Archive for the ‘Clinical Trials’ Category
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.
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
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.
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!
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!
PubMed Health’s curated collection of systematic reviews now has an important new role: enabling PubMed users to go straight from a clinical trial to systematic reviews that have considered it. Visitors to records of many thousands of trials will now see a new section to the right, called a portlet. It will show links to systematic reviews in PubMed that have cited that trial. This new portlet does not replace “Related citations in PubMed”: that will follow as usual. All of PubMed Health’s 31,100 systematic reviews since 2003 are not yet included. If there is no portlet showing, it does not mean for certain that there is no systematic review that includes the trial. There are enough reviews included, though, that this portlet should become a familiar sight when using PubMed. For additional information, visit the latest issue of the NLM Technical Bulletin.
The Coalition for Networked Information (CNI), the Association of Research Libraries (ARL), and EDUCAUSE have announced that Donald A.B. Lindberg, Director of the National Library of Medicine, has been named the 2014 recipient of the Paul Evan Peters Award. The award recognizes notable, lasting achievements in the creation and innovative use of network-based information resources and services that advance scholarship and intellectual productivity. Named for CNI’s founding director, the award honors the memory and accomplishments of Paul Evan Peters (1947–1996), a visionary and a coalition builder in higher education and the world of scholarly communication, who led CNI from its founding in 1990. The award will be presented during the CNI membership meeting in St. Louis, MO, to be held March 31–April 1, 2014, where Dr. Lindberg will deliver the Paul Evan Peters Memorial Lecture. The talk will be recorded and made available on CNI’s YouTube and Vimeo channels after the meeting concludes.
Dr. Lindberg’s interest in the potential intersection between information technology and the biological sciences stretches back to the early days of his career. He joined the pathology faculty at the University of Missouri in 1960, where he developed the first automated lab system and an automated patient history acquisition system. He implemented an automated statewide system for interpreting electrocardiograms, as well as other medical applications for the computer. Around this time, he also began publishing articles in a field that would come to be known as medical informatics, including The Computer and Medical Care, which appeared in 1968.
Dr. Lindberg has worked as a scientist for over 50 years, becoming widely recognized as an innovator in applying computer technology to health care, medical diagnosis, artificial intelligence, and educational programs. In 1984 he was appointed director of the National Library of Medicine (NLM), the world’s largest biomedical library, a post that he still holds. As NLM’s Director, Dr. Lindberg convinced the United States Congress that the Library was an essential information conduit, facilitating the decision-making process of scientists and pharmaceutical companies, and, ultimately, benefiting patients and the general public, thereby securing the organization’s robust future. He has spearheaded countless transformative programs in medical informatics, including the Unified Medical Language System, making it possible to link health information, medical terms, drug names and billing codes across different computer systems; the Visible Human Project, a digital image library of complete, anatomically detailed, three-dimensional representations of the normal male and female human bodies; the production and implementation of ClinicalTrials.gov, a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world; and, the establishment of the National Center for Biotechnology Information, a national resource for molecular biology information and genetic processes that control health and disease. Today, NLM has a budget of $327 million, more than 800 employees, and digital information services that are used billions of times a year by millions of scientists, health professionals, and members of the public.
Dr. Lindberg is a member of the Institute of Medicine of the National Academy of Sciences, and has received numerous honors and awards, including the prestigious Morris F. Collen, MD, Award of Excellence of the American College of Medical Informatics, and the Surgeon General’s Medallion of the US Public Health Service. He received his medical degree from the College of Physicians and Surgeons, Columbia University, and an undergraduate degree from Amherst College. A four-member committee selected Dr. Lindberg for the award: the late Ann J. Wolpert, director of libraries at the Massachusetts Institute of Technology; George O. Strawn, director of the Federal Networking and Information Technology Research and Development (NITRD) National Coordination Office (NCO); Sally Jackson, professor of communication at the University of Illinois at Urbana-Champaign; and Joan Lippincott, associate executive director of the Coalition for Networked Information.
Research funded by the National Library of Medicine provides new insight into why patients stop taking drugs that lower their cholesterol, and what happens when patients try those drugs, known as statins, a second time. Researchers found that more than 90% of patients who stopped taking statins because of an adverse reaction could tolerate the medication when tried again. The study is published in the April 2, 2013, issue of the Annals of Internal Medicine.
NLM grantee Alexander Turchin MD, MS, of Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School, notes that statins are commonly stopped even though their benefits are well documented. He and colleagues wanted to better understand why statins are discontinued and whether adverse reactions play a role. They conducted a retrospective study, analyzing clinical data in an electronic medical record (EMR) system. Researchers examined structured data as well as the narrative electronic notes of health providers. Those notes frequently are the only place in an EMR where adverse reactions to medications are documented. Using the NLM grant, researchers developed natural language processing software and scoured more than 5 million notes, on more than 107,000 patients, recorded over nearly a decade. The software generated data on a scale that could not have been done manually. Researchers say the next step would be to conduct a clinical trial to determine if outcomes are improved when statins are tried again, after an adverse event.
The National Library of Medicine, part of the National Institutes of Health, conducts and funds research in biomedical informatics, which involves applying computers and communications technology to the field of health. This research was supported by NLM’s Division of Extramural Programs grant RC1-LM010460. This was an NIH Challenge Grant, supported by NLM with funds from the American Recovery and Reinvestment Act. For additional information, visit the Brigham and Women’s Hospital News Release.
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 edition:
Your Microbes and You: The Good, Bad and Ugly
Trillions of microscopic creatures—like bacteria, fungi and viruses—are living in and on your body right now. We tend to focus on destroying bad microbes. But taking care of good ones may be even more important.
Gut Feelings About Gastritis: When Your Stomach’s Sick
Your stomach lining has an important job. It makes acid and proteins that help break down the foods you eat. But when the lining gets inflamed—a condition called gastritis—it can cause long-term problems.
NIH News in Health is available online in HTML and PDF formats, and print subscriptions are available free of charge.
ClinicalTrials.gov has launched a new beta version of its website, featuring a new integrated homepage and updated graphic design. In addition to the redesign, visitors will also have access to new and reorganized written content about clinical research, background information about the site, searching for studies, and maintaining study records. However, core functions of the site; including the basic and advanced search, search results options, and the study record data, will remain the same. The new site interface will run in parallel with the previous version for approximately four weeks after launch. After appropriate testing and additional minor changes it will permanently replace the previous interface in mid-September 2012.
ClinicalTrials.gov is the NLM-developed web-based registry and results database of clinical research studies. The website provides patients, clinicians, researchers, and the public with access to information about interventional and observational studies. As of August 2012, ClinicalTrials.gov contained over 130,000 clinical research studies in all fifty states and in 179 countries. Since it was launched in 2000, ClinicalTrials.gov has expanded in terms of scope, features, and intended audiences in response to the evolving policies and laws promoting the registration of clinical trials. For example, Congress enacted legislation in 2007 that added the first public results database. As a result, summary information about clinical trials of FDA-approved medical products would be freely available, whether or not the results were published in the medical literature. To accommodate the results database, new user interface features in ClinicalTrials.gov were launched in 2008, to display the results data tables and allow for searching of studies with results. Over time the Web site has featured the American Customer Satisfaction Index survey tool to collect feedback from users and usability evaluations have been conducted. The results of this user feedback, as well as the changing nature of the Web site, provided the motivation for redesigning ClinicalTrials.gov.
For additional information on the new site navigation features, new appearance, and new content, please visit the NLM Technical Bulletin and the ClinicalTrials.gov beta website.