NEWS & VIEWS CLINICAL TRIALS
ISN–ACCTS: global initiatives to improve clinical research Adeera Levin and Giuseppe Remuzzi
The International Society of Nephrology–Advisory Committee of Clinical Trials and Studies aims to ensure access to timely and unbiased expert advice for all investigators, and to facilitate the development and execution of clinical trials within a highly ethical framework. The initiative will foster high-quality, cost-effective research in a sustainable network. Levin, A. and Remuzzi, G. Nat. Rev. Nephrol. 10, 426–427 (2014); published online 10 June 2014; doi:10.1038/nrneph.2014.98
The International Society of Nephrology (ISN) represents a diverse community of clinicians, educators, basic scientists and clinical researchers. Affiliated societies and official partners include national and regional groups in high-income and low-income countries, patient groups and not-for-profit government agencies.1 In recognition of the current challenges encountered in nephrology research, the ISN has launched an initiative to foster and enhance collaborative research efforts so that high-quality clinical trials can be conducted around the world. The ISN Advisory Committee of Clinical Trials and Studies (ISN–ACCTS) is intended to serve two purposes: to ensure access to timely and u nbiased expert advice (for independent and industry investigators) and to facilitate the development and execution of clinical trials in a highly ethical framework. The ISN–ACCTS will work to protect the rights of clinical trial participants, both investigators and patients, particularly in developing countries.
‘‘
The ISN–ACCTS will be accountable to the international community...
’’
Many research groups have developed international collaborations to carry out large clinical trials, some of which involve a more formal network than others. 2-4 Academia and private industry have concordant goals to develop more-effective therapies in nephrology. Clinical trials conducted across multiple jurisdictions are
important to answer core questions and to ensure maximum generalizability of data and greater acceptance of new treatments by regulatory bodies in different countries. An appreciation of the diversity of cultures, resources, access to care and to education is fundamental to understand both the problems faced in clinical research and their solutions. Integrating the various perspectives of patients, health-care providers, scientists and funders is essential to ensure rigorous study design and execution. As the landscape of nephrology changes around the world, the burden of chronic kidney disease (CKD) is increasing, partly as a result of higher incidences of non communicable diseases, such as diabetes mellitus and hypertension, which are known drivers of CKD. Access to pathology services is increasing in developing countries; hence, the improved ability to diagnose the causes of kidney disease has highlighted the ability to identify individuals for study inclusion. Randomized control trials are essential to assess the safety and efficacy of new treatment strategies, drugs and devices; however, they might be difficult and expensive to execute. In specific countries, unique difficulties exist, such as i nadequate knowledge or expertise among local investigators, insufficient resources, limited regulatory expertise or even a lack of ethics committees to approve studies.5 Clinical research organizations (CROs) are often used by industry in conducting trials, but add to their expense. Challenges for CROs include insufficient knowledge of kidney disease among trial coordinators and a lack of access to research
NATURE REVIEWS | NEPHROLOGY
networks to identify experienced investigators. These difficulties can be e xacerbated in developing countries. The ISN–ACCTS will oversee the development of an information hub that delineates resources and research initiatives. Information offered by members on the availability of facilities for research in their countries and on existing investigatorinitiated clinical trials will be tabulated. Educational opportunities and communi cation about ongoing studies will be offered through ISN programmes and at ISN events. The ISN–ACCTS will ensure that regulatory authorities, ethics committees and patients are offered comprehensive and honest information about treatments already available for the clinical conditions that are being addressed in ongoing trials. The ISN–ACCTS will also advise privateindustry partners, investigators and government agencies on clinical trial design and conduct. This initiative will help to guide the evaluation and implementation of novel strategies (such as stepped-wedge design, enrichment protocols and pragmatic studies) to add to the armamentarium of traditional models of randomized controlled trials; identify and foster large networks of sites for patient enrolment; and develop academic centres as CROs to ensure cost-effective studies are carried out. As an independent group, the ISN–ACCTS will vet trial strat egies or details in a confidential setting and members will serve as independent, unbiased content and methodology experts. The ISN–ACCTS will also promote the
Superpopov/iStock/Thinkstock
VOLUME 10 | AUGUST 2014 © 2014 Macmillan Publishers Limited. All rights reserved
NEWS & VIEWS benefits afforded by public–private partnership so that cost-effective clinical research and effective therapies can be developed. For investigators, the ISN–ACCTS will offer vetting of trial protocols, connect those who have similar protocols and provide opportunities to mentor young investigators. Letters of support to endorse important studies and investigator abilities will be available. For governments, funding agencies and regulatory agencies, the ISN–ACCTS will represent the international community, in a unified voice, with respect to trial end points, appropriate study design and methodology in an unbiased and ethical framework. The need for internationally vetted and approved clinical trial end points for various conditions has been highlighted and is a priority for this group in 2014. The ISN–ACCTS will also advocate research into rare diseases, orphan drugs and cheaper alternatives to currently available treatments as well as inclusion of patients from low-income and middle-income countries in clinical studies. Through international networks of experts, advocacy for novel study designs and concepts, statistical methodologies and appropriate end points will be strengthened. The ISN–ACCTS will be accountable to the international community to demonstrate an increase in the
AUGUST 2014 | VOLUME 10
number of clinical studies conducted across multiple jurisdictions (either endorsed by the ISN–ACCTS or with its input). Using existing tools, conference venues and programmes, the ISN–ACCTS will promote formal training and mentoring for researchers in the execution of clinical trials. The ultimate measure of success will be an increase in the number of patients who reap the benefits of clinical-trial participation, therapeutic intervention and translation of knowledge from trials into clinical practice, coordinated through the ISN network. Of paramount importance is sustainably connecting the international nephrology community so that high-quality, meaningful research activities are part of the ethos of the specialty in the years ahead. We, as clinicians, exist in complex environments with diverse health-care services, levels of access to care and clinical trial participation. Academic–industry partnerships— whether private or public—are essential to ensure the success of our endeavors and should include patients, industry, governments, investigators, academic institutions, organizations and societies. The goal of the ISN–ACCTS initiative is to catalyse current efforts and to foster and maintain a network of local and international research collaborations. Through the iterative processes of the
scientific method and public dissemination, we can improve patient outcomes around the world. University of British Columbia, Division of Nephrology, 1081 Burrard Street, RM 60101, St Paul’s Hospital, Vancouver, BC V6Z 1Y6, Canada (A.L.). Istituto di Ricerche Farmacologiche Mario Negri, Centro Anna Maria Astori, Science and Technology Park Kilometro Rosso, Via Stezzano 87, Bergamo 24126, Italy (G.R.). Correspondence to: A.L. [email protected] Acknowledgements ISN–ACCTs members: N. Chen, R. Correa-Rotter, A. M. Cusumano, D. de Zeeuw, V. Jha, Z. H. Liu, T. Miyata, V. Perkovic, P. Ruggenenti, C. Swanepoel, D. Warnock, D. C. Wheeler. Competing interests The authors declare no competing interests. 1.
2.
3.
4.
5.
The International Society of Nephrology. theisn.org [online], http://www.theisn.org (2014). The Australasian Kidney Trials Network. aktn.org.au [online], http://www.aktn.org.au (2014). Oxford Clinical Trials Consortium. clinicaltrials.ox.ac.uk [online], http:// www.clinicaltrials.ox.ac.uk (2011). The George Institute for Global Health. georgeinstitute.org [online], http:// www.georgeinstitute.org (2013). Swanepoel, C. R., Wearne, N. & Okpechi, I. G. Nephrology in Africa—not yet uhuru. Nat. Rev. Nephrol. 9, 610–622 (2013).
www.nature.com/nrneph © 2014 Macmillan Publishers Limited. All rights reserved
ISN–ACCTS: global initiatives to improve clinical research Adeera Levin and Giuseppe Remuzzi
The International Society of Nephrology–Advisory Committee of Clinical Trials and Studies aims to ensure access to timely and unbiased expert advice for all investigators, and to facilitate the development and execution of clinical trials within a highly ethical framework. The initiative will foster high-quality, cost-effective research in a sustainable network. Levin, A. and Remuzzi, G. Nat. Rev. Nephrol. 10, 426–427 (2014); published online 10 June 2014; doi:10.1038/nrneph.2014.98
The International Society of Nephrology (ISN) represents a diverse community of clinicians, educators, basic scientists and clinical researchers. Affiliated societies and official partners include national and regional groups in high-income and low-income countries, patient groups and not-for-profit government agencies.1 In recognition of the current challenges encountered in nephrology research, the ISN has launched an initiative to foster and enhance collaborative research efforts so that high-quality clinical trials can be conducted around the world. The ISN Advisory Committee of Clinical Trials and Studies (ISN–ACCTS) is intended to serve two purposes: to ensure access to timely and u nbiased expert advice (for independent and industry investigators) and to facilitate the development and execution of clinical trials in a highly ethical framework. The ISN–ACCTS will work to protect the rights of clinical trial participants, both investigators and patients, particularly in developing countries.
‘‘
The ISN–ACCTS will be accountable to the international community...
’’
Many research groups have developed international collaborations to carry out large clinical trials, some of which involve a more formal network than others. 2-4 Academia and private industry have concordant goals to develop more-effective therapies in nephrology. Clinical trials conducted across multiple jurisdictions are
important to answer core questions and to ensure maximum generalizability of data and greater acceptance of new treatments by regulatory bodies in different countries. An appreciation of the diversity of cultures, resources, access to care and to education is fundamental to understand both the problems faced in clinical research and their solutions. Integrating the various perspectives of patients, health-care providers, scientists and funders is essential to ensure rigorous study design and execution. As the landscape of nephrology changes around the world, the burden of chronic kidney disease (CKD) is increasing, partly as a result of higher incidences of non communicable diseases, such as diabetes mellitus and hypertension, which are known drivers of CKD. Access to pathology services is increasing in developing countries; hence, the improved ability to diagnose the causes of kidney disease has highlighted the ability to identify individuals for study inclusion. Randomized control trials are essential to assess the safety and efficacy of new treatment strategies, drugs and devices; however, they might be difficult and expensive to execute. In specific countries, unique difficulties exist, such as i nadequate knowledge or expertise among local investigators, insufficient resources, limited regulatory expertise or even a lack of ethics committees to approve studies.5 Clinical research organizations (CROs) are often used by industry in conducting trials, but add to their expense. Challenges for CROs include insufficient knowledge of kidney disease among trial coordinators and a lack of access to research
NATURE REVIEWS | NEPHROLOGY
networks to identify experienced investigators. These difficulties can be e xacerbated in developing countries. The ISN–ACCTS will oversee the development of an information hub that delineates resources and research initiatives. Information offered by members on the availability of facilities for research in their countries and on existing investigatorinitiated clinical trials will be tabulated. Educational opportunities and communi cation about ongoing studies will be offered through ISN programmes and at ISN events. The ISN–ACCTS will ensure that regulatory authorities, ethics committees and patients are offered comprehensive and honest information about treatments already available for the clinical conditions that are being addressed in ongoing trials. The ISN–ACCTS will also advise privateindustry partners, investigators and government agencies on clinical trial design and conduct. This initiative will help to guide the evaluation and implementation of novel strategies (such as stepped-wedge design, enrichment protocols and pragmatic studies) to add to the armamentarium of traditional models of randomized controlled trials; identify and foster large networks of sites for patient enrolment; and develop academic centres as CROs to ensure cost-effective studies are carried out. As an independent group, the ISN–ACCTS will vet trial strat egies or details in a confidential setting and members will serve as independent, unbiased content and methodology experts. The ISN–ACCTS will also promote the
Superpopov/iStock/Thinkstock
VOLUME 10 | AUGUST 2014 © 2014 Macmillan Publishers Limited. All rights reserved
NEWS & VIEWS benefits afforded by public–private partnership so that cost-effective clinical research and effective therapies can be developed. For investigators, the ISN–ACCTS will offer vetting of trial protocols, connect those who have similar protocols and provide opportunities to mentor young investigators. Letters of support to endorse important studies and investigator abilities will be available. For governments, funding agencies and regulatory agencies, the ISN–ACCTS will represent the international community, in a unified voice, with respect to trial end points, appropriate study design and methodology in an unbiased and ethical framework. The need for internationally vetted and approved clinical trial end points for various conditions has been highlighted and is a priority for this group in 2014. The ISN–ACCTS will also advocate research into rare diseases, orphan drugs and cheaper alternatives to currently available treatments as well as inclusion of patients from low-income and middle-income countries in clinical studies. Through international networks of experts, advocacy for novel study designs and concepts, statistical methodologies and appropriate end points will be strengthened. The ISN–ACCTS will be accountable to the international community to demonstrate an increase in the
AUGUST 2014 | VOLUME 10
number of clinical studies conducted across multiple jurisdictions (either endorsed by the ISN–ACCTS or with its input). Using existing tools, conference venues and programmes, the ISN–ACCTS will promote formal training and mentoring for researchers in the execution of clinical trials. The ultimate measure of success will be an increase in the number of patients who reap the benefits of clinical-trial participation, therapeutic intervention and translation of knowledge from trials into clinical practice, coordinated through the ISN network. Of paramount importance is sustainably connecting the international nephrology community so that high-quality, meaningful research activities are part of the ethos of the specialty in the years ahead. We, as clinicians, exist in complex environments with diverse health-care services, levels of access to care and clinical trial participation. Academic–industry partnerships— whether private or public—are essential to ensure the success of our endeavors and should include patients, industry, governments, investigators, academic institutions, organizations and societies. The goal of the ISN–ACCTS initiative is to catalyse current efforts and to foster and maintain a network of local and international research collaborations. Through the iterative processes of the
scientific method and public dissemination, we can improve patient outcomes around the world. University of British Columbia, Division of Nephrology, 1081 Burrard Street, RM 60101, St Paul’s Hospital, Vancouver, BC V6Z 1Y6, Canada (A.L.). Istituto di Ricerche Farmacologiche Mario Negri, Centro Anna Maria Astori, Science and Technology Park Kilometro Rosso, Via Stezzano 87, Bergamo 24126, Italy (G.R.). Correspondence to: A.L. [email protected] Acknowledgements ISN–ACCTs members: N. Chen, R. Correa-Rotter, A. M. Cusumano, D. de Zeeuw, V. Jha, Z. H. Liu, T. Miyata, V. Perkovic, P. Ruggenenti, C. Swanepoel, D. Warnock, D. C. Wheeler. Competing interests The authors declare no competing interests. 1.
2.
3.
4.
5.
The International Society of Nephrology. theisn.org [online], http://www.theisn.org (2014). The Australasian Kidney Trials Network. aktn.org.au [online], http://www.aktn.org.au (2014). Oxford Clinical Trials Consortium. clinicaltrials.ox.ac.uk [online], http:// www.clinicaltrials.ox.ac.uk (2011). The George Institute for Global Health. georgeinstitute.org [online], http:// www.georgeinstitute.org (2013). Swanepoel, C. R., Wearne, N. & Okpechi, I. G. Nephrology in Africa—not yet uhuru. Nat. Rev. Nephrol. 9, 610–622 (2013).
www.nature.com/nrneph © 2014 Macmillan Publishers Limited. All rights reserved
