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International Clinical Trials

Border Control


European Commission proposals aim to make Europe a more attractive place to conduct clinical trials. However, there is an emerging consensus that more can be done by the pharmaceutical industry to reduce costs and the amount of administration involved in clinical trials, such as adopting simple electronic payment management systems.

In July this year, the European Commission announced proposals to alleviate the administrative burdens of clinical trials taking place in the EU, particularly across multiple regions. Conceived to address increasing administrative costs and a decline in the number of cross-border clinical trials conducted in the EU, the proposed measures are intended to facilitate the implementation of cross-border trials, ease regulatory challenges and benefit rare disease research.

CTD 2001: Critical Response

The new EU clinical trials regulations intend to tackle the decrease in the number of trials conducted in the EU as well as spiralling administration costs and delays. The European Commission reports that the number of clinical trials carried out in the EU between 2007 and 2011 dropped by 25 per cent, with applications down from over 5,000 in 2007 to 3,800 in 2011, while administrative costs have doubled (1). This trend has been largely attributed to the 2001 Clinical Trials Directive (CTD), which imposed tighter controls on monitoring and reporting drug trials in order to provide high levels of patient safety. Brought in to make clinical trials safer and standardise methods throughout the EU, the Commission admits that the CTD is “the most heavily criticised piece of EU legislation in the area of pharmaceuticals” as it has been attacked by “patients, researchers and industry alike” (2). Indeed, the Chief Clinician of Cancer Research UK (CRUK), Professor Peter Johnson, believes that the Directive has failed to deliver its aims and has affected international trials particularly badly. Johnson goes on to blame the CTD for doubling the costs of CRUK’s clinical trials due to the increase of paperwork required, which has lead to the CRUK cancelling at least one trial (3).

The Directive has increased the amount of administration and therefore costs involved in clinical trials. Suspected adverse reactions to licensed drugs and nutrients have to be recorded with every research centre, even if used in approved quantities and already confirmed as safe. Also, companies or researchers seeking to conduct clinical trials in more than one EU country must submit separate applications and reports for each country – this is time consuming and is one of the many factors increasing the cost of drug development. Currently, 24 per cent of trials conducted in the EU are part of cross-country studies, involving 70 per cent of all subjects, so changes to cross-border trials will have a considerable impact. New regulations should focus on alleviating the administrative burden of trials taking place across multiple geographies and facilitating the implementation of cross-border clinical trials. This legislation will also benefit research in areas such as rare diseases, where there may be only a few subjects in each country.

New Regulation: Streamlined Procedures

As a regulation, the new legislation will make sure that the rules for carrying out clinical trials are the same across the EU, as it will apply equally in all 27 countries. Expected to be enacted by 2016, the new regulation will replace the 2011 CTD, but must first be jointly agreed by EU governments and the European Parliament. The proposed legislation aims to ‘cut red-tape’ by streamlining the process of applying to conduct clinical trials and speeding up authorisation and reporting procedures, while ensuring patient safety and data quality (4). Under the new system, applicants seeking to conduct trials in multiple geographies will only have to submit applications for authorisation once through a standardised ‘single portal’. This will ensure a swift and comprehensive assessment that will guarantee a single decision. In addition, it will be easier to change procedures once the trial has been approved. The introduction of simplified reporting procedures will also save researchers from submitting identical information separately to various bodies and member states. These new measures will ease administrative burdens.

The new regulation also focuses on patient safety and protection through the consideration of varying levels of actual risk to subjects participating in clinical trials. The framework will be flexible enough to take into account whether the trial tests a new medicine (high risk) or compares existing ones (low risk). ‘Low-intervention clinical trials’, where the additional risk for a subject in comparison with receiving treatment in normal clinical practice is slight, will benefit from less onerous regulatory requirements and reduced authorisation times. On top of this, sponsors will not have to purchase insurance to cover compensation for any damages caused to subjects taking part in low intervention clinical trials as insurance coverage of the medical practitioner, institution or product liability insurance will be sufficient.

The commission will also be able to carry out controls in member states and other countries to ensure rules are being properly supervised and enforced. This is particularly relevant in light of the growth of clinical trials in Asia, South America and Russia and the recent unrest over the so-called ‘Slumdog Clinical Trials’ phenomenon in India with 1,144 clinical trials deaths reported in two years (5). Under the new proposal, clinical trials taking place outside the EU – but mentioned in an application to conduct trials in the EU – must also comply with regulatory requirements at least equal to those in the EU. Additionally, safety reporting will be simplified with a decrease in the number of events to be reported to EU regulators. For example, serious adverse events can bypass the sponsor and be directly reported to the European EudraVigilance database.

From May 2011, clinical trials approved in the EU were published in an official register, and the move towards increasing transparency of the conduct and results of trials continues under the new regulation to prevent redundancy and duplication of information. Patients will be able to find out whether recruitment for a clinical trial is still ongoing in order to identify trials in which they may want to take part. In order to avoid ‘publication bias’, even the unfavourable results of clinical trials will be made available to the public.

According to John Dalli, European Commissioner for Health and Consumer Policy, the new legislation could save over €800 million per year in regulatory costs (6). Approximately 4,400 clinical trials take place in the EU and European Economic Area (EEA) every year, with 60 per cent carried out by industry, so a huge number of trials will be positively affected by the proposed regulation (7). However, the pharmaceutical industry can make further cost savings by cutting administration such as manual paper-based clinical trial payment processes, which is more expensive and time consuming. Streamlining payment delivery and management processes by centralising all payment activity through a web-based system can reduce costs considerably. Realised cost savings range from millions of euros for users adopting the technology on an enterprise basis, to between €55,000 and €150,000 for a single study.

Web-Based Payment Platforms

Global web-based payment management platforms automatically deliver worldwide trial-related payments to all stakeholders. The platform operates using several types of electronic funds transfer technologies, such as international automated cleaning house (ACH), and automated check payment solutions. The system enables sponsors to access and manage all trial-related payments from a single web-based portal, thereby streamlining auditing and reporting. ePayment management technology can be used in conjunction with established clinical technologies, such as clinical trial management systems (CTMS), electronic data capture (EDC), electronic patient reported outcome technologies (ePRO) and interactive voice/web response systems (IVRS/IXRS), in order to further streamline operational processes at the site level and create additional efficiencies.

The new EU regulation to encourage cross-border clinical trials is particularly pertinent to the industry’s move towards using global web-based payment management platforms. Clinical research projects taking place across multiple geographies require payment systems that are able to accommodate multiple currencies. By adopting an automated system that is electronic as opposed to manual and paper-based, sponsors and CROs can automatically distribute payments in over 200 currencies to all investigators, sites and vendors globally.

Conclusion

Escalating administrative fees and delays as well as a reduction of clinical trials taking place in the EU, caused by the Clinical Trial Directive of 2001, has forced the European Commission to propose measures to tackle this. By streamlining authorisation and reporting processes, the new regulation will decrease the amount of onerous and often duplicated paperwork while facilitating multinational clinical trials. The commission hopes to re-establish the EU as a competitive location in which to implement clinical studies as well as bring the focus of trials back to the patient. Although the new regulation will have an impact when it finally comes into force in 2016, the pharmaceutical industry struggling under the CTD can cut administration and costs right now by implementing electronic payment management systems.

References

  1. European Commission, Fostering EU’s attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines, 2012, visit: http://europa.eu
  2. Gaffney A, New EU Clinical Trials Proposal to Ease Pharmaceutical Industry’s Concerns, 2012, visit: www.raps.org
  3. Adams S, EU red tape making drugs trials ‘impossible’, 2012, visit: www.telegraph.co.uk
  4. European Commission, Proposal for a Clinical Trials Regulation – Questions and Answers, 2012, visit: http://europa.eu
  5. New Delhi, 1144 Deaths During Clinical Drug Trials in 2 Years: Govt, 2012, visit: http://news.outlookindia.com
  6. European Commission, Fostering EU’s attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines, 2012, visit: http://europa.eu
  7. Gaffney A, New EU Clinical Trials Proposal to Ease Pharmaceutical Industry’s Concerns, 2012, visit: www.raps.org

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John Blakeley is the Chief Commercial Officer of Greenphire. John is primarily responsible for developing and executing Greenphire’s global commercial strategy as the company expands industry adoption of its core technology platforms. John was the Executive Vice President and Chief Commercial Officer of ERT (eResearchTechnology Inc), where he led a global team growing sales in excess of $300 million annually. During his 10 years at ERT, John served as Executive Vice President of Sales and Marketing, Senior Vice President of International Operations, and Vice President of International Business Development. Prior to joining ERT, John was managing director of MediServe Medical UK Limited, a medical device specialist.
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