Oncology - Complex Clinical Trials in The Fastest Growing Therapeutic Area

In the developed world, 1 in 4 people die from cancer or cancer-related disease, and cancer accounts for 13% of deaths globally.

Oncology is the fastest growing therapeutic area by revenue and number of clinical trials. There’s been a huge emphasis on developing new treatments to improve survival in patients with cancer, but these trials have become a costly undertaking for sponsor companies.

In general, clinical trials can be slow to complete and expensive to conduct when recurring issues are not swiftly and adequately remedied. The unexpected variables can then lead to:

• Inefficient trial design
• Low patient recruitment
• Difficulties with data collection and interpretation
• Sponsor or site budget restraints

These concerns are further multiplied in oncology trials, since they require even greater investments of money, time and (human) resources.  Planning and executing oncology trials can quickly become complex, mainly for the following reasons:

• Budgets:  Phase 2 and 3 oncology trial budgets  are nearly double those of non-oncology trials, per patient enrolled.
• Timelines:  Regardless of phase, oncology trials, last 14-18 months longer than non-oncology trials. (So extra delays would cause budget over-runs).
• Safety:  Oncology safety monitoring is complex due to the volume and uniqueness of adverse events, and the Common Terminology Criteria for Adverse Events (CTCAE) grading requirement.
• Complex investigational products and protocols: Oncology uses complex protocols that can require the use of:
  • Biologics (e.g. immuno-oncology drugs)
  • Precision medicine
  • Specialty lab vendors for: PK, pathology, genetic testing/deep sequencing, etc.
  • Personal devices and monitoring tools: ePRO (electronic patient reported outcome)
  • Companion Diagnostics etc.
• Comparator drugs:  Oncology trials must almost always use comparator drugs over placebo. These comparators are standard-of-care therapies that have complex administrations and adverse events of their own.
• Global sites with varying regulatory and ethics requirements for:
  • Visit assessments
  • Trial advertising
  • Subject confidentiality
  • IP supply chains, etc.
• Numerous vendors:
  • Specialty labs requiring unique kits
  • Imaging vendors providing central RECIST reads
  • Vendors shipping devices or wearables that must be constantly inventoried

But, as complicated as oncology trials may be, they represent a source of hope for people living with cancer, so it’s important to get them right.