How Patients as Stakeholders can Increase Physician Participation and Ensure Greater Access to Clinical Trials

Patient organizations are pivotal in enabling this unified approach, engaging both physicians and patients for best possible care for all

Jul 13, 2021

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Recently, I had the privilege of speaking at the World Ovarian Cancer Coalition (WOCC) Best Possible Care for All virtual event along with Dr. Deb Zajchowski, scientific director at the Clearity Foundation and Nicoletta Cerana, president of the Alliance Against Ovarian Cancer (ACTO) in Italy.

The event was part of the WOCC’s Global Ovarian Cancer Charter Summit Series - of which Teckro is a sponsor. The charter is a call to action for those committed to improving survival and quality of life for women with ovarian cancer.

One of the six global goals of the charter is best possible care, which calls for women to have access to surgery, treatments and clinical trials that optimize their chances of survival and quality of life, no matter where they live. This is something in which I have a particular interest. Cutting edge treatments are first encountered in clinical trials and these also promote best standard of care. This is especially important for “hidden” diseases such as ovarian cancer that tend to be diagnosed late.

From personal experience as a busy clinician, I know that it can often be hard for physicians to find the time to research clinical trials for their patients. It’s often a challenge to find suitable trials that are both recruiting and are accessible to patients.

For most cancers, including ovarian cancer, treatments are becoming more complex, personalized and specific as they target mechanisms that may or may not be present in an individual’s particular tumor. Thus, while fewer people may be required in such trials, recruitment becomes more difficult. For example, there may be an ovarian cancer treatment center that sees a hundred newly diagnosed people in a year, but there may be only a few patients who have tumors that express the particular molecular characteristics against which a new trial treatment is targeted.

Watch: Brendan Buckley speaks at the World Ovarian Cancer Coalition "Best Possible Care for All" virtual event

Patients as Stakeholders

During the Best Possible Care for All virtual event, I touched on the idea of the patient as a stakeholder and how this is one way of solving the access problem. To be frank, we haven’t always seen patients in trials as true stakeholders. Rather, we have tended to view them through statistical lenses as part of an overall number in a trial, expected to passively follow the instructions they receive from their trial center. Therefore, we have tended to be rather blind to the fact that it is, of course, the patients who have the biggest stake in the trial outcome.

The best designed and conducted trials are those that recognize the need for active rather than passive participation. Patients must be encouraged to know as much as possible about the trial, including why particular kinds of data are being collected. The submission by participant patients of crucial data, notably on quality of life and on the impact of investigational treatment on their lives, is crucial in most oncology trials. The highest quality data will be obtained from participants that are treated almost as if they are co-investigators.

I believe that patient organizations are essential when it comes to supporting the “patient as stakeholder” concept. Patient organizations are grounded in the trust of their members. They can have a huge amount of reach, offering the opportunity to accelerate trials and raise awareness, keeping patients and physicians informed of how best to access trials.

During the session, Dr. Zajchowski talked about the tools the Clearity Foundation has to help women get access to tumor profiling so they can see which drugs are best for them. There’s also a standalone clinical trial finder, which allows women to access trials across the United States and matches the best drugs available to each patient, including drugs in Phase III trials, which can be more “active” than standard care options.

This tool then captures the results and saves them for oncologists who can then discuss with patients the best options available. The foundation hopes to launch the tool worldwide and is a great example of the power of patient advocacy groups when it comes to a new approach to shared decision-making to help achieve optimal results for patients.

I have seen patient organizations add to the improvement of trial protocols by defining what outcomes are important to their members, as well as by commenting on whether the burdens imposed on participants in a trial are reasonable. In some instances, these may even exceed that which a sponsor or Institutional Review Board (IRB) might instinctively assume to be acceptable.

Finally, as Nicoletta Cerana of ACTO highlighted during the session, there needs to be a change of culture when it comes to physicians proposing trials. She quoted from ACTO research that an astonishing 88.4% of US physicians surveyed had never been asked to be a trial investigator. This must change. By engaging patients as stakeholders, their physicians are incentivized to participation as investigators. By leveraging the pivotal role of patient advocacy groups, we can build the unified voice necessary to accelerate clinical trial enrollment and ensure best possible care for all.

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