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Partnerships in Clinical Research

Posted on: 10 Jun 03

Summary

At every stage of the R&D process, the companies must evaluate the time, logistics, expense and expertise that they can allocate. This also entails knowing when to rely on in-house capabilities and wh
Clinical R&D Clinical development represents around 40% of R&D spend and is considered the “make or break” point for a new drug. There is a growing trend for pharmaceutical and biotech companies to outsource their clinical work to Contract Research Organizations (CROs). Outsourcing enables companies to reduce overall costs, cover gaps in capacity and improve their skill base. It also allows them to concentrate their in-house efforts on other parts of the R&D process. For small companies with limited internal resources to allocate this enables them to get the most out of their R&D investment. A mature industry The CRO industry is now considered a mature sector, with many CROs having considerable experience in carrying out clinical trials on an international basis and in a range of therapeutic areas. This means that not only are CROs capable of running a variety of clinical trials, they can also provide companies with valuable input when planning clinical development programmes. Pharmaceutical and biotech companies can benefit from a closer relationship to CROs, in order to overcome some of the perceived problems associated with outsourcing such as lack of control, adherence to timelines, and confidentiality. However, as with all partnerships, the relationship needs commitment if it is to achieve maximal results. Taking into account the views of personnel with previous experience of outsourced projects can enhance the quality of decision-making, but this depends on how well information is shared within the company. A growing trend is the outsourcing of a complete development programme for a particular drug to a CRO. Furthermore, there are now a number of smaller pharmaceutical and biotech companies whose business models are built around outsourcing all areas of development. By involving a CRO on a long-term basis, an effective partnership is developed that benefits both sets of organisations and expedites drug development. Planning ahead As trials become more complex for new generation drugs, improvements in clinical development are taking place through closer partnerships between CROs and sponsors. The clinical programme will depend on factors such as the therapeutic area of investigation, how the drug is to be used, the nature of the disease and the recruitment of suitable patients. Company requirements, such as the number of indications, route of administration and dosage forms to be pursued, will also determine the make-up of the clinical programme and are areas where the CRO can advise. Despite technological advances in pharmaceutical R&D, nearly 80 percent of all clinical studies for new products fail to finish on time, and 20 percent of those are delayed six months or longer (1). Therefore, it is important that all the factors that might affect a trial are considered at the outset and are discussed with the potential CRO. As well as benefiting from the CRO’s expertise in the actual running of clinical trials it is important to get input into any regulatory issues that might arise. Given the long time that drugs spend progressing through clinical development, the dossier submitted for regulatory review of a drug is large and extremely complex. The data and other information collected during the development of a new drug can often exceed 100,000 pages in volume and can include as many as 60-70 distinct clinical trials. This massive volume of data is costly and time consuming for companies to prepare, and so the use of a CRO experienced in dealing with different regulatory agencies can be extremely advantageous when setting up trials. References
  1. 1. Frank Kirkpatrick, “Rev Up Patient Recruitment”(Pharmaceutical Executive, April 1st 2002)
Visit the Chiltern International website at www.chiltern.com

Dr Faiz Kermani

Last updated on: 27/08/2010 11:40:18

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