The Medicines and Healthcare products Regulatory Agency (MHRA) Chief Executive, Professor Kent Woods, today welcomed the publication of the European Science Foundation’s (ESF) report into Investigator Driven Clinical Trials (IDCT).

The report highlights and analyses the main obstacles that hinder achieving an increased number of non-commercial and academic clinical trials in Europe.

It also identified the need to increase levels of funding for IDCT and adopt a ‘risk-based’ approach to regulation.

Professor Woods said although the United Kingdom has made considerable progress in streamlining the trial authorisation process, there remains scope to further improve in some of the other areas highlighted in the ESF report.

“The UK continues to lead in this type of research in Europe but we could do a lot more if critical obstacles were addressed.

Some of these are regulatory, but not all. Some are also related to the infrastructure required to carry out clinical trials.

The ESF report identifies and ranks 25 specific issues that need to be examined in the UK context,” he said. “And we will work with colleagues in the Department of Health (DoH), the Medical Research Council and the academic sector to do that.”

The EU Clinical Trials Directive on which the UK regulations are based is due to be reviewed by the European Commission in 2010 and there is strong support expressed in the ESF report for a more flexible and ‘risk-based’ legal framework.

“Extensive work is currently being carried out not only to boost the volume of clinical trials being conducted in the UK, but also the number of patients given the opportunity to participate in this research.

The challenge is to ensure the safety of patients and the integrity of the data as efficiently as possible.

Good research is an essential part of maintaining a high quality health care system. This report will help ensure that clinical trials are encouraged and that unnecessary barriers are removed.”

Notes to Editor

The MHRA authorises approximately 1200 clinical trials per year. This week, an improved Integrated Research Application Scheme (IRAS) was launched which allows a single form to be used for applications to the Agency, to an ethical committee and to the NHS.

• The total numbers of clinical trials approved in the UK have remained stable since the implementation of the EU Clinical Trials Directive in May 2004.

2005 – 1085
2006 – 1206
2007 – 1218
2008 – 1252

• Current active trials in the UK: 3000 (approx)
• Sponsor status of UK trials:   

Non-commercial         25%
Commercial                75%

• The implementation of the EU Clinical Trials Directive actually simplified the approvals process as it made it a legal requirement that approvals were needed from only a single ethics committee and the Competent Authority (MHRA in the UK) in each EU Member State involved in a clinical trial. This contrasts with the situation in the UK prior to May 2004 when multiple ethics committee approvals were needed for many trials.
• The MHRA processes Clinical Trial Applications (CTA) well within the EU guidelines.
• Initial Clinical Trial Applications are reviewed within 30 days of receipt of a valid application:

100% reviewed within 30 days
40 – 50% approved
50 – 60% given Grounds for Non-Acceptance (GNA)

• Secondary review (GNAs) completed within total of 60 days from initial receipt:

100% reviewed within 60 days
1-2% rejected (remainder approved)

• The MHRA assesses more CTAs than any other EU regulatory agency in both the commercial and non-commercial sectors.
• From 9 March 2009 all the data required to make an application to the MHRA for authorisation of a clinical trial of an Investigational Medicinal Product (IMP) can be completed within the Integrated Research Application System (IRAS) http://www.myresearchproject.org.uk
• Through IRAS all the information about a study can be entered in one place and researchers only need to go to EudraCT to obtain their EudraCT number.
• IRAS contains extensive guidance to support researchers in completing their application form. Additionally, it is now possible to generate the application form to the MHRA in the appropriate formats directly from IRAS.

In the Executive Summary of the report issued yesterday by the European Science Foundation the top five recommendations on strengthening Investigator Driven Clinical Trials (IDCT) are listed as:

1. To improve the education, training and career structure, and opportunities for scientists involved in patient-oriented clinical research.
2. To increase levels of funding for IDCT.
3. To adopt a ‘risk-based’ approach to the regulation of IDCT.
4. To streamline procedures for obtaining authorisation for IDCT.
5. To ensure that IDCT are carried out with an appropriate number of patients to produce statistically reliable results so that the trials are ‘correctly powered’.

Link to full report: www.esf.org/emrc/flidct