Why register trials on ISRCTN?
Registering a clinical trial registration on a public register is an important step in the public declaration of a research study of a health intervention, in line with international standards.
The Declaration of Helsinki and a growing number of medical journals insist on prospective registration of clinical trials before journals will consider the publication of a study protocol and/or trial results. Registration is also strongly recommended by the World Health Organization.
Clinical trial registration is not a legal requirement in all countries. UK research funding bodies that support clinical trial registration have chosen to rely on trial registration service providers such as ISRCTN.org, administered by Current Controlled Trials (CCT), to fulfill their objectives of research transparency and visibility. For example:
The ISRCTN register is administered by Current Controlled Trials (CCT).
Why does ISRCTN.org have a fee?
ISRCTN is a not for profit organisation. It has no reserves. By charging a fee for registration, it covers the cost of maintaining a public register which is free to access. The fee is set at a level which enables CCT staff to maintain the register, and to support researchers in providing complete information, including patient-friendly content.
The ISRCTN register provides a service that facilitates the registration all study designs in all areas of health care. The fee per trial is paid either by trialists themselves or by the institutions they belong to. The main UK funders of health research regard this fee as an allowable research cost.
- Maintaining and enhancing systems for online submissions, application processing and publication. This includes adding new fields to the ISRCTN dataset, in response to the needs of the clinical trial community.
- Providing permanent free access to trial records
- Preparing data in various formats for exchange with other trial platforms (WHO international portal, UK Clinical Trials Gateway)
- Reviewing submissions to make sure that all the required information has been provided
- Checking for existing registration in other registers to minimize overlaps
- Advising trialists and organisations on latest registration requirements
- Updating record at any time in the lifecycle of the study (eg when results are published)
- Reviewing and improving data coding as new fields are added
- Recommending and defining quality standards (eg for lay summary field added in June 2011)
Dissemination and permanence
- Promoting existence of trials (can include social media)
- Providing ad-hoc analyses on registration volumes and trends
- A permanent identifier for the trial (ISRCTN) and a permanent, public URL for the study
Why is a lay summary important for a trial record?
The leading partners in UK health research have a long-standing commitment to make information available in a form that patients and the public, as well as scientists, can readily understand.
A 2011 report resulting from the JISC-funded Patients Participate! Project hosted on the Association of Medical Research Charities (AMRC) website described a growing demand for medical research findings to be made accessible to the general public. A number of journals have started including summaries for the research articles they publish. There should also be lay summaries of completed and ongoing clinical trials describing in broad terms, outcomes which have not yet been published.
UK research ethics committees routinely expect that a clinical trial will appear on a public register unless there is a good reason not to register it. In 2011, with support from partner organisations, the British government launched the UK Clinical Trials Gateway website and smartphone apps. The UKCTG draws on clinical trial registers to provide information that is easier for patients and the public to understand. As well as informing the public, the UKCTG aims to draw attention to opportunities for people to participate in trials (see paragraph 2.197 on page 97 of the 2011 Plan for Growth). A key objective of the UKCTG is to make its content as accessible as possible.
In order to help research funders and the UKCTG achieve their aims, in June 2011 the ISRCTN register introduced a lay summary field which either allows trialists to submit trial detail information in plain English or to refer to an existing online summary (web pages produced mainly by CancerHelp UK and from the MRC ClinicalTrials Unit).
ISRCTN.org has been working on the following:
- Engage with organisations that require research summaries as part of their funding process to make the most of existing expertise around lay summaries
- Review and implement process changes that will encourage the use of high quality lay summaries throughout the life cycle of clinical trials
- Improve existing guidance notes in cooperation with organisations that have relevant expertise
- Work with others to make consistent advice available at every stage of the research process (ethics, funding, regulatory)
How much is ISRCTN.org charging
The fee per trial is available on the ISRCTN submission page.
How do organisations/trialists pay?
Organisations can be invoiced on a monthly basis.
Trialists can pay by credit card, cheque or bank transfer (please note that we do not accept Western Union money transfers), however we strongly recommend that payments are made by credit card, as they generally clear more quickly than other forms of payment.
- Credit card Simply fill in your card details on the invoice and either mail it to BioMed Central - Springer-Verlag, Post Box 120 141, 14302 Berlin, Germany or email it to firstname.lastname@example.org. Credit card payments can take up to 5 days to process.
- Cheque Please make payable to BioMed Central Ltd and mail to our Lockbox address: BioMed Central Ltd., PostBox 20 01 55, 60605 Frankfurt, Germany. Payments made cheque can take up to 15 days to clear.
- Bank Transfer Please use the details provided on your invoice. Bank transfer payments take up to 30 days after the transfer date to be confirmed by our Accounts Department.
Are any taxes included in this charge?
Trialists resident in the UK are liable to pay Value-Added Tax (VAT, currently 20%). Trialists outside of the UK do not pay VAT but are asked to provide a VAT number (where applicable).
Who is responsible for making the payment?
Whoever submits the application is responsible for making or arranging the payment (for instance, via his or her institution).
Do changes to exchange rates affect the amount payable for an application?
The fee is determined at the time the trial application is accepted and invoiced for. There would only be a fee readjustment if the invoice is not paid, several reminders are sent and the application is eventually reactivated several months later and a substantial change in the exchange rate may have happened.
Does ISRCTN.org offer discounts and/or waivers on fee?
Individual waiver requests will be considered on a case-by-case basis.
How does ISRCTN.org compare with other registers?
Some registers such as those that are part of the WHO network may not charge a fee because their activities are fully funded by grants. ISRCTN.org however offers a number of unique services not provided by other registries.
What are the benefits of registering with ISRCTN?
- Trials details can be submitted either directly by principal investigators using the ISRCTN online submission system or using automatic processes – this facilitates trial data transfers.
- The CCT editorial team reviews the quality and completeness of the information provided – this ensure that trial information complies with international guidelines set by the World Health Organisation and the International Committee of Medical Journal Editors (ICMJE).
- Principal Investigators (PI), the health funder or the ISRCTN register can initiate updates – this ensures that trial details are as accurate as possible at all times. Examples of updates include ethics approval, trial end date, evolution of outcomes measures, resulting publications, trial status.
- Progress reports can be provided by ISRCTN.org to health research funders at regular intervals – this provides insight on the volume and type of research.
- All ISRCTN trials are automatically pooled in the WHO trial search portal – this brings awareness of research to a wider audience.
- The ISRCTN records for trials which recruit in the UK are fed into the UK Clinical Trials Gateway (UKCTG) which aims to bring information about trials which are recruiting UK participants to the attention of a wider audience – ISRCTN.org strongly supports this and other means of improving public awareness of clinical trials and their impact on health care.
- Selected BioMed Central journals offer a 20% discount on the article processing charge to protocol authors who have registered their trial with the ISRCTN register. Authors should request a waiver during the submission process and provide their ISRCTN. For more information on this scheme, and to find out whether your protocol can be published with a discount, view the publish your study protocol page at BioMed Central.
12 April 2012