Tag Archives: Clinical trials

New article from the Collaboratory’s PRO core presents first-hand experiences and practical approaches to initiating and implementing PROs

In a new article in eGems, the NIH Health Care Systems Research Collaboratory’s Patient-Reported Outcomes (PRO) Core gathered first-hand experiences on the incorporation of PROs for both care and research. The Core uses case studies from seven programs to present practical approaches for initiating and implementing PROs. The article includes tips on instrument selection, methods for integrating PRO collection into clinical workflow, consideration for user experience, and methods to monitor and assess data quality.

Read the full article: Case Studies from the Clinic: Initiating and Implementing Patient-Reported Outcome Measures

NIH Collaboratory ABATE Infection Trial Highlighted in Wall Street Journal


Susan Huang, MD, MPH
Dr. Susan Huang

The ABATE Infection trial, an NIH Collaboratory project led by Dr. Susan Huang, is featured in the September 12 Health section of the Wall Street Journal. The article describes several studies aimed at preventing the hospital-associated infection MRSA (methicillin-resistant Staphylococcus aureus).

In the Reduce MRSA trial, published in 2013, Dr. Huang’s team demonstrated that treating ICU patients with a germ-fighting soap plus a nasal antibiotic ointment, an approach called “universal decolonization,” was superior to standard approaches in preventing MRSA infections. The ABATE Infection trial examines similar approaches to decolonization for all patients in non–critical care medical and surgical units, comparing the use of an antiseptic bath and nasal ointment to standard bathing and showering. More than 1 million showers and baths were taken over the course of the study, which has now completed enrollment. Data from ABATE are currently being analyzed, with the results expected to inform whether this strategy is effective in reducing hospital-associated infections.

“These are preventable infections and we should be able to drive them down to zero.” Susan Huang, MD

Read The Ultimate Battle Against MRSA in the WSJ.

Read more about the ABATE Infection trial.

Watch the ABATE Infection training video.

Video Highlights the Importance of Stakeholder Advisory Boards


The PATIENTS program at the University of Maryland has produced a brief video on the role of Stakeholder Advisory Boards. Stakeholders are anyone who cares about the outcomes of a clinical study to inform healthcare decisions. The board’s purpose is to advise the study team during the course of a trial to help ensure the results are relevant and important to all stakeholders.

A Stakeholder Advisory Board comprises a diverse and balanced collection of individuals and organizations from the following groups:

  • Patients, caregivers, and advocacy organizations
  • Clinicians, nursing staff, specialists, and healthcare system administrators
  • Academic investigators and other researchers
  • Public and private healthcare payers
  • Policy and guideline organizations
  • Industry sponsors and therapeutic product developers

The 4-minute video features Ellen Tambor, MA, Senior Research Manager at the Center for Medical Technology Policy and a member of the Collaboratory’s Stakeholder Engagement Core working group.

Watch the YouTube video here.

FDA Cites Collaboratory as Part of a National System for Generating Clinical Evidence

In a recent post on the FDA’s “FDA Voice” blog, Associate Deputy Commissioner Rachel Sherman and Commissioner Robert Califf describe how to overcome barriers to data sharing and create a successful national system for medical evidence generation (or “EvGen”). To foster new approaches for creating clinical evidence the authors suggest 3 principles:

“1. There must be a common approach to how data is presented, reported and analyzed and strict methods for ensuring patient privacy and data security.

2. Rules of engagement must be transparent and developed through a process that builds consensus across the relevant ecosystem and its stakeholders.

3. To ensure support across a diverse ecosystem that often includes competing priorities and incentives, the system’s output must be intended for the public good and be readily accessible to all stakeholders.”

Drs. Sherman and Califf point to substantial pioneering work being done in secondary use of data, in which data collected for clinical care are “secondarily” used for research, including projects currently underway through the NIH Collaboratory, PCORnet, and other initiatives and networks. The experience gained from these groundbreaking efforts should provide a foundation for a national system for evidence generation.

Read the full post here.

NIH & FDA seek feedback on new clinical trial protocol template


As part of their ongoing effort to improve the speed and efficiency of conducting clinical trials, the NIH-FDA Joint Leadership Council has created a draft clinical trial protocol template. The template contains instructional and sample text intended to assist NIH-funded investigators in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Feedback is sought from investigators, investigator-sponsors, institutional review board members, and other stakeholders involved in protocol development and review.

Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them. – Dr. Pamela McInnes, NIH

Details on the rationale and development of the protocol template are on these blog posts:

Notice Number: NOT-OD-16-043. Responses accepted through April 17, 2016.

You can access the template document as well as a template shell, comment form, and other resources at NIH’s Clinical Research Policy website.

CTTI Releases 2015 Annual Report


The Clinical Trials Transformation Initiative (CTTI) has released its Annual Report for 2015. The report describes major achievements from the previous year, including new recommendations and related tools and checklists for improving the safety, efficiency, and overall quality of clinical research.

Cover page of CTTI Annual Report with embedded link to CTTI webpage containing report.
2015 CTTI Annual Report

Highlights of the 2015 Annual Report include recommendations on topics including:

  • Ethics review processes
  • Good Clinical Practice training for trial investigators
  • Research protocol design
  • Engagement of patient groups as equal partners in clinical research
  • Informed consent processes
  • Safety reporting systems for research participants

A public-private partnership whose many stakeholders include government agencies, advocacy groups, professional societies, academic research organizations, and representatives from the medical products industry, CTTI’s mission is to “identify and promote practices that will increase the quality and efficiency of clinical trials.”

A PDF version of the report is available here. Previous Annual Reports are also available on the CTTI website.


 

Upcoming CTTI Webinar on Informed Consent Recommendations


CTTI-logo-127x100The Clinical Trials Transformation Initiative’s Informed Consent Project will unveil recommendations and associated resources for informed consent on Thursday, November 19.

Presenters include Jennifer Lentz, Global Informed Consent Process Owner in Global Clinical Operations at Eli Lilly and Company, and Michele Kennett, Assistant Vice Chancellor for Research and Director of the Institutional Review Board at the University of Missouri.

Topic: Informed Consent Project Recommendations
• Date: Thursday, November 19, 2015
• Time: 12 – 1 pm EST

To join the public webinar:
 
Meeting Link: Join WebEx Meeting 
Meeting Number: 732 884 847 
Meeting Password: ctti 

After you connect to the website, please follow step-by-step instructions for connecting to the audio. If you prefer to connect to audio only, you can join by phone at:

1-855-244-8681 Call-in toll-free number (US/Canada) 
1-650-479-3207 Call-in toll number (US/Canada)

Modernizing the Common Rule for the 21st Century


The New England Journal of Medicine today published a perspective by NIH Deputy Directory Kathy L. Hudson, PhD, and NIH Director Francis S. Collins, MD, PhD, in which they outline the major reforms proposed for regulations governing the ethical conduct of research involving humans, known as the Common Rule (45 CFR 46, Subpart A).

The proposed changes are meant to enhance respect for research participants, calibrate oversight to level of risk, simplify consent documents, streamline IRB review, increase privacy and security safeguards, and facilitate broad participation in research.

“These long-overdue reforms will bring the Common Rule into the 21st century. They should help the scientific community take a giant leap forward in showing respect for research participants, without whom the biomedical research enterprise would cease to exist.”

The NIH is encouraging all stakeholders—the public, researchers, and patients—to closely review the proposed changes and participate in the comment process by the December 7, 2015, deadline.

For more information on the proposed revisions:

Grand Rounds Presentation, Kathy Hudson (video)

Department of Health and Human Services' website on the NPRM 

OHRP Webinars on the NPRM

Living Textbook Chapter: Informed Consent: Emerging Issues and Controversies

Designing Fit-for-Purpose Trials with PRECIS-2


Few clinical trials are entirely explanatory (done in an idealized setting) or entirely pragmatic (done in a usual-care setting); rather, trials are situated somewhere along a continuum of applicability. Pragmatic clinical trials are trials designed with pragmatic qualities and are intended to inform decision makers, including patients, clinicians, administrators, and policymakers, about the relative benefits, burdens, and risks of a health intervention.

To help trialists assess how closely their trial’s design matches its intended purpose, a group of trialists and methodologists developed a design tool, the Pragmatic–Explanatory Continuum Indicator Summary, or PRECIS. Originally implemented in 2008, the wheel-shaped indicator tool recently underwent a revision, leading to PRECIS-2. The revised, validated tool guides trialists to prospectively consider the design of their trial along 9 domains: eligibility criteria, recruitment, setting, organization, flexibility (delivery), flexibility (adherence), follow-up, primary outcome, and primary analysis.

PRECIS-2 Wheel
PRECIS-2 Wheel*

*Kirsty Loudon et al. BMJ 2015;350:bmj.h2147. Copyright 2015 by British Medical Journal Publishing Group. Used by permission.

See the PRECIS-2 introductory video (YouTube) and below links for detailed user information.

Health Informatics Centre website
PRECIS-2 Toolkit
Wheel examples

OHRP Town Hall Meeting to Discuss NPRM


The Office for Human Research Protections (OHRP) has announced a public Town Hall Meeting to be held October 20, 2015, to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) published on September 8, 2015.

The goal of the NPRM is to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

The purpose of the Town Hall Meeting (agenda) is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM in order to clarify the NPRM proposals and better inform public comment on the NPRM. The public will be able to ask questions during the Town Hall Meeting, and to submit questions before the meeting. Watch via webinar.

Public Town Hall Meeting 
October 20, 2015, 9 am to 5 pm
Hubert H. Humphrey Building, Great Hall
200 Independence Ave SW
Washington, DC 20201

This PDF document (#2015-25564) contains details about the format of the public Town Hall Meeting and how to register or submit questions prior to the meeting.

Important deadlines:

  • While there is no registration fee, individuals planning to attend the Town Hall in person must register by 5:00 pm October 13, 2015. Registration will be accepted on a first-come, first-served basis and may be completed by sending an email to OHRP@hhs.gov, with the subject line “Registration for OHRP Town Hall Meeting.”
  • The deadline for submission of questions about the NPRM prior to the Town Hall Meeting must be received no later than 5:00 pm October 13, 2015.
  • Details on the NPRM are at the OHRP website. To be assured consideration, comments on the NPRM must be received no later than the extended deadline of January 6, 2016.