As clinical trials grow ever more complex, there are steps companies can take to keep their studies on track and on target
Clinical trials are not for the faint of heart. Conducting even one trial is a monumental task, with complex processes and issues that can derail a study's timeline and cause delays in regulatory filing, market entry and, ultimately, delivery of new therapies to patients.
To address these challenges and refocus on core strengths, sponsors are outsourcing clinical trials in large numbers. According to recently published research, an estimated 70 percent of clinical trials will be outsourced to CROs, along with high hopes for better performance on time and budget. However, even CRO-run trials sometimes need to be 'rescued', necessitating corrective action such as adding investigative sites, or terminating/retraining others. Better operational processes may also need to be put in place as may more reliable and timely status reports.
What needs rescuing?
Each clinical study presents unique challenges. Communication problems among stakeholders, employee turnover, recruitment and enrolment delays, overly complex protocols, poor site compliance; these are some of the factors leading a study to need rescuing.
Most often, a study is in danger of not being completed within an appropriate timeline, its quality is suspect or it has lost access to resources. Another possibility is that unexpected results have caused a regulatory agency to halt the trial.
Rescue support may be as simple as adding third party experts to the sponsor project team to aid in management and oversight, or may be as complex as selecting a new provider to assume responsibility for the study.
To manage this issue, numerous CROs offer rescue services, a fact that is hardly surprising given that currently four out of five clinical trials fail to meet enrolment timelines. In addition, up to half of research trial sites enrol one or no patients and, according to Cutting Edge Information, 72 percent of studies run more than one month behind schedule. These statistics cannot be ignored.
Proper identification of red flags to signal whether a study is veering off course are a key element of avoiding the need for rescue. Ask the following questions:
- What are the issues?
- Where are the bottlenecks?
- Has the clinical trial team been informed in time to take corrective action?
- How is the sponsor conducting oversight of multiple CROs?
For sponsors, this last question can be particularly daunting; the complexity of oversight becomes evident when working with multiple CROs on multiple concurrent studies. Specifically, the use of siloed custom tools and processes as part of CRO detailed reporting can mask risk identification for each individual study. Consequently, correlation of data from CROs with different reporting formats can make timely oversight difficult.
In addition, study start-up activities – one of the most inefficient and costly bottlenecks of clinical trial conduct – are often being handled via email and spreadsheets, with the potential to yield inaccurate, inconsistent and outdated data.
Beth Harper, president of Clinical Performance Partners, which provides services for study rescue and improved site performance, makes this point. "The more that the industry can move away from spreadsheets and trackers to more valuable dashboards to visualise and monitor site performance, the better position we'll be in to pre-empt issues and more effectively manage study performance, especially at the site level."
Because many tasks have frequently been performed without a consistent approach across CROs, the resulting inefficiencies have led to missed timelines and cost overruns. In response, business intelligence initiatives are a growing priority for sponsors and CROs, as executives demand greater visibility into trial data at a much faster pace. Against this backdrop, and the volumes of information generated, clinical project managers are expected to make smarter decisions on intelligence derived from clinical trial data.
Established eClinical systems – clinical trial management systems (CTMS), electronic data capture (EDC), the electronic trial master file (eTMF), and others – are in wide use but they can fall short of delivering rapid analytics and insight. Significantly, they do not address SSU. Activities such as country selection, pre-study visits, site selection and initiation, regulatory document submission, contract and budget execution, and enrolling the first patient typically define study start-up.
For stakeholders, bringing a higher level of predictability and quality to this multistep process is critically important as it could mitigate the need for study rescues. Recognising this gap, eClinical system providers that are extending their technology solutions to include study start-up activities are: Adobe Lifecycle, goBalto, NextDocs, Intralinks, ePharmaSolutions, and others.
With real-time study start-up data, the project management team is free to focus on issues and bottlenecks affecting the clinical study. Time is not wasted assembling and discussing status updates, instead, stakeholders can view this information in real-time ahead of scheduled status meetings.
Real-time alerts to help decision-makers intervene immediately or before a major setback are also crucial as intervention usually happens after an issue has occurred.
It is critical for sponsors and CROs to leverage new innovative technologies to aid in their goals of streamlining clinical trials by empowering oversight, casting light on bottlenecks, reducing study rescue, and ultimately, getting life-saving drugs to market more quickly.
This works via true business intelligence – the ability to proactively identify and resolve bottlenecks in real-time, instantly view study status, quantify performance of the clinical team, and discover meaningful patterns in study start-up data. Today's industry leaders in clinical trials recognise that CROs that are able to produce high-quality data and visualisation of study progress will translate into competitive advantage and will be a critical tool in their fight against wayward studies destined for rescue.
Craig Morgan is brand development director at study start-up company goBalto