September 14, 2018: Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials (John Hubbard, PhD, Barry Peterson, PhD, Cheryl Grandinetti, PharmD)

Speakers

John Hubbard, PhD
Healthcare Strategic Advisory Board
Genstar Capital

Barry Peterson, PhD
Independent Consultant

Cheryl Grandinetti, PharmD
Office of Compliance, Office of Scientific Investigations, Division of Clinical Compliance Evaluation
Center for Drug Evaluation and Research
Food and Drug Administration

Topic

Advancing the Use of Mobile Technologies for Data Capture & Improved Clinical Trials

Keywords

Clinical trials; Mobile health technologies; Clinical Trials Transformation Initiative; CTTI; FDA; Data integrity

Key Points

  • The goal of CTTI’s Mobile Clinical Trials program is to develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission.
  • Potential benefits of using mobile technology include higher quality, patient-centric endpoints and fewer barriers to participation in clinical trials.
  • Data access issues to consider before selecting a mobile technology include:
    • How will the data generated by the mobile technology be accessed and used by the manufacturer?
    • What data will be provided by the manufacturer to the sponsor?
  • The mobile era creates new data security demands.

Discussion Themes

CTTI’s recommendations aim to help sponsors determine the right device to use, how to write the protocol for remote data capture, and how to protect and analyze the data.

Know what you want to measure before selecting the mobile technology. The appropriateness of the selection should be justified through verification and validation processes.

Ensure the authenticity, integrity, and confidentiality of data over its entire lifecycle.

To reduce risk in large trials, conduct feasibility studies before full implementation.

Visit CTTI for more recommendations and resources for mobile clinical trials.

 

Tags

@CTTI_Trials, @PCTGrandRounds, #MobileTech, #pctGR

September 7, 2018: NIH Collaboratory: Research Transformation in Progress (Adrian Hernandez MD, MHS, Kevin Weinfurt, PhD, Lesley Curtis, PhD)

Speakers

Adrian F. Hernandez, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine

Kevin Weinfurt, PhD
Professor and Vice Chair for Research
Department of Population Health Sciences
Duke University School of Medicine

Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Duke University School of Medicine
Interim Executive Director, Duke Clinical Research Institute

Topic

NIH Collaboratory: Research Transformation in Progress

Keywords

Clinical trials; Research studies; Healthcare delivery; Clinical care; embedded pragmatic clinical trials; ePCTs; Peer-reviewed journals; Demonstration projects; NIH funding

Key Points

  • The goal of the NIH Collaboratory is to strengthen the national capacity to implement cost-effective large-scale research studies that engage healthcare delivery organizations as research partners.
  • Embedded pragmatic clinical trials bridge research into clinical care.
  • The NIH Collaboratory has contributed to 80 publications about embedded pragmatic trials in peer-reviewed journals.
  • Six new demonstration projects were recently added to the NIH Collaboratory portfolio:
    • Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training (ACP PEACE)
    • Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
    • Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (GGC4H: Guiding Good Choices for Health)
    • Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED)
    • Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
      Primary Palliative Care for Emergency Medicine (PRIM-ER)

Discussion Themes

The NIH Collaboratory is addressing many of the challenges and logistical barriers to conducting pragmatic clinical trials embedded in healthcare systems. There is still progress to be made in explaining the value and benefit of embedded PCTs (ePCTs) to healthcare leadership.

The NIH Collaboratory workshops have had a positive impact and have increased NIH’s interest in supporting the conduct of ePCTs.

Determining how pragmatic clinical trials can be conducted more routinely will be critical to their impact.

 

Tags

@texhern, @lmhcurtis, @PCTGrandRounds, #pctGR #ClinicalResearch, #researchstudies, #clinicaltrials, #clinicalcare, #peerreviewed

August 24, 2018: FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research (Mark Huffman, MD, MPH)

Speaker

Mark Huffman, MD, MPH
Associate Professor of Preventive Medicine and Medicine-Cardiology
Northwestern University Feinberg School of Medicine

Topic

FoodSwitch USA: A Mobile Platform for Packaged Food Surveillance and Behavioral Research

Keywords

FoodSwitch app; Mobile platform; Behavioral research; Packaged food surveillance; Crowdsourcing; Food supply; One Brave Idea; Community engagement; Health research; Food labeling

Key Points

  • FoodSwitch USA is a mobile platform that uses crowdsourcing for packaged food surveillance and can be used for behavioral research.
  • Crowdsourcing can be used to generate ideas, improve data collection, and enhance community engagement in health research.
  • The Global Food Monitoring Group brings together data on nutritional information for processed foods and can be used to drive national and international improvements in the food supply. There are 31 countries involved, with two-thirds representing lower to middle income countries.

Discussion Themes

There are hopes that FoodSwitch USA will eventually be classified as a mobile medical app by the FDA because the goal is to prove that if the application is used, it can help people lower their blood pressure by reducing their salt intake.

The FoodSwitch USA project is in the early stages of community engagement. There are current efforts to increase media exposure so that more are aware of the application and its benefits. The benefits include an easier sign up process, no “up-selling” to a premium model, and no linkage to any profit-driven interests.

 Crowdsourcing data “noise” can be reduced at the Label Insight level. Learn more about Food Switch USA and Label Insight.

 

Tags

@Mark_Huffman, @NUFeinbergMed, #MobilePlatform, #pctGR, #OneBraveIdea, #processedfoods, #communityengagement, #healthresearch, #crowdsourcing

August 17, 2018: The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet Demonstration Project (David Arterburn, MD, MPH, Kathleen McTigue, MD, MPH, Neely Williams, Mdiv, Laura Rasmussen-Torvik, PhD)

Speakers

David Arterburn, MD, MPH
Kaiser Permanente Washington

Kathleen McTigue, MD, MPH
University of Pittsburgh Medical Center

Neely Williams, Mdiv
Patient Collaborator, Mid-South CDRN

Laura Rasmussen-Torvik, PhD
Northwestern Medicine

Topic

The PCORnet Bariatric Study: Preliminary Results from a Large PCORnet Demonstration Project

Keywords

PCORnet bariatric study; Weight loss; Diabetes risk; Stakeholder involvement; Health systems data; Clinical data research networks; Adjustable gastric band; Roux-en-Y gastric bypass; Vertical sleeve gastrectomy

Key Points

  • In 2014, the PCORnet Obesity Task Force was established to help generate and prioritize obesity research topics. Their work led to a Patient-Centered Outcomes Research Institute (PCORI) funding announcement for two topics: weight loss surgery and effects of antibiotics on weight in children.
  • The PCORnet Bariatric Study assessed the three most commonly used weight loss procedures and impacts on weight loss/gain, improvement in diabetes risk, and adverse events over 1-, 3-, and 5-year periods. 
  • More than 46,000 adults and nearly one dozen health systems helped contribute data in the PCORnet Bariatric Study.

Discussion Themes

The qualitative aims of the PCORnet Bariatric Study will complement the quantitative aims by incorporating interviews with surgeons and bariatric patients. The analysis of the qualitative aims is still ongoing.

The dissemination plan for the PCORnet Bariatric Study includes lay summaries for each of the project aims. When all publications have completed the peer-review process, the lay summaries will be developed and publicly shared.

The PCORnet Bariatric Study is an example of the power of aggregated data using the PCORnet Common Data Model (CDM). Visit the PCORnet CDM webpage to learn more.

 

Tags

@PCORnetwork, @davearterburn, #pctGR, #weightloss, #diabetes, #sleevegastrectomy

August 10, 2018: Using a Novel mHealth Platform to Obtain Real-World Data for Post-Market Surveillance: A NEST Demonstration Project (Sanket Dhruva, MD, MHS)

Speaker

Sanket Dhruva, MD, MHS
Assistant Professor of Clinical Medicine, UCSF School of Medicine
Cardiologist, San Francisco VA Medical Center

Topic

Using a Novel mHealth Platform to Obtain Real-World Data for Post-Market Surveillance: A NEST Demonstration Project

Keywords

Real world data; Post-market surveillance; Clinical data; National Evaluation System for Health Technology; NEST Coordinating Center; Medical device; Mobile health; Patient-generated data

Key Points

  • In an effort to ensure the continued safety and effectiveness of medical devices after they are on the market, the NEST demonstration project evaluated an mHealth platform to obtain real-world data for post-market surveillance.
  • The NESTcc demonstration project provides an opportunity for surmounting the challenges of longitudinal clinical data and addressing the limitations of current paradigms for medical device research in the post-market setting.

Discussion Themes

Sustaining high levels of patient engagement with participants can be challenging when the trial is conducted virtually. Shorter follow-up periods, building a “community” of patients, and helping patients understand the potential link to clinical care are a few of the ways patient engagement can be supported.

The NESTcc demonstration project is not yet in the analysis phase, so a common data model has not been established for the analysis of electronic health record (EHR) data. The challenges are recognized because of all the different data sources that will have to be linked.

Sync for Science and CMS Blue Button 2.0 share a similar model to that of the NESTcc demonstration project. The premise is that patients should be able to receive their data. Whenever patients obtain more information about their data, it’s good for both patients and researchers.

 

Tags

@UCSFMedicine, @DeptVetAffairs, @NESTccMedTech, @fitbit, @jsross119, @nilaydshah1, #realworlddata, #pctGR, #clinicaldata, #medicaldevice, #mobilehealth, #sleevegastrectomy, #gastricbypasssurgery, #mobile, #heartrate, #sleepdata

August 3, 2018: A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Underdiagnosed Atrial Fibrillation in a Large Health Plan Population (Steven Steinhubl, MD)

Speaker

Steven R. Steinhubl, MD
Director of Digital Medicine, Scripps Research Translational Institute
Associate Professor, Molecular Medicine, Scripps Research

Topic

A Digital Pragmatic Direct-to-Participant Clinical Trial for Identifying Underdiagnosed Atrial Fibrillation in a Large Health Plan Population

Keywords

Atrial fibrillation; Pragmatic clinical trials; Digital media; Participant engagement; Mobile health; mhealth; Wearable devices; mStops

Key Points

  • Up to 30% of individuals with atrial fibrillation are potentially asymptomatic and underdiagnosed.
  • The mHealth Screening To Prevent Strokes (mStops) study aims to determine if participant-generated data can improve the identification of atrial fibrillation relative to routine care.
  • Studies have shown that 88% of U.S. adults use the internet and 77% own a smartphone. With these data in mind, the study team designed a screening intervention for atrial fibrillation that enabled 100% digital interactions with all participants.
  • Study participants wore a self-applied electrocardiogram (ECG) monitoring patch at home during routine activities for four weeks.

Discussion Themes

Participant engagement in pragmatic studies can be challenging. Through the mStops study, investigators learned more about how to best engage participants by reaching out in a digital manner so that participants felt less pressured to participate.

Participants in the study experienced very few technology-related difficulties.

Read more about mStops in a recent JAMA article.

 

Tags

@SteveSteinhubl, @ScrippsRTI, #atrialfibrillation, #clinicaltrial, #pctGR

July 27, 2018: Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and Hydrochlorothiazide: Results and Lessons Learned (Karen Margolis, MD, MPH, Steven Fortmann, MD)

Speakers

Karen Margolis, MD, MPH
HealthPartners Institute, Minneapolis, MN

Stephen Fortmann, MD
Kaiser Permanente Center for Health Research, Portland, OR

Topic

Pilot Study for a Pragmatic Trial Comparing Chlorthalidone and Hydrochlorothiazide: Results and Lessons Learned

Keywords

Comparative effectiveness; Hypertension; Thiazides; Pragmatic clinical trial; HCTZ; Chlorthalidone; Electronic health record

Key Points

  • The THIAZIDES pilot study was designed to evaluate feasibility of conducting a low-cost, pragmatic, multicenter trial that directly compares the effects of chlorthalidone (CTD) and hydrochlorothiazide (HCTZ) on cardiovascular events such as heart attack, stroke, heart failure, and mortality.
  • The study used existing clinical and electronic health record (EHR) systems, with no study visits, to identify and recruit eligible study patients, distribute study medication, and collect operational, safety, and outcomes data.

Discussion Themes

Many study aspects worked well, including cluster randomization at the physician level, the willingness of physicians to take part in this kind of research, the high proportion of eligible patients receiving the intervention, and the completeness of EHR data and safety labs.

Challenges of this pilot study included difficulties with electronic discontinuation of medications, usability of real-time pharmacy data, issues with the chosen opt-out method, and higher out-of-pocket costs of the CTD medication.

 

Tags

@Collaboratory1, @PCTGrandRounds, @KPCHR, #pctGR

July 20, 2018: Developing Technology-Derived Novel Endpoints for Use in Clinical Trials: Recommendations and Case Examples from the Clinical Trials Transformation Initiative (Will Herrington, MA, MBBS, MD, MRCP, Rob DiCicco, PharmD, Jen Goldsack, MA, MBA, OLY)

Speakers

Will Herrington, MA, MBBS, MD, MRCP
MRC-Kidney Research UK Professor and
David Kerr Clinician Scientist
Nuffield Department of Population Health, University of Oxford

Rob DiCicco, PharmD
Principal Consultant
TransCelerate BioPharma Inc.

Jen Goldsack, MChem, MA, MBA, OLY
Senior Project Manager
Clinical Trials Transformation Initiative

Topic

Developing Technology-Derived Novel Endpoints for Use in Clinical Trials: Recommendations and Case Examples from the Clinical Trials Transformation Initiative

Keywords

Clinical Trials Transformation Initiative; Mobile technology; Clinical trials; Endpoints; Patient centricity

Key Points

  • The Clinical Trials Transformation Initiative (CTTI) is committed to driving the adoption of technology-derived novel endpoints in clinical trials.
  • CTTI developed a 6-step process to help develop novel endpoints. The process includes identifying an aspect of health affected by the disease that the patient cares about, selecting suitable mobile devices for capture, and describing the study population for whom the endpoint will be targeted.
  • There is a need for sophisticated analytical methods in determining how mobile technology can best be used to generate novel endpoints.

Discussion Themes

There are a variety of benefits of using mobile technology in clinical trials. Patient centricity, efficacy, and efficiency are the primary areas of potential advantage.

CTTI developed a Mobile Clinical Trials (MCT) program to identify and address the challenges related to planning for and conducting clinical trials that use mobile technologies. Four areas of focus include decentralized clinical trials, novel endpoints, stakeholder perceptions, and mobile technologies.

 

Tags

@Collaboratory1, @CTTI_Trials, #mobiletech, #ClinicalTrials, #pctGR

July 13, 2018: Clinical Trial Data Sharing: Perspectives from Participants and PCORI (Michelle M. Mello, JD, PhD, Steven Goodman, MD, MHS, PhD)

Speakers

Michelle M. Mello, JD, PhD
Professor of Law, Stanford Law School
Professor of Health Research and Policy, Stanford University School of Medicine

Steven Goodman, MD, MHS, PhD
Associate Dean, Clinical and Translational Research
Professor of Medicine and Health Research and Policy
Stanford University School of Medicine
Vice-chair, PCORI Methodology Committee

Topic

Clinical Trial Data Sharing: Perspectives from Participants and PCORI

Keywords

Clinical research; Data sharing; Data metrics; Patient-Centered Outcomes Research Institute; PCORI; Patient participation; Patient perspective

Key Points

  • The presenters conducted a study that explored patients’ perspectives on being included in clinical trials. The study aimed to understand how patients feel about being part of trials and potential risks associated with the use of their clinical data.
  • Results from the study are published in “Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing” in the New England Journal of Medicine.
  • The majority of participants indicated that potential health benefits for their children or themselves is their primary reason for their clinical trial participation.
  • The majority of participants view the benefits of data sharing as greatly outweighing the potential risks.

Discussion Themes

The distinction between anonymous and de-identified data is an important one. Many people do not know what de-identified means and lack understanding that it is different from data being anonymous.

Data linkage is key in achieving data longevity. It would be interesting to extend some of the findings to better understand how the average American understands how their data could potentially be reused.

While the results of this study are not generalizable to those not actively participating in clinical trials, it is important to note that historical data have shown that most people prefer being asked to use their data for research purposes.

 

Tags

@Collaboratory1, @MichelleM_Mello, @goodmanmetrics, @NEJM, #clinicaltrial, #datasharing, #pctGR

June 29, 2018: Policy & Priorities: Rethinking University Research with State Data (Aaron McKethan, PhD)

Speaker

Aaron McKethan, PhD
Assistant Professor of Population Health Sciences, Duke School of Medicine
Senior Policy Fellow, Duke-Margolis Center for Health Policy
Chief Data Officer, NC DHHS

Topic

Policy & Priorities: Rethinking University Research with State Data

Keywords

State data; Policy implications; Research; Analytic priorities; Front-end technology

Key Points

  • In order to effectively incorporate state data in university research, policy implications must be considered at the beginning of the planning process.
  • There is a need for analytic priorities when determining how to rethink university research with state data.
  • What is known? What is not known? What are the highest-priority questions? These are the types of questions that must be asked when determining analytic priorities for the inclusion of state data in university research.
  • Using state data to help support university research provides better front-end technology, collaboration with community-based organizations, and more.

Discussion Themes

Being explicit about the type of analytics and the research questions we are trying to answer, will improve the process of better understanding how policy and priorities of the state can be used to impact university-level research.

To impact policy, we must be open to arrangements between the state and universities that will potentially generate research results may be hard to publish but could be widely impactful.

The notion of incorporating state data into university-level research is, in a way, related to the work of NIH Collaboratory and PCORnet. All entities are working towards making research more accessible and practical.

 

Tags

@Collaboratory1, @A_McKethan, @dukemargolis, #statedata, #opiod, #pctGR