text
stringlengths 4
164
| label_descriptions
sequence | Another_Study
bool 2
classes | Business_Administrative
bool 2
classes | Covid19
bool 2
classes | Endpoint_Met
bool 2
classes | Ethical_Reason
bool 2
classes | Insufficient_Data
bool 2
classes | Insufficient_Enrollment
bool 2
classes | Interim_Analysis
bool 2
classes | Invalid_Reason
bool 2
classes | Logistics_Resources
bool 2
classes | Negative
bool 2
classes | No_Context
bool 2
classes | Regulatory
bool 2
classes | Safety_Sideeffects
bool 2
classes | Study_Design
bool 2
classes | Study_Staff_Moved
bool 2
classes | Success
bool 2
classes |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
"Tapering doses" protocol arm was not effective for treatment retention outcome. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
1 Indication for further investigations (brain ultrasound). 2 Change of study design toÊ efficacy study with historical control group. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
1. Very low enrollment rate. Ê Ê 2. Recent studies question the effect of adding panitumumab in this category of patients. Ê Ê 3. Too high toxicity rate | [
"Insufficient_Enrollment",
"Safety_Sideeffects",
"Another_Study"
] | true | false | false | false | false | false | true | false | false | false | false | false | false | true | false | false | false |
10/2005 PI assigned duties as trauma physician in addition other duties | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
12/15/2008 Voluntarily placed on inactive status-requested by the PI | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
13 of 15 patients recruited.Study patients responded with no safety signals. RecruitmentÊ slow,timely end of study necessary to keep development timelines | [
"Business_Administrative",
"Insufficient_Enrollment"
] | false | true | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
2 complications with midazolam | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
20 subjects completed for a pilot, further funding required to continue study" | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
2011 Thailand flooding led to loss of GMP pharmacy, project delays, and further regulatory Ê challenges. | [
"Logistics_Resources",
"Regulatory"
] | false | false | false | false | false | false | false | false | false | true | false | false | true | false | false | false | false |
36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
5 immune related serious adverse events in Phase 1 study | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
50% of eligible patients refused to enter the study | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
6 month vital status report not collected after 28 day follow up analysis indicated no difference between placebo & tezosentan | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
65 patients were included after 2 years instead of 140 | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
7% enrollment. Study terminated after a small number of recruited patients | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
A business decision was made to not initiate this study. | [
"Business_Administrative",
"Invalid_Reason"
] | false | true | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
A cluster of adverse events in everolimus arm was noted. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
A cluster of deaths in the BCG-arm compared with controls | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
A decision was made to discontinue the study due to a change in the strategic direction of the company. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
A decision was made to not move forward with the study. No participants were enrolled or Ê treated. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
A higher rate of late rejection was seen in the low tacrolimus arm. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
A lack of a potential patient. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
A new alternative treatment caused the decrease in the rhythm of recruitment. | [
"Insufficient_Enrollment",
"Another_Study"
] | true | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
A new alternative treatment for patients who have progressed after treatment with trastuzumab, has caused the decrease in the rhythm of recruitment." | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
A new protocol was developed to replace this protocol in 2008, with removal of ATG andÊ extension of MMF duration. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
A new study has began recently | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
A new study is being designed. No patients were enrolled. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
A paper on the same topic came out just before we wanted to start our study. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
A pending new protocol will replace this study. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
A preliminary analysis of 11 patients confirmed the safety profile of NCX-1000 but did not demonstrate the efficacy required. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
A re-evaluation of research risks to participants were greater than originally anticipated | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
A significant reduction in head injuries coupled with more frequent use of crainectomy reduced Ê the number of potential subjects. | [
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
A sister study using Frova at a 10 mg dose had adverse effects. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
AG-1749 superior to Gefarnate in ulcer prevention | [
"Success",
"Endpoint_Met",
"Negative"
] | false | false | false | true | false | false | false | false | false | false | true | false | false | false | false | false | true |
AMAG not continuing with Combidex, the study drug" | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
AML assessment of response in the Part B patients (9) find treatment failure in all instances. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
AOI Pharma is reassessing the development strategy for perifosine. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
AOI Pharmaceuticals, Inc. decided to terminate the license agreement. No further clinical development by AOI Pharmaceuticals, Inc. will be pursued." | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
APPRISE closure prompted by SWOG S0205 not meeting primary endpoint-improving OS. APPRISE enrollment closure due to similar design;no unexpected safety data | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
AVE5530 in hypercholesterolemia was stopped due to insufficient efficacy | [
"Study_Design",
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | true | false | false |
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Ê Rigel Pharmaceuticals. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
AZD1704 has essentially similar PK profile in Japanese subjects as in Caucasians. One of the main purposes of the study has thereby been achieved. | [
"Endpoint_Met"
] | false | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false |
Abandoned due to lack of recruitment Oct 2006 | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Abnormality prevalence revealed to be much lower than expected. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Absence of patients for recruitment | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
According to the study design, in the first step the number of responses was lower than the number required (< 7)." | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual Goal Met | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation. | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Accrual factor | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual goal for interventional part not achievable | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual has been very slow. We are currently determining whether or not to keep the trial going as is or to close the trial and write a new protocol. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual is suspended due to COVID-19. | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Accrual is very poor | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual problems | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual rate was too low | [
"Insufficient_Enrollment",
"Study_Design"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | true | false | false |
Accrual too difficult to meet | [
"Logistics_Resources",
"Study_Design"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | true | false | false |
Accrual was not optimized | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrual was suboptimal and increasing the number of patients was not feasible. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Accrural was completed | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
Achieving site readiness and enrolling the trial within a reasonable time | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Acrrual target was not being met | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
Active Duty principle investigator currently deployed | [
"Business_Administrative",
"Study_Staff_Moved"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false |
Additional equipment is needed. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
Additional research | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Administrative | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Administrative closed due to funding | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Administrative reasons | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Administrative reasons. | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Administrative suspension | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Administratively complete. | [
"Business_Administrative",
"Endpoint_Met",
"Invalid_Reason",
"Success"
] | false | true | false | true | false | false | false | false | true | false | false | false | false | false | false | false | true |
Adult patient population barriers. | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
Adverse Events | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Adverse findings from nonclinical carcinogenicity studies. | [
"Safety_Sideeffects",
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
After 1 year only 2 subjects enrolled and treated thus no meaningful efficacy analyses could be performed. | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
After 190 weeks [7 patients left] it was terminated for administrative reasons | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
After IELSG25A study amendment, patients subject of the present study were eligible for inclusion in the IELSG25A study" | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
After Preliminary results indicate need to make numerous changes to protocol, and therfore will end, rewrite, and then begin again." | [
"Study_Design"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false |
After a discussion, we decided to withdraw the study." | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
After an extensive review,the ASPIRE in CKD study was terminated because it was not possible to complete the study in an appropriate time frame." | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
After an extensive review,the ASPIRE in CKD study was terminated because it was not possibleÊ to complete the study in an appropriate time frame. | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
After initiation of study many studies reported an equivalence of SNB and ALND which led to Ê widespread adoption of the former as standard procedure. | [
"Another_Study"
] | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
After interim analysis it was determined that the risks were too great in comparision to theÊ results | [
"Safety_Sideeffects",
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | true | false | false | false |
After interims analysis standard errors for inflammatory and nutritional markers varied Ê widely, that the power calculation required unattainable goals | [
"Study_Design",
"Insufficient_Data"
] | false | false | false | false | false | true | false | false | false | false | false | false | false | false | true | false | false |
After pilot study no difference in the primary end point was found between the two primary.Ê Non-inferiority trial not deemed feasible. | [
"Logistics_Resources",
"Study_Design",
"Negative"
] | false | false | false | false | false | false | false | false | false | true | true | false | false | false | true | false | false |
After primary completition date, experimental drug was no longer available | [
"Logistics_Resources",
"Study_Design",
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | true | false | false | false | false | true | false | false |
After reports of turbidity in urine in 4 of 8 volunteers in the 4th cohort, the study was halted temporarily." | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible. | [
"Safety_Sideeffects"
] | false | false | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false |
After treatment of 7 patients, it was decided that the handling characteristics of the test device should be upgraded before continuing the trial as planned." | [
"Logistics_Resources"
] | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false |
After utilizing all available recruitment resources, it was determined that the recruitment goal for the study could not be achieved" | [
"Insufficient_Enrollment"
] | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false | false | false |
After year 1, there was insufficient statistical power to detect a difference in the primary outcome measure during planned study period." | [
"Negative"
] | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false |
Aims of the study re-evaluated, did not justify allocation of resources." | [
"Business_Administrative"
] | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
All AstraZeneca sponsored clinical trials of AZD8931 have been halted | [
"No_Context"
] | false | false | false | false | false | false | false | false | false | false | false | true | false | false | false | false | false |
All enrollment, treatment, follow-up & data analysis completed" | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
All of the mentioned aim and objectives were achieved before the February 2007 | [
"Endpoint_Met"
] | false | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false |
All patients during the study period were subjected to peripheral blocks or were excluded fromÊ the study due to exclusion criteria | [
"Endpoint_Met",
"Safety_Sideeffects"
] | false | false | false | true | false | false | false | false | false | false | false | false | false | true | false | false | false |
All patients recruited | [
"Invalid_Reason"
] | false | false | false | false | false | false | false | false | true | false | false | false | false | false | false | false | false |
All sites have been put on hold due to the ongoing COVID-19 pandemic | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
All subject enrollment/follow up is on hold due to COVID-19 pandemic | [
"Covid19"
] | false | false | true | false | false | false | false | false | false | false | false | false | false | false | false | false | false |
Dataset Card for Clinical Trials's Reason to Stop
Dataset Summary
This dataset contains a curated classification of more than 5000 reasons why a clinical trial has suffered an early stop. The text has been extracted from clinicaltrials.gov, the largest resource of clinical trial information. The text has been curated by members of the Open Targets organisation, a project aimed at providing data relevant to drug development.
All 17 possible classes have been carefully defined:
- Business_Administrative
- Another_Study
- Negative
- Study_Design
- Invalid_Reason
- Ethical_Reason
- Insufficient_Data
- Insufficient_Enrollment
- Study_Staff_Moved
- Endpoint_Met
- Regulatory
- Logistics_Resources
- Safety_Sideeffects
- No_Context
- Success
- Interim_Analysis
- Covid19
Supported Tasks and Leaderboards
Multi class classification
Languages
English
Dataset Structure
Data Instances
{'text': 'Due to company decision to focus resources on a larger, controlled study in this patient population."',
'label': 'Another_Study'}
Data Fields
text
: contains the reason for the CT early stop
label
: contains one of the 17 defined classes
Data Splits
[More Information Needed]
Dataset Creation
Curation Rationale
[More Information Needed]
Source Data
Initial Data Collection and Normalization
[More Information Needed]
Who are the source language producers?
[More Information Needed]
Annotations
Annotation process
[More Information Needed]
Who are the annotators?
[More Information Needed]
Personal and Sensitive Information
[More Information Needed]
Considerations for Using the Data
Social Impact of Dataset
[More Information Needed]
Discussion of Biases
[More Information Needed]
Other Known Limitations
[More Information Needed]
Additional Information
Dataset Curators
[More Information Needed]
Licensing Information
This dataset has an Apache 2.0 license.
Citation Information
[More Information Needed]
Contributions
Thanks to @ireneisdoomed for adding this dataset.
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