External barriers to effective care in clinical research

Therapeutic drug development in oncology has reached new heights in recent years with the emergence of targeted agents. To date however, clinicians have limited registered therapeutics for treatment only, i.e. trastuzumab and lapatinib. This phenomenon is not specific to breast cancer. We must ask ourselves - why is this the case? Where do the obstacles lie and what needs to change to move forward efficiently?
The answers are complex in nature and solutions involve establishing sincere partnerships. Future targeted and non-targeted therapy trials hold the key. The uptake of tissue sampling for biomarker analyses and translational research to progress the understanding of cancer biology is integral to this.
A change in direction of trial design is also required. Inherent difficulties with conventional trial design and drug evolution stratagems in their application to targeted therapeutics exist. They are part of the reasons why drugs fail at the costly phase III stage. Options include using validated alternative clinical endpoints and the neoadjuvant setting to test early drug signals.
The explosion of targeted agent trials and advances in genomics has generated vast amounts of data. However, efforts to exploit such data to improve standards in patient outcomes have lagged behind research efforts. Data sharing environments are called for involving co-operation with industry and academia to re-use data to test hypotheses, generate new biomarkers and clinical trials and set contemporary benchmarks in cancer therapy.
Collaboration must exist between pharmaceutical companies and academia. The progress of clinical trials in the future will strongly rely on co-operation between governments/regulatory bodies and the research industry to break down administrative barriers, assist in acquiring knowledge about standards of care in different countries, provide flexibility of drug registration and establish a partnered cost relationship for expensive targeted therapies.
These new streamlined drug development methods and partnerships need to be adopted by the pharmaceutical industry academia, regulatory bodies and government in order to progress effective clinical research.
Of course, the above only touches the surface of these complex issues. The many aspects involved in Barriers to Effective Care will be discussed as part of the Clinical Science Symposia on Wednesday 21 March, from 16:00 to 17:30( ESC)