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European Pharmaceutical Contractor

Striking the Right Chord

Martin Robinson of the International Academy of Clinical Research (IAoCR) talks to EPC about the exciting changes that 2012 brought, as well as some of his predictions for the industry in the next 12 months

EPC: 2012 has been an exciting year for IAoCR, what has been the highlight for you?

MR: I think we have struck a real chord with the industry and there is a genuine enthusiasm for accreditation of clinical research professionals. It has been great to bring together leaders and influencers from contract research organisations, pharmaceutical companies and not for profit organisations to debate how accreditation can help to overcome the two years’ experience issue.

Additionally, we have had the support of UK MP Virendra Sharma from the Health Select Committee, who stated that he would form a cross-party group to discuss accreditation of clinical research professionals.

And what have you found most challenging?

Being pioneers in introducing genuine accreditation and in producing the GxP Training Guidelines – a set of training standards for clinical research professionals. Being a pioneer means you are exposed at the front of the field, but we’ve had the confidence to stick with what we believe is right and keep going.

In addition, we have challenged the status quo regarding the number of years’ experience required for CRAs. Evidence shows that this figure provides no guarantee that a CRA can perform their role effectively, yet many sponsors still stipulate this as a requirement. Length of time does not take into consideration the quality or breadth of the experience a person has had, nor how well they perform as a result of that experience. Independent assessment of competence is far more meaningful and can help to get good CRAs working on clinical trials sooner.

IAoCR met with UK Home Secretary Theresa May in December; what did you discuss?

Theresa May was interested to hear about how accreditation can help to fill the skills shortage in the industry and to help graduates find employment, and so she referred us to see David Willets, the UK Minister of State for Universities and Science. She was also concerned about the lack of accreditation in the industry.

We have now met with the Special Advisor to David Willetts and have committed to write a paper on the matter, which will then be circulated to relevant Parliamentarians.

If you could change one aspect of the pharmaceutical industry, what would it be and why?

Clinical research is a slow-moving sector and many of the problems are longstanding. There should be a lot more professionalism in the way that trials are conducted. I believe there should be accredited clinical research units throughout Europe which are solely dedicated to conducting clinical trials and offering a top quality service to patients and industry alike.

Do you feel as though there is enough knowledge shared between countries?

I think knowledge sharing within the EU has improved with the advent of the EMA. The sharing of knowledge needs to increase between countries where clinical research is wellestablished and the less experienced developing world. However, simply sharing knowledge is not enough; it’s how you act on that knowledge. I think a lot more could be done to protect patient rights, safety and well-being in developing countries.

Finally, what changes do you forecast for 2013?

I would like to see the growth and spread of universal standards for clinical research professionals. We’re setting up an international task force to create competencies for monitors, project managers and investigators. This will enable organisations to have more confi dence when hiring people, or contracting their services. Hopefully everyone will take a more thoughtful risk-based approach to the way that trials are conducted and move away from the ‘box ticking’ mentality which sometimes dogs our industry.

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Martin Robinson PhD is Principal Director of IAoCR. He has over 15 years’ international experience in training and education in clinical research. Previously,he has worked for Covance, where he had a number of roles in training and development and project management.
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