Archive for the ‘Clinical Trials’ Category
Check out the December 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:
- Making a Healthier Home: Cast Toxins From Your Living Space
Take a look around your home. Do you know what’s in your household goods and products? Some chemicals can harm your health if too much gets into your body. Becoming aware of potentially harmful substances and clearing them out can help keep you and your family healthy.
- Tai Chi and Your Health: A Modern Take on an Ancient Practice
Tai chi is sometimes referred to as “moving meditation.” There are many types of tai chi. They typically combine slow movements with breathing patterns and mental focus and relaxation. Movements may be done while walking, standing, or sitting.
- Oxygen Therapy for Patients with COPD
Certain people with the lung disease known as COPD will not benefit from long-term oxygen therapy, a new study reports. The finding will help doctors and patients choose among different treatment options for this common condition, which makes it hard to breathe.
- When Clinical Research Is in the News
There are many types of clinical studies. Each has its own strengths and weaknesses. Knowing more about the different types can help you think critically about the health and research news you see and hear.
NIH News in Health is available online in both HTML and PDF formats. Additionally, you can get trusted, up-to-date health information from NIH News in Health added directly to your site via NIH content syndication. 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!
The Fall 2016 issue of NIH MedlinePlus the Magazine features topics including the latest in cancer research, lymphedema, vasculitis, the opioid overdose epidemic, clinical trials, and healthy pregnancy. The cover features actress and director, Kathy Bates, who developed lymphedema following a double mastectomy due to breast cancer. Bates has been a strong advocate for those with the disease. A national spokesperson for the Lymphatic Education & Research Network, she shares her story with NIH MedlinePlus magazine.
The issue also features an article about cancer research. In January 2016, President Obama announced the “Cancer Moonshot” initiative to double the pace of research. The initiative aims to make more therapies available to more patients sooner. It also seeks to improve the ability to prevent cancer and detect it at an early stage. NIH MedlinePlus magazine sat down with Dinah Singer, PhD, one of the three co-chairs of the Cancer Moonshot Initiative’s Blue Ribbon Panel and Director of the National Cancer Institute’s Division of Cancer Biology, to learn about its progress.
NIH MedlinePlus the Magazine is the free, trusted consumer guide to the vast array of authoritative online health and medical information in MedlinePlus. Published four times a year, the magazine showcases the National Institutes of Health’s (NIH) latest medical research and healthcare information. NIH MedlinePlus the Magazine is freely available as a print subscription, e-mail alerts, and online.
The project NLM 4 Caregivers is designed to increase awareness of NLM resources among family caregivers who actively seek health information online using social media tools such as Facebook, Twitter, blogs, and listservs, for discussing and exploring health issues. NLM 4 Caregivers discusses a wide variety of resources for searching and managing medications, such as PillBox and DailyMed, tools for locating clinical trials (ClinicalTrials.gov), and tools for accessing both consumer health information (MedlinePlus) and the latest biomedical research (PubMed).
NLM 4 Caregivers shares health resources relevant to caregivers through many mediums, such as:
On July 7, NN/LM PSR presented Saving Time with PubMed Subject-Specific Queries! for the NLM Express webinar series. Kate Flewelling, Health Professions Coordinator, NN/LM Middle Atlantic Region, provided some tips and tricks for preformulated PubMed searches on drugs, health information technology, public health and other topics.You can view the webinar by visiting our Distance Learning page or by clicking on the YouTube video player below.
Note: To switch to full screen, click on the full screen icon in the bottom corner of the video player. To exit the full screen, press Esc on your keyboard or click on the Full screen icon again. If you have problems viewing full screen videos, make sure you have the most up-to-date version of Adobe Flash Player.
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.
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.
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.
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.
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!
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.