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European Pharmaceutical Contractor

Editors Letter

It is well-known that if a drug causes an adverse event in one patient in every thousand then, to detect this reliably, you need to observe at least 3,000 patients who are taking the drug. If such a drug is treating a life-threatening condition, such odds might be regarded as acceptable; however, if the drug is for a common but well-managed condition then the life of drug itself would be threatened.

Today, in 2014, we are seeing ever-larger clinical trials – partly because, in order to show that a drug is significantly better than the standard treatment, large studies are required, and partly because we wish to detect adverse events before the drug is marketed.

These remarks inform two of the topics that are covered in this edition of EPC: pharmacovigilance (PV) and patient recruitment.

European PV initiatives have grown out of an increasing awareness that the vast majority of drugs have side-effects, and the need to know how serious and prevalent these are. As Shuna Mason at CMS points out, this means the handling of medicinal product safety is now generally managed at an EU level. She details the current regulations and brings us up-to-date in this important area (page 35).

William Long of Sidley Austin explores another aspect of PV. As the demand for transparency in clinical trials grows – and as researchers and regulators demand access to data generated by pharmaceutical companies – the issue of data protection is becoming more Editor’s letter prominent (page 18). This also applies to post-marketing PV studies. Long gives us the latest on this, particularly with respect to the UK Data Protection Act, which gives subjects right of access to their personal PV data and incorporates EU guidance.

As patients become aware of their rights to data protection, there is a growing risk that they may feel it is yet another reason to not participate in a trial – particularly with press reports of physicians being under pressure to share data, and bodies such as the UK NHS being prone to “losing” data.

Hana Ayoob from the AKU Society looks at the challenges of patient recruitment, discussing it in the context of the ultra-rare disease alkaptonuria (page 38). In a rare disease study, every single patient recruited is crucial. This means embarking on time-consuming approaches, even if the results are limited. Most important, she says, is building a relationship with the patients involved.

Finally, concerning a subject particularly close to my heart, Andrew Townshend and Judy Swilley at INC Research examine contract research organisation (CRO) partnerships and strategic collaborations with sponsors and across industry (page 26). They note that, with the demands of global biopharma companies having reached unprecedented levels, the importance of truly evolving the working relationship between sponsors and CROs has never been greater.

Analysing the current state of play, the authors note that, although only a limited number of sponsor-CRO relationships have progressed to true alliance status, companies are aware of the advantages of evolving traditional tactical-based relationships into more strategic partnerships. Key to success is creating the right roles and infrastructure to support largescale partnerships effectively.

The benefits of close collaboration across project teams on both sides can be many, and it allows for significantly improved application of best practices and first-hand experience at all levels. So collaboration and communication is all, whatever the level of strategic partnering.

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