Frequently asked questions

General
What is a randomised controlled trial?
What is prospective registration of trials?

About the metaRegister of Controlled Trials (mRCT)
Who is the mRCT for?
Is access to the mRCT free?
What does the mRCT contain?
Is the mRCT a complete record of trials around the world?
What kind of organisations give information to the mRCT?
What kind of information is available for each trial?
Is the information in the trial records reviewed by Current Controlled Trials before being included in the database?
How do I find out more about a trial?
How do I find out whether I am eligible to take part?
Can I use this website to take part in a trial?
How do I know whether a trial is a good one in which to take part?
If the trial seems to be complete, how can I find the result?
Do I need to have scientific knowledge to use the database?
What does the Links section contain?
What is the difference between the mRCT and the Links section?
Why would an organisation wish to contribute information to the mRCT?
What safeguards are there for organisations contributing data to the mRCT?
What is an International Standard Randomised Controlled Trial Number?

General
Q. What is a randomised controlled trial?
A. A clinical study in which two (or more) forms of care are compared. The participants are allocated to one of the forms of care in the study, in an unbiased way, by using the play of chance.

Q. What is prospective registration of trials?
A. In recent years there has been increasing support for greater openness about clinical trials while they are in progress. This means that it is possible to find out about the trial earlier, rather than having to wait until it is complete (sometimes years later) and the results are published. Declaring details of a trial at its outset is known as prospective registration.

About the metaRegister of Controlled Trials (mRCT)
Q. Who is the mRCT for?
A. The free information contained in the mRCT provides a service to the following groups:

• people using evidence from controlled trials who want to be confident that they are aware of all of the trial evidence relevant to a particular question;
  
• research funding agencies (public, commercial and charitable) who want to take their funding decisions in the light of information about relevant ongoing research, both to avoid duplication of effort and to promote collaboration; and
  
• patients, participants, and other decision-makers who wish to be informed about trials in which they can participate or to which they can contribute in other ways.

Q. Is access to the mRCT free?
A. The mRCT is freely available to all users online.

Current Controlled Trials initially undertook to make no charge to research funders (and others) for depositing material in the mRCT (unless significant editing was required). During its first four years the mRCT was funded by the Science Navigation Group, but funds are no longer available. An unsuccessful bid for three years' funding from the European Union led Current Controlled Trials to look to trial sponsors and other register-holders to support the effort to provide information on ongoing trials free to the user. From October 2002, therefore, organisations wishing to include their trial register in the mRCT have been asked to contribute to the costs of processing, indexing and displaying the information. For details of the scale of charges, please contact info@controlled-trials.com.

Q. What does the mRCT contain?
A. The mRCT is being expanded all the time; there are thousands of randomised controlled trials going on around the world. We are keen to make the mRCT as comprehensive and valuable a resource as possible. So far, it contains more than 14,000 records, most of which provide specified data items, about ongoing and some completed randomised controlled trials in all areas of healthcare, throughout the world.

Q. Is the mRCT a complete record of trials around the world?
A. The mRCT is not a comprehensive record of all randomised trials worldwide. It is therefore wise to search other sites (for example those in Links section) to complement the information in the mRCT. All registers taking part in the mRCT are asked to update their records at least once a year, and many choose to do so more frequently.

Q. What kind of organisations give information to the mRCT?
A. We are currently building the mRCT by asking organisations that fund randomised controlled trials to share their register of information on these trials. The registers come from medical research charities, pharmaceutical companies, public funding bodies and others with an interest in trials. These might include patient support groups, who sometimes gather information on ongoing trials even if they have not actually funded them. So far, participating registers are from the UK, Canada, America, Australia and Hong Kong. Click here for a full list of contributors.

Q. What kind of information is available for each trial?
A. The Ad Hoc Group for Prospective Registration of Controlled Trials, which met in the UK in July 1998 to take forward initiatives in this area, advised upon the information considered essential for clinicians, patients and researchers to identify trials that may be of interest. All participating registers were asked to try to meet this minimum dataset drawn up by the group.

Since then, we have changed this dataset following advice that slightly different information is required to meet the needs of clinicians, researchers, patients and the public. However, we do not reject trial registers that are currently unable to offer the complete list, rather we see it as a long-term goal for the future. Click here to see a full list of the revised data items.

Q. Is the information in the trial records reviewed by Current Controlled Trials before being included in the database?
A. The records come from a variety of sources, as follows:

• Trial registers contributed to the mRCT: the quality, currency, and accuracy of these records are the responsibility of the organisations contributing them.
  
• Records held in outside websites that are searchable via the mRCT search facility - these are the responsibility of the source website.
  
• Records submitted by individual trial investigators (lead principal investigator or equivalent) - these are the responsibility of the lead principal investigator.
  

Q. How do I find out more about a trial?
A. Contact details are provided at the end of every trial record if you would like further information. In addition, we hope that the trial record will offer access to the patient information material, designed to explain the trial to patients and other participants.

Q. How do I find out whether I am eligible to take part in a trial?
A. In many of the trial records the 'eligibility criteria' section describes the kind of participant that is suitable for the trial (in the section called inclusion criteria) or unsuitable for the trial (exclusion criteria).

Q. Can I use this website to take part in a trial?
A. No. The mRCT is a source of information only. But for those who are interested in participating in a specific trial or in obtaining further information, there are contact details at the end of every trial record. Wherever possible these contacts will link automatically to an email address, to save you time. Once you have found a trial that might be of interest, you should consult your own doctor or specialist for advice.

Please note: The information in the site is not intended to be a substitute for professional medical advice. The information should not be used to diagnose or treat a health problem or disease without consulting with a qualified health care provider. Users of the site are advised to consult a health care provider with any questions or concerns about their condition. See Terms and Conditions for further details.

Q. How do I know whether a trial is a good one in which to take part?
A. Once you have found a trial that might be of interest, you should consult your own doctor or specialist for advice. You might also like to ask your relevant local or national patient group (or voluntary organisation) for their views.

Before any trial is allowed to start, the investigators in charge have to obtain approval from the appropriate ethical committee or board, that represents the interests of the patient.

All trials in the planning phase (that are not yet recruiting patients) may not yet have obtained approval from the appropriate ethical committee or board. You can be sure that all trials that have started recruiting patients will have received such approval.

Please note: The information in the site is not intended to be a substitute for professional medical advice. The information should not be used to diagnose or treat a health problem or disease without consulting with a qualified health care provider. Users of the site are advised to consult a health care provider with any questions or concerns about their condition. See Terms and Conditions for further details.

Q. If the trial seems to be complete, how can I find the result?
A. If Current Controlled Trials is provided with details of the publication of results of a trial these will be included in the trial record. If no details are available, you could ask the person listed as the contact in the 'Further Information' section at the end of every trial record. You might prefer to search the literature database PubMed and/or the Cochrane Controlled Trials Register of published trials.

Q. Do I need to have scientific knowledge to use the database?
A. We hope that the information will be of use to anyone with an interest in health care. However, we are aware that some of the registers we receive do contain quite complex information, and we regret that it may be difficult for some users to understand. If the record does not include information on how to access the patient information material (designed to explain the trial to the patient), the named contact for the trial should be able to advise.

Q. What does the Links section contain?
A. The Controlled Trials Links section contains more than 200 links to other websites that make available registers of trials. Each link is introduced by a brief description written by Current Controlled Trials. Each of these external registers has to be searched individually.

Q. What is the difference between the mRCT and the Links section?
A. The mRCT is a searchable international database of ongoing (and some completed) randomised controlled trials in all areas of health care. So far it provides access to 20+ trial registers - containing more than 14,000 records. When you enter keywords in the mRCT search facility you will be searching all these records. You do not have to search each register separately.

The Links section gathers together more than 200 links to registers of trials in other websites, with a short description of each. As these outside sites are not incorporated into one database, each one has to be searched individually. In time we hope that these other trial registers will share their trial records with the mRCT.

Q. Why would an organisation wish to contribute information to the mRCT?
A. There is increasing support for prospective registration of randomised controlled trials. Indeed, in some countries, laws or Government guidelines require it. By contributing information to the mRCT, organisations are leading the way in adding to the body of knowledge available for all who are interested in the subject. In particular, they will be helping researchers to provide concrete evidence on which doctors and other health professionals may base their decisions on patient care. Organisations will also be bringing their trials to the attention of a wider, interested audience.

Q. What safeguards are there for organisations contributing data to the mRCT?
A. The Memorandum of Understanding summarises the responsibilities of Current Controlled Trials as hosts of the mRCT, and of the research funding (and other) bodies that provide the information to the mRCT. Key safeguards include:

• Data submitted to the mRCT will be owned by those organisations submitting the data.
  
• Current Controlled Trials Ltd will make no charge to users for browsing the mRCT and extracting data.
  
• Neither the ownership of the mRCT nor the data contained therein can be passed on to a third party without the unanimous permission of the research funders/register providers.
  
• Current Controlled Trials will provide to research funders/register providers depositing information on the site at least six months' notice of termination of the arrangements.
  

Current Controlled Trials Ltd has been granted an International Standard Serial Number (ISSN 1467-1018) for the mRCT, thereby undertaking to deposit a permanent record of the mRCT, in an electronic format (CD-ROM), at the end of each year, with the five UK copyright libraries.

Q. What is an International Standard Randomised Controlled Trial Number (ISRCTN)?
A. The International Standard Randomised Controlled Trial Number (ISRCTN) is a simple numbering system for the unique identification of trials worldwide. Acting rather like the ISBN (International Standard Book Number) on the back of every book, it will simplify the identification of trials and provide a unique number that can be used to track all publications and reports resulting from each trial.

Please let us know if you have any questions that you would like us to answer and then add to this section.

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