Internet Resources Guide

December 1, 2008
Applied Clinical Trials
Volume 0, Issue 0

Web sites of interest to the clinical trials professional, including clinical trials listings, FDA and government sites, tools, and popular industry organizations.

CLINICAL TRIALS LISTINGS

The Adult AIDS Clinical Trials Group (AACTG)

http://aactg.org

Featuring occasional news regarding AIDS trials and listings of trials according to location, state, type of trial, and eligibility requirements. AACTG is funded by the Department of Health and Human Services, the National Institutes of Health, and the National Institute of Allergy and Infectious Diseases.

(Photography: Getty Images Illustration: Isabella Blumberg)

Canada Trials

http://canadatrials.com

A free service that utilizes a multicriteria searchable database of clinical trials sponsored by public institutions and nonprofit Canadian organizations. The site allows researchers to post trials or submit a center profile to be viewed by sponsors. In addition to searching for trials that are actively enrolling patients, users can learn about various patient support groups.

CancerHelp UK

http://www.cancerhelp.org.uk/

A free information service sponsored by Cancer Research UK that provides information on cancer treatments and research along with a search engine that allows users to search clinical trials by type of cancer, trial name, or drug. This well-designed site also features a recommended reading list for over 30 different types of cancers and an impressive index of related links.

Clinical Trials On-Line

http://clinicaltrials.coh.org/specific_search.aspx

A facet of the City of Hope National Medical Center Web site that allows users to search for the Center's clinical trials by phase, study objective or studies that contain a particular keyword within the protocol summary (i.e., drug name, type of treatment). Site is available in English and Spanish. Currently, it lists only cancer related studies, so call 1-877-482-HOPE (4673) if interested in trials involving diabetes, HIV/AIDS or other life-threatening diseases.

CenterWatch Clinical Trials Listing Service

http://www.centerwatch.com

CenterWatch lists over 41,000 active trials run by both industry and government. Searchable by disease, state or keyword, the site is designed for easy access by both patients and industry.

Clinical Trials Search.org

http://clinicaltrialssearch.org

A Web site dedicated solely to listing clinical research studies, allowing potential volunteers to search for trials by location—both within and outside the United States—as well as by condition or sponsor. The site provides a list of most popular searches and a list of resources ranging from news articles to various trial registries.

ClinicalTrials.gov

http://www.clinicaltrials.gov

This longtime National Institutes of Health (NIH) database lists many of the Institutes funded clinical trials and has a wealth of search options, including location, disease, treatment type, and age group. There is a particular focus on AIDS and cancer trials.

National Cancer Institute

http://www.cancer.gov/clinical_trials

This search site allows users to find trials by stage/subtype of cancer, type of trial (i.e., prevention, diagnostic or genetic), and distance. The site also has educational materials on clinical trials as well as information on trial results.

National Institute for Health and Clinical Excellence (UK)

http://www.nice.org.uk

This Web site provides guidance on the use of new and existing medicines and treatments, the appropriate treatment and care of people with specific diseases and conditions, and whether procedures used for diagnosis or treatment are safe enough and work well for routine use. While aimed at the UK, the site also attempts to cover sources from the rest of Europe as well as the United States.

National Research Register (UK)

http://https://portal.nihr.ac.uk/Pages/NRRArchive.aspx

What was created to provide a public, searchable listing of health research activity in the UK has now been archived into a searchable database of records collected in the National Research Register up until September 2007.

PhRMA Clinical Study Results Database

http://www.clinicalstudyresults.org

Part of a drive to make clinical trial results for pharmaceuticals marketed in the United States more transparent, this Web-based repository includes voluntarily submitted results from clinical trials (both published and unpublished) by different pharmaceutical companies.

http://SearchClinicalTrials.org

http://www.ciscrp.org/fastsearch/searchform.asp

A Web site designed especially for the public that simplifies the search process for finding U.S. and Canadian trials, results, and news.

WHO Health Metrics Network

http://www.who.int/healthmetrics/en

This site has a searchable database that contains information related to surveys, vital registration, surveillance, routine Health Information Systems, and population health research–related activities carried out in countries from 1994 to the present.

WHO International CT Registry Platform

http://www.who.int/ictrp/en

Serving as a forum to establish best practices for clinical trial registration, this site facilitates access to worldwide information about controlled trials and their results, trial registration datasets, background information, and news.

WHO Research Tools

http://www.who.int/research/en

This site offers links to many valuable WHO resources, including an index of all WHO publications since 1948 and articles from WHO-produced journals and technical documents since 1985, the WHO Statistical Information System (WHOSIS), and the the WHO Communicable Disease Global Atlas.

FDA SITES

FDA Homepage

http://www.fda.gov

Providing information for consumers, industry, and health professionals, this site covers current science and research, regulations and laws, background information about the FDA, new drug approvals, and drug safety information.

The Center for Drug Evaluation and Research (CDER)

http://www.fda.gov/cder

The official site for the drug branch of the FDA, which includes up-to-date news from CDER as well as general drug information, such as drug safety and side effects, new drug approvals, and alerts and warnings. This site also contains details on guidances developed by the agency and enforcement information.

Guidance Documents Specific to CDER

http://www.fda.gov/cder/guidance/index.htm

A listing of guidance documents arranged by subject, as well as links to additional information about guidances, including updated lists of ones that are new, revised, or withdrawn.

The Office of Regulatory Affairs (ORA)

http://www.fda.gov/ora

A resourceful site that includes compliance, inspectional, and science references, a list of popularly requested documents, recent ORA publications, and hot topics, such as training courses, GLP and AIP lists, and ORA events.

ADDITIONAL GOVERNMENT SITES

Centers for Medicare & Medicaid Services

http://cms.hhs.gov

This site provides a listing of different CMS programs and detailed information for each, an up-to-date newsroom, the top 10 links on the site, as well as numerous links related to research, statistics, and data.

European Medicines Agency

http://www.emea.europa.eu

The official EMEA site includes background information about the Agency, including its committees, events, meetings, job opportunities, and press releases. Beyond this, the site contains information on products, EU legislation, emerging science, as well as the Agency's long-term strategies.

National Institutes of Health

http://www.nih.gov

Along with a detailed overview of the Agency, the site provides an A-Z index of health topics, grant information, current industry news, research results, and a listing of the institutes, centers, and offices that make up the NIH.

Agency for Healthcare Research and Quality (AHRQ)

http://www.ahrq.gov

AHRQ supplies a variety of clinical information ranging from scientific reviews, medical treatment and research findings, comparative clinical effectiveness, and new technology reviews to current and archived clinical practice guidelines. There is also an area to learn about funding opportunities as well as quality and patient safety.

TOOLS

EDGAR; SEC Filings and Forms

http://www.sec.gov/edgar.shtml

For those required by law to file forms with the U.S. Securities and Exchange Commission (SEC), this site provides all the filings available through the Electronic Data Gathering, Analysis, and Retrieval system (EDGAR), as well as instructions for searching its database.

The Federal Register

http://www.gpoaccess.gov/fr/index.html

A Web-based filing of the rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. Documents are provided from 2000 on and are available in Summary, PDF, ASCII text, or HTML format.

ORGANIZATIONS

Association of the British Pharmaceutical Industry

http://www.abpi.org.uk

Links to data and statistics on industry in and outside the UK, ABPI publications (mostly free PDFs), training and career opportunities, as well as educational sections on the research process along with resources for schools. Other valuable links include to the IFPMA Clinical Trials Portal and—for UK folks—the Department of Health's Joint Working Toolkit.

Association of Clinical Research Organizations

http://www.acrohealth.org

A Weekly Roundup gathers the latest industry news, with links to stories from sources like Reuters, the BBC, and drug companies. The site addresses three groups: CROs; pharma & biotech sponsors; and patients & patient advocates. Visitors can access ACRO members' company profiles; and in addition to a list of National Regulatory Agencies, there's a link to FDA's comprehensive list, which appears to include every existing agency.

Association of Clinical Research Professionals

http://www.acrpnet.org

Membership has its privileges but nonmembers can find out about CRA and CRC certification, upcoming events, and online and classroom courses. A Most-Popular Pages section helps navigate the site, and "Public Policy" brings Washington alive with insight on Congressional and FDA updates. In 2009 the site plans to launch a facebook-like member directory, a Wikipedia for researchers, eForums, and a resource library.

Biotechnology Industry Organization

http://www.bio.org

An in-depth site on everything bio that includes an industry calendar, a membership directory with links to each company's Web site, news, blogs, podcasts, reports, videos, and audio teleconferences and interviews. Visitors can also learn about the history of biotechnology.

Clinical Data Interchange Standards Consortium (CDISC)

http://www.cdisc.org

Provides free downloadable CDISC standards, news on the latest initiatives, links to regulatory documents and published articles, a PDF archive of the CDISC Newsletter, White Papers section, and a comprehensive CDISC Glossary of clinical research terms, acronyms, and abbreviations. There's also an active discussion board.

Center for Information & Study on Clinical Research Participation (CISCRP)

http://www.ciscrp.org

In addition to http://SearchClinicalTrials.org, which finds U.S. and Canadian trials and trial news, the public-friendly site has a store that sells clinical research related brochures, DVDs, posters, and books. Visitors will find a wealth of information and resources—facts, figures, Web sites—and have the chance to join the Clinical Research Volunteers Community, where patients, families, and caregivers can connect.

Drug Information Association (DIA)

http://www.diahome.org

Find out about upcoming DIA events, webinars, training courses, continuing education programs, internships, and the association's two certification programs in clinical research and project management. DIA's online community, WebOffice, is for members only but nonmembers do have limited access to the site's job bank and can view resumes but not post them.

Health Level 7 (HL7)

http://www.hl7.org

Six main categories make up this standards developing organization's site: About HL7, Events, Members Only, Membership, Resources, and Work Groups. Not all of the resources are accessible to nonmembers, like the HL7 Wiki, but most are, including the bookstore where HL7 Standards, databases, and the Reference Information Model (RIM) can be ordered.

Pharmaceutical Research and Manufacturers of America (PhRMA)

http://www.phrma.org

Visitors can watch PhRMA TV or listen to PhRMA radio and learn about diseases, pharmaceuticals, and plenty more. There's also PDFs on topics like cancer and women's health, instructional videos, helpful links, a database that lists drugs currently in clinical trials or at FDA for review, and reports on medicines in development for 15 different therapeutic areas.

Regulatory Affairs Professionals Society (RAPS)

http://www.raps.org

Pick up a Title 21 CFR Pocket Guide at the bookstore, scan Career Connections for a new job or employee, check out upcoming RAPS meetings, or peruse the courses available at RAPS Online University. Professional advancement opportunities also abound: In addition to offering certification in medical devices and regulatory affairs, there's a career development section.

Society for Clinical Data Management

http://www.scdm.org

A new educational portal leads to SCDM University and its upcoming webinars as well as a number of resources professionals can use to prepare for the clinical data manager certification exam, which SCDM offers. The site also lists the International Network of Clinical Data Management Associations with links to members' Web sites and features a job postings section.

Society of Clinical Research Associates

http://www.socra.org

Find upcoming SoCRA meetings and conferences, instructions for submitting scientific, regulatory, and technical articles for the SoCRA Source journal, in-person courses, a classified section for clinical research jobs, and information on the Certification Program for Clinical Research Professionals.