Expanding Clinical Trials

Cancer Research Ideas - Expanding Clinical Trials (Archived)

Cancer clinical trials continue to be the gold standard by which new preventive, treatment, supportive care, and other interventions are tested and compared with existing interventions. New clinical trial designs are emerging with the recognition that a single cancer type may consist of many different molecular subtypes and that a given molecular alteration may drive many different types of cancer. At the same time, it is important that more patients have the opportunity to enroll in trials, to ensure that the results of trials are as broadly applicable as possible and that answers are obtained as quickly as possible.

The submission period for Expanding Clinical Trial ideas ended on July 1. However, we encourage you to sign up for regular e-mail updates about the National Cancer Moonshot Initiative at the Cancer Moonshot Milestones web page.

Research Area: Expanding Clinical Trials

Collaborate to Include Comorbid Conditions in Study Samples

We study cancer in narrow cohorts, excluding comorbidities. By doing so we miss critical info that can lead to earlier identification/treatment. While we must stratify samples, we can do so and include comorbidities that lead to disease pathways.

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What is the research problem :

Ignoring comorbid conditions in stratifying samples may mean missing clues to development of cancer. E.g., lung cancer (BAC) can develop in pulmonary fibrosis; rarely studied together, they may have similar pathways. Studying both can yield new paths

How will your solution make a difference :

Such efforts could find similar/identical pathways for development of lung cancer and fibrosis, for example, leading to more research on early ID and treatment of either or both conditions. Sharing data across NIH divisions would be cost-effective.

What is your proposed solution :

The comorbid conditions may be in non-NCI divisions. NIH should convene cross-organizational committees to see intersections of relevant research and survey existing non-NCI grantees to ID prospective contributions of research data. E.g., NHLBI can share data on pulmonary fibrosis with NCI sharing data on lung cancer, or data from the National Lung Screening Trial can be mined for PF and cancer. Familial cases may yield genomes to be studied.

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Research Area: Expanding Clinical Trials

Collect Family History: Provide Global Access to Registries

If data collection is restricted to the US, we may mischaracterize some familial cases as sporadic. We need to include Family History in the NIH/FDA Clinical Trial protocol template (sec.7.1.1) and provide global access to registries/biobanks.

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What is the research problem :

We may miss key genomic data if we restrict data collection to the US and don't collect family history of the cancer and comorbidities. We may see a case as sporadic when, with family history or access to int'l registries, would label it familial.

How will your solution make a difference :

Collecting family history is inexpensive done prospectively, can find patients whose genome should be sequenced, and match a family with related families, to provide larger samples. Global access to tissue/bio-banks can identify familial cases.

What is your proposed solution :

Family History of the target cancer and associated co-morbidities should be included in NIH/FDA proposed Clinical Trials Protocol Template under Medical History section 7.1.1. We need global access to tissue and biobank registries for qualified researchers, with information about what data are routinely collected. Since most of us in the US came from "across the pond" in some sense, such info is critical, and can lead to new research directions.

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Research Area: Expanding Clinical Trials

Stereotactic Radiosurgery for Breast Cancer

A novel, breast stereotactic radiotherapy device is now undergoing testing on an FDA approved investigation device exemption protocol. This device has immense potential as a one day, noninvasive, curative treatment for early stage breast cancer.

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What is the research problem :

Standard breast cancer treatment includes excision followed by several weeks of radiotherapy. Stereotactic radiosurgery has proven an effective alternative to surgery in lung/brain cancer but has yet to be explored for breast cancer.

How will your solution make a difference :

Data generated from this study could revolutionize the management of early stage breast cancer. A single, noninvasive, outpatient procedure, performed in 90 minutes, could completely replace the current 11+ week standard of surgery and radiation.

What is your proposed solution :

Preoperative stereotactic breast radiosurgery will be piloted with this novel device. To develop a completely non-surgical approach to breast cancer, we must identify predictors of response to treatment. Extensive pre- and post-radiation functional MRI, serum biomarker sampling, and pathologic assessment will help to identify surrogates for complete pathologic response (pCR). We expect a pCR in 80+% of patients as seen in other disease sites.

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Research Area: Expanding Clinical Trials

Inject HAMLET directly into metastasis and use it profylactic

HAMLET detects and binds to tumorcells. Inject HAMLET directly into metastasis in for example skeletton, muscle, liver, brain to prolong survival for cancerpatients and hopefully in some cases cure the patients.

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What is the research problem :

I have heard that HAMLET gets at least partly inactivated by albumin in blood. An antibody that binds to the site so that HAMLET can´t bind to albumin would be good if that is possible. HAMLET could perhaps be bound to contrastagent to detect cancer.

How will your solution make a difference :

Cancerpatients with metastasis and no hope of being cured by present techniques can hopefully get HAMLET treatment, live longer and perhaps be cured without suffering from adverse effects. Peopel with high risk of getting cancer can prevent it.

What is your proposed solution :

Inject HAMLET in metastasis. (Repeat if necessary or cool the area down if blood/albumin is present). HAMLET could be administered by percutan intervention. Inhale HAMLET to treat lungcancer. Operationarea or cancer could be covered by HAMLET to reduce risk of cancer cells being left in the area. Profylactic inhalation, lavage,drink it, topical use on skin (albinos), cervix(SIN1) or in body cavities to prevent cancer if hereditary risk.

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Research Area: Expanding Clinical Trials

Understanding Decisions to Participate – or Not -- in RCTs

Research is needed to understand how potential participants perceive risks and benefits of participation in RCTs in order to increase recruitment, especially among older participants and those in underserved communities.

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What is the research problem :

Only 3% of cancer patients participate in clinical trials, for a variety of reasons that aren’t well understood. Better information about how potential participants perceive risk and benefit could influence recruitment and retention.

How will your solution make a difference :

Decision-making is a key avenue through which behavioral processes may influence perceptions of risk and benefits of various cancer treatments. Findings from this research may influence population of a new generation of cancer trials.

What is your proposed solution :

Multidisciplinary research on decision-making offers a fresh avenue for elucidating risk- benefit perception to improve clinical trial participation. Application of this type of research to this problem can help determine what factors influence participation, and what decision supports are most helpful in various groups.

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Research Area: Expanding Clinical Trials

Patient Centered Approach to Clinical Trials

The needs, preferences, and values of cancer patients should be incorporated into clinical research studies. This approach could facilitate adherence of currently enrolled clinical trial patients as well as recruitment of new enrollees.

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What is the research problem :

Patient needs, preferences, and values are not consistently assessed or considered as part of clinical research studies. There is also limited follow-up with patient participants regarding study results.

How will your solution make a difference :

Patients will be engaged as active partners, not passive participants. Better inclusion and understanding of their role might facilitate adherence of currently enrolled patients as well as recruitment of new enrollees.

What is your proposed solution :

Develop communication protocols informed by patients, caregivers, and families. Provide mechanisms for patients to communicate personal goals related to clinical trial in which they have been enrolled. Allow for the meaningful incorporation of patient-reported outcomes into findings. Report back to patients and families in a timely manner, before public dissemination. Request feedback to improve process.

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Research Area: Expanding Clinical Trials

Improve participation in clinical trial

Low and/or slow accrual to clinical trials is a critical barrier to making advances in cancer treatment. Improving access to trials and medical oncologists referrals to centers offering clinical trials would greatly speed up our progess.

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What is the research problem :

There is a critical need for greater enrollment in clinical trials. The major barriers are 1) not all doctors inform/refer patients to trials and 2) Medicare rules can limit patient's access to out-of-state trials.

How will your solution make a difference :

By increasing enrollment in trials, we will develop new and better therapies much more rapidly than our current process. Expanding Medicare patient access to trials will greatly aid in this process.

What is your proposed solution :

Require clinicians to discuss clinical trial options with all patients. Make mandatory and track outcomes/compliance (with EMRs, as with safety training in hospitals). Make these data public to encourage competition across institutions for 100% compliance. For access, allow Medicare patients to access clinical trials across state lines rather than restricting access to in-state options.

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Research Area: Expanding Clinical Trials

Make enrolling in clinical trials patient-centric

Flip the clinical trial enterprise from trial-centric to patient-centric by bring the trial to the patient. Currently we are trial focused for accrual. We need to focus on patients to find the right trial for them and enable access to that trial.

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What is the research problem :

Patients have a hard time finding a trial that they qualify for and do not have access to all trials. All patients need to have access to all trials.

How will your solution make a difference :

All patients would have access to clinical trials regardless of where they live. This would lead to equitable opportunities for new therapies among all patients.

Trials would accrue faster.

New treatments would move forward faster.

What is your proposed solution :

Develop systems that identify the best trial for the patient based on eligibility and patient preference.

Bring the trial to the patient. Have easy open/easy enrollment trials that can be opened when the patient needs it and where the patient is.

Have pre-qualified sites, including community sites, that can open any government funded trial at anytime – using central irb and on-line forms, etc. that is low on cost/resources.

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Research Area: Expanding Clinical Trials

Help patients identify appropriate clinical trials

Create "clinical trial finder" regional centers staffed with healthcare personnel trained to help patients assess best clinical trial option anywhere in US--not only identify trials, but choose best trial option and together with patient

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What is the research problem :

Patients need help finding clinical trial that gives them best chance of effective treatment. Currently they can search trials to match geographic and inclusion requirements, but have no way to assess medical suitability of each trial.

How will your solution make a difference :

More patients will be willing to participate in clinical trials because they will have help finding a trial that meets their needs and offers a valid treatment option they feel comfortable with.

What is your proposed solution :

Make preclinical data available to pts and healthcare providers. Create regional centers staffed by patient navigators (PNs) and docs trained in clinical trial assessment: how to evaluate trial reqts nationwide, use IT tools to match EHR data to reqts, assess which trial has best chance of helping (e.g., this drug treats brain mets, that one is more potent for EGFR, etc.), find patient supports for travel, & collaborate with patients.

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Research Area: Expanding Clinical Trials

Expand access to clinical trials for rare cancers

Train doctors at community-based hospitals to act as local "hands-on" clinical trial check-in locations so trials for rare and oncogene-driven cancers will increase accrual (and more patients will have access)

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What is the research problem :

Clinical trials for rare and oncogene-driven cancers are often underpowered. Limited trial locations create barriers to patients (travel, time away from family and work, travel costs)

How will your solution make a difference :

More patients will be able to enroll and have access to targeted and immunotherapies, trials will be adequately powered, researchers will have access to more diverse patient tissues, more researchers can access data.

What is your proposed solution :

Have more community-based (CB) hospitals partner with academic medical centers (ala Lung MAP model) to act as clinical trial check-in sites. Telehealth allows real-time connection with primary investigators when needed. Train docs at CB sites to perform required hands-on exams of patients and properly collect necessary tissues and data. Forward tissues to central NCI biobanks. Open source genomic analysis of tissues.

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