Rapid evolution of outsourcing and offshoring of clinical trials has raised concerns regulators have failed to keep pace with changes. This has increased focus on actions taken by contract research organisations (CRO) and sponsors to self-regulate conduct of clinical trials.
“It remains an area of grave concern that the parties that earn most money with the trials – CROs and sponsors – seem to be the most important monitors in non-traditional trial regions”, says a report by SOMO, a Dutch non-profit organisation.
To make the process more transparent SOMO recommends creation of a “world-wide compulsory trial register in which all parties involved in the trial, including contractors and subcontractors, are disclosed”. This would build on, and fill gaps in, national and international trial registry initiatives.
Including subcontractors in the register addresses concerns, raised in the report, about the impact of CROs outsourcing work. Subcontracting by CROs “fragments clinical trial-related tasks further” and can lead to “a lack of comprehension of the full trial process”.
Sponsors told SOMO CROs must inform them of subcontractor use, and in many instances prior consent is needed, but the authors are concerned about regulators. For instance, the National Institute of Health of Peru (INS) found a CRO subcontracted monitoring without telling regulators.
An unwillingness to share information was encountered by SOMO during its research. SOMO said it is concerned about “the extreme lack of transparency of CROs in particular and of the pharmaceutical sector in general”.
Other recommendations include: increase in overseas inspections; inclusion of participants’ views in inspections and audits; and making independent verification of Declaration of Helsinki-compliance part of marketing authorisation applications (MAA).
Ensuring standards
SOMO began researching the report with the expectation it would find pharmaceutical research and development outsourcing shared problems with other sectors. Potential problems suggested by SOMO include lowering of standards because of cost and competition pressures.
To ensure CROs meet legal and ethical standards sponsors have developed mechanisms to select, monitor and evaluate outsourcing partners. Consequently, SOMA says measures to protect patients appear to be in place but calls for the reassurance of independent oversight.
An earlier Association of Clinical Research Organizations (ACRO) report into overseas clinical trials found CROs have taken steps to ensure quality and ethical standards are the same in all countries in which they operate.
More research is underway. “A preliminary study of multinational trials sponsored by ACRO, demonstrates that there are no quality differences across or among regions”, said John Lewis, vice president of public affairs at ACRO.