Help:How to add a trial to the clinical trials wiki

This page provides directions and help for those who wish to add a trial to the clinical trial wiki. For the blank template, click here.

Complete Title of Study
In this section add the complete title as it appears at clinicaltrials.gov or as it appears in the main publication of the paper.

An example would be:

Global Utilization Of Streptokinase And Tpa For Occluded Arteries

Study Acronym (The trial's abbreviation if there is one)
Often a trial will have an abbreviation, and this is called an acronym. Place that here. Also make sure that the acronym redirects to the page with the full name of the trial. To learn how to redirect a page click here.

An example of an acronym would be:

GUSTO

which stands for Global Utilization Of Streptokinase And Tpa For Occluded Arteries

Principal Investigator, Co-investigators, and Collaborating Institutions
If you know the name of the principal investigator (the person who led the trial) type it in here. This should be followed by the other investigators names. You can also copy and paste the authorship from the primary article reporting the results. A list of names cannot be copyrighted.

An example would be:

Principal Investigator: Tom Smith, M.D.

Co-investigators: Susan Harris, R.N.; Jane Doe, M.D.

Institutions: Duke University

Overview of Trial
Provide a short summary of the goals of the trial here.

An example would be:

The goal of the ABC trial was to evaluate the safety and efficacy of XYZ among 2345 patients hospitalized with PDQ.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Clinical trials involve highly select groups of patients with a specific disease.

Add here the specific disease state and specific population within that disease state that is being studied. It is important to be as specific as possible here. For instance, don't just use the word cancer. Use terms like breast cancer or better yet, the specific type of breast cancer.

An example would be:

Invasive ductal carcinoma of the breast

Another example would be:

First ST elevation myocardial infarction presenting in the first six hours of symptoms

Study Phase (e.g. Phase I,II,III,IV)
Type in the Phase of the trial.

Example:

Phase I

The definitions of phases of trials are below:

Phase I Trials These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.

Phase II Trials Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.

Phase III Trials Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness  of the drug has been obtained, and are intended to gather additional information  to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.

Phase IV Trials After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug's risks,benefits, and optimal use in a broader group of real world patients.

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
International:

National:

Single Center:

Multicenter:

Randomized trial

Case control study

Observational study

Longitudinal study

Cross-sectional study

Blinding

Unblinded trial

Single blind trial

Double blind trial

Triple blind trial

Placebo controlled

An example would be:

International, multicenter, randomized, double blind, placebo controlled

Another example would be:

Single center, non-randomized observational study

Study Arms and How They Were Treated (Intervention) (Explanation here)
Describe the assignment of study arms and the intervention each group received.

Example: Patients were randomized to active drug and placebo on a 2:1 ratio.

Primary Pre-Specified Endpoint
The key endpoint or finding of the study that was agreed upon before the trial ended (pre-specified).

Example:

Death

Another example:

The composite of death, recurrent myocardial infarction and stroke

Secondary Endpoints
Endpoints other than the key endpoint.

Example: Major bleeding

Inclusion Criteria
A set of requirements or conditions a study subject must meet in order to participate in a clinical trial. These often include, but are not limited to age, sex, disease state, and medical history.

Example: Male or female between the age of 21-55 with acute coronary syndrome.

Exclusion Criteria
A set of characteristics that preclude a study subject's participation in a clinical trial.

Example: Patients under age 18 or over 65; previous administration of statin therapy; inability to provide informed consent.

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
The measured effect of the intervention on the key endpoint.

Example: Compared to placebo, the study drug was associated with an absolute reduction in the the pre-specified primary endpoint from 18.4% (n=572) to 14.1% (n=585)(p=0.03), which is a relative risk reduction of 25.

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
The measured effect of the intervention on the secondary endpoint.

Example: The treatment was associated with a reduction in the incidence of the prespecified secondary end point by 11% (p = 0.035).

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
The measured effect of the intervention on the exploratory endpoints.

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
The measured effect of the intervention on the safety endpoint.

Conclusions of the Investigators (Quote the investigators conclusions here)
Summary of the trial findings and their implications.

Example:

Among patients with pdq, administration of abc was associated with a % absolute riks reduction in the risk of ___ (Insert the primary endpoint here). ABC appears to be a suitable alternate treatment for pdq.

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
Discussion of the principal findings, interpretations, and implications of the trial.

Limitations include:

Inadequate sample size

Bias (Ascertainment bias, Optimism bias, Selection bias,Omitted-variable bias)

Confounders

Multicollinearity

An example would be: This analysis is a non-randomized retrospective analysis, and as such it is possible that both identified and unidentified confounders may have influenced the outcomes. Randomized trials enroll a select groups of patients, and the results of this trial may not be applicable to all patients with the disease.

Slides
Powerpoint presentation detailing the key aspects and/or commentary of the clinical trial.

Video Commentary
Upload any videos related to this clinical trial in this section. To learn how to insert a video, click here.

References (How to insert a reference)
List all relevant references here. Include the authors of article, title, name of journal where published, year published, volume number and the page numbers.

Example:

Gibson CM, Pride YB, Frederick PD, et al (December 2008). "Trends in reperfusion strategies, door-to-needle and door-to-balloon times, and in-hospital mortality among patients with ST-segment elevation myocardial infarction enrolled in the National Registry of Myocardial Infarction from 1990 to 2006". Am. Heart J. 156 (6): 1035–44. doi:10.1016/j.ahj.2008.07.029. PMID 19032997

External sites for further information (How to insert links)
List other websites containing information related to the clinical trial.

Ages
__ years to ___ years

Gender
Indicate whether men, women or both were enrolled.

Accepts Healthy Volunteers (Answer yes or no)
Some trials accept healthy patients to participate in the study. Indicate whether this clinical trial recruits healthy volunteers.

Enrollment Period
Study start and end date.

Recruitment Status (Explanation)
Indicate whether the trial is not yet recruiting, recruiting, enrolling by invitation, active but not recruiting, completed, suspended, terminated, or withdrawn.

Enrollment
Total number of study subjects participating in the clinical trial.

Study Sponsor
Indicate whether the study was initiated by the investigator, or specify a company name. (This may not have yet been ascertained.)

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
Reference the source of the information displayed on this page.

The content of the clinical trial wiki consists of fields that have been suggested by the World Health Organization and wwww.clinicaltrials.gov.