When Indian regulators implemented a series of new clinical trial regulations in 2013, clinical trials in India ground to a halt. Under the new regulations, clinical trial sponsors would be responsible for compensating participants who were injured or died during the trial, even if the death or injury was unrelated to the trial itself. Virtually all clinical trials sponsors, including the National Institutes of Health, stopped initiating any new trials. Less than two percent of the world’s clinical trials were unfolding in a country that is home to one-seventh of the world’s population. Barbara Bierer, MD, co-director of the Multi-Regional Clinical Trials (MRCT) Center, had been following the dilemma in India closely.
Bierer and Mark Barnes, then at Harvard University, had launched the MRCT Center in 2011 to define and address emerging issues in global clinical trials. By bringing together a variety of stakeholders, the center aims to find solutions to improve the integrity, safety and rigor of trials around the world.
After the new regulations were announced, Bierer and her colleagues reached out to government officials and industry and academic stakeholders in India, organized roundtable discussions and, over the course of more than 14 visits to the country, worked closely with Indian leaders to help to develop fair amendments to the earlier legislation and address the issues resulting from regulatory reform. The MRCT Center has been involved in training, and in developing scalable tools that will assist the appropriate application of the regulations such as a tool to assess causality to determine whether a death or injury is directly linked to a clinical trial. Their efforts continue today.
Through ongoing efforts, the MRCT Center and its partners are working to develop solutions to allow clinical trials to flourish while also creating safeguards for trial participants not only in India, but also in China, South Africa and elsewhere. According to Bierer, the faculty co-director and co-chair of the MRCT Center, addressing emerging issues related to clinical trials will require a global perspective and multi-disciplinary approach.
“Several organizations in the U.S. are dedicated to national clinical trials efforts, but a significant proportion of clinical trials are global in nature,” said Bierer. “Long-term solutions to problems arising from the globalization of clinical research will require input from multi-disciplinary stakeholders – including academics, industry, not-for-profit organizations, regulators and patient advocates around the world. The future of clinical research, for the benefit of patients worldwide, is predicated on addressing these issues.”
During her time at BWH and in her previous role as senior vice president of research at BWH, Bierer became increasingly interested in the problems that arise in international clinical trials. Together with Barnes, a lawyer specializing in health care law, Bierer assembled a team to help meet four main objectives:
- Develop standards
- Establish best practices
- Identify opportunities for improvement
- Improve transparency
Over the MRCT Center’s first year, Bierer and Barnes worked to raise sufficient donations to hire a small staff. Rebecca Li began as the executive director in 2012; a project manager was hired shortly thereafter, and the center has grown successfully over the last several years. The center, which is a part of BWH’s Division of Global Health Equity, moved to BWH in 2015.
“Under Dr. Bierer’s leadership, the MRCT center has helped build the processes and organizations needed to do research in nations suffering from poor health systems and a large burden of illness,” said Paul Farmer, MD, PhD, chief of BWH’s Division of Global Health Equity and co-founder of Partners In Health (PIH). “These are the very places where we need to find the answers to pressing questions in health care delivery, and in this, the center’s work fits squarely in the division’s mission to achieve health equity globally.”
Since its inception, the MRCT Center has undertaken nine major projects, of which seven are heavily or exclusively focused on regulatory, legal and policy issues. The other two projects focus on ethics and clinical trial safety, including returning aggregate and individual results from the trial to participants and increasing data transparency and data sharing.
The problems that the MRCT Center and its partners are trying to address are nuanced and complex, and even when legislators have the best of intentions, solutions can create unforeseen challenges. At a Partnership Grand Rounds meeting in January, Bierer gave an example from one of the new points of legislation that has been put in place in India. To ensure that informed consent had been obtained from all participants in a trial, including those who could not read or write, the new legislation would require that every participant be subject to an audio-video recording in which their consent for participation in a clinical trial would be documented. However, many sites for trials lacked audio/visual equipment, and in some instances, participants did not want to be recorded for privacy or cultural reasons. Additionally, no plans were in place for where to store the video recordings once submitted.
“Each issue – such as obtaining informed consent – is complicated,” said Bierer. “At the MRCT Center, we address the complexities and work through the solutions collectively. We have a shared appreciation for the kinds of compromises sustainable solutions require, and we are receptive to the feedback of the multiple stakeholder groups with which we engage.”
In 2015, the MRCT Center convened a two-day conference of thought leaders in clinical data transparency, developing a vision for an interoperable platform for data sharing. This year, at a conference this March at the Wellcome Trust, leaders will present plans to launch a new not-for-profit organization charged with directing, implementing and governing a global clinical trial data-sharing platform. These plans articulate an approach whereby data from multiple sources can be integrated, enabling researchers to access and combine data across various platforms and sponsors.
The Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard was recently honored with the 2015 Award for Excellence in Human Research Protection-Best Practice for its exceptional work in promoting the well-being of human research participants. Read more in BWH Awards, Honors & Grants.