Methods Matter: Accelerating Oncology Clinical Trials

Kenneth G. Faulkner PhD |

It takes approximately 10.5 years for an oncology drug to make it to market. Sadly, this isn’t fast enough for many cancer patients. What’s the reason behind these long clinical development timelines and how can the industry accelerate studies to bring life-changing treatments to patients faster? 

Quote from Ken Faulkner

In this blog series we’ll put a spotlight on all the challenges pharmaceutical companies and CROs face when developing new cancer treatments, including the important role at-home data capture solutions are now playing as pharma moves towards more decentralized oncology studies. We will also explore how eClinical technologies can pave the way to faster, higher quality and more cost-effective cancer trials.

Key Reasons for Long Trials

Before we dive into the detail, let’s take a look at some of the key reasons oncology trials are taking so long:

  • Patient recruitment is an issue in every clinical trial. However, due to strict and often narrow eligibility criteria, this issue is exacerbated even further in oncology trials.     
  • Retaining patients for the duration of the study is a challenge, with many sadly not surviving until the end. Making sure that a trial starts on time, runs as efficiently as possible, and produces clear results that can be analyzed quickly is all vital to successful trial outcomes. 
  • We all know that poor data quality delays trials but incredibly, 50% of clinical trial sponsors continue to capture important patient reported outcomes (PRO) data with error-prone paper diaries.  This is despite the fact that electronic solutions have been repeatedly proven to overcome the compliance, illegibility and other significant data quality problems associated with these paper-based data capture tools (Figure 1).                                                                                                                                         
  • Oncology trials are becoming increasingly complex, with an 86% increase in endpoints and a 60% increase in the number of procedures required by the FDA in recent years. It’s not surprising that half of sites are failing to meet enrollment criteria and nearly a third fail to enroll any patients at all. What’s more, if sites find a trial to be too burdensome, they won’t remain engaged, and patient compliance and engagement are also likely to suffer.
  • A lack of real time insight into site performance means sponsors are unable to proactively engage with low-performing sites. Sites are also at a disadvantage due to a lack of visibility into real-time patient compliance trends.

eCOA data

Figure 1: Patient compliance significantly improves with eCOA1

Put simply, new and potentially life-saving drugs are being unnecessarily delayed. 

The good news is that researchers can do something about this today. By embracing the immense benefits eClinical technology and services have to offer, they can accelerate their trials and achieve higher-quality, regulatory-compliant data.  

Accelerating Oncology Trials

In this series we’ll review exactly what sponsors can do and explore how clinical trial sponsors and their CRO partners can:      

  • Reduce study start-up times, burden and costs while still getting the highest quality PRO data by utilizing pre-built electronic Clinical Outcome Assessment (eCOA) libraries of commonly used oncology assessments (such as EORTC QLQ C-30 and EQ-5D-5L).
  • Accelerate recruitment by ensuring only the correct patients are enrolled.  Sponsors who leverage centralized core labs’ highly precise over-reads of important cardiac safety assessments can eliminate the faulty enrollment decisions that are often made when sites rely only on ECG machine measurements (which have significant rates of false negative and false positive results). 
  • Make it easier for patients to participate in trials by offering them the choice of using their own mobile phone (Bring Your Own Device, or BYOD) to complete electronic assessments at home, or taking part in a video call with their doctor to reduce their number of site visits.     
  • Leverage advanced trial oversight tools to identify poor performing sites and patients in near real-time and deliver refresher training and support to get them back on track.           
  • Minimize human error in trials that require medical imaging by ensuring important safety and efficacy data reads and over-reads are efficient and accurate through the use of advanced, Artificial Intelligence-based imaging solutions.
  • Make more informed study go/no-go decisions by identifying potential patient safety issues in real time through proven trial oversight monitoring tools.
  • Speed up database lock by replacing time-consuming and error-prone manual processes with automated, secure data transfer and verification of source documents.

Taken together, the advantages that eClinical technologies offer and the resulting higher quality data they deliver enable clinical trial sponsors and CROs to shorten oncology clinical trial timelines and reduce development costs, all of which can make a big difference in getting new treatments to patients sooner.

Kenneth G. Faulkner, PhD is Vice President of eCOA Science at ERT.

 References:

  1. Stone A, et al. 2002. Patient non-compliance with paper diaries. BMJ 2002; 324:1193
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