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Adis Clinical Trials Insight has been relaunched to provide
an expanded and enhanced system to support global Pharmaceutical
and Biotechnology companies with the identification and
assessment of published and ongoing clinical studies. The
increased coverage includes not only difficult-to-monitor
ongoing studies, but also all studies presented at the top 100
meetings and published in the top medical journals. ACTI is a
leading source of in-depth and up-to-date global clinical trial
data.
Key papers are selected and evaluated by Adis editorial specialists
and are presented in a structured and consistent format to provide a
clear evaluation of the study, the comparative treatment outcomes
key messages and results. Drug and regimes, results and side effects
are presented in easy-to-read tables.
Adis Clinical Trials Insight also provides a percentage score for
clinical trials as an independent guide to the quality of the trial,
design and reporting. Since July 2000, the clinical relevance of a
study has been rated on a 3-point scale.
Adis Clinical Trials Insight has four record types:
Best Evidence Records - Published and presented clinical trial
evidence that will be instrumental in changing prescribing
practice. Available from 1990 onwards.
Supporting Evidence Records - Published and presented clinical
trial evidence that contributes to the body of knowledge
surrounding a therapy. Available from 2005 onwards.
Ongoing Trial Records - Integrated information about a trial,
tracked from the first public mention, including interim
results through to completion of the trial. Available from
2005 onwards, and updated frequently.
Citation Only Records - Short records containing a citation
and descriptors available from 1990 to 2004. They have been
superceded by Supporting Evidence records which contain
more data.
Adis Clinical Trials Insight covers therapeutic areas,
and within these areas, hundreds of indications. The
therapeutic areas covered are:
Advances in the Treatment of Nausea and Migraine
Affective Disorders
Alzheimer's Disease and Cognition Disorders
Antibacterials
Antithrombotics
Antivirals
Anxiety Disorders
Arrhythmias
Diabetes
Epilepsy and Seizure Disorders
Heart Failure
Hyperlipidaemia
Hypertension
Irritable Bowel Syndrome
Ischemic Heart Disease
Men's Health
Neurological Disorders
Obesity
Obstructive Airways Disease
Oncology
Pain Control
Parkinson's Disease and Movement Disorders
PharmacoEconomics
Psychotic Disorders
Rheumatic Disease
Transplant Rejection
Upper GI Disorders
Vaccines
Women's Health
Use ACTI to answer questions like:
- what trials are currently underway in a specfic disease area?
- what review articles have been published on ACE-inhibitors
over the past five years?
- have there been any fair to excellent trials on the
therapeutic use of tryptophan?
- what cardiovascular disorders are induced by salbutamol?
Sources:
Over 2000 international medical and biomedical journals,
difficult-to-monitor ongoing studies, studies presented at the
top 100 meetings, and all major press releases.
Example of a Best Evidence record:
AN - Accession number & update:
0800865495 20060101.
TI - Title:
Aspirin vs ticlopidine: therapeutic use
Myocardial infarction
The STAMI trial
(BEST EVIDENCE).
SO - Source:
Adis Clinical Trials Insight.
CR - Cited reference(s):
Ticlopidine versus aspirin after myocardial infarction (STAMI)
Trial. Journal of the American College of Cardiology,
{J-Am-Coll-Cardiol}, Apr 2001, vol. 37, p. 1259-1265, ISSN:
0735-1097. Scrutinio-D, Cimminiello-C, Marubini-E, Pitzalis-MV,
STAMI-Group, et-al. S Maugeri Foundation, Bari, Italy.
CF - Conference information:
Bethesda Conference: Care of the Adult with Congenital Heart
Disease, 32nd, Bethesda, Maryland, USA, October 2000.
SI - Study names/identifiers:
Study-of-Ticlopidine-Versus-Aspirin-After-Myocardial-Infarction,
STAMI.
EV - Evaluation:
Global Study Outcome:
Efficacy: Ticlopidine = Aspirin
Tolerability: Ticlopidine = Aspirin
Study Messages:
Efficacy:
Ticlopidine is at least as effective as aspirin for secondary
prevention of cardiovascular events in patients after
myocardial infarction.
Tolerability:
There are no significant differences in the frequency or
severity of adverse events in patients with acute myocardial
infarction treated with ticlopidine or aspirin.
Results Highlights:
Efficacy:
Triclopidine was at least as effective as aspirin for
secondary prevention of cardiovascular events in patients
after myocardial infarction. At 6 months, the composite
endpoint (nonfatal myocardial infarction, fatal stroke,
documented angina pectoris, or cardiovascular death or death
from any cause) occurred in 8.0% of ticlopidine recipients
and 8.0% of aspirin recipients.
Tolerability:
There was no significant differences in the frequency or
severity of adverse events in patients with acute myocardial
infarction treated with ticlopidine or aspirin. Serious
adverse events occurred in 2.4 and 1.5% of ticlopidine and
aspirin recipients, respectively. 7.2 and 4.8% of ticlopidine
and aspirin recipients, respectively, withdrew from therapy
because of adverse events.
Adis assessment:
Positive Features:
well defined patient selection and exclusion criteria;
detailed demographical data; patients randomised to comparable
treatment groups; drug comparison used to reduce variation;
double-blind trial design; compliance assessed by table counts;
methodology, results and adverse events fully reported; study
limitations discussed
Negative Features:
study duration too short to fully assess efficacy and
tolerability
Adis evaluation: 88
Clinical relevance: B.
SD - Study Details:
Study purpose:
Clinical studies have shown that both aspirin and ticlipidine
have beneficial effects in patients with cardiovascular
disease. Aspirin is the standard therapy for secondary
prevention of cardiovascular events in patients after
myocardial infarction (MI). However, there is a lack of data
concerning the efficacy of ticlopidine for secondary
prevention in patients after MI.
The Ticlopidine Versus Aspirin After Myocardial Infarction
(STAMI) trial compared the efficacy and tolerability of
ticlopidine with those of aspirin in patients with acute MI
treated with thrombolysis.
Author comment:
'Despite an apparent trend toward a lower reinfarction rate
with ticlopidine, the frequency of the primary combined
endpoint of death, reinfarction, stroke and angina was no
different between the two treatment groups. These data
indicate that an ADP (adenosine diphosphate) inhibitor, such
as ticlopidine, is at least as effective as aspirin in
preventing recurrent events in post-MI patients treated with
thrombolysis.'
Study details:
Design: Double-blind, multicentre, parallel,
randomised
Control: Drug comparison
Phase: III
Methods: Patients were randomised within 30 days
of MI.
Endpoints: Angina pectoris event rate,
Cardiovascular death, Death rate,
Myocardial infarction event rate,
Stroke event rate
Name: Study of Ticlopidine Versus Aspirin
After Myocardial Infarction, STAMI
Companies: Sanofi-Synthelabo
Subject details:
Type: Patients
No: 1470
Age: >= 18 (mean 59) years
Sex: 1232 male & 238 female
Location: Unknown
Disease: Myocardial infarction
Co-morbid conditions: Diabetes mellitus,
Hypercholesterolaemia, Hypertension
Characteristics: Patients also had hypertension (34%),
hyperlipidaemia (38%), and/or diabetes
mellitus (15%). 8% of patients had had
a previous MI.
Concomitant medication: ACE inhibitors, beta-adrenoceptor
antagonists, clcium channel antagonists,
HMG-CoA reductase inhibitors,
thrombolytics
TR - Treatments:
Aspirin
-------------------------------------------------------------
Drug/Treatment Dose Route Frequency Duration
-------------------------------------------------------------
Aspirin 160 mg/day PO bid 6 months
-------------------------------------------------------------
Ticlopidine
-------------------------------------------------------------
Drug/Treatment Dose Route Frequency Duration
-------------------------------------------------------------
Ticlopidine 500 mg/day PO bid 6 months
-------------------------------------------------------------
RS - Results:
-------------------------------------------------------------
Events at 6 months Ticlopidine Aspirin
(n = 734) (n = 736)
-------------------------------------------------------------
Total 59 (8.0%) 59 (u.0%)
Cardiovascular death 6 (0.8%) 5 (0.7%)
Nonvascular death 1 (0.1%) 0
Nonfatal myocardial infarction 8 (1.1%) sup(a) 18 (2.4%)
Nonfatal stroke 4 (0.5%) 3 (0.4%)
Documented angina pectoris 40 (5.4%) 33 (4.5%)
-------------------------------------------------------------
a p < 0.05 vs aspirin.
SE - Side effects:
Side effects (patients) Ticlopidine Aspirin
(n = 734) (n = 736)
--------------------------------------------------------------
Withdrawals because of adverse events 53 (7.2%) 35 (4.8%)
>= 1 drug-related adverse event 90 (12.3%) 72 (9.8%)
Serious adverse events 18 (2.4%) 11 (1.5%)
Events:
gastrointestinal system 64 (8.7%) 54 (7.3%)
platelet, bleeding and clotting disorders 8 (1.1%) 7 (0.9%)
white cell and RES 4 (0.5%) 1 (0.1%)
red blood cell 1 (0.1%) 1 (0.1%)
general 2 (0.3%) 2 (0.3%)
skin and appendages 14 (1.9%) 5 (0.7%)
liver and biliary system 3 (0.4%) 0
respiratory system 3 (0.4%) 1 (0.1%)
--------------------------------------------------------------
RES - reticuloendothelial system.
DE - Descriptors:
Drug: Aspirin-therapeutic-use; Ticlopidine-therapeutic-
use;
Disease: Myocardial-infarction-treatment.
AS - Adis therapeutic area(s):
Ischaemic-Heart-Disease; Antithrombotics.
CC - EphMRA ATC codes:
B01C; B01C02; M01A01; N02B02.
AC - WHO ATC codes:
A01AS05; B01AC05; B01AC06; M01AX; N02BA01.
LG - Language:
English.
ED - Entry date:
20010517.
LE - Length:
13,183 characters, approximately 8 PC screens.
OC - Occurrences:
PARAGRAPH
TI (1).
R2 - Best evidence record:
Y.
Example of an Ongoing Trial record:
AN - Accession number & update:
0700000853 20060101.
TI - Title:
Docetaxel +- infliximab: adverse reactions
Anorexia, asthenia, cachexia and weight loss
Phase III trial in patients with unresectable non-small cell
lung cancer
(ONGOING TRIAL).
SO - Source:
Adis Clinical Trials Insight.
CR - Cited reference(s):
1.) ClinicalTrials.gov: US National Institutes of Health
2.) Mayo Clinic.
SI - Study names/identifiers:
CDR0000069417, National-Cancer-Institute;
IRB1063-02, Mayo-Clinic-Institutional-Review-Board;
NCCTG-N01C9, North-Central-Cancer-Treatment-Group;
NCI-P02-0226, National-Cancer-Institute;
NCT00040885, ClinicalTrials.gov:-US-National-Institutes-of-
Health.
SD - Study details:
Study details:
Status: In progress
Design: Double-blind, multicentre, randomised
Control: Drug combination comparison
Phase: III
Endpoints: Bodyweight, Quality of life, Response
rate, Survival, Time to disease
progression
Study Center: Mayo Clinic Cancer Center
Subject details:
Type: Patients
Planned No: 220
Location: USA
Disease: Asthenia, Weight loss, Cachexia, Anorexia
Patient Inclusion: Unresectable NSCLC considered incurable
with other therapies; patients aged 65
or over with an Eastern Cooperative
Oncology Group (ECOG) performance status
of 0-2 or patients aged under 65 with an
ECOG performance status of 2
Patient Exclusion: Prior docetaxel for metastatic NSCLC,
symptomatic or untreated brain metastases,
prior radiotherapy to >25% of bone marrow,
symptomatic or known untreated brain
metastases.
DE - Descriptors:
Drug: Docetaxel-adverse-reactions; Infliximab-
adverse-reactions;
Disease: Anorexia-drug-induced; Asthenia-drug-
induced; Cachexia-drug-induced; Weight-
loss-drig-induced;
Pharmacoeconomic: Quality-of-life;
Other Elderly.
AS - Adis therapeutic area(s):
Oncology; PharmacoEconomics.
CC - EphMRA ATC codes:
A07E; L01C; M01.
AC - WHO ATC codes:
AA07E; L01CD02; L04AA12; M01.
LK - Related ADRD records:
ADRD accession numbers: 00000849; 00004155.
LG - Language:
English.
ED - Entry date:
20050816.
LA - Latest update:
20060210.
LE - Length:
3,687 Characters, approximately 2 PC screens.
OC - Occurrences:
PARAGRAPH
AN (1).
R1 - Ongoing trial record:
Y.
Label/description Example
AN Accession number 1_: 800864577.AN.
& update 2_: 20060101.AN.
- see also Limit options -
TI Title 3_: RESTENOSIS WITH STENT.TI.
For record type 4_: TY=ONGOING-TRIAL
SO Source 5_: SO=ADIS-CLINICAL-TRIALS-
INSIGHT
CR Cited reference(s) 6_: EUROPEAN WITH HEART.CR.
or abbrev. journal names 7_: EUR-HEART-J.CR.
or ISSN 8_: 0195-668X.CR.
or author 9_: JOHNSON-RG.CR.
or institution 10_: RADCLIFFE WITH OXFORD.CR.
CF Conference information 11_: AIDS WITH JANEIRO.CF.
SI Study names/identifiers 12_: ABCIXIMAB WITH DEVICE.SI.
or 13_: CADILLAC.SI.
EV Evaluation 14_: EFFICACY WITH DIABETES.EV.
or clinical relevance 15_: CL=A
- see also Limit options -
TX Text (includes SD, TR, RS) 16_: GERMAN WITH CLL.TX.
SD Study details* 17_: CLL WITH DOSE ADJ
ESCALATION.SD.
or study design 18_: SD=DOUBLE-BLIND
or study control 19_: SC=DRUG-CLASS-COMPARISON
or study phase 20_: SP=III
or study endpoints 21_: SE=CLINICAL-CURE-RATE
or study status 22_: ST=IN-PROGRESS
or companies 23_: CO=ELI-LILLY
for a list use 24_: ..ROOT CO=MERCK
or locations 25_: LO=LATIN-AMERICA
- see also Limit options -
TR Treatments 26_: FLUTICASONE WITH
INTRANASAL.TR.
RS Results 27_: TARGET ADJ VESSEL.RS.
SE Side effects 28_: KIDNEY ADJ CALCULUS.SE.
DE Descriptors* 29_: HIV WITH TREATMENT.DE.
or 30_: HIV-INFECTIONS-TREATMENT.DE.
or drug descriptors 31_: DRUG=L-NDDP-THERAPEUTIC-USE
or disease descriptors 32_: DISEASE=GOUT-TREATMENT
or pharmacoeconomic desc. 33_: ECON=COST-EFFECTIVENESS
or other descriptors 34_: OTHER=CORONARY-STENTING
AS Adis therapeutic area(s)* 35_: RHEUMATIC ADJ DISEASE.AS.
or 36_: AS=RHEUMATIC-DISEASE
CC EphMRA ATC codes 37_: D01A01.CC.
or for a broader search 38_: D01#.CC.
AC WHO ATC codes 39_: D01AA01.AC.
or for a broader search 40_: D01A#.AC.
LK Related ADRD records 41_: 00015630.LK.
LG Language* 42_: FRENCH.LG.
or 43_: LG=FR
For a list use 44_: ..ROOT LG=
ED Entry date 45_: 20051114.ED.
or year 46_: YEAR=2005
- see also Limit options - 47_: YR=2005
LA Latest update 48_: 20060223.LA.
- see also Limit options -
LE Length - Display only -
OC Occurrences - Display only -
R1 Ongoing trial record 49_: Y.R1.
R2 Best evidence record 50_: Y.R2.
R3 Supporting evidence rec 51_: Y.R3.
R4 Citation only record 52_: Y.R4.
* The ROOT command is especially useful in these paragraphs to
establish, for example, how a descriptor appears in the database.
Initial search to select records 1_: ONCOLOGY
EV Evaluation score 2_: ..L 1 EV>70
PA Number of patients 3_: ..L 1 PA>100
PP Number planned patients 4_: ..L 1 PP WL 80,150
ED Entry date YYYYMMDD 5_: ..L 1 ED<20050630
YEAR Publication year YYYY 6_: ..L YEAR=2004
LA Latest update YYYYMMDD 7_: ..L 1 LA>20060531
UDATE Update date YYYYMMDD 8_: ..L UDATE>20051231
UMONTH Update month YYYYMM 9_: ..L UMONTH WL
200511,200512.
By paragraph, for example show title and cited reference(s)
for the first five records of search number 1:
1_: ..PRINT 1 TI, CR 1-5
By using a named format:
SHORT AN TI SO CR CF AS ED LA
MEDIUM AN TI SO CR CF SI EV SD TR RS SE AS LG ED LA
LONG AN TI SO CR CF SI EV SD TR RS SE DE AS CC AC LK LG
ED LA LE OC
ALL AN TI SO CR CF SI EV TX(SD, TR, RS) SE DE AS CC AC LK LG
ED LA LE OC
KWIC Context of search terms from EV TX(SD, TR, RS) and SE
paragraphs
HITS All paragraphs in which search terms occur
FREE AN TI SO DE CC AC LG ED LE OC
For example:
2_: ..P MEDIUM 1,3-4
Regardless of whether you use paragraph(s) or a named format,
the appropriate R1-R4 paragraph will also be displayed,
indicating the record type (for pricing purposes).
Adis Clinical Trials Insight was relaunched in 2006. Prior to
this, it was available on DataStar as three databases (ACTI, ACZZ,
and AC00) with separate date ranges and slight variations in
structure. Since the relaunch there is only one database - ACTI.
The labels ACZZ and AC00 have become just synonyms and point to
the ACTI database. ACTI has data from 1990 to date.
Terminology:
Generic drug names (INN/Adis preferred terms) are used. When an
INN or other non-proprietary name has not been established,
the research code, chemical name or other generic name is used.
Coverage:
The coverage dates in ACTI are based on dates when the
documents were released by Adis; they are not based on
publication dates of original articles cited in ACTI. Summary
of date types:
Entry date (paragraph ED and limit ED, also Quicks YEAR=, YR=
and limits YEAR and YR) is the date of creation of the record
by Adis in their Clinical Trials Insight product.
Latest update (paragraph LA and limit LA) is the date on which
the record was last updated by Adis. This tends to be found in
Ongoing Trials records.
Update date (second item in paragraph AN, and limits UDATE and
UMONTH) is the date on which the record was last updated in the
DataStar ACTI database.
MEDWORD should be used in ACTI.
..RANK and ..MAP:
This functionality is available in the DE, AS, CC, AC, LK, and
LG paragraphs.
For a complete guide to Adis Clinical Trials Insight search as
BASE-ACTI in the BASE database.
ADIS DATA INFORMATION BV
Database copyrighted by Adis Data Information BV. Data may not be
duplicated in hard copy or machine-readable format without
written permission of Adis Data Information BV.
If data is to be distributed under The Dialog Corporation's
Redistribution and Archiving (ERA) policy, distribution
is restricted to the company and geographical boundaries of the
country where the data was downloaded. Data which has been
downloaded under this provision may not be sold or resold to a
third party outside the company organization.
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