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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdDesign of trials
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 |
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2007 |
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| 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; 185:5 |
Flexible trials pose regulatory questions. |
| CRA 2007; 190:1 |
ABPI issues latest draft of revised Phase I guidelines. |
| 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; 191:7 |
Research calls into question the use of composite clinical
endpoints. |
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CRA 2007; 193:6 |
EMEA guideline on trials in small populations. |
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CRA 2007; 195:7 |
Usefulness of post-marketing studies questioned by sponsors. |
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2006 |
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CRA 2006; 167:2 |
Standard clauses for data transfer are underused says EC report. |
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CRA 2006; 167:4 |
US initiative to improve cancer therapy through development of biomarkers. |
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CRA 2006; 168:6 |
Study design to account for the impact of dose-limiting adverse effects. |
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CRA 2006; 169:6 |
FDA issues draft guidance on patient-reported outcome instruments. |
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CRA 2006; 172:5 |
Biomarkers under examination in Europe. |
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CRA 2006; 173:1 |
Adaptive study designs improve efficiency. |
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CRA 2006; 173:2 |
European Medicines Agency reflects on adaptive study design. |
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CRA 2006; 173:4 |
Canada updates guidance on clinical trial records. |
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2005 |
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CRA 2005; 143:7 |
What is a Thorough Phase I ECG study? |
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CRA 2005; 144:1 |
EMEA releases guidance on the assessment of risk/benefit. |
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CRA 2005; 146:8 |
Achieving medication compliance. |
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CRA 2005; 151:8 |
Practical issues: screening subjects for clinical trials. |
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CRA 2005; 152:2 |
New draft guidance on clinical trial endpoints for approval of cancer
drugs and biological agents. |
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CRA 2005; 159:8 |
The wisdom of Bert Spilker. |
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CRA 2005; 161:7 |
Avoiding failure in Phase III. |
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CRA 2005; 163:3 |
Adequate data management plans are critical to the success of the modern
trial. |
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2004 |
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CRA 2004; 127:5 |
Who runs the safest trials: industry or government? |
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CRA 2004; 128:1 |
IRB halts enrolment in trial after subject suicide. |
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CRA 2004; 134:7 |
Bioequivalence guidelines for India. |
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CRA 2004; 138:6 |
The importance of late-phase research. |
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CRA 2004; 139:2 |
Changing face of Phase I research. |
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CRA 2004; 139:3 |
EORTC streamlines research processes. |
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CRA 2004; 139:3 |
Obtaining trial data from population subgroups. |
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CRA 2004; 139:5 |
Insight into epidemiology and drug development. |
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CRA 2004; 142:8 |
Use of call centres in quest for better subject recruitment. |
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CRA 2004; 142:12 |
Increase in IT spending for clinical trials. |
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2003 |
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CRA 2003; 106:4 |
Financial stability of study site could could affect trial conduct. |
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CRA 2003; 110:5 |
Better customer relationship management improves trial efficiency. |
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CRA 2003; 114:3 |
Guidance on estimating the safe starting dose for adult healthy
volunteers. |
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CRA 2003; 115:6 |
Patient support. |
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CRA 2003; 119:6 |
Improving the quality of patient diary data. |
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CRA 2003; 122:7 |
FDA's common submission standards. |
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2002 |
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CRA 2002; 91:4 |
Reduce the need for protocol amendments by improving protocol quality. |
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CRA 2002; 92:2 |
Draft guidance on the Trial Master File and archiving. |
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CRA 2002; 100:12 |
Overview of documents produced by the ICH process. |
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CRA 2002; 100:20 |
Is over-regulation a real risk to the future of clinical research? |
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CRA 2002; 101:6 |
Design of orphan drugs trials in children. |
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1999 |
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CRA 1999; 31:1 |
Protocol signature may have legal implications.
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CRA 1999; 34:4 |
New ICH guidance on choice of control group.
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