The value of developing an immunotherapy has grown over the past few years – as science and technology has developed far enough to help the immune system better recognize cancer cells as an abnormality within the human body. The potential of this cancer treatment is huge as it would allow healthy cells to remain unaffected. The new methods scientists are trying to develop include vaccines and monoclonal antibodies that target specific molecules on a cancer cell’s surface according to Sharon Moore, MD, Chief Medical Officer, Chiltern in their recent white paper Understanding Immuno-oncology Trials.
Designing and implementing trial in this space is very difficult. Here are just a few of the challenges conducting clinical trials in immuno-oncology faces:
- Difficulties in determining the amount of treatment that should be used for the patients. As the traditional methods for determining effectiveness including toxicity and pharmacokinetics are not relevant in the success it’s difficult to determine success related to the amount of treatment that was used.
- Endpoints for success are hard to determine, but biomarkers have emerged as a key player in finding the right end points
- Timing of the clinical trials are also difficult. Much of this treatment is personalized so developing the treatments to fit within a clinical trial time window is also another challenge. Logistics of the treatment storage and timing of the trial do to difficult to determine end points also prove to be challenges when conducting clinical trials.
- Trials take a considerable amount of time – so when conducting trials across countries, often parallel therapies emerge causing issues in the clinical trail judgement process. Also due to the rarity of certain diseases, it is often difficult to find the right people to participate in a clinical trial
Do the risks in developing an immuno-oncology treatment outweigh the challenges? Why or why not?
Immuno-oncology is one of the hottest topics at our annual BIO-Europe Spring® event. We’re putting the final touches on this year’s program. To get notifications as to when the program is ready, sign up to receive email updates!