Regulatory affairs: additional value?

The regulatory hurdle of drug development is often the most troublesome. However, it puts CROs in a powerful position to showcase their regulatory knowledge.
Sep 01, 2008

Faiz Kermani
Initially, pharmaceutical companies only handed select portions of clinical trial work to CROs and the arrangement was always characterized by a degree of 'fear of losing control' over the project. With time, this has changed, and CROs are now much more involved in the clinical trial process and expected to provide strategic input. The Tufts Center for the Study of Drug Development reported that in 2004, CROs managed 23000 Phase I–IV clinical trials worldwide, monitored more than 150000 clinical investigators and enrolled more than 640000 new subjects.1 The study also revealed that projects involving high CRO usage stuck closer to timelines as such projects were submitted more than 30 days closer to their projected submission date.

In recognition of these trends, many CROs have expanded the number of services they offer. This has seen them move past simply helping with day-to-day operational tasks, and major CROs can now handle almost any aspect of the trial process and related activities.

Regulatory affairs

One area of drug development that pharmaceutical companies often struggle with is the regulatory stage. This final phase of drug development is the last hurdle before a drug reaches the market and is beyond the control of companies. There are often problems as the process involves an external regulatory agency that reviews the data in an independent fashion. As regulatory agencies are government bodies, and thus accountable to the public, public safety is paramount and their decision-making must be geared towards this factor rather than a company's hopes and expectations.

The author says...
CROs are in a powerful position to demonstrate their expertise. As they work on different projects, many have dealt with a range of international regulatory scenarios and are at an advantage as regulatory affairs departments in many pharmaceutical companies have often not been exposed to the same level of variation.

The outcomes of regulatory reviews cannot be predicted, but companies can be better prepared by planning ahead and seeking good advice on regulatory options and guideline changes. If a sponsor is using the services of a CRO that has a regulatory affairs department, it would be wise for the sponsor to consider asking their opinion. As CRO regulatory affairs personnel frequently deal with regulatory agencies, they often build up a more realistic picture of what is expected, whereas a sponsor can be overly biased because of expectations for a specific product. In addition, CRO regulatory personnel tend to work concurrently with numerous agencies in different global regions across various projects, whereas the sponsor is often limited to national markets for a set number of products. This allows CROs greater insight into the nuances of decision-making within regulatory agencies. Companies accustomed to dealing with a particular regulatory agency can find that changing countries dramatically alters the regulatory strategy and the time involved in gaining approval for a trial.

As the pharmaceutical industry operates on an international basis, it is crucial to understand the manner in which international regulatory guidelines are changing. There is also a great deal of cross-talk between regulatory agencies, which should not be underestimated. Regulatory questions that arise with an agency on one side of the world may appear elsewhere. To provide value to sponsors, CROs have had to become experts in international guidelines so that they can provide advice at the outset of a trial.

European changes

An example of how CROs can provide value occurred in May 2004 with the implementation of the European Clinical Trials Directive and its associated legislation. Prior to this date, there had been diverse processes of initiating and conducting clinical trials among Member States, as well as Iceland, Liechtenstein, Norway and other members of the European Economic Area where the Directive is also binding. Many sponsors had become accustomed to the pre-directive era and were frustrated by the impending changes. For CROs, there was no choice but to become as familiar with the new procedures as quickly as possible to advise potential clients.2