Cost effectiveness in clinical trials

It can cost $1 billion to bring a new drug to market. Economic, scientific and political pressures to reduce healthcare costs, generic competition and short patent protection times are a challenging scenario for pharma today.

Clinical trials may consume up to 40% of drug development costs, representing huge potential for improving cost effectiveness. Potential cost savings have been estimated at 30–65%. Broadly speaking cost effectiveness is the relationship between monetary inputs and desired outcome. Key cost drivers for clinical trials include drug class and target indication, geographical location and local regulations and trial set-up. Equally important factors are study centre and investigator fees, site visits and travel costs, patient recruitment, drug importation and labelling, and not least project management.

The desired outcome is critical to ensure the trial results answer the question(s) posed. Information provided should assist regulatory authorities in assessing benefit versus risk. For a smooth and rapid market authorisation, the need for the trial, validation of the primary endpoint, appropriateness of study design and hypothesis, and the power of the trial should be determined. Avoidance of unnecessary costs, fulfillment of regulatory requirements, robustness of results and quality of data should be taken into account. Similarly, before the study starts, data collection should be assessed for timely data capture, trial centre motivation, adequate experience and sufficient training of study staff, access to the right patient population, and adequate facilities and resources. It should also be considered whether the local and national infrastructure/ environment are consistent with the trial objectives. If any one of these points is in question this may imply potential failure.



Savings through outsourcing
Partnership between a sponsor and a CRO can lead to important cost reductions and risk mitigation. CROs with experience of the target indication can serve in an advisory capacity for trial design and set-up. Knowledge of local guidelines and suitable study centres is invaluable for patient retention. Familiarity with local language and cultural and ethical differences also makes outsourcing an attractive option.

Outsourcing a clinical trial may be carried out by a traditional approach in which the CRO is responsible for organising the clinical trial, and managing the trial site. Patient recruitment and study performance may remain the study centre responsibility. Specific advantages of outsourcing to a CRO include access to the necessary resources and expertise. Site management, where management of the trial site is performed locally at one centre in one country, offers a specialist clinical trials function and relieves the clinic physicians from the tasks and burden of a clinical trial. In a third approach, an investigator network organisation can perform all aspects of the trial across several centres and several countries with or without the involvement of a CRO.

Placing clinical trials
Differences exist between various locations around the world with regard to patient availability, cost efficiency, relevant expertise, regulatory requirements, and national infrastructure and environment. A country attractiveness index of these parameters ranks Russia, Czech Republic, Poland and Hungary in the ten highest scoring countries. CROs in these countries provide opportunities for reducing clinical trial costs. The challenge is to balance the drawbacks such as cultural differences and poor infrastructure with the advantages of large patient populations, faster recruitment and attractive revenue implications.

Company profile

HCR is a contract research company providing its clients with a complete range of flexible contract clinical services, locally and globally.

For further information, visit: www.harrisonclinical.com