Is global consistency in GCP interpretation an achievable goal?
pharmafile | November 16, 2011 | Feature | Research and Development |Â Â Â
The potential benefits of standardisation in the conduct of an increasingly global clinical research effort are enormous. The promise of increased quality and efficiency and the pursuit of ever-higher standards to benefit patients are common goals for both the Pharmaceutical industry and partner organisations that include increasingly competent CROs offering worldwide solutions. The growing partnership of sponsors and expert external providers of course means an increasing emphasis and responsibility for organisations to focus on higher standards and quality measures. The cornerstone of this approach is Good Clinical Practice, but what actually is Good Clinical Practice? Do we all have a consistent interpretation? Can we organise and operate in a way that improves consistency and makes sense whilst meeting our clinical development needs?
We all think we know what Good Clinical Practice is; it is well recognised as the international ethical and scientific quality standard for studies involving human subjects. However, there remains an anomaly lurking at the heart of clinical research. The basis of GCP differs between depending upon the type of research being undertaken; for example medicines research (based upon ICH E6) and medical device research (based upon ISO standards).
In the UK, only about 15% of clinical research submitted to research ethics committees for consideration relates to medicinal product research. A massive 85% of research is struggling to comply with the tenets of GCP, which have been developed primarily for use in pharmaceutical research. Even within the more defined areas of GCP such as medicines research, interpretation of guidelines such as ICH E6 and the European Clinical Trials Directive 2001/20/EC (EUCTD) often varies from territory to territory, between different competent authorities and different research ethics committees.
In a competitive environment those CROs at the forefront of innovation are increasingly involved in trials other than those of medicinal products, including large scale trials sponsored by non-commercial organisations. What is needed is a globally agreed core standard setting out the principles of GCP applicable to all clinical research in humans and which are interpreted consistently to inform legislation and regulation in all territories where clinical research occurs, whilst also respecting local cultural values.
GCP for medicines research, based initially upon ICH E6 and enacted into law in regulations such as the Code of Federal Regulations (21 CFR) or the EUCTD, are perhaps furthest along the path to global harmony but many differences remain, both between the US and Europe, other territories and indeed within Europe itself. Since I last addressed this issue, has more progress been made? Certainly there have been moves in the right direction. The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) launched a joint initiative in July 2009, the pilot phase of which ran to March 2011. One of the stated objectives of the initiative was to share information on the interpretation of GCP.
Meanwhile, in Europe a public consultation to assess the functioning of the EUCTD was held from October 2009 to January 2010. A concept paper has now been released for consultation to assess the impact of a legislative proposal to revise the Directive. This specifically tries to address the issue of the requirements set out in the EUCTD being applied differently in different Member States. National differences, of course, make multinational clinical trials more burdensome and expensive, which has a negative impact on clinical research. Both of the above initiatives reflect an increasing recognition of the importance of standardisation which works not in theory but in research practice, a new and welcome perspective.
For QED Clinical Services focus on standardisation and quality in clinical research for the delivery of our customers’ goals has been the foundation of consistent delivery of project and strategic goals. At the same time it has been an effective recipe for long lasting partnerships and better relationships. The QED model enhances quality through standardised processes that are delivered through franchised expert local partner organisations that operate worldwide to meet our customers’ objectives on time and on budget.
We are able to provide a high quality and proactive solution for our customers that meet with the challenges of standardisation whilst at the same time blending real time local thinking and regulatory understanding. In a much larger world, the importance of understanding local culture and patient needs, as part of a full service global clinical project has never been more important. Of course, people will follow mandatory standards such as the EUCTD but better research is delivered to a higher standard when they work as part of a committed global and also local team that has both corporate oversight and local contribution. Ultimately sharing partnership goals and using a proven foundation of standards of excellence as their guide in the consistent global interpretation of GCP.
By Susan Ollier, BSc, MRQA, HonFICR, CSci – director of UK operations, QED Clinical Services Ltd.
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