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Archive for the ‘Clinical Trials’ Category

NIH Issues Single IRB Policy to Streamline Reviews of Multi-Site Research

Accelerating clinical research studies benefits researchers, research participants, and all who stand to gain from research results. Today, the time it takes to go from a sound research idea to the launch of a new, multi-site clinical research study is too long. A major contributor to the delay is that too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants. To address this bottleneck, NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States. The NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research sets the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects.

IRBs play a critical role in reviewing and approving studies involving human research participants. IRBs evaluate the potential benefits of research and risks to participants. In the past, most clinical research studies were carried out at single institutions. Now studies are increasingly conducted at multiple sites to help increase the number and diversity of the participants, improve operational efficiencies, and accelerate the generation of research results. However, for the majority of multi-site studies, the IRB at each participating site continues to conduct an independent review. This review adds time, but generally does not meaningfully enhance protections for the participants. This new NIH policy seeks to end duplicative reviews that slow down the start of the research.

NIH will support applicant and awardee institutions as they implement the new policy with guidance and resources, such as a model authorization agreement that lays out the roles and responsibilities of each signatory, and a model communication plan that identifies which documents are to be completed, and when. You can learn more about the process that NIH followed to come to this final policy, including gathering public feedback, by visiting the Office of Clinical Research and Bioethics Policy (OCRBP) web site.

Now Available: Recordings of NLM Theater Presentations at the 2016 MLA Conference!

The NLM exhibit booth at the Annual Meeting of the Medical Library Association (MLA) featured theater presentations to bring users up-to-date on several NLM products and services. Presentation recordings are now accessible from the NLM web site. The average video length is 20 minutes.

NCBI Minute Webinar on May 4: Linking PubMed and ClinicalTrials.gov

Registration is available for the next NCBI Minute webinar on Wednesday, May 4, at 9:00 AM PDT. The presentation will include a short tutorial that will teach two ways to filter PubMed searches for publications linked to clinical trials in clinicaltrials.gov; you’ll also learn how to use the ClinicalTrials database to get more information on trials of interest.

After registering, you will receive a confirmation email with information about attending the webinar. After the live presentation, the webinar will be uploaded to the NCBI YouTube channel. Any related materials will be accessible on the Webinars and Courses page; future webinars are also listed on this page.

ICMJE Proposal for Sharing Clinical Trial Data: Submit Your Feedback by April 18!

The Committee of Medical Journal Editors (ICMJE) is seeking feedback on proposed requirements for sharing clinical trial data from any interested stakeholder, including clinical trial participants, librarians, patients, editors, and researchers. Read the editorial published in Annals of Internal Medicine, “Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors” and submit your comments by April 18! You can also check out previously posted comments. Submitted comments will be posted within one business day.

March 2015 Issue of NIH News in Health Now Available!

Illustration of 9 men and women of differing ages and ethnicities.Check out the March issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research. In this issue:

  • Be a Partner in Clinical Research: Help Others, Help Yourself
    Did you know that you can participate in clinical research? Whether you’re healthy or sick, young or old, male or female, you’re probably eligible to participate in some type of clinical study. Maybe you or a loved one has an illness, and you’d like to help scientists find a treatment or cure. If you’re healthy, you can help researchers learn more about how the body works or how sickness can be prevented.
  • Better Check Your Bowels: Screening for Colon and Rectal Cancer
    Colorectal cancer is the second-leading cause of cancer death nationwide. But it can usually be cured when caught early. Screening tests like colonoscopy can save lives by catching problems before symptoms even appear, when treatments might work best.
  • Are You at Risk for Alcohol-Medication Interactions?
    Many people may be both drinking alcohol and taking prescription drugs that interact with alcohol, according to an NIH-funded study. The finding highlights the need to talk with a health care professional about the risks of drinking alcohol while taking prescription medications.
  • Measles: Preventable with Vaccines
    Measles is a highly contagious disease caused by a virus. It starts with a fever, followed by a cough, runny nose, and red eyes. A rash of tiny, red spots then breaks out and spreads. Measles can be especially dangerous to children under 5 years old. It can lead to pneumonia, swelling of the brain, and even death. The good news is that measles can be prevented by getting a vaccine.

NIH News in Health is available online in both HTML and PDF formats. Print copies are available free of charge for offices, clinics, community centers, and libraries within the U.S. Visit the NIH News in Health Facebook page to suggest topics you’d like to see covered, or share what you find helpful about the newsletter!

Deadline Extended for Public Comments on Proposals to Enhance Transparency of Clinical Trial Results

In November, the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) released for public comment two proposals to increase the transparency of clinical trials via information submitted to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine. One is a Notice of Proposed Rulemaking (NPRM) that describes proposed regulations for registering and submitting summary results of certain clinical trials to ClinicalTrials.gov in compliance with Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products. The second proposal is a draft NIH policy that would extend the similar registration and reporting requirements to all clinical trials funded by NIH, regardless of whether they are subject to FDAAA. Both proposals aim to improve public access to information about specified clinical trials, information that is not necessarily available from other public sources.

The public may comment on any aspect of the NPRM or proposed NIH Policy. Written comments on the NPRM should be submitted to docket number NIH-2011-0003. Commenters are asked to indicate the specific section of the NPRM to which each comment refers. Written comments on the proposed NIH Policy should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email; mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; or by fax at 301-496-9839, by March 23, 2015.

Thai Clinical Trials Registry Added to the MEDLINE Databank Sources

NLM will be including the databank name for the Thai Clinical Trials Registry (TCTR) starting with citations to articles published in 2014. TCTR is a World Health Organization (WHO) primary clinical trial registry. The MEDLINE Databank Sources webpage has been updated to include this new listing.

Other clinical trial databank sources that appear in the Secondary Source ID [SI] element in the PubMed MEDLINE display include:

  • ClinicalTrials.gov Database (NIH/NLM)
  • Australian New Zealand Clinical Trials Registry
  • Chinese Clinical Trials Registry
  • Clinical Research Information Service, Republic of Korea
  • Clinical Trials Registry – India
  • German Clinical Trials Register
  • EU Clinical Trials Register
  • Iranian Registry of Clinical Trials
  • International Standard Randomized Controlled Trial Number (ISRCTN.org) Register
  • Japan Primary Registries Network
  • The Netherlands National Trial Register
  • Pan African Clinical Trial Register
  • Brazilian Clinical Trials Registry
  • Cuban Public Registry of Clinical Trials
  • Sri Lanka Clinical Trials Registry

HHS and NIH Request Public Comments on Steps to Enhance Transparency of Clinical Trial Results

The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) are releasing for public comment two proposals to increase the transparency of clinical trials via information submitted to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine. The first is a Notice of Proposed Rulemaking (NPRM) that describes proposed regulations for registering and submitting summary results of certain clinical trials to ClinicalTrials.gov in compliance with Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products. The second proposal is a draft NIH policy that would extend the similar registration and reporting requirements to all clinical trials funded by NIH, regardless of whether they are subject to FDAAA. Both proposals aim to improve public access to information about specified clinical trials, information that is not necessarily available from other public sources. The proposals are not intended to affect the design or conduct of clinical trials or define what type of data should be collected during a clinical trial. Rather, they aim to ensure that information about clinical trials and their results are made publicly available via ClinicalTrials.gov. A summary of the proposed changes is available from the NIH.

The public may comment on any aspect of the NPRM or proposed NIH Policy. Written comments on the NPRM should be submitted to docket number NIH-2011-0003. Commenters are asked to indicate the specific section of the NPRM to which each comment refers. Written comments on the proposed NIH Policy should be submitted electronically to the Office of Clinical Research and Bioethics Policy, Office of Science Policy, NIH, via email; mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892; or by fax at 301-496-9839, by March 23, 2015. All comments will be considered in preparing the final rule and final NIH Policy.

November 2014 Issue of NIH News in Health Now Available!

Composite illustration of a couple dancing, a woman swimming, a scale, diary, and vegetables.Check out the November issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research. In this issue:

  • Preventing Type 2 Diabetes: Steps Toward a Healthier Life
    People with diabetes have a problem with blood sugar. Their blood sugar, or blood glucose, can climb too high. Having high levels of sugar in your blood can cause a lot of trouble. Diabetes raises your risk for heart disease, blindness, amputations, and other serious issues. But the most common type of diabetes, called type 2 diabetes, can be prevented or delayed if you know what steps to take.
  • Parkinson’s Disease: Understanding a Complicated Condition
    We rely on our brains for every movement we make, whether writing, walking, talking, or even sleeping. But a serious brain disorder like Parkinson’s disease can rob a person of the ability to do everyday tasks that many of us take for granted. There’s no cure, but treatment can help. And researchers continue to seek new understanding to improve medical care.
  • Progress Toward a Bird Flu Vaccine
    An experimental bird flu vaccine triggered a powerful immune response in more than half of the volunteers who received it. The approach might lead to better vaccines against a variety of flu viruses.
  • Participating in Alzheimer’s Research
    Alzheimer’s disease is a brain disorder that slowly destroys memory and thinking skills. Eventually, affected people can’t perform even simple tasks. There’s no cure, but researchers are now testing new ways to diagnose, treat, or even prevent Alzheimer’s disease.
  • Featured Website: Safe to Sleep
    Sudden infant death syndrome (SIDS) is the leading cause of death among infants between 1 month and 1 year of age. Find out how you can reduce your baby’s risk of SIDS and other sleep-related causes of infant death.

NIH News in Health is available online in both HTML and PDF formats. Print copies are available free of charge for offices, clinics, community centers, and libraries within the U.S. Visit the NIH News in Health Facebook page to suggest topics you’d like to see covered, or share what you find helpful about the newsletter!

MLA Theater Presentations Available!

The NLM theater presentation recordings are available from the NLM Web site and have been announced in the NLM Technical Bulletin. The Technical Bulletin article lists the topics. Besides the usual PubMed Update, there are The ACA, Hospital Community Benefit and Needs Assessment: NLM Resources and NLM Resources Used in Disasters. The recordings are also available from the NLM Distance Education Resources page.

Lori Tagawa and Kay Deeney were available for the Using the ClinicalTrials.gov Results Database presentation because the speaker hadn’t been able to attend MLA. We answered questions from the audience!