How to add a trial to the clinical trials wiki

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

This page provides directions and help for those who wish to add a trial to the clinical trial wiki. If you need more help contact the WikiDoc hotline at (617)-632-7590 or email us [2].

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)

Randomized trial

Case control study

Longitudinal study

Blinding

Single blind:

Double blind:

Triple blind:

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)

None reported

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

None reported

Exclusion Criteria

None reported

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)

None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)

None reported

Conclusions of the Investigators (Quote the investigators conclusions here)

None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)

None reported

Slides

None reported

Video Commentary

None reported

References (How to insert a reference)

None reported

External sites for further information (How to insert links)

None reported

Ages

__ years to ___ years

Gender (Indicate whether men, women or both were enrolled)

None reported

Accepts Healthy Volunteers (Answer yes or no)

None reported

Enrollment Period (Study start and end date)

None reported

Recruitment Status (explanation)

None reported

Enrollment (Total number of patients enrolled)

None reported

Study Sponsor (e.g. Investigator initiated or company name)

None reported (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)

None reported

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