As of July 1, 2015, the MRCT Center has moved administratively to the Division of Global Health Equity, under the leadership of Dr. Paul Farmer, at the Brigham and Women’s Hospital (BWH), a Harvard teaching hospital. The Division of Global Health Equity serves as an academic and research home for more than 40 Harvard and BWH faculty who are engaged in teaching, patient care and research around the world and domestically.
The integration of the MRCT Center into the Division offers a community of colleagues and a network of thought leaders globally, as well as infrastructure for program strengthening and expansion. The mission of the MRCT Center will remain unchanged and will be strengthened through this new partnership. The MRCT Center will continue to have a collaborative relationship with Harvard, including the continued involvement of multiple Harvard faculty members and student interns.
In the process of this move, the URL of the MRCT Center’s website changed to: mrctcenter.org, and our email addresses changed to @MRCTcenter.org. Web searches and emails to previous addresses will be redirected. The general email box for the center is admin@MRCTcenter.org. Our full name is now: The MRCT Center of Harvard and Brigham and Women’s Hospital.
On March 30-31st, 2015, over seventy committed international stakeholders joined together at the Harvard Faculty Club in Cambridge Massachusetts to deliberate how to promote and coordinate clinical trials data transparency. Over the two day conference, renowned experts from academia, industry and others shared their organizational experiences in data sharing, distilled best practices, described lessons learned from case studies, reviewed recommendations from the Institute of Medicine report: Strategies for Responsible Sharing of Clinical Trial Data, and considered how best to put those recommendations into practice.
The explicit goal of the conference was to develop an approach whereby:
Expectations and practices of registration and results reporting of all clinical trials would be regularized among industry and academia;
Greater access to participants-level clinical trial data could be facilitated using a common portal;
Researchers would be able to access and combine data across various platforms and sponsors, to multiply opportunities for data analysis; and
Research participant privacy can be safeguarded
The assembled participants separated into four parallel break-out sessions to discuss lessons learned in their ongoing data sharing initiatives and to consider options for promoting clinical trials data sharing and bringing consistency to data sharing efforts. The data sharing models that emerged from these discussions shared similar characteristics including:
Organizational structure – A centralized, international, not-for-profit organization responsible for a coordinated data sharing initiative;
A centralized and single portal – A central user interface with a robust search engine functionality, including information on trials around the world, with the capability to grow and add data from new sponsors;
Governance – Creation of an empowered central multi-stakeholder body with authority and accountability to enable the long term vision wherein a not-for-profit entity may promote and oversee the data sharing enterprise end-to-end;
Data requirements – Sufficient data pedigree including, data definition and metadata to enable the appropriate integration of datasets across studies and sponsors for analysis;
Shared or common services – Efficient shared or common services across data generators / sponsors (policy setting, data de-identification, and when appropriate, criteria for independent review panel decisions); and
Flexibility – A data platform that accommodates differing expectations and research needs, including the ability to download data if freely available and the ability to host data for those data generators that do not wish to do so themselves.
Consensus in three primary action areas was identified, with a goal of working toward implementation over the next 18 months. These areas encompass:
The creation of a working group tasked with development of specific principles, operating guidelines, and characteristics of the suggested not-for-profit organization and its governance. The goal of the not-for-profit organization would be to oversee, create, implement and direct a sustainable data-sharing platform. Initially this working group will be led by MRCT Center at Harvard and the Wellcome Trust, with active participation from the John and Laura Arnold Foundation.
The results and recommendations of the working group would be reviewed and commented upon by a variety of public and private stakeholders, not limited to the participants in the March 2015 Harvard meeting. Discussions and follow-up will be expanded to include the perspectives of trial registries, start-up companies, university leaders, public sponsors, disease foundations and medical journals.
Policy initiatives and a communication plan will be created to promote and incentivize clinical trials data sharing. This will potentially include journal publishing requirements, academic and faculty acknowledgements of contributions relevant for promotions, and others, to promote practices of open data in the academic setting.
The participants of the data-sharing workshop demonstrated their personal commitments to data transparency and agreed that progress toward a sustainable solution may be challenging but is an important transformative goal.
This conference, which followed from an earlier multi-stakeholder conference held at Harvard in May 2013, was supported and hosted by The MRCT Center at Harvard, the Laura and John Arnold Foundation, and the Wellcome Trust.
On March 30-31st, 2015 over 70 committed international stakeholders joined together at the Harvard Faculty Club to discuss solutions to Clinical Trial Data Sharing.
Prior to the conference, Deloitte partnered with the MRCT Center to identify common principles, views on data sharing, and methods for sharing of participant level clinical trial data across a cross-section of those anticipated to attend the conference.
Interviews conducted with 21 individuals from industry, foundations, and academia identified common principles for sharing of participant level clinical trial data. Interviewees supported the sharing of data to advance science and improve public health if the following were given:
Protecting patient rights and privacy
Ensuring responsible conduct of research and good stewardship of data
Maintaining incentives for those who generate data to conduct new research
The survey also showed that 100% of respondents supported the value of data sharing and the aggregation of data, but specifics of what data to share varied from making all data available to making data available on request after internal review for legal and competitive risk. A central system that allows for interoperability was widely considered to be the preferred option, however, many challenges needed to be addressed, including:
Use of common data standard
Resources to anonymize data
Data repository for academics
User friendly system
Ability to combine data easily
Common criteria or common review board
Governance of the central system
Moreover, to improve transparency, interviewees plan to or are currently publishing metrics of data requests and track reasons for denial. Data from respondents show that 93% of data requests have been approved, though the time for approval varied widely. Reasons for denying a request for data include: proposal lacks clear scientific merit, data requested is not appropriate for the study proposal, Data Use Agreement was not signed, out of scope for informed consent, etc. To achieve a shared vision for an interoperable system, key process points should be harmonized such as proposal review, uploading data, system framework, and end of study requirements. The full results may be accessed here.
MRCT hosted a Data Transparency Conference at Harvard, 30-31 March.
More than 70 participants from academia government, industry, and nonprofit organizations gathered at the Harvard Faculty Club for a 2-day conference focused on how to harness the full potential of participant level data sets for secondary use.
Conference participants developed a vision for a future governance model that envisioned the ideal system as a federated data platform allowing access to data from a variety of sources with broad search capabilities.
Learn More about the MRCT Center’s work in clinical trial data sharing and transparency.
Standardizing Informed Consent Forms (ICFs) and Data Use Agreements (DUAs) across multiple sponsors may considerably streamline the data sharing process.
A multi-stakeholder working group at the MRCT Center released revised ICF and DUA templates at the March Data Transparency Conference. The revised DUA template provides legal text for a data sharing agreement between a recipient institution and a supplying institution. The ICF provides suggested text for prospectively informing participants on how broadly their data will be shared and with whom. Further comments on these documents are welcome and can be sent to MRCT@harvard.edu.
In March, we submitted public comments to the National Institutes of Health in response to the Proposed Rule for Clinical Trial Registration and Results Submission. Our comments addressed the need for:
Providing non-technical summaries that follow health literacy principles and use non-promotional language so that they benefit trial participants and their families
Extending and coordinating results submission deadlines
Adopting standard data formats across agencies
Mandatory expanded access reporting, and
Extending the timeframe for submitting corrections of clinical trial information.
MRCT Center at Harvard 2014 Annual Meeting was held on 3 December 2014 and was attended by by more than 60 stakeholders from governmental agencies, pharmaceutical industry, academia, patient advocates, media representatives and others. MRCT Center at Harvard’s Annual Progress Report 2014 was released at the meeting.
The meeting focused on returning aggregate results to research participants. MRCT Center at Harvard faculty co-directors presented drafts of the Return of Results Guidance Document and Toolkit which was followed by perspectives from various stakeholders. In addition, the faculty co-directors gave an overview of MRCT Center at Harvard’s work in India addressing regulatory issues, causality determination, and compensation calculation. Presentations and Proceedings from this meeting are now available
