Expanding Clinical Trials

Environment, lifestyle, behaviors and PROs inform precision med

Environment, lifestyle, behaviors and PROs inform response to, and adherence with, precision medicines and should be standard reporting in clinical trials.

What is the research problem

Precision medicines the potential for non-adherence to therapies, tamoxifen and aromatase inhibitors being prime examples, patient reported outcomes (PROs) are vital to understanding the full scope of patient relevant toxicities and improvements.

How will your solution make a difference

PMI Cohort Program – Building a Research Foundation for 21st Century Medicine, NIH 2015, report stated to fully understand the benefits of precision medicine requires the inclusion of measurement of molecular, environmental, and behavioral factors.

What is your proposed solution

Framing clinical trials funding opportunities that are inclusive of environmental and behavioral factors will further our understanding of how epigenetics, lifestyle and behaviors contribute to response to targeted therapies. Further, patient reported outcomes (PROs) should be standard reporting in precision medicine clinical trials as a companion to the CTCAE in order to inform adherence and decision making.

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Expanding Clinical Trials

Placebo

More people would enter clinical trials if they were guaranteed to receive the actual drug instead of a placebo.

What is the research problem

Many late stage cancers patients will not enter clinical trials due to the possibility of receiving a placebo. Their time is short so they want the actual medications.

How will your solution make a difference

More people would be willing to enter into a clinical trial and I believe more doctors would recommend clinical trials.

What is your proposed solution

We already have a lot of information on the survival time without treatment, can we discontinue some of these placebos and just give the medications in the trials.

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Expanding Clinical Trials

Atavistic Chemotherapy is the Solution

I would donate my intellectual property on this invention to the Moonshoot Initiative, if this approached is pursued and demonstrated to be effective in the treatment of cancer, as I have demonstrated in my own clinical trials.

What is the research problem

The reason why we do not have effective treatments for inoperable and metastatic cancer is not due to the lack of research, but simply a lack of understanding of the disease. The nature of cancer cells has been misconstrued for the last 100 years.

How will your solution make a difference

I believe this novel way to understand and treat cancer will change for ever the treatment of cancer in the world.

Our current inhumane and ineffective therapies will be a thing of the past, a dark chapter in medical history.

What is your proposed solution

In the 26-min video found in the link below, I explain why our understanding on the nature of cancer has been fixated in a error, the consequences of that fixation, and a more logical explanation is proposed. This is further supported with some examples of complete cancer regressions of in patients previously regarded as terminal or hopeless. Please watch in FULL SCREEN

 

https://drive.google.com/open?id=0B-9Pl1SFEPJFZnI1SFZuQUJETXM

 

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Patient First Clinical Trial Recruitment

Patients don't have an easy way to determine which cancer trials they are eligible for. We've built an automated system where a patient can chat with our AI about their treatments and see options they are likely to qualify for and we help them apply

What is the research problem

There are 18,000 actively recruiting clinical trials for cancer on clinicaltrials.gov but a patient can't easily understand which trials are for their specific condition and stage that they are likely to qualify for.

How will your solution make a difference

Many cancer patients don't even think about participating in a trial because they don't know which ones are for their condition and stage without being an MD to understand the criteria. We want to remove this barrier to increase enrollment.

What is your proposed solution

We've built and launched a system where patients can talk with our AI chat bot about their condition, treatments they've had, and how far they are willing to travel. Our system them takes this information and provides the patient with a list of trials specific to their condition and stage that they are highly likely to qualify for, making it the best location a patient can go to find all of their trial options.

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Insurance Denials for Cancer Clinical Trial Participation

What is the research problem

Although the ACA requires most Americans to have insurance coverage, not all Americans are covered for cancer clinical trial participation.

How will your solution make a difference

Will eliminate a barrier to enrollment and by including Medicaid participants, will decrease health disparity in this under-represented population in all clinical trials.

What is your proposed solution

Issue guidance for commercial insurers to include a shorten approval timeline for preauthorization to participate. Revise Medicaid coverage guidelines to ensure all Medicaid participants are covered. Eliminate grandfathered status.

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Get information to community general oncologists

Too many general oncologists are unaware of the explosion of new drugs and trials for lung cancer.

If they had up to date information they might refer more patients for trials. Many patients are unaware that their oncologists are out of date.

What is the research problem

Not enough patients referred for trials.
Many oncologists sorely deficient in newer developments.

How will your solution make a difference

Hopefully more patients will receive better care and be referred for trials.

What is your proposed solution

Disseminate information to all general oncologists on the explosion of new drugs in lung cancer.
They can be reached through their boards
Internal medicine and pulmonary physicians too need to be made up to date. Offer free video conferences.
Require participation in CME for lung cancer.

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Expanding Clinical Trials

Metastatic Pheochromocytomas and paragangliomas

I have metastatic pheo and was the patient rep on a clinical trial here in the UK. The trial closed for lack of numbers despite the eligibility criteria being changed not long before the trial closed. Everyone involved was very disappointed.

What is the research problem

This is a rare disease with a low number of patients. MiBG treatment can be helpful but researchers think that a combination treatment would enhance the success rate. A larger patient base in the US would make such a trial viable.

How will your solution make a difference

Prolong life and improve quality of life. Perhaps find a cure. There are currently very few options for this patient group. If such a trial were sucessful it may also be helpful for other Neuroendochrine tumour patients.

What is your proposed solution

A trial of an anti cancer drug alongside MIBG radio-targeted therapy for advanced pheochromocytomas and paragangliomas. Using a similar anticancer drug to the one proposed in the trial described here http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-vandetanib-alongside-MIBG-radio-targeted-therapy-for-phaeochromocytomas-and-paragangliomas-vibrant#undefined

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Poor Clinical Trial Accrual.

In order to attract patients, forced randomization has to change. We need newer faster trial designs. RTC is not the only way to arrive at truth. If biostatisticians are so obdurate that they can't fathom a different approach, please fire them.

What is the research problem

The problem is dismal adult accrual to trials at a rate of 3 to 5%.

How will your solution make a difference

Patients will be much more willing to join trials if they know they will get the arm (treatment) they want to treat their cancer.

What is your proposed solution

My proposed solution is development of new, innovative biostatistical designs and approaches. RCT does not work for small, fast personalized clinical trials. Let patients self-randomize to the arm they want to be in. If they follow all the rules of that arm, their participation and outcome should count just as much as if they were randomized to that treatment. Design new approaches to dividing participating patients into groups.

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cannabinoid integrative oncology

launch large research program to investigate phytocannabinoid-based preparation as antitumor agents.

rationale for this has been summarized by NCI here: http://www.cancer.gov/about-cancer/treatment/cam/hp/cannabis-pdq

What is the research problem

Cannabis and other mis-scheduled botanicals are not placed based on scientific facts but rather culture war politics. How can we develop cancer treatments when free research inquiry is blocked? Two NIMH directors were removed or nearly fired over it

How will your solution make a difference

improve cancer treatment--promising areas include glioblastoma multiformae, prostate cancer, lung ca, numerous forms of breast ca, lymphomas, and others.

What is your proposed solution

Locally grow Cannabis for research purposes to study its use in clinical practice via a model of cannabinoid integrative oncology. These would easily produced botanical cannabinergic modulators. Such signalling in CNS and periphery plays a key role in mood, appetite, memory, pain perception, muscle tone, tumor regulation, inflammation, immunoregulation, neuroprotection, bone growth, tumor regulation, and other physiologic processes.

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Treatment Strategies in Potentially Resectable Pancreas Cancer

There is no standardized treatment modality for potentially resectable pancreatic cancer. Treatment strategies for potentially resectable patients of pancreatic cancer consist of surgery first or chemotherapy first.

What is the research problem

Pancreatic cancer is a very aggressive disease. Approximately 30% of all patients receiving chemotherapy first do not respond to it. Approximately 30% of patients who receive surgery first recur soon after surgery.

How will your solution make a difference

This proposed clinical trial will help ensure that patients are receiving the right treatment for their disease and give physicians assurance that their patients are receiving the right treatment.

What is your proposed solution

I propose a clinical trial to establish a standardized method of treating this subset of pancreatic cancer patients. Mesenchymal tumors respond better to chemotherapy, but epithelial tumors respond better to surgery. Mesenchymal status can be determined by immunohistochemical analysis. Patients should be randomized to one of two treatment arms based on their mesenchymal status. To determine efficacy, patients should be followed until death.

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Platform sequencing for the National Clinical Trials Network

Basket and umbrella trials within the National Clinical Trials Network (NCTN) bear huge administrative burden in building genomic screening for each endeavor; this becomes inefficient very quickly. One screening platform should be built for the NCTN.

What is the research problem

Tailoring genomic screening efforts to individual NCTN umbrella and basket trials like MATCH, ALCHEMIST and Lung-MAP is inefficient, time-consuming & burdensome. Ultimately patient lives are impacted by the delay and repetitive use of resources.

How will your solution make a difference

Trials can resume operating without the cost & administrative burden of reinventing the "genomic screening" wheel for each protocol. Sequencing data will be available for all trials. Patients benefit because trials will open sooner.

What is your proposed solution

The National Clinical Trials Network (NCTN) should perform genomic screening of tumors routinely for all patients enrolled on its clinical trials by implementing a single uniform screening platform for all trials and patients.

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Liver cancer

Nutritional cures for Liver Cancer include the following:- Frankincense oil shrinks tumors, while

Cannabis oil reduces Biliary cancer to a great extent.

What is the research problem

Can these published cures on the internet be medically verified?

How will your solution make a difference

Since these are non invasive cures that does not require hospitalization and if clinically proved to be effective, as claimed, people living in the developing world would benefit a great deal.

What is your proposed solution

Your stamp of approval for these claims.

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Make Phase 1 and 2 Clinical Trials Accessible Across USA!

Cancer patients are unable to participate in Phase I or II Clinical Trials because the trials are conducted at Cancer Centers far away from the patients' place of residence. Ask leading cancer centers to work with smaller institutions across the USA.

What is the research problem

A cancer patient has found a clinical trial that she/he wants to participate in. But, the clinical trial is in a far away State, and the patient cannot travel that far. Patients cannot enroll in the trail, and trial enrollment also suffers.

How will your solution make a difference
  1. Patients can get access to these Phase I or II drug-combination trials near where they live.

  2. Phase I or II trials enrollment numbers will most likely increase.

  3. Working drug combinations for cancer can be identified faster!

What is your proposed solution

If the combination of drugs being tested in a clinical trial are already available nationwide leading institutions should be required (FDA mandated perhaps) to work with cancer centers in other cities across the USA, so that patients can enroll in these Phase I or II trials at their hometown cancer centers where they are already being treated. The leading and other institutions should make sure patients get access to these life-saving trials.

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Enabling 'basket' trials for pediatric and adult cancers

A US/EU/Chinese patent issued, CE marked therapeutic device for tissue engineering, uses safe radio-frequencies in the presence of an instantaneous magnetic field to target any solid tumor- sparing normal tissue - to effectively treat and palliate.

What is the research problem

Being able to target all solid tumors, without the need for precise genomic stratification will increase the spectrum of patients that can be treated. Using precise, diagnostic MRI mediated proton density measurements will enable a 'basket' trial.

How will your solution make a difference

Our 'patient-centric' approach would simplify this complex disease, made even more complex by delays of costly precision diagnostics and stratification, obviating life-threatening toxicities imposed by 'palliative' chemo/radio-therapy at life's end.

What is your proposed solution

Conduct compassionate clinical trials for advanced solid tumors in adults and pediatric cancer patients, who have currently failed multiple lines of treatment. The tissue engineering platform technology has been proven to effectively treat as well as palliate. Undergoing cancer treatment without collateral damage, and extending life with disease free survival is possible. Good quality of life is paramount to patient compliance in clinical trials.

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SBRT Dose Escalation in Stage III lung cancer

Patients diagnosed with locally advanced NSCLC have a poor prognosis with 5-year survivals of 15-20% after chemoradiotherapy. RT dose escalation may improve survival and local control but new innovative approaches are needed

What is the research problem

Lung cancer remains the number one cancer killer in the U.S. Local control in the chest remains poor. Since radiation therapy is a major contributor to controlling cancer locally, we need an innovative approach to dose escalation and improve outcome.

How will your solution make a difference

Stereotactic radiation has a proven track record in controlling stage I lung cancers. We can apply the same principles to more advanced lung cancer to help improve survival through local control.

What is your proposed solution

Kentucky along with many states continue to have high rates of tobacco abuse and lung cancer rates. Given the lack of progress in improving outcome for stage III lung cancer patients and suggestions that radiation dose escalation may improve outcomes, we propose a phase I-II SBRT dose escalation to enlarged lymph nodes as well as the primary tumor mass. Conventional treatment planning is too toxic for dose escalation and a new approach is needed.

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