Oncology is a unique therapeutic area of clinical research with a variety of factors that require particular attention when carrying out clinical studies.
What are the unique traits of oncology?
- The ultimate endpoint for registration of a new drug is still “Overall Survival Time”
- Many oncology indications are treated using a combination of either surgery or radiotherapy and chemotherapy where most chemotherapy treatments are composed of various drug combinations
- Although all cancers share the common trait of “abnormal growing cells”, the heterogeneity of histological and immunological features of each disease is extensive
- Even within each disease entity, different genotypes of immunologic surface makers can determine or rule out treatment success.
- As anti-cancer drugs are highly toxic, treatment modifications due to adverse reactions is very common and make it difficult to create a population of homogenously treated patients.
- The average cost of cancer treatments range from approximately $5,000 USD per year to over $100,000 USD per year for patients with brain tumors.
- Except for the most common tumor types – breast cancer, colorectal cancer and lung cancer – in most other indications, the number of patients is usually low within each center, thus resulting in slow recruitment of trials with a multitude of centers.
Adaptive Designs have been increasingly gaining attention during the past years. These designs provide greater flexibility for Investigators/pharmaceutical companies by using an iterative process of:
- Collecting Data
- Analyzing the collected data
- Making decisions on the study design parameters according to the outcome of the analysis
- Collecting additional data
In this highly diversified area of drug development, adaptive designs offer features which enable Investigators to find effective drugs more quickly for the benefit of the patients. More and more, Investigators and pharmaceutical companies use the advantages of adaptive designs over traditional, fixed designs in order to:
- Decrease the necessary sample size in trials
- Increase the probability of success in each trial
- To shorten the development process time of a new drug
Have an upcoming study in oncology? Consult one of our expert biostatistians on the application of clinical trial design.