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International Clinical Trials

Editor’s Comment

 

Some years ago I visited a large preclinical CRO in the UK. As part of the visit, I was shown into a large warehouse, only a small corner of which was occupied. This was their specimen repository. When I asked why such a large building housed such an apparently small collection of specimens, they replied that they were leaving room for the future! I haven’t been back to this CRO, but I assume that the storage of samples by this company has since occupied considerably more space.

It is easy to overlook, I suppose, how important storage really is. Similarly, another CRO told me of a Phase 1 study they had conducted where they had run a trial on behalf of a leading pharmaceutical company. The company was reluctant to carry out all the analytical procedures suggested by the CRO. However, the CRO carefully stored the samples it had taken from the volunteers and when, several years later, their sponsor returned and asked to repeat the study with additional analyses, the CRO was able to say “you don’t need to repeat the study, merely to analyse the samples we have” – and charged them a considerable fortune to do so.

On 22nd May BioStorage Technologies will be sponsoring a symposium in Brussels on the modern technology of sample storage. I personally will be moderating the conference, which will also include a presentation on the update of the European Clinical Trials Directive. If you would like to find out more about the symposium, which is being held in conjunction with Informa’s Partnering with Central Labs, ECG and Imaging Labs conference, see page 72. As a precursor to this meeting, readers may be interested in the article I have written with Richard Barrett (page 50) reviewing the central laboratory business, which is under pressure to expand globally as the international clinical trials market grows.

Kenneth Lee and Helen Neal of PRA (page 10) illustrate the globalisation of clinical trials, and the plethora of samples and difficulties that may occur in running them, in their article about the studies taking place in South-East Asia (SEA). They lay out some of the criteria for success in the SEA region and emphasise in particular the need to understand and embrace the cultural nuances of the various countries involved. Indeed, as they say, “one size does not fit all.”

Back in 1988 I was part of the team helping a Japanese company run a study in hypertension. I suggested to the CRO conducting the study that it might be possible to vary the dose being given to incoming patients according to the results obtained from the previous patients. This idea was not well received and the company went forward with a typical Phase 3 study. I guess this was too early in the progress of adaptive clinical trials to be accepted but, as Denis Gossen and Dominique Demolle of Aepodia suggest in their article (page 18), early phase trials in particular can benefit from the flexibility offered by adaptive designs. They note that performing clinical trials with adaptive designs may well permit new therapy research to be developed in a much more efficient way, and can offer additional insights that may improve later studies. Overall, this should increase R&D efficiency and allow patients to benefit sooner from new products. Note also that adaptive design was one of the themes of the Phase 1 and 2a Clinical Trials conference organised by Informa, which I have reviewed on page 71.

Early preparation, excellent planning and good reporting are all themes addressed in this issue. Quality must also be built into studies while organisations such as the Metrics Champion Consortium help to ensure that the quality of international clinical trials is maintained (page 40).

Thanks to all our contributors to this rich edition of International Clinical Trials and I hope some of you will be able to join us in Brussels.

and finally...

There is much to look forward to in the August 2012 issue. In our eClinical Management focus, we will be investigating how new data visualisation technology and statistical analysis software can make the clinical development process more efficient, reducing the cost for sponsors and increasing safety for patients. We will also be examining how mobile technology can promote a patient-centric approach in late phase research, making real-time collection of accurate data a reality. Other themes under the microscope in the August issue will include an update on the clinical research scene in South America, and a do’s and don’ts guide to recruiting patients through social media channels. If you have an idea for an article, email your suggestion to john@samedanltd.com. To revisit past editions, you can access International Clinical Trials’ digital archive of articles on www.samedanltd.com


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