Clinical jobs providers that are increasing the number of clinical trials they conduct to test the efficacy of new medicines are being forced to alter the way they operate as a result of growing regulatory complexity, it has been suggested.
A panel of leaders from the research-based drug industry highlighted the difficulties faced by pharmaceutical companies testing treatments in emerging global markets at a recent meeting hosted by the Tufts Center for the Study of Drug Development (CSDD) in Boston.
The industry executives, who met as part of the institute's Executive Forum Roundtable, agreed that the increasing complications associated with running clinical trials is generating significant amounts of data, which requires drug developers to make improvements to the way in which they manage information.
Additionally, the leaders felt that the success of self-regulated affairs groups is dependent on their ability to understand and respond to conflicting requirements between agencies and authorities on an international basis.
"What a company does in one region can very likely affect how regulators treat it elsewhere," remarked Christopher-Paul Milne, associate director of Tufts CSDD.
Mr Milne also suggested it is now a minimum requirement for pharmaceutical firms to understand local regulations and trends, as well as how the activities of competitors' are shaping the emerging patterns.
His comments were reflected in the beliefs of the executives, who agreed that treatment developers need to solicit the views of new stakeholders and incorporate those perspectives into drug development schemes early in order to appropriately define a development plan.
In addition, it was noted that flexibility may be a primary factor contributing to the success of drug development strategies.
"What's true today in the regulatory environment in a particular region may not hold sway when trials are completed in a few years' time, requiring a rapid shift in development strategy," Mr Milne added.
His comments come after research from the Tufts CSDD revealed that the number of international pre-clinical and clinical studies in process reached 8,600 in 2010, compared with approximately 4,900 in 2000, suggesting that the process is a viable way to test new medication.
For this reason, the substantial growth has forced regulatory authorities to contend with increased demands relating to monitoring the safety and efficacy of studies, as well as reviewing their outcomes.
The Tufts CSDD, which will convene a number of Forum Roundtables in the next two years, provides information to assist drug developers, policymakers and regulators improve the quality of pharmaceutical development, review and utilisation.
Following the acknowledgement of increased strain placed on pharmaceutical companies as a result of growing regulations in emerging international markets, the US Department of Health and Human Services (DHHS) has called for the removal of red tape.
According to amednews.com, the proposals would significantly speed up the process of monitoring and approving clinical trials that are funded by the government, which could help ease the burden faced by the country's estimated 30,000 clinical investigators.
The plans emerge after approximately 70 per cent of clinical trials were pushed to community-based settings as a result of commercialisation caused by the increasing cost of academic studies.
Announced in July, the DHHS proposals call for all domestic sites involved in an investigation across multiple locations to be monitored by a single review board, which is legally responsible for adhering to regulations and ensuring that participants are fully aware of the associated risks.
Kenneth A Getz, senior research fellow from the Tufts CSDD, said: "So many boards have different sets of guidelines they follow and there is so much inconsistency. And, as a result, there is a lot of bureaucracy and inefficiency.
"Using a single institutional review board would greatly assist sites in dealing with so many of the problems that come from contradictory board assessments."