In an exclusive Q&A, new ACRO Chairman Ciaran Murray says conducting trials in countries such as China and India is critically important for speeding up drug development.
Murray, CEO of ICON, was elected chairman of the Association of Clinical Research Organisations in January, and spoke to us about pharma's stalled R&D spending, data transparency and growth opportunities for the top eight CROs.
OUTSOURCING-PHARMA.COM: What are your predictions for the size of the CRO market in the next few years?
MURRAY: We expect the CRO market to continue to grow over the new few years, albeit at a slightly more steady pace than we have seen over the last couple of years – we estimate somewhere in the region of 5-10% per annum.
Although overall R&D spending is expected to be to be relatively flat, outsourcing penetration continues to increase and we expect more of this outsourcing work to be conducted by the top eight CROs, essentially the ACRO members.
Sponsors are experiencing pressure to publish data from all clinical trials, while they claim this transparency could harm patient confidentiality. What is the stance of CROs? Should the publication of more trials, including failed trials, be an absolute requirement?
In the end, CROs do not own this data, the sponsors do, so this is not an issue that ACRO is leading on. That said, ACRO has endorsed the joint position of EFPIA and PhRMA, which we believe establishes a responsible framework for data sharing.
We do have very real concerns about patient confidentiality. As the organizations that are gathering and analyzing much of this data, we also have practical operational concerns, like ensuring that informed consent agreements accurately represent how data may be used. This issue is not as simple as some of the transparency advocates make it seem.
Accusations have been levelled that CROs conduct trials in less developed countries because they are cheaper and it is easier to recruit patients. Is there a justification for targeting LDCs for trials? What measures must CROs take to ensure patients are protected?
We adhere to the same standards of GCP and patient protections wherever in the world we are conducting trials. There are many reasons to conduct trials in non-traditional countries with patient access being one of them.
For example, China and India together constitute about 37 percent of the world’s population. Should we ignore these countries? Keep in mind also that we are helping our clients develop drugs that will benefit patients everywhere, not only in the US or in Europe. So it is critically important that we conduct trials globally while ensuring that the highest standards of quality and patient safety are maintained.
A couple of years ago ACRO funded a study, which was published, that showed there were no statistically significant differences in data quality between established and emerging regions. The bottom line is accessing a global population accelerates the process of new drug development, which benefits patients everywhere.
What are your plans as Chairman for 2014?
In Europe, we are concentrating on the Clinical Trials Regulation, the Privacy Regulation and, to a lesser extent, transparency issues including so-called “sunshine” laws. In the US we are working to ensure the tax system rewards research and development so the US remains competitive in the area of clinical research. Finally, we continue to work with our partners in the biopharmaceutical industry to find ways to bring innovation and efficiency to the drug development process.