PFC taps HMO database to run clinical trial simulations

07-Jun-2010 - Last updated on 08-Jun-2010 at 10:33 GMT

CRO PFC Pharma Focus is using a HMO database to provide feasibility information before a clinical trial starts, reducing costs, risks and developmental timelines.

The service from PFC taps into pharma’s desire to increase the number of successful trials. It performs this role by running simulations of clinical trials and altering different variables to predict their impact.

Underpinning these predictions is the database built by health maintenance organisation (HMO) Maccabi HealthCare Services over the past 15 years. The database contains cradle-to-grave information, such as imaging and drug purchasing, collected from 2m people.

Switzerland-based contract research organisation (CRO) PFC uses this information to predict the feasibility of clinical trials. Ran Frenkel, vice president of business development at PFC, gave Outsourcing-Pharma the example of using the system to predict recruitment.

By applying a list of inclusion and exclusion criteria to the database PFC can predict the recruitment rate. These criteria can then be altered to assess the impact on the rate of recruitment. Performing this process gives an idea of the optimal criteria before a trial starts.

“PFC can now offer clients enhanced research planning services, including feasibility studies, patient profiling and real time automated patient recruitment tools”, said Frenkel in a press statement.

The system can also be applied to safety. Frenkel said that by viewing the disease profiles of people on the database PFC can identify potential risks and eliminate them before the actual clinical trial starts.

PFC is now fully commercialising the system but has already begun providing it to some clients. Frenkel said these clients have been “very receptive” to the technology and “gained information that saved lots of money because of better planning”.

Alternative systems

Trial feasibility can be assessed using questionnaires but this process is subjective and makes assumptions, said Frenkel. In contrast, the database consists of actual patient information collected by 3,600 physicians and updated daily.

Frenkel said that two UK-based companies also provide access to data but these lack details included in Maccabi’s. The other products are built from data provided by general practitioners(GP). In addition to GPs, Maccabi collects data from specialists, such as gynaecologists.

Furthermore, databases collated by other HMOs are primarily for billing purposes, said Frenkel, making it difficult to apply them to this model. This puts PFC in a strong position in a niche which allows it to offer “significant added value”, said Frenkel.

PFC has access to the database under an exclusive five-year deal. Over this period PFC and Maccabi will share the costs and profits. PFC can only view anonymous patient information and is unable to edit the database.