1. In Vivo
  2. >>Archive

Novel Clinical Trial Designs In Oncology: An Histology-Independent Approach

Cancer’s heterogeneity is a leading reason why product development in this therapeutic area is so risky and costly – and why the pharma industry has not yet addressed all needs in the market. Because low-incidence tumors present recruitment challenges and have lower commercial potential than high-incidence ones, they receive less attention from drug developers; meanwhile, new therapies for high-incidence tumors must demonstrate higher efficacy than therapeutic alternatives in order to differentiate themselves.

For years, drug developers have used histology as the fundamental analytical unit by which they study new agents for their effectiveness. Homogenous patient cohorts (based on their histological distinctions) produce more predictable outcomes. This rationalization is consistent with the mechanisms of action for many cytotoxic agents and some classes of targeted therapies. For example, the cytotoxic effects of taxanes in breast, ovarian, prostate, and lung tissues are likely attributable to inherent metabolic properties of the tumor, such as drug absorption/uptake, DNA replication/cell division, and mechanisms of drug resistance. Likewise, the effects of angiogenesis inhibitors (e.g., bevacizumab) in certain solid tumors are related to the neovascularization properties of specific tumors and the molecular targets that are involved.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

‘I Want Everything To Go Faster’: Medidata’s CEO On Pushing The Strategic Accelerator

 
• By Jo Shorthouse

Appointed CEO 12 months ago, Anthony Costello wasted no time in orchestrating strategic change at Medidata. He talked to In Vivo about the art of the pivot and how to constantly push boundaries.

Three Steps To Investor Heaven For Founders: Articulate, Explain, Clarify

 
• By Ashley Yeo

Capital remains available for good healthtech projects, but it is more concentrated and harder to find than of late. Founders and inventors must know how to unlock it. The BioWales 2025 investor panel told them where they could be going wrong.

Deals Shaping The Industry, March 2025

 
• By In Vivo Team

An interactive look at pharma, medtech and diagnostics deals made during March 2025. Data courtesy of Biomedtracker.