Several media outlets have reported on the Access to Medicines Index and the report's assertions regarding clinical research organizations. Unfortunately, none of these media attempted to contact ACRO or its members for comment.
The Access to Medicines Index fundamentally misrepresents the relationship between research sponsors and clinical research organizations (CROs) and demonstrates a total lack of understanding of the CRO industry.
The report does not cite any evidence that clinical trials overseen by CROs adhere to lower standards of patient safety, ethics or quality. This is because no such evidence exists.
The members of the Association of Clinical Research Organizations conduct more than 11,000 clinical trials in 115 countries involving more than two million research participants each year. Our industry would not exist if it did not adhere to the highest standards of ethics, safety and quality.
Further, the report states increased use of CROs leads to "potentially different clinical practices" and that CROs are subject to a "lower level of reputational and financial exposure in the event of problems with the trial." Both of these assertions are patently false.
In fact, one of the great benefits that CROs bring to the drug development process is a level of global standards and practices that ensure trials are conducted to the same high standards anywhere in the world.
As to reputational and financial risk, CROs actually face more exposure if there is a problem with a trial because poor performance can be a death knell for a CRO whose primary business is research. In this business, reputation is everything.
Clinical trials are the linchpin of the process that develops new medicines for patients and pharmaceutical companies focus on safety and quality whether those trials are conducted in-house or by highly-specialized research organizations. From the perspective of ACRO members, the sponsor-CRO relationship is built on system of "trust but verify" and to suggest anything less is simply uninformed.
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. The association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 75,000 professionals worldwide and annually conduct more than 11,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel.