturally relevant among the popu­
mon language, and have protected time transfer collaboration for the develop­ lations they serve. The culture of quality
for ongoing support for the duration of ment of research infrastructure to sup­ and quality monitoring that was prompt­
the project. Fifth, role-specific coaching port the rigorous testing and implemen­ ed by the technology transfer process has
pairings allow for efficient and special­ tation of evidence-based practices, impacted practices at the Institute and
ized mentoring and facilitate the use of tes­tifying to its successes and providing the treatment centers. In addition, some
modeling and observation as learning key considerations for transnational of the solutions generated by network
strategies. Sixth, vital for the survival of tech­nology transfer. A recent systematic participation and collaboration have in­
the project is the identification of invest­ review of implementation frameworks cluded strategies to improve outreach
ed leaders at all levels of the mentee’s conducted by Moullin (24) acknowledg­ to the population in need. The newly-
country/institution: Ministry of Health, es the multiple existing models for tech­ established research infrastructure can
at the participating institutions, and at nology transfer and explains that not all serve as a wide dissemination platform
the community/clinic level. Seventh, the models include the full range of con­ for evidence-based practices, thus ad­
implementation of randomized clinical cepts involved in implementation. Ward vancing the quality of care for substance
trials demands careful evaluation of the and colleagues (42) summarize com­ abuse and mental health in Mexico. All
local regulatory and ethical guidelines, mon elements of 28 models of knowl­ of these accomplishments translate into
administrative processes, and approvals edge transfer, but argue that studies on gains for the population.
needed in order to ensure local compli­ the topic have focused narrowly on de­ Organizational readiness for change
ance, as well as plan timelines according­ terministic approaches instead of on has been defined as the extent to which
ly. Eighth, partners must allot time and the broad explanations of the journey organizational members are psychologi­
resources to the cultural adaptation of all from knowledge to action. Literature cally and behaviorally prepared to imple­
research interventions, measures, and (43) has also described the components ment organizational change (46–48). In
procedures prior to implementation. For for capacity building and sus­tainable this case the Node, the Institute, and the
example, adaptations need to be consid­ transfer of technology to developing participating sites were motivated and
ered when deciding on participant reim­ countries. open to change; the context of the newly
bursement and staff compensation struc­ The work presented here shows how created centers generated the opportuni­
ture for research. some of these frameworks’ core concepts ty for an improvement in practice; fund­
Although in the United States partici­ were applied to a methodology for devel­ ing was readily available; and skilled
pants are reimbursed for time spent on oping research infrastructure for addic­ staff were ready to take on this initiative.
research, this might not be standard tion and mental health treatment lacking It is possible that this readiness facilitated
practice elsewhere. The adaptation pro­ in LMIC. While the concepts described in and sustained the practices gained.
cess should involve consideration and our methods have been presented in the
discussion of the intended purpose of literature, the novel contribution of this Limitations
the practice, and how its implications paper is its application. Our work initiat­
or consequences may vary once im­ple­ ed the first research-to-practice network A limitation of this project was that,
mented in a different country. Similarly, implementing clinical trials for mental even though it could be clearly shown

Rev Panam Salud Publica 38(3), 2015 239

Special report Horigian et al. • Technology transfer for a clinical trials network in Mexico

that the technology transfer goals were As the Institute moves into the sus­ Nacional Contra las Adicciones (Mexico
achieved, we did not take baseline mea­ tained practice of implementing new City, Mexico). A special acknowledg­
surements of organizational readiness randomized clinical trials on evidence- ment is also given to Christiane Farenti­
for change or key theoretical or empiri­ based models, it might also serve as a nos and Thelma Vega who provided in­
cal mediators of the change process. A consultant for other countries in Latin tervention training and coaching on the
second limitation was that although America aspiring to do the same. Fur­ clinical trial; to Manuel Paris and Luis
training and capacity building are es­ thermore, the Mexican Clinical Trials Anez who trained intervention raters;
sential to the technology transfer pro­ Network could act as a foundation and to the Caribbean Basin and Hispanic
cess, they do not guarantee that the in­ for multinational collaboration among Addiction Technology Transfer Center,
novation will be sustained for the substance-abuse researchers and practi­ which provided training on the Addic­
long-term. A lack of funding, of incen­ tioners throughout Latin America. tion Severity Index. Finally, special
tives, or of knowledge when facing new Finally, implementation research calls thanks to Kathy Carroll and her team at
practices, among other possible factors, for subsequent efficacy and effectiveness Yale University (New Haven, Connecti­
could undermine the project’s long- research to confirm that outcomes were cut, United States), whose Motivational
term impact. indeed improved by this method of Enhancement Therapy for Spanish Speak­
technology transfer. In the case of the ers served as the basis for the clinical trial.
Conclusions Node-Institute collaboration, this follow-
up research should be done with these Financing. This work was funded by
The partnership between the Florida objectives: first, to examine the process of the United States Department of State
Node Alliance of the NIDA CTN and the transfer of the “know how” from the (grants SINLEC11GR0015 and S-INLEC­
Mexico’s National Institute of Psychia­ Node to the National Institute of Psychia­ 11GR020) awarded to the Instituto Na­
try, through its collaborative technology try; and second, to examine the adoption cional de Psiquiatría Ramon de la Fuente
transfer, created the Mexican national and implementation of the evidence- (Mexico City, Mexico) and the University
clinical trials network to generate local based practices that the Mexican Clinical of Miami (Miami, Florida, United States),
evidence on effective treatments. The Trials Network tests. Such studies are respectively. Support for this work was
Clinical Trials Unit, the coordinating currently underway to better understand also provided by the National Drug
center for the network, with its multifac­ whether we were able to change practice. Abuse Treatment Clinical Trials Net­
eted infrastructure is making contribu­ Subsequent studies could examine wheth­ work (grant U10DA13720) and by the
tions to both science and practice in the er changes in practice translate into im­ National Center for the Advancement
field. The Unit, besides adopting systems proved patient outcomes. of Translational Sciences (grant 1UL­
and methods for implementing and 1TR000460) both aw­ar­ded to the Univer­
overseeing clinical trials in real world Acknowledgements. The authors wish sity of Miami. The opinions, findings and
settings, has developed the capacity to to thank the on-site principal researchers conclusions stated herein are those of the
serve as trainers in core research assess­ of the first trial by the Mexican Clinical authors and do not necessarily reflect
ment measures, to conduct quality and Trials Network: Ricardo Sánchez Hues­ those of the funding organizations.
intervention fidelity monitoring, and to ca, Carlos Lima Rodriguez Rodríguez,
train and supervise clinicians in the in­ and Ana De la Fuente Martín. We also Conflicts of interest. The spouse of a
terventions tested. Its versatile structure appreciate the participation of the fol­ study team member is an employee of
can disseminate evidence-based practic­ lowing institutions: Centros de Inte­ INFOTECHSoft, Incorporated (Miami,
es to community treatment centers and gración Juvenil (Mexico City, Mexico); Florida, United States), a subcontractor
can be used to evaluate current treatment Centro “Nueva Vida” de Atención Pri­ on this study.
programs. By building this network, con­ maria para las Adicciones, Puebla-Sur
ducting the first trial, and applying prac­ (Puebla, Mexico); Centro de Trastornos Disclaimer. Authors hold sole respon­
tices to new projects, a bridge between Adictivos, Instituto Nacional de Psiquia­ sibility for the views expressed in the
science and practice has been erected tría Ramón de la Fuente (Mexico City, manuscript, which may not necessarily
that has the potential to reach farther into Mexico); Centro Nacional Para la Pre­ reflect the opinion or policy of the RPSP/
the future. vención de las Adicciones; and Comisión PAJPH and/or PAHO.

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RESUMEN Los países de ingresos bajos o medios (PIBM) carecen de una infraestructura de inves­
tigación y de la capacidad para llevar a cabo investigaciones clínicas rigurosas sobre la
eficacia del tratamiento de la drogadicción y los problemas de salud mental que orien­
Transferencia de tecnología ten la práctica clínica. Se estableció una asociación entre la Florida Node Alliance de la
para la implantación de una National Drug Abuse Treatment Clinical Trials Network de los Estados Unidos y el
red de investigaciones Instituto Nacional de Psiquiatría de México con objeto de mejorar la práctica en mate­
ria de tratamiento de la drogadicción en México. La finalidad de esta asociación fue la
clínicas sobre el tratamiento de crear una red nacional mexicana de investigaciones clínicas constituida por inves­
de la drogadicción y los tigadores y proveedores de tratamiento de la drogadicción capaces de ejecutar ensayos
problemas de salud mental clínicos aleatorizados de eficacia en entornos comunitarios. Se implantó un modelo de
transferencia de tecnologías. La Florida Node Alliance compartió el el conocimiento y
en México la experiencia para la creación de la infraestructura de investigación con objeto de
ejecutar investigaciones clínicas aleatorizadas en programas comunitarios, por medio
de módulos de capacitación común y específica, entrenamiento en funciones específi­
cas, emparejamientos, modelado, vigilancia y retroalimentación. El proceso de trans­
ferencia de tecnología fue de tipo bidireccional en cuanto se basó en la retroali­
mentación sobre la viabilidad y la adecuación cultural para el contexto en el que se
llevaron a cabo las prácticas. El Instituto, a su vez, lideró la iniciativa para crear la red
nacional de investigadores y profesionales de México y llevar a cabo el primer ensayo.
Un modelo colaborativo de transferencia de tecnología resultó útil para la creación de
una red mexicana de investigadores y proveedores de tratamiento capaz de cambiar
las prácticas nacionales de investigación y tratamiento en materia de drogadicción. Se
exponen las consideraciones clave para la transferencia transnacional de tecnología.

Palabras clave Transferencia de tecnología; ensayos clínicos como asunto; práctica clínica basada en
la evidencia; redes de información de ciencia y tecnología; trastornos relacionados con
sustancias; salud mental; investigación sobre servicios de salud, métodos; México.

242 Rev Panam Salud Publica 38(3), 2015