Research, Development, & Regulatory Roundtable (R3)

Topic: Expanded Access (Compassionate Use) for Drugs and Devices Abstract: The MRCT Center of Brigham and Women’s Hospital and Harvard and Ropes & Gray, LLP are pleased to announce the first meeting of the Research, Development,... [See Details]

Topics: 1) Update on the GDPR, including discussion of the EU/US data privacy framework; 2) Considerations for ensuring accurate clinical trials data OPEN TO THE PUBLIC GDPR: This session will involve a panel discussion exploring developments occurring... [See Details]

Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070 Deliverables Projects [See Details]

Research Collaboration with China: Where are we now with Data Privacy, Export Controls, and Foreign Influence? Deliverables Projects [See Details]

Challenges in Decentralized Clinical Trials – Open Discussion Forum Deliverables Projects [See Details]

The Revolution in Online Behavioral Advertising – What it Means for the Research Enterprise Deliverables Projects [See Details]

The provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization Deliverables Projects [See Details]

An overview of the FDA’s recent final guidance on clinical decision support (“CDS”) software, with a focus on its application to clinical research settings. Deliverables Projects [See Details]

In an increasingly connected world, clinical trials and other research activities are no longer state- or country-specific. Not surprisingly, the globalization of research activities creates any number of legal and compliance challenges for stakeholders involved in... [See Details]

As more states move to legalize marijuana, the regulatory landscape is becoming increasingly complex. The number of sponsors and researchers inquiring about these regulations has also increased. Clinical research involving cannabis is subject to both federal... [See Details]

The core activities of clinical trials are typically conducted at physical locations referred to as “sites.” Traditionally, these sites are hospitals or academic medical centers. While these traditional sites remain important fixtures in the clinical trial... [See Details]

The European Union (“EU”) General Data Protection Regulation (“GDPR”) and its effect on research activities was the first topic addressed by the R3 at its initial meetings in 2018. In the four years since those meetings,... [See Details]

Research that is executed in part or in whole through remote modalities, such as telemedicine and health care providers who visit participant homes, is increasingly commonplace yet complicated. Decentralized research raises novel questions regarding whether and... [See Details]

In the past 18 months there have been several important developments related to the GDPR, including the Schrems II decision, the resulting European Data Protection Board guidance on cross-border data transfers, and the issuance of revised... [See Details]

In recent years, FDA has increasingly focused on honing its approach to regulating digital health tools and technologies, including those used in the research setting. This presentation focused on the Agency’s risk-based approach to regulation in... [See Details]

Some state privacy laws apply to specific types of data that might be used in research. Other state privacy laws, sometimes referred to as omnibus privacy laws, regulate the collection and use of personal data throughout... [See Details]

Meeting attendees overviewed and discussed the history of LDT regulation, shifting approaches to LDT regulation before and during the COVID-19 pandemic, strategies for navigating LDT regulation, and the relevance of FDA’s investigational device exemption framework to... [See Details]

Decentralized clinical trials (DCTs) are clinical trials that are executed in part or in whole through remote modalities, such as telemedicine, smart phone applications, and health care providers who visit participant homes. Vendors engaged in DCTs... [See Details]

There has been an increase in sustained interactions between sponsors of clinical research or their designees and potential and enrolled study participants and their families. Sponsor interactions with study participants and their families raise certain legal... [See Details]

Research misconduct allegations may trigger reporting obligations to domestic and international funding agencies, health regulatory authorities, and others. R3 attendees, which included representatives from U.S. funding and regulatory agencies, academia, and biopharmaceutical companies, discussed the challenges... [See Details]

Communication between journals, publishers, and institutions on questions of research misconduct is often lacking due to several reasons, including the speed with which journals seek to resolve these questions and institutional hesitancy to breach the confidentiality... [See Details]

When an academic institution or life sciences company becomes aware of allegations of research misconduct (i.e., fabrication or falsification of data and/or images, and plagiarism) relating to their researchers, a challenging and time-intensive process of review... [See Details]

Meeting attendees discussed the clinical research regulatory landscape during the COVID-19 pandemic, identifying areas that could be improved upon to foster less burdensome and higher-quality research. Deliverables Projects Meeting Summary Released on: July 7, 2020 Topics:... [See Details]

The second part of the meeting will address the effect on clinical research of fraud and abuse laws, including the Anti-Kickback Statute and the Beneficiary Inducement provisions of the Civil Monetary Penalty Law, as well as... [See Details]

The first part of the meeting will address the ongoing National Institutes of Health (NIH) and U.S. Department of Defense (DoD) investigations into foreign influence in American research. The NIH and DoD investigations have focused on... [See Details]

Attendees focused on regulatory ambiguities surrounding sIRB usage as research enterprises prepare to transition to full compliance with the Revised Common Rule. Attendees also addressed interpretations of the phrase 'key information' and examined how much authority... [See Details]

Regulatory Challenges for Decentralized Clinical Trials Decentralized trials promise to modernize the research landscape, optimizing the trial experience for participants, investigators, and sponsors by increasing access to experimental and other therapies and rendering trials more convenient... [See Details]

An increasing number of companies and research institutes wish to enroll their own employees and students in research studies. While employees can serve as a convenient source of potential study participants, enrolling one’s own employees and... [See Details]

China’s new Regulation of Human Genetic Resources (HGR) took effect on July 1, 2019. The regulation closely scrutinizes all HGR-related activity from upstream collection of human biospecimens to downstream exploitation and sharing of the biomaterials and... [See Details]

The third Research, Development, and Regulatory Roundtable (R3) was held at the Washington, D.C. offices of Ropes & Gray LLP on March 7, 2019. Stakeholders convened to discuss Secondary Uses of Health Care Data for Clinical... [See Details]

Attendees discussed the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies. Among other things, we considered the impact of each avenue on long-term drug development, the resources... [See Details]

Convening representatives from academia, industry, and government, this conference explored the impact of the EU GDPR on human subjects research, highlighting the challenges posed by the GDPR to clinical research, biobanking and databanking, and big data... [See Details]