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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdSafety reporting
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
| 2007 |
|
| CRA 2007; 183:5 |
Final report published on first-in-man studies. |
| CRA 2007; 184:4 |
Recommendations for high-risk first-in-man studies
highlight key areas for sponsors. |
| CRA 2007; 185:4 |
Strengthening US drug safety. |
| CRA 2007; 186:3 |
MHRA modifies process for first-in-man studies. |
| CRA 2007; 186:4 |
HHS updates guidelines on event reporting requirements in
USA. |
| CRA 2007; 186:6 |
Sponsors fail to run promised post-marketing studies. |
| CRA 2007; 188:1 |
ICH proposals for Development Safety Update Report. |
| CRA 2007; 189:1 |
True consequences of TGN1412? |
| CRA 2007; 189:4 |
Drive for consistent, global periodic safety reporting for clinical
trials. |
| CRA 2007; 190:1 |
ABPI issues latest draft of revised Phase I guidelines. |
| CRA 2007; 190:1 |
New guidance: US adverse event reports. |
| CRA 2007; 191:2 |
EMEA releases draft guideline on first-in-man clinical
trials. |
| CRA 2007; 191:4 |
UK's ABPI to issue revised Phase I guidelines. |
|
CRA 2007; 192:4 |
FDA advises on adverse event reporting. |
| CRA 2007; 192:6 |
Coordination of pre-approval GxP inspections. |
| CRA 2007; 195:2 |
Common findings in pharmacovigilance inspections. |
| CRA 2007; 195:7 |
News from the DIA conference. |
|
CRA 2007; 195:7 |
Usefulness of post-marketing studies questioned by sponsors. |
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|
| 2006 |
|
|
CRA 2006; 164:4 |
New FDA guidance on Data Monitoring Committees. |
|
CRA 2006; 164:5 |
Canada's mandatory AR reporting. |
|
CRA 2006; 165:1 |
FDA issues guidance on efficiencies in early clinical drug development. |
|
CRA 2006; 165:7 |
FDA's new drug safety initiative. |
|
CRA 2006; 166:1 |
State-of-the-art computer software to aid safety report analysis in UK. |
|
CRA 2006; 166:2 |
FDA issues guidance on efficiencies in early clinical drug development. |
|
CRA 2006; 166:5 |
Warning letters pick up more consent violations. |
|
CRA 2006; 166:7 |
FDA and AdvaMed Workshops on Postmarket Safety of Devices. |
|
CRA 2006; 168:2 |
TeGenero monoclonal antibody causes shock side-effects in UK trial. |
|
CRA 2006; 168:5 |
Q & As on the FDA's Drug Safety Oversight Board. |
|
CRA 2006; 168:6 |
Study design to account for the impact of dose-limiting adverse effects. |
| CRA 2006; 168:6 |
Predicting drug efficacy and safety in new regions. |
| CRA 2006; 168:7 |
Analysis of adverse events. |
| CRA 2006; 168:7 |
Detecting rare adverse events: sample size considerations. |
| CRA 2006; 168:7 |
Predictive safety testing consortium to share information. |
|
CRA 2006; 169:2 |
EC issues revised Detailed Guidance on ethics committee applications. |
|
CRA 2006; 170:2 |
The cause of the Phase I problem in the UK. |
|
CRA 2006; 170:3 |
EU guidance on post-authorisation data following exposure to medicines
during pregnancy. |
|
CRA 2006; 170:5 |
Post-marketing safety: why identifying a safety issue is not enough. |
|
CRA 2006; 170:8 |
Non-clinical safety evaluation of drug or biologic combinations. |
|
CRA 2006; 171:2 |
Revised Detailed Guidance on adverse reactions. |
|
CRA 2006; 172:2 |
MHRA issues final report on TGN1412 clinical trial. |
| CRA 2006; 172:6 |
EU issues guidance for comment on direct healthcare
professional communications. |
|
CRA 2006; 173:8 |
FDA criticised by GAO. |
|
CRA 2006; 174:1 |
Sixth TGN1412 volunteer leaves hospital. |
|
CRA 2006; 174:2 |
No compensation for injured research subjects in the USA? |
| CRA 2006; 174:7 |
Corautus gene therapy trial placed on clinical hold. |
| CRA 2006; 174:7 |
Task force on 'higher risk' research. |
|
CRA 2006; 174:8 |
Phase I trials under precautionary measures. |
| CRA 2006; 175:5 |
Guidelines released to improve the conduct of early-stage
trials. |
| CRA 2006; 175:8 |
Reducing time and costs. |
| CRA 2006; 176:11 |
Future ICH work focuses on safety. |
|
CRA 2006; 177:1 |
FDA warning letter highlights the need for careful subject recruitment and
strict protocol compliance. |
|
CRA 2006; 177:2 |
Duff report makes 22 recommendations to improve the safety of volunteers in
clinical trials. |
|
CRA 2006; 178:6 |
Ineligible trial subject suffers gastric bleed. |
|
CRA 2006; 179:7 |
Active soldiers in clinical trials. |
|
CRA 2006; 180:2 |
IOM releases report on US drug safety. |
| CRA 2006; 181:2 |
New 'Memorandum of Understanding' between MHRA, COREC and
GTAC. |
| CRA 2006; 182:6 |
Health Canada publishes findings of its inspection programme
for safety reporting. |
| CRA 2006; 182:8 |
Florida investigator fails to protect subject safety. |
| |
|
| 2005 |
|
| CRA 2005; 144:7 |
Problems with Cox-2s cause public alarm. |
| CRA 2005; 145:6 |
Deficiencies in FDA post-marketing safety surveillance
highlighted. |
| CRA 2005; 145:8 |
Public concern grows about release of safety warnings. |
| CRA 2005; 147:7 |
Reporting adverse events to IRBs. |
| CRA 2005; 148:8 |
FDA accused of being toothless. |
| CRA 2005; 149:8 |
Revised FDA advice on electronic transmission of ICSRs. |
| CRA 2005; 150:3 |
FDA issues final risk minimisation guidances. |
| CRA 2005; 152:3 |
How harmonised is SAE reporting to investigators? |
| CRA 2005; 154:1 |
European Medicines Agency issues guidance on data elements
for transmission of ICSRs. |
| CRA 2005; 155:2 |
Inspection reveals trial commenced without IND. |
| CRA 2005; 155:7 |
MHRA approach to mandatory electronic ICSR reporting. |
| CRA 2005; 156:7 |
EMEA makes statement on NSAIDs. |
| CRA 2005; 157:8 |
GCP and pharmacovigilance. |
|
CRA 2005; 160:4 |
Identifying the most frequent violations of FDA regulations. |
| CRA 2005; 161:5 |
MHRA patient reporting scheme. |
| CRA 2005; 162:2 |
Electronic reporting of safety data now mandatory in
Europe. |
| |
|
| 2004 |
|
| CRA 2004; 124:1 |
Getting to grips with pharmacovigilance inspections. |
| CRA 2004; 124:5 |
FDA warnings to manufacturers on PADE reports. |
| CRA 2004; 126:7 |
Brazil to reorganise adverse events reporting system. |
| CRA 2004; 127:2 |
Understanding EudraVigilance. |
| CRA 2004; 127:5 |
Who runs the safest trials: industry or government? |
| CRA 2004; 128:1 |
IRB halts enrolment in trial after subject suicide. |
| CRA 2004; 134:2 |
Drug manufacturer fails to report adverse drug
experiences. |
| CRA 2004; 135:7 |
Adverse reactions cause hospital admissions. |
| CRA 2004; 142:11 |
FDA moves to strengthen safety programme for marketed
drugs. |
| CRA 2004; 142:12 |
Increase in IT spending for clinical trials. |
| |
|
| 2003 |
|
| CRA 2003; 104:6 |
ICDRA adopts new safety recommendations. |
| CRA 2003; 107:7 |
Research deaths cause more trials to be stopped in USA. |
| CRA 2003; 109:5 |
FDA proposes rule to improve safety. |
| CRA 2003; 110:1 |
EU releases final versions of five Detailed Guidance
documents. |
| CRA 2003; 111:9 |
New guidance on safety reporting. |
| CRA 2003; 111:11 |
The European database of suspected unexpected serious
adverse reactions (Eudravigilance). |
| CRA 2003; 113:5 |
Are new approaches in pharmacovigilance required? |
| CRA 2003; 116:7 |
Terminology for reporting adverse events. |
| CRA 2003; 117:7 |
New EudraVigilance website launched. |
| CRA 2003; 118:6 |
EMEA reminds marketing authorisation holders of ICSRs. |
| |
|
| 2002 |
|
| CRA 2002; 82:8 |
Adverse events cost NHS half a billion a year. |
| CRA 2002; 85:2 |
ICH process continues to make good progress - latest
Steering Committee meeting report. |
| CRA 2002; 86:2 |
ICH GCP has improved trial quality in Europe - but safety
reporting in the US is a cause for concern. |
| CRA 2002; 87:6 |
EU policy paper on safety transmissions. |
| CRA 2002; 88:3 |
Drug development and safety management. |
| CRA 2002; 93:6 |
Benefits of proactive drug safety monitoring. |
| CRA 2002; 94:7 |
Safety reporting and the SUSARs database. |
| CRA 2002; 97:5 |
Safety reporting requirements: complications foreseen. |
| CRA 2002; 100:12 |
Overview of documents produced by the ICH process. |
| CRA 2002; 101:4 |
Is it necessary to collect pre-dosing adverse event data? |
| |
|
| 2001 |
|
| CRA 2001; 69:6 |
Patient ADR reporting in UK. |
| CRA 2001; 76:6 |
Doctors need AE education. |
| |
|
| 2000 |
|
| CRA 2000; 40:3 |
Different rates of AE reporting in different countries.
|
| CRA 2000; 42:2 |
ICH E2C and the Periodic Safety Update Report. |
| CRA 2000; 45:1 |
European inspections reveal safety reporting deficiencies.
|
| CRA 2000; 45:3 |
Electronic safety reporting guidelines. |
| CRA 2000; 46:5 |
Deficient safety reporting for Prozac? |
| CRA 2000; 57:2 |
Reporting adverse events on medical devices to the FDA.
|
| CRA 2000; 59:6 |
Safety data for POM to P switch. |
| |
|
| 1999 |
|
| CRA 1999; 24:2 |
Important medical occurrences will be serious adverse
events. |
| CRA 1999; 24:4 |
Redefinition of unexpected adverse events. |
| CRA 1999; 24:5 |
Reporting unexpected adverse reactions. |
| CRA 1999; 31:5 |
Safety reporting procedures. |
| CRA 1999; 34:6 |
ADR reporting in children. |