However, these trials have been rare, and the main goal of this panel was to propose a histology-agnostic trial that can act as a potential blueprint for other investigators to follow, thus making the drug testing and approval process faster and more efficient. This design, which could potentially be generalized for broader use, would utilize a "learn as you go" approach, allowing for adaptation of the trial based on tumor responses to therapy. The other panel members reiterated that multi-histology trials will be more efficient, and discussed the importance of having a well-specified, defined diagnostic that accurately measures the marker of interest and defines the appropriate patient population to be treated.
The discussion following Panel One addressed multiple issues and challenges that this type of trial design may encounter, including patient accrual, refractory tumors, and combination drug trials.
Additionally, many attendees and panelists again emphasized the importance of the development of companion diagnostics and the implementation of diagnostic tests in the community setting, especially as novel driver mutations continue to be identified.
In keeping with the organizational goals of the Friends of Cancer Research, Dr. Panel Two discussed trial approaches to test the utility of maintenance therapy.
Many cancers may respond well to initial treatment but eventually progress or relapse, and maintenance treatment with targeted therapies, which often have fewer side effects than standard chemotherapy, presents an opportunity to prevent or delay cancer progression.
As discussed by Dr. Richard Schilsky and patient advocate Patty Spears, while maintenance therapy is attractive in theory, it may not necessarily be superior to allowing patients a "break" from treatment before beginning second-line therapy, and it increases the exposure of patients to the toxicities of that therapy.
Therefore, rigorous studies are necessary to demonstrate the clinical benefit of maintenance therapy. This panel presented two clinical trial scenarios to evaluate how studies should be designed to test the benefits of long-term maintenance with targeted therapies. In the first scenario, patients are placed on a targeted maintenance therapy immediately after obtaining best-response to traditional first-line chemo. In the second scenario, patients are maintained on a targeted therapy that was a component of first-line therapy throughout subsequent lines of therapy.
Tal Zaks noted that the trial designs outlined will require more resources and will face real-world challenges to enrollment and timely completion, especially for drugs that are already available in the marketplace.
Further, studies of maintenance therapy must be designed to show an improvement in either overall survival or patient symptoms. Panel Three discussed the barriers to symptom measurement oncology clinical trials and the inclusion of symptom information in oncology drug labels, as well as possible solutions to those barriers. Brian Seal, symptom measurements are often neglected in favor of efficacy measurements because of the many methodological and logistical challenges to measuring symptoms.
These challenges can be overly time-consuming and expensive to overcome. Members include representatives of government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.
Clinical Trials is an international peer reviewed scholarly journal that addresses topics of interest to individuals involved in the design and conduct of clinical trials.
The primary aim is advancing knowledge on the design and conduct of clinical trials related research methodologies. Covering the design, conduct, analysis, synthesis and evaluation of key methodologies, the journal remains on the cusp of the latest topics, including ethics, regulation and policy impact.
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