New targeted therapies are revolutionising cancer treatment – they can turn cancer into a chronic disease. However, they do not work for everyone and some patients, who have initially responded to these novel therapies, become resistant and their disease progresses. There are a huge number of novel targeted therapies in pre-clinical and early clinical trials.

Patient with resistant disease often seek out these trials as a means to stay alive and some patients’ lives have been saved by finding information about such trials on the Internet. Unfortunately, information about clinical trials in progress is often shrouded in a veil of secrecy, and patients find it hard to locate trials that address their specific condition.

A series of recent events has brought about consensus in support of a comprehensive approach for a public registration and reporting of Clinical Trials in form of a Clinical Trials Registry.

EU Clinical Trials Directive (Directive 2001/20/EC)

In 2001, the EU had passed the "Clinical Trials Directive" (Directive 2001/20/EC of the European Parliament and of the Council), which was then implemented in national law across Europe until 2004. The Directive aimed to be a first step towards harmonisation of clinical trials across Europe, and to improve patient safety. Even though it was meant to cover all trials in humans, it was mainly designed on the strict requirements that are needed for company-sponsored trials aimed to test and approve a new drug.

It has been successful in improving "good clinical practice" (training of staff, ethical soundness, patient protection, harmonized procedures, better reliability of trial data, EU-wide trial registration).  However, there are also clear signs that the Directive has hindered cancer research in Europe. It has multiplied the administrative burden, legal risk and costs for researchers running trials. It has also led to a significant decrease of non-commercial "investigator-initiated trials", and eventually of clinical research moving out of the EU. For example, in some cancers, no new therapy optimization trials have been initiated in some countries since the Directive came into effect.

To assess the achievements and also shortcomings of the Directive, and to discuss potential solutions, the European Commission has started a public consultation on 9 Oct 2009.  See consultation paper here. In January 2010, ECPC has submitted a detailed response to the consultation after collecting very helpful feedback from its membership. In total, 108 submissions were made by all stakeholders.

World Health Organisation (WHO) Policy on Clinical Trial Disclosure

In 2005, the World Health Organisation (WHO) has taken initiative to improve public disclosure of information on clinical trials to strengthen the research process and its ability to win public trust in clinical trials. ECPC has been involved in the process of public consultation where opinions from the industry, regulators, medical journals, clinicians and patient groups were considered.

In May 2006, after no evidence was brought forward that disclosure would threaten competition and innovation, the WHO announced its policies requiring that all interventional clinical trials be registered with a minimum data set of 20 items without any delay, prior to the first patient's enrolment.

However, compliance with those policies is still voluntary. A combined effort of of legislation, medical journal editors, funding agencies, research ethics committees and register policies needs to be taken to ensure compliance of investigators and the industry with the WHO policies.

See also

• WHO consultation: ECPC Open Comment 1st round - 2nd round
  
• Bulletin of the WHO (6 June 2006) - Giving patients better access to trial information

WHO Clinical Trials Search Engine

The WHO has built the WHO International Clinical Trials Registry Platform (ICTRP). This website, provides a single search engine for a number of clinical trial registers. The platform aims to make sure that a complete view on all ongoing clinical trials, without any duplication, is being made available to the public through one single search portal.  This improves research transparency and the validity and value of the scientific evidence base. See also WHO International Clinical Trials Registry Platform (ICTRP)

ECPC Position on Clinical Trials

• ECPC's Comments on the Clinical Trials Directive 2001/20 EC (30 September 2007)
• ECPC Comments on "Consultation for data fields from EudraCT made available on EudraPharm" (The European database on medicinal products for the public) (14 October 2008)
• ECPC position on Clinical Trials Disclosure
• ECPC Background information on Clinical Trials

ECPC in the press on Clinical Trials:

• HSCNews Article about Clinical Trials with ECPC interview (October 2005)
  
• CancerWorld 1/2008: No trial about us without us! (January 2008)

Other helpful links

• Canadian Institute of Health Research: The Ottawa Statement - Ethical, scientific/research and public health rationale for transparency (April 2005)
  
• European Medicines Agency (EMEA) - European CTs database (EudraCT) - EudraPharm
  
• Coalition of national cancer cooperative groups - cancertrialshelp.org
• National Cancer Institute (NCI) - cancer.gov

Clinical Trial Databases and Registries

• ClinicalTrials.gov (USA) - www.clinicaltrials.gov
• CancerHelp Clinical Trials Database (UK) - www.cancerhelp.org.uk/trials (database of cancer trials that are recruiting in the UK, including lay information, recruiting trials, closed trials and trial results)
• German Clinical Trial Register (DE) - www.germanctr.de
• TrialCheck.org - www.trialcheck.org
• IKC net (Netherlands) - http://www.ikcnet.nl/trials/
• NCI.gov Clinical Trials Register (USA) - http://www.cancer.gov/clinicaltrials

Company Trial Databases

• PhRMA Clinical Study Results Database - www.clinicalstudyresults.org
• IFPMA Clinical Trials Portal - clinicaltrials.ifpma.org
• Association of the British Pharmaceutical Industry (ABPI) - Phase III/IV Trials in UK - https://www.cmrinteract.com/clintrial/
• Novartis Clinical Trials - www.novartisclinicaltrials.com/
• Roche Trials - http://www.roche-trials.com
• EmergingMed - www.emergingmed.com