Podcast December 8, 2017: Data and Safety Monitoring in Pragmatic Clinical Trials (Greg Simon, MD, MPH, and Susan Ellenberg, PhD)

 

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Greg Simon, principal investigator of the Suicide Prevention Outreach Trial (SPOT), and Susan Ellenberg, a member of the Collaboratory Regulatory/Ethics Core, speak with moderator Dr. Adrian Hernandez about the factors that determine the need for a Data and Safety Monitoring Board (DSMB) in pragmatic trials.

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Want to hear more from Drs. Simon and Ellenberg, with their colleague Dr. Sugarman? View the full Grand Rounds presentation. 

We encourage you to share this podcast with your colleagues and tune in for our next episode with Grand Rounds speakers Drs. Richard Platt and Christopher Granger, who will discuss “IMPACT-AFib: An 80,000 person Randomized Trial Using the Sentinel Initiative Platform.”

Read the transcript here.

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Podcast November 14, 2017: Moderators’ Edition: Discussion of the Future of the NIH Collaboratory

In this episode of the NIH Collaboratory Grand Rounds podcast, Drs. Adrian Hernandez and Kevin Weinfurt, two NIH Collaboratory Co-PIs and podcast moderators, discuss their predictions and hopes for the NIH Collaboratory in the next year.

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We encourage you to share this podcast with your colleagues and tune in for our next edition with Dr. Susan Ellenberg on “Data and Safety Monitoring in Pragmatic Clinical Trials.”

Read the blog and the full transcript here.

 

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Podcast October 27, 2017: Bringing Machine Learning to the Point of Care to Improve Suicide Prevention (Greg Simon, MD, MPH)

In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Greg Simon of the Kaiser Permanente Washington Health Research Institute speaks with the NIH Collaboratory’s Dr. Lesley Curtis about the integration of machine learning into suicide prevention.

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Want to hear more from Dr. Simon and his colleagues? View the full Grand Rounds presentation.

Read the transcript here.

We encourage you to share this podcast with your colleagues and tune in for our special “Moderators’ Edition” episode of the podcast with Grand Rounds moderators Dr. Adrian Hernandez and Dr. Kevin Weinfurt.  It will be posted the week of November 13th.

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Podcast October 6, 2017: Health Is More Than Healthcare (Karen DeSalvo, MD, MPH, MSc)

In this second episode of the NIH Collaboratory Grand Rounds podcast, Dr. Karen DeSalvo, former acting Assistant Secretary for Health and Human Services, speaks with the NIH Collaboratory’s Dr. Kevin Weinfurt about the factors other than healthcare systems than impact the health of our communities.

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Want to hear more from Dr. DeSalvo? View the full Grand Rounds presentation. 

We encourage you to share this podcast with your colleagues and tune in for our next episode with Grand Rounds speakers Drs. Greg Simon, Susan Shortreed, and Don Mordecai, who will discuss “Bringing Machine Learning to the Point of Care to Improve Suicide Prevention.”

Read the transcript here.

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Podcast September 29, 2017: Preprints: What, Why Not, and How (Harlan Krumholz, MD)

In this first episode of the NIH Collaboratory Grand Rounds podcast, Dr. Harlan Krumholz of Yale University Medical Center speaks with the NIH Collaboratory’s Dr. Adrian Hernandez about the ways preprint servers can help accelerate scientific progress through greater access to research results.

Click on the recording below to listen to the podcast.

Want to hear more from Dr. Krumholz? View the full Grand Rounds presentation. 

We encourage you to share this podcast with your colleagues and tune in for our next episode with Grand Rounds speaker Dr. Karen DeSalvo, who will discuss “Health Is More Than Healthcare.”

Read the transcript here.

 

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August 11, 2017: Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience

Speaker

Gordon R. Bernard, MD, Melinda Owen Bass Professor of Medicine, Executive Vice President for Research, and Director, Vanderbilt Institute for Clinical and Translational Research at the Vanderbilt University Medical Center

Topic

Embedding Clinical Trials Into Care Delivery: The Vanderbilt Experience

Keywords

Pragmatic clinical trials; CTSA; Clinical and Translational Science Award; Learning healthcare system; Translational science; Study design

Key Points

  • Vanderbilt’s CTSA program serves as a reusable platform to foster a learning healthcare system. The platform consists of study-specific tailoring for protocol customization and endpoint selection, as well as a reusable fixed infrastructure for institutional and regulatory policy, master protocols, clinical decision support, clinical registries, real-time EHR data capture, expert cores, and a standing data and safety monitoring board.
  • In a learning healthcare system, clinical operations are integrated with clinical research to support research endeavors that answer real-world questions in clinical settings. Novel study structures permit informatics-enhanced interventions and data collection.

Discussion Themes

Are there data to demonstrate the “value” of combining learning (research) with operations?

How do you present the idea of having a partnership between research and clinical care to the hospital? How do you get buy-in?

Is there concern that you will stifle evolving technologies that would work if done after a year or two of learning how to do it?

Prioritize study questions by evaluating how quickly it will take to get an answer, how important the question is, or whether there will be clear benefit to patient outcomes.

For More Information

Read more about Vanderbilt’s CTSA program at https://victr.vanderbilt.edu/pub/vuctsa/index.html.

Tags
#pctGR, #LearningHealthSystem
@PCTGrandRounds, @Collaboratory1, @PCORnetwork

 

August 4, 2017: PCORnet Research Innovations: Engagement, Dissemination, and (Hopefully) Tech Transfer Pilots

Speaker

Thomas Carton, PhD, MS, Louisiana Public Health Institute, and Principal Investigator of PCORnet’s REACHnet Clinical Data Research Network

Topic

PCORnet Research Innovations: Engagement, Dissemination, and (Hopefully) Tech Transfer Pilots

Keywords

Pragmatic clinical trial; Clinical research; Patient engagement; PCORI; PCORnet; NCATS; REACHnet; Clinical Data Research Network

Key Points

  • PCORnet is a national “network of networks” designed for people-centered research. It consists of 20 Patient-Powered Research Networks (PCRNs), 13 Clinical Data Research Networks, and a Coordinating Center.
  • PCORnet’s Research Innovation Workgroup was created to pilot test network-driven innovations and boost the efficiency of pragmatic clinical trials. PCORnet is collaborating with the National Center for Advancing Translational Sciences (NCATS) Recruitment Innovation Center to foster shared learning and a joint dissemination approach.
  • The workgroup distributed an engagement survey to see which innovative tools held the most interest across PCORnet. The highest ratings were for tools that allowed study results to be returned to patients and those that allowed e-consent of patients to registries or clinical trials.
  • Dissemination and sharing of results will involve a series of PCORnet Best Practices webinars (coordinated with NCATS) to highlight tool sets and promote tech transfer between networks.

Discussion Themes

What are the best methods for promoting the use of PCORnet’s Commons and engagement overall? Are there incentives for networks to share these innovative tools and materials?

The PCORnet Commons is a site for uploading and sharing tools. Technological adoption of the site is an ongoing process.

For More Information

To learn more about PCORnet’s approach to engagement in research, visit http://www.pcornet.org/about-pcornet/engagement-in-research/.
Read more about PCORnet’s Commons collaborative space.

Tags
@Collaboratory1, @PCORI, @PCORnet, @NCATS_NIH_gov
#ClinicalTrials, #ClinicalResearch #pctGR, #PCORnetwork

 

July 28, 2017: FDA says will not object to waiver of informed consent for minimal risk studies in new guidance

In a new guidance, the US Food and Drug Administration (FDA) explains that it does not intend to object to the conduct of a minimal risk clinical study if the institutional review board has waived or altered the requirement for informed consent. While the Common Rule, a policy that applies to 17 federal agencies, allows waivers or alteration of informed consent for studies that carry no more than minimal risk, the FDA does not currently have such a provision. The 21st Century Cures Act gives the FDA authority to permit this exception, and the new guidance makes this intention clear until FDA regulations are updated to reflect the change.

Read the full guidance: IRB Waiver or Alteration of Informed Consent forClinical Investigations Involving No More Than Minimal Risk to HumanSubjects

July 28, 2017: The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges

Speakers

Galia Siegel, PhD, National Institute of Mental Health (NIMH)

Anna Ordonez, MD, MAS, National Institute of Mental Health (NIMH)

Scott Kim, MD, PhD, Department of Bioethics Clinical Center, National Institutes of Health

Kate Comtois, PhD, MPH, Harborview Medical Center, University of Washington School of Medicine

Topic

The DSMB Role in Pragmatic Trials: NIMH Progress and Challenges

Keywords

Data and Safety Monitoring Boards; DSMB; Pragmatic clinical trial; Clinical trial registries; CTTI; Post-randomization informed consent; Study designs; Zelen design; Stepped-wedge randomization; Suicide Prevention Outreach Trial (SPOT)

Key Points

  • Pragmatic trial study designs that involve post-randomization informed consent or stepped-wedge randomization pose new challenges for review by Data and Safety Monitoring Boards (DSMBs).
  • The FDA will now allow a waiver or alteration of informed consent for qualifying randomized controlled pragmatic trials.
  • Experiences in the NIMH-funded Suicide Prevention Outreach Trial (SPOT) suggest a need for better knowledge of the implications of post-randomization consent design in clinical trials.
  • Potential benefits of post-randomization consent for research participants include reduced burden and less unnecessary information on the consent form. This type of informed consent also better mimics real-life outcomes. Benefits of post-randomization consent for investigators include 100% participation in the trial’s control arm and fewer resources needed for the consent process.

Discussion Themes

When there is an opportunity to obtain consent, when is waiver permissible?

Include stakeholders in discussions of thresholds for study participation and plans for safety monitoring.

A high refusal rate in post-randomization consent may lead to selection bias, which is a threat to the benefit of randomization.

There is a delicate balance between the interests of the participant and the interests of the trial, making the monitoring of adverse events so critical.

For More Information

To learn more about data monitoring in pragmatic trials, visit http://ctj.sagepub.com/content/12/5/530.full

Tags
@NIMHgov, @NIH, @NIHbioethics, @Collaboratory1, @US_FDA, #clinicaltrials, #clinicalresearch #pctGR

 

July 21, 2017: CTTI Registry Trials Project: Evaluation and Design of Registries for Conducting Clinical Trials

Speaker

John Laschinger, MD, FDA and Jules Mitchel, MBA, PhD, Target Health

Topic

CTTI Registry Trials Project: Evaluation and Design of Registries for Conducting Clinical Trials

Keywords

Pragmatic clinical trial; Clinical research; Clinical trial registries, CTTI

Key Points

  • Stakeholder collaboration to leverage patient registries for quality trials will result in maximum impact in clinical research
  • Patient protections, interoperability, and data quality are key considerations for designing registry-embedded clinical trials
  • CTTI recommendations for existing registries include evaluation of historical evidence for quality and privacy/security elements on a suitable platform.
  • Recommendations also include following industry and regulatory guidelines and creating methods for compliance in real-world use
  • Relevancy, reliability, and robustness are key factors in suitability of registry for regulatory purposes and reuse across clinical trials

Discussion Themes

The beauty of a registry is that the majority of the data needed is already there, and it does not have to be recreated from scratch.

Patient-reported outcomes and patient-centered outcomes that are in the older registries were likely not designed in partnership with patients so there should be some mechanisms for assessing that.

Facilitating bidirectional engagement by moving registries to platforms is necessary for optimizing patient engagement in research.

Overcoming barriers to using existing registry data use starts with changing the approach to adoption through demonstration projects and unified commitment among stakeholders.

Cost and sustainability are major considerations when building registries because of user management and maintenance, but if created thoughtfully, these registries can be used efficiently.

For More Information

To learn more about the CTTI Registry Trials Project, visit https://www.ctti-clinicaltrials.org/projects/registry-trials

Tags
@DCRI, @CTTI_Trials, @Collaboratory1, @US_FDA, @TargetHealthInc, #clinicaltrials, #pctGR