Clinical Trials in Medical Rehabilitation

Recently published federal rules and requirements for clinical trials

  • Statement on Article Publication Resulting from NIH Funded Research
    To help protect the credibility of papers arising from its research investment, NIH encourages its stakeholders, including grantees, contractors, intramural researchers, and librarians, to help authors: 1) adhere to the principles of research integrity and publication ethics; 2) identify journals that follow best practices promoted by professional scholarly publishing organizations; and 3) avoid publishing in journals that do not have a clearly stated and rigorous peer review process.
  • Clinical Trial Requirements for Grants and Contracts
    NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.
  • Clinical Trials: Special Considerations for Career Development, Fellowship, Training, and Research Education Programs (NOT-OD-18-001) (Published November 6, 2017)
    The purpose of this notice is to provide prospective applicants for career development, NRSA fellowships or training grants, and research education grants advanced information about the upcoming funding opportunity announcements (FOA), expected dates of FOA issuance, and application due dates. As indicated in NOT-OD-17-043, effective January 25, 2018, all grant applications with plans to conduct independent clinical trials must be submitted in response to an FOA which specifically states that independent clinical trials are allowed.
  • Policy Supporting the Next Generation Researchers Initiative (NOT-OD-17-101) (Published August 31, 2017)
    This policy amends the definitions of, and policies supporting, early stage investigators (ESIs). In addition, it creates a new policy for early established investigators (EEIs), previously referred to as mid-career investigators, and describes how NIH will monitor the implementation of the policy to determine the impact on ESI and EEI diversity in the NIH portfolio.
  • Federal Policy for the Protection of Human Subjects (Published January 19, 2017)
    The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
  • Inclusion Across the Lifespan - Policy Implementation (Published December 19, 2017)
    The purpose of this policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also clarifies potential justifications for age-based exclusion criteria, and requires participant age at enrollment to be provided in progress reports The policy applies to all grant applications submitted on or after January 25, 2019. Until then, ongoing research and grant applications/proposals are subject to the Inclusion of Children in Clinical Research Policy.

NIA Clinical Research Study Investigator's Toolbox

This tool box provides researchers and their study teams with a central source of materials to plan studies, incorporate consistent processes, collect accurate data, and maintain appropriate safety oversight.

NIH Reporter

Learn about active NIH funded medical rehabilitation research projects.

Access the list on the NIH RePORT website.

Recently published on ClinicalTrials.gov

June 19, 2018
Incline Training to Personalize Motor Control Interventions After Stroke
Condition:   CVA (Cerebrovascular Accident)
Interventions:   Other: Incline treadmill walking;   Other: Decline treadmill walking
Sponsor:   VA Office of Research and Development
Not yet recruiting
June 21, 2018
Aging Back Clinics
Condition:   Chronic Low Back Pain
Intervention:  
Sponsor:   VA Office of Research and Development
Not yet recruiting
June 11, 2018
Protective Stepping & MS
Condition:   Multiple Sclerosis
Intervention:   Behavioral: Protective step training
Sponsors:   VA Office of Research and Development;   Arizona State University
Not yet recruiting
June 20, 2018
Resilience and Well-Being Pilot Study
Conditions:   Chronic Pain;   Depression;   PTSD;   Injuries;   Illness, Chronic;   Physical Disability
Intervention:   Behavioral: Resilience and Well-Being Program
Sponsor:   VA Puget Sound Health Care System
Recruiting
June 14, 2018
Combined Robotic Training and tDCS in Chronic SCI
Conditions:   Spinal Cord Injuries;   Tetraplegia
Interventions:   Other: transcranial direct current stimulation;   Other: sham transcranial direct current stimulation
Sponsors:   Burke Medical Research Institute;   New York State Spinal Cord Injury Research Board (SCIRB)
Recruiting
June 13, 2018
Walkbot Robotic Training for Improvement in Gait
Conditions:   Ischemic Stroke;   Gait, Hemiplegic
Interventions:   Device: Walkbot;   Behavioral: Physical Therapy
Sponsors:   Burke Medical Research Institute;   P&S Mechanics Co., LTD/ South Korean Government Grant
Recruiting
June 15, 2018
Respiratory Muscle Strength Training in Presbyphonia
Condition:   Presbylarynx
Interventions:   Device: Inspiratory Muscle Strength Training (IMST);   Device: Expiratory Muscle Strength Training (EMST);   Behavioral: Voice Exercises
Sponsor:   Medical University of South Carolina
Not yet recruiting
June 20, 2018
A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition:   Non-small Cell Lung Cancer
Interventions:   Drug: Atezolizumab;   Drug: MTIG7192A;   Drug: Placebo
Sponsor:   Genentech, Inc.
Recruiting
June 15, 2018
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)
Condition:   Ulcerative Colitis
Interventions:   Drug: UTTR1147A;   Drug: UTTR1147A Placebo;   Drug: Vedolizumab;   Drug: Vedolizumab Placebo
Sponsor:   Genentech, Inc.
Recruiting
View all on ClinicalTrials.gov

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