The Association of Clinical Research Organizations (ACRO), the US professional body for companies with a focus on clinical research, has elected David Spaight, president of MDS Pharma Services, as its chair for 2008.

“I am pleased to assume leadership of ACRO at such an exciting time for our industry as CROs are experiencing unprecedented growth,” Spaight commented. The Washington-based association’s activities during 2007 included:

- Planning and presenting three FDA-sponsored meetings: a workshop on defining and implementing quality in clinical research; a stakeholders’ meeting on post-approval studies for medical devices; and a meeting on the development of standards for imaging data.
- The Clinical Data Acquisition Standards Harmonization Initiative (CDASH), launched as part of the Food and Drug Administration’s (FDA) Critical Path programme for streamlining drug development. The project, which ACRO is moving forward with the Clinical Data Interchange Standards Consortium, involves developing standardised case report forms to facilitate the transmission of clinical trial data.
- ACRO also joined the Foundation for National Institutes of Health’s (NIH) Biomarkers Consortium, a partnership between industry, the FDA, the NIH and other stakeholders that aims to facilitate the discovery, development and qualification of biomarkers.
- In Europe, ACRO submitted formal comments and participated in stakeholder discussions on the European Medicines Agency’s (EMEA) draft guidelines on first-in-human trials for potential high-risk medications. The US association also focused on strengthening working relationships with other stakeholders in the EU, collaborating on regulatory issues with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European CRO Federation (EUCROF) and other groups.
- In Asia, ACRO met with officials from the Chinese Ministry of Health and the State Food and Drug Administration in Beijing, as well as representatives of the Beijing Pharma and Biotech Center (BPBC) and other industry executives, at the annual Health Industry Forum to discuss potential opportunities for collaboration in that market. The meetings stemmed from an invitation from the Secretary for Science and Technology of the Chinese Embassy in Washington.
- ACRO continues to develop relations in India with the Ministry of Health, the Drugs Controller General and the Indian Council of Medical Research, participating most recently in a stakeholder summit on US-Indian partnerships in health care that examined India’s growing role in global health care and clinical research.

Dr Stephen DeCherney, chief innovation officer at Quintiles Transnational, has been appointed as ACRO’s chair-elect for the current year. He said the association’s members were committed to “increasing ACRO’s role as a global leader in discussions around patient safety, regulatory issues in the US, Europe and in emerging markets around the world, and innovations to enhance the clinical research process”.