Clinical Trials

Clinical trials are critical for the development of new therapies for lung cancer.

Recent scientific and drug-development advances have created new opportunities and complexities in today’s lung cancer treatment and research paradigm. This has raised important questions about how best to optimize clinical trial design, patient selection, and regulatory requirements, especially given the rapidly evolving treatment landscape and emerging opportunities with new targeted agents, immunotherapies, and combination approaches.

Scientific and Clinical Roundtables

LUNGevity’s Scientific and Clinical Roundtables bring together key stakeholders from across the lung cancer ecosystem, including domestic and international regulators, industry partners, clinicians, and patients, to discuss challenges and opportunities in designing and executing rational clinical trials and making them more accessible to patients.

The Roundtables provide a platform to prioritize actionable issues and work toward solutions to improve the lung cancer clinical trial landscape for patients, clinicians, drug developers, and regulators, ultimately speeding new treatments to patients faster.

Since 2015, the program has developed and expanded to include several work streams to reform and improve clinical trials. These areas include the following.

Streamlining Clinical Trials

The goal of this Roundtable series is to streamline clinical trials and make them more accessible to patients. The three active work streams include:

  1. Expanding eligibility criteria
  2. Streamlining reporting of suspected unexpected serious adverse reactions (SUSARs) and adverse events
  3. Creating a prospective real-world control arm

Patient-Reported Outcomes

The goal of this Roundtable series is to better gather patient-reported outcomes (PROs) that are meaningful to patients and ensure that the information is communicated to patients in a way that is useful to aid in their decision making. The specific questions being asked include:

  1. Why collect PROs and other patient-experience data in cancer trials?
  2. What PRO concepts should be measured?
  3. How can PROs be best measured?
  4. How can we analyze and communicate this data?

Roundtable Meeting Summaries

March 23, 2018

Veteran Enrollment in Clinical Trials

The goal of this Roundtable series is to identify barriers and opportunities to ensure that veterans have access to clinical trials – both standing up more industry trials within the VA Health Care System as well as facilitating veteran access to clinical trials outside of the VA health system. This Roundtable series engages with senior leadership from the Veterans Health Administration, practicing clinicians with the VA, National Association of Veterans’ Research and Education Foundations (NAVREF), and industry partners.

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