Are we keeping research participants safe enough?
- Convoluted Rules, Bureaucracy Threaten UK Clinical Research. Moran, Nuala // BioWorld International;4/7/2010, Vol. 15 Issue 14, p1
The article reports on the review conducted by the Academy of Medical Science in Great Britain on 11 legislation pieces governing clinical trials. The review was prompted by evidence that complicated legislation and conventions governing medical research are driving companies overseas,...
- Indian Regulatory Update: Jan-May 2014. Suvarnapathaki, Kedar // Perspectives in Clinical Research;Jul-Sep2014, Vol. 5 Issue 3, p139
The article presents a list of regulatory update on clinical trials in India including guidance for audio-visual recording, cases of clinical trial related serious adverse events (SAEs), and submission of SAEs.
- Honey vs. Vinegar. Ganter, Jane // Applied Clinical Trials;Feb2002, Vol. 11 Issue 2, p12
Focuses on a concrete and practical plan to encourage improvement in the U.S. legal system for the protection of human research subjects in clinical trials. Emphasis on regulatory compliance; Creation of national program that will give awards for excellence in human research protection;...
- Pediatric Clinical Studies in Japan. Uchiyama, Akiyoshi // Applied Clinical Trials;Jul2002, Vol. 11 Issue 7, p57
Examines the impact of regulations on pediatric clinical trials in Japan. Status of pediatric indications; Obstacles to pediatric clinical trials; Promotion of pediatric clinical research.
- European Clinical Trials Rules Are Not Working. O'Donnell, Peter // Applied Clinical Trials;Oct2002, Vol. 11 Issue 10, p24
Explores the implications and merits of the clinical trials regulations in the European Union. Impact of the regulations on the pharmaceutical industry; Principles of good clinical practice; Procedures for reporting suspected unexpected serious adverse reactions.
- India Keeps Ban On Phase I Trials. // Asia Monitor: South Asia Monitor;Oct2003, Vol. 9 Issue 10, p8
Reports on a ban by the Indian government to ban foreign pharmaceutical companies carrying out phase I clinical trials in India. Advantages to foreign companies from removal of the ban.
- Filling in the EU Gaps on Clinical Trials Rules. O'Donnell, Peter // Applied Clinical Trials;Jun2002, Vol. 11 Issue 6, p34
Focuses on the concern of the pharmaceutical industry on the gaps in the rules about clinical trials. Requirements for clinical research directive; Series of consultation documents on manufacturing practice; Management of clinical research data.
- Is overregulation a problem in clinical trials? Wardecki, Marek // Applied Clinical Trials;Oct2005, Vol. 14 Issue 10, p16
Presents a letter to the editor about overregulation in clinical trials.
- New CRO Italian Law Undergoes Alterations. Criscuolo, Domenico // Applied Clinical Trials;Nov2009, Vol. 18 Issue 11, p14
A letter to the editor is presented in response to the article on alterations on the new Italian law concerning clinical trials in the April 2009 issue.