Can the Abysmal 3% Success Rate of Oncology Clinical Trials be improved?

The war against cancer is being fought at many levels, with newer drugs targeting novel targets joining the queue to go through clinical trials. However, according to a recent research study, the failure rate of clinical trials in oncology stands at 97%, due to issues related to a lack of efficacy with some drugs and unacceptable toxicity with others.(Wong, Siah and Lo, 2019). The study also found that many of the cancer drugs studies are found to work via off-target effects, as their Mechanism of Action (MOA) is poorly understood in many cases, leading to some of the following issues:

Inadequate characterization of target-specific inhibition
Use of surrogate biomarkers as endpoints, which do not provide added benefit over using a biomarker as a criterion for screening
Interlaboratory variability between assay performance, without reasonable cause

Following are some guidelines that can potentially improve the FDA approval rate in the future.

Increase accuracy of the characterization of target-specific inhibition by the drug.
Derive precise, reliable and informative results from the biomolecular interaction analysis and understand the drug’s MOA better.
Be highly selective when conducting biomolecular interaction assays.
Stay aware that some key drug targets, which were previously thought to be essential for cancer treatment, have turned out be non-essential for the survival of cancer cells.
Some other cancer drugs turned out to have an MOA which owes its efficacy to off-target toxicity or interactions and not because they are attacking the specifically targeted genes, proteins, or tissues cancer cells rely on for their survival and growth.
Knowing the MOA of some known and potent anti-cancer agents could help us discover new cancer targets to design new and better drugs.
Many times, promising drug candidates end up as failures, as the right clinical trial has not been designed to test them.
Demand highly reproducible research.
Ensure that the evidence of a drug’s efficacy is carefully evaluated and the rationale for targeting a particular target is ratified.

Everyone in the oncology ecosystem needs to take a hard look at all the failed medicines to understand what went wrong, before sinking millions into a new drug, which could join them soon without ever making it to the market. There’s no doubt that we need to revise the way we choose cancer drug targets, reanalyze the assumptions and validate them all over again. This is an imperative when we see the number of drug targets destined to fail, as 97% of them do, on human patients whose lives are literally put on the line, in every clinical trial. How can Lumiseek help? Lumiseek offers a core framework to streamline communication across various categories of oncology-focused individuals and organizations to play an effective role in managing basic research and clinical trials. Our award-winning platform enables you to find collaborators with complementary expertise to establish and manage projects together in a mutually beneficial manner. Lumiseek registers qualified cancer-focused organizations of all types and has mechanisms to securely and privately communicate with them to develop a synergy with their near-term goals. The project management module lays out project roles, deliverables, tracking (budget and timelines), activities, and integrates other external or legacy systems used by the users or their parent organizations. The personal network management system, on one hand, allows users to create groups within their professional network (e.g. potential collaborators met at conferences, key opinion leaders, reviewers etc.). On the other hand, it allows users to create temporary communication groups that may last only for the life cycle of a project. Because Lumiseek is developed by professionals with extensive experience across most functions of the cancer care value chain, all the requirements of various stakeholders in the field of oncology have been considered and incorporated into the platform. Explore these benefits to see whether you can eliminate any or all of the errors which creep into the management of a clinical trial, before initiating your next one.