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New Investigators. International Applications. Identify Collaboration Opportunities. Draft Specific Aims. Outline Your Experiments. Know Your Audience. Write Your Research Plan. Build Your Team. Multiple Principal Investigators.

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Here, they observed an intra-tumoural increase in levels of glucose and glycogen levels, and the ketone body, 3-hydroxybutyrate, in those tumours that had a fall in Ki67 post-metformin. The authors speculated that these changes reflected increased fatty acid oxidation and shunting of glucose to glycogen as a consequence of direct mitochondrial effect.

also carried out metabolomic profiling of historic ovarian cancer samples taken from patients that had received metformin.

They reported reduced levels of a number of mitochondria metabolites compared with untreated controls including TCA intermediates and short-chain acyl carnitines, consistent with mitochondrial interference.

A small pilot study of metformin in healthy patients with Li-Fraumeni syndrome, a cancer predisposition disorder associated with germline p53 mutations, has shown the potential of using other mitochondrial assays in drug studies.

Here, Wang et al. showed that the oxygen consumption rate OCR was reduced in extracted peripheral blood mononuclear cells. Additionally, there was an increase in the OCR to extracellular acidification rate ECAR ratio suggestive of a switch from oxidative to glycolytic metabolism in response to metformin in Li-Fraumeni patients.

Skeletal muscle phosphocreatine was also measured using 31 P magnetic resonance spectroscopy with an increased phosphocreatine recovery time after metformin consistent with a mitochondrial effect.

We recently conducted a window study, the NEOMET trial, to profile the bioactivity of metformin in breast cancer and characterise heterogeneity of metabolic response. Shortly after diagnosis with primary breast cancer, patients underwent a baseline and post-metformin dynamic 18 F-FDG PET-CT scan and ultrasound-guided tumour biopsies for mRNA sequencing and metabolomics profiling.

We utilised functional imaging with dynamic 18 F-FDG PET-CT to identify subtle changes in glucose uptake into the primary tumour.

This allows for kinetic analysis of tumour FDG uptake generating a flux constant K FDG that describes the rate of intra-cellular FDG phosphorylation. Additionally, by using an input function, in this case from aortic blood flow, dynamic imaging adjusts for any metformin-induced changes in circulating blood glucose.

Using this sensitive methodology, we observed a significant increase in K FDG following metformin treatment but no change in the standard static 18 F-FDG uptake measures SULmax and SULmean standardised uptake values normalised for lean body mass. We then went on to carry out mRNA sequencing of the tumour samples pre- and post-metformin and identified multiple mitochondrial pathways that were upregulated at the transcriptomic level.

Additionally, metabolomic profiling of the samples demonstrated decreases in the levels of several mitochondrial metabolites including two short-chain acyl-carnitines consistent with findings from another metabolomic study of tumour samples from metformin-treated patients.

By integrating these datasets, we were then able to observe two distinct metabolic responses; a an OXPHOS transcriptional response OTR group for which there is an increase in OXPHOS gene transcription and decreased short-chain acyl-carnitine levels, and b an FDG response group with increased 18 F-FDG uptake.

Ongoing work is aimed at identifying baseline biomarkers that can discriminate between these two groups. This case study describes how the integration of multiple assays including novel molecular imaging, transcriptomics and metabolomics can provide, for drugs that target cancer metabolism, substantial insight into the nature of target engagement, selection of patients and mechanisms of resistance.

Further work is ongoing and, based on this initial characterisation of dynamic response to metformin, we plan to assay for baseline markers of interest with a view to informing future stratification in late-phase clinical trials.

For example, prior preclinical analysis has suggested that mutations in mtDNA encoding for mitochondrial complex 1 may define metabolic response to biguanide therapy. Window study designs can enable detailed characterisation of the pharmacodynamic effects of drugs or the tumour biology that lies behind an imaging signature.

Such studies may occur in the setting of the short window prior to instigation of standard therapy just after diagnosis offering a unique opportunity to study pharmacodynamic response in the setting of a tumour unperturbed by prior therapy.

Modern molecular imaging, and metabolomic and functional genomic techniques, can now be applied to pharmacodynamic cancer metabolism studies, and are powerful tools to identify target engagement and understand resistance to therapy. However, it is important to be attentive to window trial design as flaws in sample handling, choice of assay and insufficient power will compromise a study.

Ashton, T. Oxidative phosphorylation as an emerging target in cancer therapy. Cancer Res. Article CAS Google Scholar. Tabernero, J. et al. Dose- and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors.

Stein, E. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood , — Faubert, B. Lactate metabolism in human lung tumors. Cell , — e Fan, T. Altered regulation of metabolic pathways in human lung cancer discerned by 13 C stable isotope-resolved metabolomics SIRM.

Cancer 8 , 41 Article Google Scholar. Hensley, C. Metabolic heterogeneity in human lung tumors. Cell , — van Asselt, S. Everolimus reduces 89 Zr-Bevacizumab tumor uptake in patients with neuroendocrine tumors.

van Kruchten, M. Positron emission tomography of tumour [ 18 F]fluoroestradiol uptake in patients with acquired hormone-resistant metastatic breast cancer prior to oestradiol therapy.

Imaging 42 , — Linden, H. Quantitative fluoroestradiol positron emission tomography imaging predicts response to endocrine treatment in breast cancer. Lord, S. Integrated pharmacodynamic analysis identifies two metabolic adaption pathways to metformin in breast cancer.

Cell Metab. McGowan, D. Buparlisib with thoracic radiotherapy and its effect on tumour hypoxia: A phase I study in patients with advanced non-small cell lung carcinoma. Cancer , 87—95 Teoh, S. Fluciclovine 18F is a marker for high-affinity glutamine transporter ASCT2-mediated amino acid transport in breast cancer.

Turkbey, B. Radiology , — Google Scholar. Witney, T. Preclinical evaluation of F-fluoro-2,2-dimethylpropionic acid as an imaging agent for tumor detection. Glunde, K. Choline metabolism in malignant transformation. Cancer 11 , — Schug, Z.

Acetyl-CoA synthetase 2 promotes acetate utilization and maintains cancer cell growth under metabolic stress. Cancer Cell 27 , 57—71 Jadvar, H.

Prostate cancer: PET with 18F-FDG, 18F- or 11C-acetate, and 18F- or 11C-choline. Kostakoglu, L. Association of tumor washout rates and accumulation of technetiumm-MIBI with expression of P-glycoprotein in lung cancer. CAS PubMed Google Scholar. Piwnica-Worms, D. Enhancement by tetraphenylborate of technetiumm-MIBI uptake kinetics and accumulation in cultured chick myocardial cells.

Walker-Samuel, S. In vivo imaging of glucose uptake and metabolism in tumors. Jones, C. Amide proton transfer imaging of human brain tumors at 3T. Cai, K. Characterizing prostate tumor mouse xenografts with CEST and MT-MRI and redox scanning.

Bolan, P. MR spectroscopy of breast cancer for assessing early treatment response: Results from the ACRIN MRS trial. Imaging 46 , — Andronesi, O. Pharmacodynamics of mutant-IDH1 inhibitors in glioma patients probed by in vivo 3D MRS imaging of 2-hydroxyglutarate. Nelson, S.

Metabolic imaging of patients with prostate cancer using hyperpolarized [1- 1 3 C]pyruvate. Romero, Q. Ki67 proliferation in core biopsies versus surgical samples - a model for neo-adjuvant breast cancer studies.

BMC Cancer 11 , Doroshow, J. Oncologic phase 0 trials incorporating clinical pharmacodynamics: from concept to patient. Chandel, N. Are Metformin Doses Used in Murine Cancer Models Clinically Relevant? Hadad, S. Evidence for biological effects of metformin in operable breast cancer: a pre-operative, window-of-opportunity, randomized trial.

Breast Cancer Res. Bonanni, B. Dual effect of metformin on breast cancer proliferation in a randomized presurgical trial. Niraula, S. Metformin in early breast cancer: a prospective window of opportunity neoadjuvant study.

Kalinsky, K. Presurgical trial of metformin in overweight and obese patients with newly diagnosed breast cancer. Cancer Invest. Laskov, I. Anti-diabetic doses of metformin decrease proliferation markers in tumors of patients with endometrial cancer. Schuler, K. Antiproliferative and metabolic effects of metformin in a preoperative window clinical trial for endometrial cancer.

Below, we have compiled some examples of successful advertising from past studies — and while every trial will have its own unique considerations, these can serve as good inspiration for compiling an IRB packet with plenty of options. One of the top reasons reported by clinical trial participants is their desire to help advance science.

Many individuals are often interested in the messaging that revolves around helping those diagnosed with their condition and helping to pioneer better treatment.

Creating ad copy that focuses on the altruistic benefits of trial participation can be particularly effective. While the FDA restricts clinical trials from prominently highlighting benefits in a way that may appear coercive, calling out compensation, access to potential treatments, and working with medical professionals are all allowed within reason.

In the below example, this ad prominently calls out the benefit that participants can complete this trial from home and will receive compensation, without over-emphasizing it in a way that might get the ad rejected.

Ads that are more general may lead to more clicks, but using specific and targeted language in ad copy can increase the ultimate likelihood of patient enrollment.

When possible, it can be useful to select ad photos that reflect a symptom of the condition or life with the disease. Using this campaign as an example, we knew that lupus is two to three times more common in women of color, so many of our ad images reflected this demographic.

Platforms such as Facebook and Google Ads offer a variety of formats to choose from, including stories, videos, carousels, and graphics.

These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking

Sample trial opportunities - Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the funding These clinical trial advertising sample ideas are designed to engage patients while following strict FDA and IRB guidelines Clinical research and trials offer hope for many people and a chance to help researchers find better treatments for others in the future Reach patients who are searching for trial opportunities. Paid search ads can be a great way to connect with patients who are actively looking

An example of a low-paying research study would be an interview-only study in which participants are asked questions, and are not given any investigational treatment. Some studies are conducted to assess how well packaging or instructions can be understood and followed.

Another example of a low-paying research study may be a specimen collection study, in which participants may only be required to give a blood, saliva, or nasal swab sample.

These studies may only take a few hours, or less. Higher-paying clinical trials may involve investigational vaccines, medications, medical devices, or tests. A Phase I study for an investigational vaccine will usually pay more than a Phase III study for the same investigational vaccine.

This is because Phase I studies are the first to involve human subjects, the potential side effects, risks, and benefits may not be clear. Inpatient studies — which require one, or more, overnight stays in a clinic — frequently pay more than outpatient studies, which only require one, or more visits.

Most Velocity studies are outpatient studies. To better understand the compensation for Phase trials, it may help to understand the investigational product the trial is studying.

For example, a trial for a potential multiple sclerosis medication may require longer visits, more intensive symptom tracking, and one-on-one visits with neurologists. Alternatively, a vaccine study, such as a COVID vaccine or RSV vaccine study Velocity is conducting, may require a few visits that only require a medical exam, administration of the investigational vaccine or placebo, and blood draws.

Velocity is fully transparent about study requirements and potential compensation — you can ask about compensation during your first phone call with Velocity or at your in-office screening.

Compensation will also be covered as part of the informed consent process. Velocity tends not to include compensation amounts in our study advertisements for the following reasons:. Velocity is transparent about study requirements and potential compensation — you can ask about study compensation during your first phone call with Velocity or at your in-office screening.

Velocity has sites nationwide that are conducting paid research studies in a wide range of therapeutic areas. Visit our Learning Center to read all about clinical trials, or click the links below to explore related topics:.

Can I Get Paid for Participating in a Clinical Trial? All About Paid Research Studies. May 4, Examples of Low-Paying Research Studies An example of a low-paying research study would be an interview-only study in which participants are asked questions, and are not given any investigational treatment.

Examples of High-Paying Research Studies Higher-paying clinical trials may involve investigational vaccines, medications, medical devices, or tests. How to Learn About Compensation Velocity is fully transparent about study requirements and potential compensation — you can ask about compensation during your first phone call with Velocity or at your in-office screening.

Velocity tends not to include compensation amounts in our study advertisements for the following reasons: Every clinical trial has inclusion and exclusion criteria that dictate who may actually qualify for the study.

Not everyone can join every trial. Once we determine your eligibility for certain research studies, we can then provide details about potential compensation.

Depending on several circumstances, a participant may not earn the maximum amount for their time in the study if they do not qualify, or if they do not complete all aspects of a study. Clinical trial participants may withdraw consent to their involvement with the study at any time.

In this case, the participant may not receive the maximum amount. We do not want to give people the impression that a lump sum is paid up front, nor do we want to coerce people to volunteer just to earn money. Clinical research can have risks, just like routine medical care and the activities of daily living.

While some of the risks are minor, other risks are more serious. Some clinical research participants may experience complications that require medical attention. It is rare for people to be seriously injured or die from complications related to clinical trial participation.

The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team. The study team will also explain the purpose of the study and what will happen while you are in it and will answer any questions you have.

Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you.

The research team should be able to answer your questions before you decide. While every study is different, here are some general questions you will want answers to before you decide. Most of this information will also be in the informed consent document you will need to sign before you join a study.

You can also download a PDF of the questions below and print it before you meet the study team. Follow us on Facebook and Instagram. Duke Header Image Link. Home Clinical Trials at Duke. Clinical Research Participants Clinical trials require different types of people.

While they may receive no direct benefit, healthy volunteers may choose to participate in clinical research because they want to help others and contribute to advancing science.

Patient Volunteers People with a health condition or disease may take part in a research study to gain access to a new therapy; take a more active role in their health; or contribute to better understanding, diagnosing, or treating that disease or condition. While some patient volunteers may receive a direct benefit from participating, the overall goal of the clinical trial may be to understand the risks and benefits of a treatment and to scientifically prove whether it is effective.

Who Can Participate? These factors can include: Age Gender Type and stage of a disease Previous treatment history Other medical conditions. story text. location text. Deciding to Volunteer There are different ways to participate in clinical research. Types of participation can include: Completing a questionnaire about health or behaviors, or answering questions in an interview with researchers.

Donating a tube of blood or a tissue sample. Taking part in a clinical trial to find out if new therapies are safe and effective. Helping researchers understand how the healthy body works. Clinical Trial Directory. Our doctors and providers offer many opportunities for you to participate in clinical research.

Find a Clinical Trial. Understanding the Risks Clinical research can have risks, just like routine medical care and the activities of daily living.

The level of risk or harm. The chance of that risk or harm happening. Where to Find the Risks The risks of a specific research study are described in detail in the informed consent form and will be explained to you by the study team.

Questions to Consider Before Volunteering to Be in a Study Educating yourself about the study and its risks and benefits will help you determine if participation in a clinical trial is right for you.

What is the main purpose of the study? Why is this study being done? Why is it important? Why is the study needed and what important questions will it answer? If this is a clinical trial, what phase is it?

Why do researchers believe the treatment being tested may be effective? Has it been tested before? What were the results of earlier studies of this treatment?

How likely are those results to apply to me? What treatments will I receive during the study?

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