Expanding Clinical Trials

Standardizing systems to enhance efficiencies using IT

Enrolling patients in clinical trials is expensive and difficult for providers. Creating electronic interfaces that focus on clinical trial information and standardizing them on a national level will cut cost, improve communication and accuracy.

What is the research problem

Collecting and managing large data in medicine by individuals is time-consuming and expensive. Large data collection via automated connectivity will enhance care for both patient and physician.

How will your solution make a difference

More interaction with online tools that create ease in identification, enrollment, and management during a clinical trial will improve understanding, efficiency, and ultimately help patients and providers conquer disease.

What is your proposed solution

-Create standardized electronic intake forms for every patient that can be updated with the latest concern in advance of the appointment. Similar forms can assess toxicities during treatment, after treatment and in long-term follow-up.
-Use electronic media to select appropriate patients and to present clinical trial information to a wider population.
- Collaborate with large insurance databases to study questions of high impact to society.

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Expanding Clinical Trials

New genetic mice need to be developed for adult cancers.

Most genetic mice used now only represent familial versions of disease, if they are developed with a mutation.

What is the research problem

Researchers have been using genetic mice that are really familial models, and then using their trial results to justify a human trial on sporadic cancers.
This is explained in more detail in my attachment. Click on "Comments" to see the attachment.

How will your solution make a difference

The mouse should represent only one type of cancer, and there should be a familial and sporadic version for that cancer. This would provide real and relevant results in human trials, if the mice trials matched the human disease being trialed.

What is your proposed solution

Researchers lump in any number of human trialists from both familial, (usually around 10%), and sporadic diseases, (usually around 90 %). No attempt is made to keep results from familial and sporadic diseases separate. Familial and sporadic results must be kept separate. New genetic mice should be developed to represent each known familial fault. Other mice need to be developed for adult sporadic versions of cancer.

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Expanding Clinical Trials

HAMLET (protein) kills cancer cells and multi resistant bacteria

HAMLET is effective against for example brain tumors (glioblastoma), bladder cancer and colon cancer. HAMLET has killed many different types of tumor cells in vitro and in animal models. Effect has been seen in humans. It has no known side effects.

What is the research problem

We need new cancer treatments that are more efficient and has no negative side effects. Hamlet is the future! Multiresistant bacteria is a hugh growing problem threatening our society and our lives, we need new HAMLET treatment for that also.

How will your solution make a difference

HAMLET is a potential cure for at least 30 different types of cancer in humans! HAMLET make multi resistant bacteria sensitive to ordinary antibiotics again so that the antibiotics can kill the bacteria, this is a revolution in medicine! Contact me!

What is your proposed solution

Start clinical trials in big scale. Treat cancer by injecting HAMLET in the spinal canal, pleura cavity, in lungtumours, abdomen, esophagus, colon, liver metastasis, skelettal metastasis and so on. Inhale it against lungcancers. Use it when operating on a tumour or after taking biopsy. Use HAMLET prophylactic to prevent colon cancer from developing. Attach Hamlet to gaudolinium to help diagnose cancer with MRI, HAMLET binds only to cancer cells.

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Expanding Clinical Trials

More efficient clinical trials for gynecologic cancers

A new paradigm for gynecologic cancer clinical trials would involve umbrella trials with adaptive trials designs. Results: Reduce barriers to opening new trials; increase availability and flexibility; increase enrollment; more rapid clinical advances

What is the research problem

Clinical trial enrollment for gyn cancers has fallen by 90% in recent years; few trials are available nationally. All gyn cancers are rare and specific subsets lead to even fewer available patients. Current implementation is woefully inefficient.

How will your solution make a difference

By entirely rethinking how we design and implement clinical trials for women with gynecologic cancers, which are relatively rare, we can increase the pace of progress towards personalized therapies while including women with rare subtypes.

What is your proposed solution

Society of Gynecologic Oncology proposes umbrella trials, running studies in parallel under 1 protocol using centralized IRB to increase access/efficiency. All advanced/metastatic endometrial cancer patients could enroll in 1 trial with allocation to various arms based on phenotype or genotype. Using adaptive trial design, arms could be opened, closed and replaced to increase efficiency of single or combination agent discovery and validation.

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Expanding Clinical Trials

Redesigning and inclusion of drugs to treat cancer

There has been decades of research on candidate drugs from herbs that never make it to clinical trial. Triptolide has been shown to be effective on all NIH lines of cancer cells, and several others. And modern drug design should be utilized.

What is the research problem

Drug companies have been reluctant to use promising plant extracts but there is a need to redesign some of these potential candidates to utilize the best of both worlds. In particular colominic acid is being used instead of polyethylene glycol.

How will your solution make a difference

Plant derivatives generally do not make it into clinical trials despite decades of good results in vivo. This provides a mechanism to enhance delivery that only drug companies can offer, by using the latest to maximize delivery and compatibility.

What is your proposed solution

Some older cancer drugs have been redesigned as polysialic acid mimetics [ www.ncbi.nlm.nih.gov/pubmed/26443186 ] and others are using the more biologically compatible colominic acid [ www.ncbi.nlm.nih.gov/pubmed/18307285 ] . The idea here is to best candidates for cancer treatment - triptolide, berberine, artemisinin - but package them using natural forms of polysialic acid to enhance delivery and reduce toxicity.

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Expanding Clinical Trials

Chemo-ID for Predicting Patient Response to Cancer Chemotherapy

ChemoID diagnostic assay assists oncologists in optimizing cancer therapy for their patients by testing standard-of-care chemotherapy drugs against Cancer Stem Cells (CSCs) which are an underlying cause of tumor recurrence and metastasis.

What is the research problem

Current anticancer treatments destroy the rapidly dividing cells that form the bulk of the tumor, but are largely ineffective against the root of the cancer, the cancer stem cells (CSCs). The majority of patients recur due to the presence of CSCs.

How will your solution make a difference

The ability to personalize therapy by providing the physician with drug response information on a panel of approved drugs should aid in the selection of the most effective chemotherapy for individual patients resulting in improved clinical outcomes.

What is your proposed solution

ChemoID is a new CLIA certified test that measures the sensitivity and resistance of both CSCs and bulk of tumor cells to various FDA approved chemotherapy agents. By testing multiple chemotherapies on a patient's tumor cells before starting a clinical treatment, the ChemoID assay enables improved outcomes. Patient access to ChemoID can be increased through collaborations and partnerships with healthcare providers, payers, and industry.

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Expanding Clinical Trials

Accelerating drug repurposing with multiple arm trials

Drug repurposing is an exciting avenue to improve patients’ outcomes. It is a fast, adaptive, cost-effective, safe and de-risked drug development strategy. However, a clear strategy to sort what's benefical for patients from what's not is lacking.

What is the research problem

Large, practice-changing repurposing clinical trials prove difficult to implement for financial reasons. Repurposing opportunities being multiple, testing one intervention at a time is time- and cost-inefficient to sort out which ones are beneficial.

How will your solution make a difference

Instead of supporting trials here and there with repurposed drugs, multiple interventions could be tested within one trial, ensuring faster access to possibly effective therapeutic options already in our cabinet and more efficient use of resources.

What is your proposed solution

Several oncology trials have used multiple arms to address multiple clinical questions within the same trial. Examples include ICON-7 and STAMPEDE.
We need more multi-arm trials to test repurposing ideas. STAMPEDE has been and will be testing several repurposing arms (i.e. zoledronic acid, celecoxib, metformin). We suggest that the NCI implements a separate program for testing repurposing ideas for various cancers and settings.

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Expanding Clinical Trials

Statistically significant AYA cohorts in clinical trials

Young adults are the least represented age group in clinical trials. Inadequate trial participation as expected equals inadequate survival benefit for decades,

What is the research problem

How to get adequate young adult access/participation in clinical trials. We don't assume peds tumors are the same as adult tumors. We shouldn't assume YA tumor biology is the same as older adult tumor biology. Difficult to enroll is our system fault

How will your solution make a difference

The cancer moonshot won't fail young adults like Nixon's war on cancer has.

What is your proposed solution

Every trial should be reviewed by a panel of AYA onc specialists to determine when a statistically significant AYA cohort is needed to identify age specific survival disparities for future AYA trials. Transparency reporting will be important with the current system that very poorly enrolls young adult participants onto clinical trials to determine where the failures in enrollment occur and why.

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Expanding Clinical Trials

Vegan diets

"Stop Feeding your Cancer" is about patients with brain tumors and some other advanced cancers and how their tumors stabilized and even shrunk on Ornish type diet. T Colin Campbell's work indicates even further benefits from a vegan diet.

What is the research problem

Patients are deluged with misinformation about what kinds of diets reverse disease or promote disease. There have been no clinical trials for vegan diets despite growing evidence that protein elevates IGF, Neu5Gc causes cancer, and many others ...

How will your solution make a difference

The proof is in the pudding so the debate will continue about vegan diet versus ketogenic for cancer. The ketogenic diet was tried and failed in a small clinical trial. Patients need to know what really helps and right now they are confused.

What is your proposed solution

Provide funding for clinical trials using vegan diets, especially high carbohydrate, low protein, low fat diet as explained and researched by T Colin Campbell. Both Ornish and Adventist Health Study show that reducing animal products reverses disease, including cancer, but there has not yet been a formal clinical trial testing Dr Campbell's findings that there is no point where eliminating animal products is not associated with better health.

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Expanding Clinical Trials

Rethink the requirement for chemo and radiation to enter trials.

There should be greater flexibility as to whether patients need to undergo chemo and radiation before being allowed to participate in clinical trials. This should be a decision between doctor and patient because there are pros and cons to both.

What is the research problem

The problem is that many forms of chemo and radiation end up with the development of highly resistant stem cell populations that come back even stronger and also create treatment resistance to any further treatments. This should be discussed.

How will your solution make a difference

Some new experimental treatments will do better if patients do not have to first go through standard radiation and chemo in cancers where it is known that treatment resistance gets worse.

What is your proposed solution

This dilemma should be discussed with patients and it should be optional whether or not to have chemo and radiation before proceeding to try new experimental treatments. If I were a patient I would not want to undergo a process that causes both stem cells and treatment resistance to increase and then hope the next treatment could deal with that. Especially for cancers where the standard chemo and radiation do not do much, allow to opt out.

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Expanding Clinical Trials

Cannabis - Whole Plant Research and Clinical Trials Needed

The fed govt has failed to explain their inaction in marijuana research, while countries such as Israel, Spain - even China- are much further ahead in cannabinoid research. Surveillance of, and epidemiological studies on medical cannabis are needed.

What is the research problem

Patent No. 6630507 is held by the HHS and covers the use of cannabinoids for treating a wide range of diseases. However, under US fed law, it is defined as having no medical use? Research for medicinal purposes such as cancer is not taking place.

How will your solution make a difference

By allowing research of the whole plant and the entire spectrum of medical benefits that many cannabinoids found in cannabis provide, we can significantly widen the possibility of revealing a much larger percentage of medicinal benefits for cancer.

What is your proposed solution

Following upon Senator Elizabeth Warren's query to several federal agencies, we respectfully propose:
• The supply of cannabis for research purposes
• Interagency/Interstate coordination & research applications
• Surveillance and epidemiological studies
We must accelerate our efforts towards turning cancer into a manageable, and potentially curable or even preventable, disease –and cannabis absolutely must be a part of that research strategy.

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Expanding Clinical Trials

Determine Effective Ways to Improve Clinical Trial Processes

ASCO is pleased to submit this Cancer Moonshot idea: Determine Effective Ways to Improve Processes Associated with Conducting and Managing Clinical Trials. Please see the attached document for a more detailed proposal.

What is the research problem

According to multiple surveys of the research community, sites are overwhelmed by the administrative and regulatory requirements associated with conducting and managing clinical trials, which are impediments at various stages of the trial process.

How will your solution make a difference

Improving administrative and regulatory processes will help expedite clinical trial implementation and facilitate clinical trial participation for research sites and sponsors. Such improvements will help ensure patients have timely access to trials.

What is your proposed solution

NCI should help launch a trans-HHS, multi-stakeholder analysis of regulatory requirements related to clinical trials and create a single, uniform standard for conducting trials that involve federal funds and/or are submitted to federal agencies for review. The federal government should also leverage the movement toward electronic conduct of trials and submission of data by creating a single online platform for submitting adverse event reports.

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Expanding Clinical Trials

Trial Accrual and Representativeness of Research Participants

ASCO is pleased to submit this Cancer Moonshot idea: Clinical Trial Accrual and the Representativeness of Research Participants.

What is the research problem

There are many structural, clinical, and logistical barriers to participation in trials. As a result, there are disparities in participation based on (1) race and ethnicity, (2) age, (3) income, (4) education, (5) geography, and (6) gender.

How will your solution make a difference

Enrollment of a broader population on clinical trials and gathering clinically relevant data elements in clinical trials would help improve the relevance of the evidence base to patients seen in real world practice while accelerating progress.

What is your proposed solution

NCI, extramural investigators, and corporate sponsors should ensure that eligibility criteria for clinical trials are broadened and rationalized so as to allow greater participation by more diverse patient populations. Research funds should come with the requirement that investigators provide a scientific and safety rationale for each eligibility criteria included in a clinical trial.

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Expanding Clinical Trials

A Dietary Change

Many prominent scientists believe that a plant based diet, rather than a traditional Western diet, has extensive health benefits. It is time that such a study is undertaken.

How will your solution make a difference

If the results of such a study show a strong correlation between a plant based diet and a low incidence of cancer, we would have a very low cost means of preventing cancer and we would save billions of dollars in health care costs annually.

What is your proposed solution

A very simple and low cost solution to prevent cancer before it starts may be to eat a plant based diet rather than a traditional Western diet. I propose that the NCI study two cohorts, one that eats a traditional American diet for (say) 3 years and the other that eats a plant based diet (as noted in The China Study by T. Colin Campbell) during the same time period, and compare the results relative to cancer (and heart disease) occurrence.

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