Trial sites call for more EDC and recruitment investment

19-Feb-2009 - Last updated on 19-Feb-2009 at 13:00 GMT

Study site operators want greater use of EDC technologies and more pharma industry investment to boost patient recruitment and reduce delays in clinical trials, according to an industry report due to be published next week.

The study, conducted by clinical research industry analysts CenterWatch, was designed to examine the relationship between drug developers and almost 2,000 clinical trial sites worldwide.

Ahead of the report’s official unveiling at the upcoming ExL Pharma’s Investigator Relationship Management conference, lead author Mary-Jo Lamberti, director of CenterWatch’s market research unit, told Outsourcing-pharma about some of the trends that had emerged.

Dr Lamberti explained that, in addition to improved use of electronic data capture (EDC) and recruitment resources, the trial sites called for simpler study protocols requiring fewer amendments as well as greater flexibility on budgets and any modifications that must made.

In the globalised drug market, regulators, keen that trials are representative of diverse populations, are increasing the pressure on drug firms to conduct them at multiple suites.

This will undoubtedly benefit clinical research organisations (CROs) offering EDC platforms to pharmaceutical industry sponsors seeking to ensure data uniformity and consistency of studies carried out in multiple countries.

Additionally, growth of the trials sector in emerging markets like China, India and, more recently, Central and Eastern Europe, has further increased the need for effective remote management systems.

EDC can save $15m, study

The CenterWatch findings fit very well with the results of survey conducted by UK research group Datamonitor in 2008, which revealed that EDC and electronic trials management systems could save life science and pharmaceutical firms up to $15m (€11.8m) a year in mailing and protocol distribution costs alone.

Principal author, Datamonitor's Ruchi Mallya, predicted that: “An efficient e-clinical platform will provide companies with substantial cost and time savings and will play a vital role in changing the research process for the better.”

Mallya also suggested that e-clinical technologies will play a vital role in the implementation of adaptive trials that require continuous analysis and modification of protocols and added that demand for effective solutions would continue to grow through to 2012.

The predicted expansion is good news for EDC players like Phase Forward, Medidata and Metavante Technologies, which bought Bio-Imaging’s e-trials business CapMed in January.

The rise of the EDC market will also be a boon for contracting majors such as Parexel and Jubilant Organosys, which have begun providing electronic data management to clients both as a part of their respective clinical development offering and as a stand alone outsourced service.