Clinical Trials in Medical Rehabilitation

Recently published federal rules and requirements for clinical trials

  • NIH DIrector's Statement: Update on NIH’s efforts to address sexual harassment in science
    In this statement released February 28, 2019, the NIH senior leadership announced the actions they were taking as they await the Working Group of the Advisory Council to the Director (ACD) on Changing the Culture to End Sexual Harassment recommendations and other input to strengthen thier efforts. These thems include: demonstrating accountability and transparency; clarifying expectations for institutions and investigators to ensure a safe workplace and inform the agency; providing clear channels of communication to NIH; and listening to victims and survivors of sexual harassment and incorporating their perspectives into future actions.
  • 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 Department of Health and Human Services has updated the Common Rule for Protection of Human Subjects. This will impact specific policies and programs in NIH and implementation as of January 21, 2019, including review of the grant application by the IRB, posting of consent document, and categories of exempt research.
  • 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.

NIH Medical Research Initiatives

Journal Articles

Bamman MM, Cutter GR, Brienza DM, Chae J, Corcos DM, et al. Medical Rehabilitation: Guidelines to Advance the Field with High-Impact Clinical Trials Arch Phys Med Rehabil. 2018 Aug 24. pii: S0003-9993(18)31113-4. doi: 10.1016/j.apmr.2018.08.173. [Epub ahead of print] PMID: 30148997.

Ronald L. Wasserstein, Allen L. Schirm & Nicole A. Lazar (2019) Moving to a World Beyond “p < 0.05” The American Statistician, 73:sup1, 1-19, DOI:10.1080/00031305.2019.1583913/

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

April 8, 2019
Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Spinal Cord Injury Patients
Condition:   Spinal Cord Injuries
Interventions:   Drug: Placebo;   Drug: Oxycodone;   Other: Essential Oil
Sponsor:   Spaulding Rehabilitation Hospital
Recruiting
April 9, 2019
Reducing Hopelessness Through Enhanced Physical Activity in Adults With Ischemic Heart Disease
Conditions:   Ischemic Heart Disease;   Hopelessness;   Physical Activity;   Motivation;   Social Support
Interventions:   Behavioral: Motivational social support from nurse;   Behavioral: Motivational social support from nurse with additional support from significant other;   Behavioral: Attention control
Sponsors:   University of Illinois at Chicago;   National Institute of Nursing Research (NINR)
Not yet recruiting
April 16, 2019
Prehabilitation and Enhanced Recovery After Surgery to Improve Acute Wound Healing Complications in Soft Tissue Sarcoma Treated With Neoadjuvant Radiotherapy
Condition:   Soft Tissue Sarcoma
Interventions:   Other: Exercise;   Other: Enhanced Recovery after surgery;   Other: Psychological screening with counselling services as needed;   Other: Dietary Counseling Services
Sponsors:   Washington University School of Medicine;   ReVital Cancer Rehabilitation
Not yet recruiting
April 16, 2019
Optimization Principles in Hemiparetic Gait
Condition:   Stroke
Intervention:   Behavioral: Manipulation of spatiotemporal coordination during walking
Sponsors:   University of Southern California;   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Recruiting
April 16, 2019
Living in Full Even (LIFE) With Pain Study
Conditions:   Musculoskeletal Pain;   Chronic Pain
Interventions:   Behavioral: Cognitive Therapy (CT);   Behavioral: Mindfulness Meditation (MM);   Behavioral: Activation Skills (AS)
Sponsors:   University of Washington;   National Center for Complementary and Integrative Health (NCCIH)
Recruiting
April 19, 2019
Botox for the Treatment of Chronic Exertional Compartment Syndrome
Condition:   Compartment Syndrome of Leg
Intervention:   Drug: OnabotulinumtoxinA Injection
Sponsor:   University of Wisconsin, Madison
Recruiting
April 12, 2019
Agonist-Antagonist Myoneural Interface for Functional Limb Restoration After Transtibial Amputation
Condition:   Amputation
Interventions:   Procedure: AMI transtibial amputation;   Procedure: Standard transtibial amputation
Sponsors:   Massachusetts Institute of Technology;   National Institutes of Health (NIH);   Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not yet recruiting
April 9, 2019
Interventions for Concussion-Related Convergence Insufficiency in Children
Conditions:   Concussion;   Convergence Insufficiency
Interventions:   Behavioral: Standard Community Concussion Care (SC);   Behavioral: SC plus Simple Convergence Procedures (SC+);   Behavioral: SC plus Office-based Vergence/Accommodative Therapy (SC+VAT)
Sponsors:   Mitchell Scheiman;   Ohio State University;   University of Alabama at Birmingham;   Marshall B. Ketchum University;   Stanford University;   Children's Hospital Medical Center, Cincinnati;   Children's Hospital of Philadelphia;   Boston Children’s Hospital;   New Jersey Institute of Technology
Not yet recruiting
April 16, 2019
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
Condition:   Rheumatoid Arthritis
Interventions:   Drug: Baricitinib;   Drug: TNF Inhibitor
Sponsors:   Eli Lilly and Company;   Incyte Corporation
Not yet recruiting
View all on ClinicalTrials.gov

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