By Linda Christmas, Chief HR Officer, Chiltern and Bill Donovan, Chief Source Officer, Chiltern
The development of new therapies and treatment regimens for treating cancer is vital. However, oncology clinical trials can be complex and lengthy because of the highly variable biology of the disease and the increasing demands of the regulatory bodies. Supporting new drug development requires recruiting and retaining the best possible qualified research professionals for oncology-focused clinical trial teams.
Though the five year survival rate for cancer has increased to 68% in 2010 from 50% in the 1970s, cancer is still the second leading cause of death in the US . To meet these needs, drug development in oncology is extremely active – according to PhRMA (Pharmaceutical Research and Manufacturers of America), there were 981 different therapeutics in development for cancer in 2012.
In drug development within each distinct therapeutic area, phase I trials involve healthy volunteers. However, because cancer drugs are often more likely to have toxic side effects, phase I and phase II trials in oncology will generally recruit patients with advanced, untreatable, or heavily pretreated disease, who are often physically frail and on a number of concomitant medications. These patients may also be willing to accept higher levels of risk or of toxicity, especially if they have only weeks or months to live, as either they wish to take any opportunity for treatment or they feel that they can contribute to overall knowledge about the disease. The trials can be long and have multiple treatment arms, according to the stage of disease, level of pretreatment, cancer type and subtype, and other factors.