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Transforming Clinical Trials

By Study NeedBy Study Role

June 3, 2020

Best Practices to Improve Cancer Clinical Trials

Similar challenges for different sponsors

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      Rita Frawley

      Rita Frawley

      Program Director


    There is the old adage that the customer is always right. And to a degree that is true. But when you are trying to challenge the status quo as we are with Teckro – the way things have always been done isn’t necessarily the way they should be done.

    But change is not without lumps and bumps along the way. It is in my capacity as a customer success manager that I can help ease teething problems for new study teams and accelerate success for our sponsors by sharing best practices we’ve learned along the way. It is always reassuring to study teams that problems they face are problems we’ve seen and managed for other sponsors.

    And let’s face it, the problems with clinical trial operations are big but not insurmountable. By thinking differently, sponsors have the opportunity to make clinical trials safer, more efficient, and more effective.

    There is no sweeter thing in my customer success manager role than helping a sponsor achieve meaningful business results from Teckro. Solving problems in pharma comes down to changes with people and process, aided by technology. But it also requires a mindshift, which is where in my role in customer success comes in, we are helping to challenge traditional approaches to show there is a better way.

    Challenges Sponsor Face with Cancer Trials

    I recently participated in a panel discussion during the Outsourcing in Clinical Trials virtual conference (of course socially distanced from my fellow presenters), and I highlighted a few categories of challenges that sponsors face when it comes to cancer trials:

    • Keeping sites and patients engaged, especially for long studies ​
    • Helping research staff properly execute complex protocols ​
    • Protecting patient safety, particularly toxicity management

    This list is of course not necessarily unique to cancer, but it gave me a good platform to highlight best practices for how sponsors can approach clinical trial challenges in a way that helps all stakeholders. That’s in contrast to other software that satisfies some study stakeholders but causes others (namely sites) frustration.

    The example I used in the presentation was a 10-year oncology study with a large number of sites and about 4,500 patients enrolled.

    Keeping sites and patients engaged​.

    When we looked at engagement, this was a big problem for both site staff and patients. Given the study duration, there was a high rate of turnover for both CRAs and site staff. Additionally, patient visits became less regular as the trial progressed – typically every six months or so. There was a huge issue and a real concern to keep patients engaged for 10 years, especially for patients whose health outcomes were not improving.

    Helping research staff properly execute complex protocols.

    Study design complexity, particularly visit schedules, was the second area we helped the sponsor to address. Oncology trials typically have many visits​ and a very detailed list of assessments or procedures for each visit​. Add to this, there are usually a larger number of protocol amendments that include changes to visit procedures.​ For this particular sponsor, there were 6 protocol amendments in just over two years. Not surprising, sites resorted to creating cheat sheets for visits. The question was how to make it easier for research staff to execute the trial based on the current protocol.

    Protecting patient safety.

    The third challenge I discussed, which is one of the most severe on patients, was related to toxicity and safety management. The study team worried about only being reactive​ and finding out about issues after they happened​. We worked with them to gain visibility so they could potentially pre-empt AEs and SAEs​ and proactively guide site staff on how to address issues.

    Connecting Stakeholders, Increasing Visibility

    At the end of the day, it’s about visibility. We see it time and again where sponsors, monitors and sites all feel disconnected from each other. In reality, clinical trial success relies on connecting all of these stakeholders for the entire duration of a trial. Of course, a lot of emphasis is put on the initial stages and patient recruitment, but the communication and trial guidance needs to be a steady flow throughout a trial.

    In my role at Teckro, I help connect these dots with proven best practices, enabled by our technology. And while the customer is always right – we are showing them a better way to move their trials into the digital age, especially now with social distancing and other COVID-19 challenges.