Takeda Clinical Trials
About Clinical Trials
What’s a clinical trial?
A clinical trial is a type of research [?] that evaluates an investigational or marketed medicine (or other intervention) in people. An intervention is any process or action that is the focus of a clinical trial. This can include a medication, vaccine, medical device, or procedure that is either investigational or already available. Interventions can also be something like a survey, educational material, or an interview.
Clinical trials are important for determining whether a new medicine, vaccine, or other intervention might work.
In a clinical trial, participants are assigned to receive one or more interventions or a control (sometimes called a placebo[?]). Participants in clinical trials are people who have volunteered to be part of the trial and are usually referred to the trial by the doctors who are treating their condition. The personal information of all participants is protected by privacy laws and only used anonymously. Patient confidentiality is taken very seriously and numerous measures are taken to ensure that the privacy of participants is maintained.
Clinical trials are important for public health because they help researchers discover new and better ways to treat patients and improve health.
Who initiates and runs clinical trials?
In order for a clinical trial to take place, someone has to initiate it. This person (or organization) is called the Trial Sponsor.
The trial Investigator is the person who actually conducts the trial.
Is a study the same as a clinical trial?
On this website you will see the term “clinical trial” used most often as it is generally considered synonymous with the term “clinical study.” There are 3 main types of trials: Interventional, non-interventional/observational, and expanded access/compassionate use.
An interventional trial is one that is intended to evaluate the efficacy, safety, or other information of an investigational compound or new use of an already marketed product. The intervention assignments are determined by the trial protocol. The majority of the trials found on this website are interventional trials.
A non-interventional (or observational) trial (most often referred to as a non-interventional study) involves collecting data to answer a specific research question relating to an approved product. The product and treatment is prescribed according to the current clinical practice and is not decided in advance by the trial protocol.
When a trial is designated as expanded access or compassionate use, it means regulators have allowed manufacturers to provide investigational new medicines to patients with serious diseases or conditions who cannot participate in a clinical trial.
What are the phases of clinical trials?
Clinical trials are divided into separate phases based on the objectives and characteristics of the trial. Each phase plays an important role in the development of a new medicine or therapeutic intervention.
The phases are:
- Phase 0
- This is an early trial designed to explore several aspects of an intervention, with no therapeutic or diagnostic goals. There usually is very limited human exposure to the product in this phase.
- Phase 1
- Trials in phase 1 are frequently conducted with healthy volunteers and focus on evaluating the safety of an investigational medicine. The goal is to find out what the most common and serious adverse events are. Often, investigators also evaluate how the body breaks down and eliminates the compound from the body.
- Phase 2
- This is when researchers begin to collect data on the efficacy of a compound. The efficacy refers to how well that product works to control the disease or condition it’s being investigated to treat. This is evaluated by comparing how participants receiving the investigational medicine respond vs. participants receiving a different treatment—often an inactive substance called a placebo[?]. Safety continues to be evaluated, and short-term adverse events are monitored.
- Phase 3
- In phase 3, researchers gather more information about safety and efficacy by studying more diverse patient populations and different dosages. When appropriate, this is when a compound may be studied in combination with other medicines.
- Phase 4
- Once a new medicine is approved for marketing, sponsors[?] may still choose to or be required to gather additional information about a drug's safety, efficacy, or optimal use. This is what’s referred to as phase 4 of the clinical trial process.
What does the status of a clinical trial mean?
A trial’s status indicates whether the trial is open or closed to enrolling new participants.
Trial recruitment statuses you may see on this site include:
- Ongoing, open to enrollment (includes trials that are “Recruiting” and “Enrolling by invitation”).
- No longer open to enrollment (includes trials that are “Active, not recruiting”).
- Not yet enrolling (includes trials that are “Not yet recruiting”).
- Ended prematurely (Includes trials that are “Suspended,” “Terminated,” and “Withdrawn”).
- Completed (includes trials that have ended normally).
What information is provided for each trial?
When you select one of the trials from your search, the first thing you’ll see is the protocol information about the trial. It’s a written description of the design of a particular trial that includes relevant scientific background and statistical information. In addition, the completed trials summary result information may be provided that generally includes efficacy, safety, and potentially pharmacokinetic and other results, but does not include patient-level data from each participant. If patient level data is available for a given clinical trial, a link will be provided along with the study results to allow qualified researchers to access our data request system via the Vivli portal.
Terms You Might See
What is the Trial ID and do I need to know this to search?
In addition to registry database identifiers such as the NCT #[?], trials may have one or more additional IDs assigned to them by the Sponsor. You do not need to know the ID of any trial to search, but if you are looking for a specific trial, knowing the trial ID is a quick way to pull up the information. Trial IDs also can be helpful for when you want to discuss a particular trial with your doctor.
What is an NCT #?
An NCT number (#) is the clinicaltrials.gov identifier, a unique identification code given to each clinical trial registered on ClinicalTrials.gov, where all Takeda clinical trials based in the United States also are registered. The format is always the same and includes the letters “NCT” followed by an 8-digit number.
Other registries have their own identifiers, such as the EudraCT #, which is a unique number assigned to a trial when registered with the European Union Drug Regulating Authorities Clinical Trials (EudraCT) database.
What is a placebo?
A placebo (often referred to as a “sugar pill”) is a substance that does not contain active ingredients but is made to look and taste identical to the actual drug being studied. Trials are called “placebo-controlled” when one group of trial participants is assigned to this placebo medication; this is called the control group. Having a control group helps the trial investigator determine if the changes noted during the trial are due to the actual medication or if they may be a side effect of the brain’s ability to feel different if it thinks it’s taking medication.
What is a compound?
This is the technical term for a trial medication or “product.” It refers to the pharmaceutical formulation of the product. Before being approved for use, products are generally referred to by their compound names.
About this Website
Where does the information on TakedaClinicalTrials.com come from?
The information about Takeda clinical trials found on this website is authored by Takeda and pulled from clinicaltrials.gov, a website maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).
Takeda trials not registered on clinicaltrials.gov also may be manually added to this website by Takeda.
The primary intent of this website is to provide access to clinical trial information from Takeda-sponsored clinical trials as outlined below.
The primary sources for clinical trial registration information are the applicable public registries in a given country or region (such as www.clinicaltrials.gov in the United States, the European Union Clinical Trials Register [EU CTR], the Japan Pharmaceutical Information Center Clinical Trial Information [JapicCTI], or the local registry in your country or region).
Alternatively, information on current or past trials can also be sought through the World Health Organization (WHO) International Clinical Trials Registry Platform, which consolidates searching across multiple registries into one portal.
In an effort to consolidate available Takeda-sponsored clinical trial information and to facilitate greater transparency, Takeda has developed this website to supplement information available on clinical trial register databases. Takeda makes all reasonable efforts to provide current and comprehensive summary information regarding active Takeda-sponsored interventional clinical trials and result summaries for completed trials supporting new medicines that received their first approval on or after January 01, 2005, on this website (at a minimum).
The clinical trial information provided on these registry databases and this Takeda website, constitute the totality of Takeda clinical trial registration and disclosure compliance information.
Takeda is dedicated to transparency, making information about its clinical trials readily accessible to the public. Learn more about our transparency policy.
Is TakedaClinicalTrials.com the only place where I can find information on Takeda’s clinical trials?
You can find information about Takeda’s clinical trials from a range of resources.
The primary intent of this website is to consolidate available Takeda-sponsored clinical trial information from global clinical trial databases and other sources to facilitate greater transparency and enhanced access to Takeda clinical trial information.
As such, this website facilitates access to clinical trial information that can be found on applicable public registries in a given country or region as required by law and in keeping with pharmaceutical industry guidelines (such as www.clinicaltrials.gov in the United States, the European Union Clinical Trials Register [EU CTR], the Japan Pharmaceutical Information Center Clinical Trial Information [JapicCTI], or the local registry in your country or region).
Alternatively, clinical trial information also can be sought through the World Health Organization (WHO) International Clinical Trials Registry Platform, which consolidates searching across multiple registries on one portal.
It should be noted that while the goal of this website is to help consolidate available, publically disclosed information about Takeda clinical trials in 1 location, this website may not represent the entirety of all such information. Takeda makes public clinical trial protocol information and results summaries on public databases as required by law or industry guidelines. These required public disclosures are supplemented by information on this website, and together all of these sources represent the totality of Takeda’s available clinical trial information.