Is Your Clinical Outsourcing Clear?
In the pharmaceutical industry, the majority of companies now outsource the clinical trial process, with a massive 67 per cent of pharma and bio organisations outsourcing more than half of their trials.
Companies recognise that clinical development is both unpredictable and time-consuming, and it is estimated that inefficiencies in the process lead to seven out of ten trials being delayed or cancelled, at a cost of $1.1 million (£680,000) in daily prescription revenues.
As a result, many organisations are focusing on establishing contract research organisation (CRO) accountability, running trials in emerging markets and entering into risk-sharing partnerships as potential, albeit risky, means of smoothing this process.
However, an obstacle for many is a lack of transparency and consistency in the global clinical outsourcing process – an issue recently addressed by SOMO, a Dutch non-profit organisation.
A recent article in Outsourcing Pharma highlighted how SOMO is calling for a global compulsory register of all contractors and subcontractors involved in each clinical trial to be created for this purpose.
This is because the evolution of the outsourcing and offshoring of clinical trials has led to concerns that regulators have failed to keep up with changes and has increased the focus on the efforts made by CROs and sponsors to self-regulate conduct in these trials.
The SOMO report explained: "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".
[inlinead] In order to make the process more transparent, the organisation recommends the creation of a worldwide compulsory trial register, in which all parties involved in the trial are disclosed, including any contractors and subcontractors.
Such a measure would help to build on national and international trial registry initiatives and explain any grey areas, the firm claims.
In particular, including subcontractors in the register would address concerns about the impact of CRO outsourcing work, as SOMO claims that CRO "fragments clinical trial-related tasks further" and could lead to "a lack of comprehension of the full trial process".
A survey of sponsors carried out by the organisation found that CROs need to inform them when subcontractors are used, as in many instances prior consent is required, while concerns about regulators are also lingering.
The SOMO study noted that there was a distinct unwillingness to share information and the company expressed its concern at the "extreme lack of transparency of CROs in particular and of the pharmaceutical sector in general".
Some of the other recommendations in the report included increasing overseas inspections and including participants' views in inspections and audits, as well as making independent verification of Declaration of Helsinki compliance part of marketing authorisation applications.
According to the Dutch firm, it began research on the report expecting to find pharmaceutical research and development outsourcing shared problems with other sectors, but it found both unique and existing and potential problems, such as the lowering of standards due to cost and competition pressure.
In order to ensure that CROs meet both legal and ethical standards, sponsors say they have developed mechanisms which select, monitor and evaluate outsourcing partners.
As a result, measures to protect patients are now in place, but further reassurance of independent oversight is needed.
Last year, a report by the Association of Clinical Research Organisations (ACRO) into overseas clinical trials found that CROs have taken steps to ensure that both quality and ethical standards are the same in all countries in which they operate, and now a further study is in the pipeline.
[inlinead] At the time, John Lewis, vice president of public affairs at ACRO, commented: "A preliminary study of multinational trials sponsored by ACRO demonstrates that there are no quality differences across or among regions."
It is clear that sponsors and pharmaceutical organisations alike feel that boosting transparency in the clinical outsourcing trial process would be of benefit to all members of the sector in the long term, by cutting daily prescription revenues and ultimately shortening time to market.