Author: Dana Fletcher

Dana Fletcher serves as Medical and Technical Writer for Hart Clinical Consultants (HCC), providing technical content for HCC’s online presence. With more than 20 years’ experience in medical research in corporate and academic environments, and extensive experience with medical devices in cardiology, vascular surgery, infectious disease, and transfusion medicine, as well as experience with therapeutic integrative medicine modalities, Ms. Fletcher brings exceptional expertise and valuable insight to her writing for HCC.

In the past, Ms. Fletcher was Clinical Affairs Manager for Terumo BCT, where she managed all aspects of US clinical trial operations for new technologies in pathogen reduction of transfusion products. Before Terumo BCT, Ms. Fletcher worked for Abbott Vascular as Senior Clinical Research Associate for the Vessel Closure program, and led a team as Clinical Project Manager for the Carotid Stent and Embolic Protection program.

Before joining Abbott Vascular, Ms. Fletcher held several positions with Ischemia Technologies in Arvada, Colorado, including Manager of Clinical Development, Technical Services Specialist, and Clinical Affairs Associate. Early in her career, she was a Patent Investigator and Laboratory Research Associate with Biostar, Inc., in Boulder, Colorado, which specialized in point of care in vitro diagnostics for infectious disease testing.
Ms. Fletcher is the owner of Evida Clinical Consulting, an independent consulting firm primarily engaged in medical and regulatory writing, data analysis, and project management.

Ms. Fletcher holds a Master of Arts degree in Biology (Cell Immunology focus) from the University of Colorado at Denver and a Bachelor of Science degree in Biology from The Pennsylvania State University. She is currently working on her Doctorate degree in Health Services Research in the Colorado School of Public Health at the Anschutz Medical Campus in Denver, Colorado, with an expected graduation date in 2018.

Dana Fletcher's Contributions



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STAFF SPOTLIGHT – PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

STAFF SPOTLIGHT 

PATTI LAWRENCE IS PROMOTED TO SENIOR CRA

Four years ago, a voice from Patti Lawrence’s past called her cellphone. Jim Hart, Chief Executive Officer of Hart Clinical Consultants, needed someone with clinical experience working in a cardiac cath lab. From that one phone call, Patti began a new phase in her professional career as a Clinical Research Associate, initially filling device proctoring roles, but diligently training as a clinical monitor. For the difference between the two roles, click here.

Since those days in 2013, Patti has worked on nine medical device trials with HCC, as both proctor and monitor. When she first joined HCC, she had very little monitoring experience, so she read everything she could about it while she was mentored by Jim and Stan Reaves, HCC’s Chief Operating Officer. Certification as a Clinical Research Professional (CRP) requires a minimum of two years’ experience in the field. In October of this year, Patti took and passed the SOCRA CRP certification exam.

Please help us congratulate Patti on her earning the CCRP certification and on her recent promotion to Senior Clinical Research Associate. 

Patti’s continued commitment and contributions to HCC, shine through her with her obvious love for her work. According to Stan Reaves, among her many accolades is a vast knowledge of cardiac and vascular anatomy and physiology. This knowledge and many years in the cath lab translates to client appreciation for her ability to teach difficult topics with simplicity, great analogies, and examples that lead to a thorough understanding by the learner. Stan provided this story that exemplifies Patti’s contribution to HCC, “Patti saw a need for education of team members for a stroke intervention trial and put together a presentation to teach the folks working on the project. She has also recently taken on the lead role for a seminal peripheral vascular device study, for which she has developed a strategy for training 40 study sites as part of her responsibility for coordinating site coverage.” A can-do attitude, perseverance, and an aptitude for adapting to most personality profiles enables Patti to develop strong working relationships with even the most demanding individuals for the long game.

Medical Device Executive Eric Knuteson had this to say about working with Patti to support clinical trials at Osprey Medical (Minnetonka, MN), “She exemplifies professionalism beyond reproach and is a calm pro who is able to navigate any customer situation with intuitive approaches to details and challenging requirements. She sacrifices her personal schedule to meet any clinical last-minute need, like booking last-minute travel on a Sunday afternoon.”

Patti says she could not be happier than she is right now working for HCC. “I truly enjoy working with and meeting new people” she says of the job, and enjoys the travel associated with it.  She is planning to use some of the travel perks she’s been collecting to go experience the Aurora Borealis up close by standing underneath, listening to the hissing and crackling of this natural phenomenon.

We are blessed to have Patti as part of our HCC family. Thank you, Patti, for being a key player and for your continued commitment to excellence in all you do!

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

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Experience managing all phases of clinical trials

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Extensive on-site monitoring experience using a variety of data collection processes

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Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

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Cath lab professionals with extensive proctoring experience…HCC works with you

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HART HEALTHY TIPS: THE GREAT AMERICAN SMOKEOUT

HART HEALTHY TIPS:

THE GREAT AMERICAN SMOKEOUT

Save the date Thursday, November 16th! The American Cancer Society holds a very important event that day, which can be the first day towards quitting smoking for many people.

It’s The Great American Smokeout!

According to the Centers for Disease Control and Prevention, approximately 36.5 million Americans (15.1% of all adults) smoke cigarettes. Smoking causes several life-threatening diseases such as cancer, stroke, lung and heart diseases, diabetes, emphysema, and chronic bronchitis. Over 16 million Americans have diseases caused by smoking. In the United States alone, cigarette smoking causes more than 480,000 deaths per year. The financial costs of smoking are significant with a $300 billion price tag in the United States, and direct medical costs of over $170 billion. Despite these costs, quitting can be difficult.

Many smokers want to quit, but don’t know where to start. According to a government study nearly 70% of adult smokers want to quit, but only 6 % could stop smoking. Withdrawal symptoms such as irritability, anxiety, having trouble focusing, feeling angry, cravings for tobacco products, and weight gain can make it hard to stick to a plan.  If a smoker can make it through these symptoms, the health implications are significant.

                                                                                                   *2015 Centers For Disease Control and Prevention

Health benefits begin within 20 minutes of quitting by lowering heart rate and blood pressure. After 1 year the risk of coronary heart disease is cut in half and after 5 years the risk of stroke is reduced to that of a nonsmoker. The risk of coronary heart disease returns to that of a nonsmoker 15 years after quitting. The sooner a person quits the better, too. Quitting at age 30 can add approximately 10 years of life expectancy compared to waiting until age 60 to quit, which only adds 3 years. A good plan can help reach goals of quitting.

The Great American Smokeout event is dedicated to increasing awareness of the importance of quitting and urges smokers to not only to quit for the day, but to make a plan to quit for good.  

Steps to a good plan for quitting:

  • Make the decision to quit
  • Pick a quit date and mark it on the calendar
  • Inform friends and family for support
  • Purge all cigarettes
  • Practice saying, “No thank you, I don’t smoke.”
  • Review support options such as nicotine replacement therapy, prescription drugs, support programs, acupuncture, herbal supplements, and mind-body practices

On your quit day, be sure to not smoke at all. Staying busy will help keep urges away. Be sure to drink plenty of water, start any nicotine replacement therapy chosen, and avoid situations where smoking is prevalent. If the urge to smoke arises, use the 4 D’s to help fight the urge: delay, deep breathe, drink water, and do something else.

So, take the challenge to invite a smoker in your life to the save the date, Thursday, November 16th, the first day to life without smoking.           

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

banner1

Experience managing all phases of clinical trials

banner3

Extensive on-site monitoring experience using a variety of data collection processes

shutterstock_73949041

Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

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Cath lab professionals with extensive proctoring experience…HCC works with you

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HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

HCC NEWS: THE VERMONT CARDIAC NETWORK CONFERENCE

On September 28, 2017, HCC staff members Cheryl Calhoun and Stan Reaves attended the Vermont Cardiac Network (VCN) Conference held in picturesque Woodstock, Vermont. VCN was established in 1984 to assure cardiac health status of Vermonters and other nearby residents. It is a group of physicians and nurses committed to providing quality educational programs in cardiac care and networking for the healthcare communities within Vermont and western New Hampshire.  More information can be found about the organization here.  VCN holds three conferences each year and this year approximately 100 people attended this Fall conference.

Stan Reaves presented “Late-Breaking Cardiac Clinical Trials Update” to the group. Stan presented introductory materials on the evolution of clinical trials, emphasizing the key elements of patient safety, informed consent, and ethics.  By illustrating mistakes made in the past, he drove home the message of safety and ethics; capitalizing on the importance of patient advocacy in all that we do.  Stan also reviewed recent drug and device clinical trials relative to cardiac care with the premise of using clinical trials to “build a better pump, better pipes, or better valves”.

Stan’s presentation was well-received by the group, garnering positive comments on the evaluation form, such as:

As a result of this presentation, …

  • I will look into nursing research as a career; better understanding of symptom control, and when to make referrals.
  • I will be more careful to spend extra time with patients describing procedures to ensure they make informed decisions, i.e., consents. 
  • I will better walk patients through explanation of the informed consent process.

Other presentations included:

“Sleep Disorders and the Impact on the Heart” by David Alsobrook, MD (North Country Hospital, Newport VT), which addressed the normal sleep cycle, where in the cycle certain sleep disorders interfere, and the structural changes that occur in the heart and circulatory system as a result of prolonged periods of increased intrathoracic pressures and hypoxia.

“The Structural Heart Journey-Learning to walk, to running the Marathon” by Faye Straight RN, BSN CRCC (University of Vermont Medical Center, Burlington VT), which presented the evolution of the Structural Heart Program at UVMC, from their start with the Medtronic CoreValve Evolut R trial for high risk (high STS scores) aortic stenosis subjects to their current program on target to treat 200 patients with severe aortic stenosis by Transcatheter Aortic Valve replacement (TAVR) this year.

Hats off to VCN for their fabulous work for the people of Vermont and New Hampshire!  Check them out here.

Many thanks to Chery, who has served on VCN’s Board of Directors since 2012, and who provided excellent feedback on the conference for this post, and to Stan Reaves who gave an engaging and informative talk at this year’s Fall VCN Conference.

Hart_MAP_Locations-r2

Our CRAs are located across the US, allowing for regional coverage of your project

banner1

Experience managing all phases of clinical trials

banner3

Extensive on-site monitoring experience using a variety of data collection processes

shutterstock_73949041

Experts at implementing FDA GCP regulations and ICH guidelines for clinical trials

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Cath lab professionals with extensive proctoring experience…HCC works with you

Vulnerable Populations: who are they?

Vulnerable Populations: who are they?

This is the fourth in a series of articles about medical ethics.  Our previous posts in this series included the basics of medical ethics, the difference between utilitarianism and deontology, and the Belmont Report.

Today we will review vulnerable populations.  The idea of vulnerable populations falls under the ethical construct of respect for persons.  Remember that this principle is about autonomy, where an autonomous individual is capable of making decisions about their personal goals and beliefs. In research, this means that participants of research voluntarily agree to participate and have enough information provided to them for them to make that decision reasonably. Individuals who lack this capacity, either fully or partially, are considered vulnerable because they may not have the maturity or capacity to make an informed decision.

 

Vulnerable groups include children, the poor, elderly people, homeless, the mentally ill, and racial or ethnic minorities. It can also include the uninsured or uneducated. In the case of prisoners, soldiers, or other institutionalized individuals, they may be under the influence of subtle coercion or undue influence.  Vulnerabilities may be classified as physical, psychological, or social according to the American Journal of Managed Care.

The FDA regulates clinical research in certain vulnerable groups specifically.  Children, prisoners, pregnant women, mentally or physically handicapped or disabled persons, and economically or educationally disadvantaged persons are specifically addressed in the US Code of Federal Regulations Title 21, Part 56.111, Criteria for IRB approval of research, and under Health and Human Services regulations, Title 45, Part 46.201, Subpart B—Protections for pregnant women, human fetuses, and neonates involved in research, Subpart C—Protections pertaining to biomedical and behavioral research involving prisoners, and Subpart D—Protections for children involved in research.

With approximately 1% of US residents incarcerated as of 2013, the issue of research ethics in this population is an important one. A 2002 report indicated that despite the requirements of  45 CFR 46, Subpart C that curtails most research on prisoners, the majority of this type of research occurs outside the purview of federal regulations and without review or approval by an IRB. Little research is conducted in prisons as medical clinical trials or biomedical studies, however, most studies were social, behavioral, program evaluations, or record review in nature.

Using prisoners as an example, we’d like to remind you that the number of vulnerable individuals is growing in the US. The issues surrounding medical care, and specifically research in these populations continue to challenge bioethicists and clinical researchers. So, continue to ask questions during protocol and informed consent development, while consenting potential participants, and while reviewing medical records to be aware of patients who may fit a vulnerable description.

Thank you for tuning into HCC’s ethics series.

Essential documents Deep Dive: Agreements

Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure,  clinical protocol/protocol amendments, informed consent tracking,  and the use of advertisements.  Today we will be reviewing financial documents and insurance required prior to beginning a clinical trial.

The Good Clinical Practice (GCP)  guideline, ICH E6 R2, doesn’t go into great detail regarding how financial agreement should be arranged, but it does state that it should be addressed.  The guideline states that financial aspects of a trial should be documented in an agreement between the sponsor and the investigator or institution (page 19), and defines a contract as a “written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters” (page 3).

Many research institutions have checklists for what should be included in a contract between a study sponsor and the institution.  Things that may be required to address in your agreements yet may be overlooked include:

  • Agreement that procedures will be used to protect research participants
  • Dissemination of findings—roles that investigators and sponsors will play in publications, presentations, or other disclosure of results to the medical community, regulatory bodies, and patients
  • Responsibility for medical care for research-related injuries
  • Agreements for sponsor reporting of safety issues to the institution
  • Handling of intellectual property
  • Indemnification or insurance

If required by the applicable regulatory requirements, the sponsor should provide insurance or should indemnify the investigator or institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence (page25). In years past, it was virtually unheard of for sponsors in the United States to be required to purchase this type of insurance for U.S. -located studies. However, in recent years, the trend is growing for large institutions to require such a policy.

Generally, it is good business practice to have written agreements for each area that could be of value to the parties, such as intellectual property, for each area of potential liability, such as payments for research-related injuries, and for potential areas of disagreement, like dissemination of information.  It is no different for a clinical trial and the ICH E6 R2 GCP guidelines speak to the importance of having these documents in place without dictating exactly how they should be implemented.

Thank you for reading HCC’s glossary series!

Hart Health Hints for September 2017: Atrial Fibrillation

This installment of Hart Health Hints celebrates a year of this blog series that aims to inform our viewers about some important health tips. We especially love finding out about events in our communities that help bring awareness to health problems that our friends, our families, or ourselves may have. 

In our industry, we are experts in technical details of the disease processes and cutting-edge treatment solutions, but sometimes we are not as involved in community health, and know much less about the opportunities available to educate ourselves and our loved ones about various conditions.

This month we are highlighting National Atrial Fibrillation Awareness Month, sponsored by the American Foundation for Women’s Health.

Many people in our communities may ask, “What is A-FIB?”  Atrial fibrillation, or A-fib, is a condition where the heart beats irregularly. This condition is very common, but often little is known about it.  If left untreated, it can lead to dementia, heart failure, stroke, and death.  StopAfib.org is an advocacy organization dedicated to raising awareness around A-fib, and describes the condition in detail, provides links for A-fib resources and treatment information, and fosters communication among the A-fib community.

So, even if you don’t know anyone with atrial fibrillation, we encourage you to take a few moments this September to learn more about the resources available in your community for people wanting to learn about this interesting, and often ignored condition.  Try looking here and here for more information.

                                                                                                                       Pic courtesy of knowthrombosisday.org

Have a great September, and keep learning!

Hart Healthy Challenge Grand Finale!

Hart Healthy Challenge Grand Finale!

We have successfully completed our 2017  Hart Healthy Month and our Hartians all did a phenomenal job of becoming more aware of their day-to-day activities and eating habits.

 As was expected, some people were able to do more than others, but the point is to start somewhere, even if that somewhere is contemplation and awareness.  The funny thing is… that advice applies to all parts of life!  Then the next step is finding one small thing to do differently that you can manage to fit into your life and doing it!

Activities for the month were entered as separate tickets into a lottery pool, with more activities logged equaling more tickets in the lottery.  At the end of the month, two names were drawn from a hat to win a $250 Fitness Toolkit.  Our winners were:

  • Dan Beck, who said he’ buy a FitBit activity tracker and gym clothes as part of his fitness toolkit, and
  • Cheryl Calhoun, who said she might get a personal trainer with hers.

No matter what they decide to put in their toolkit, Congratulations to them both!

Some fun items that other Hartians said they would like in their dream fitness toolkits include:

  • Athletic shoes and clothes
  • Zumba!
  • TRX equipment
  • Yoga gear (mat, studio gift card)
  • Elliptical or rowing machine
  • Swimming accessories (goggles, fins, kickboard)
  • Words of encouragement
  • Extra time in the day
  • A clone 🙂

Above is a Grand Finale, in case you’re wondering.

So, now that our month long challenge is completed, we challenge our Hartians and all of you to continue to make small changes in your lifestyle.  To truly form a new habit, it takes on average 66 days according to a study in the European Journal of Social Psychology. Depending on the behavior you are trying to change, individual characteristics, and your circumstances, it could take anywhere between 18 and 254 days to ingrain a new habit in your life. 

This month was a great start, but think of lifestyle change as a long game.  Slow and steady improvements, patience, and time will get you to where you want to be!

Stay tuned to learn which charities HCC is donating to as part of our Hart Healthy Month!

Hart Clinical Consultants Contact page

March is National Kidney Month

March is National Kidney Month

Did you know that 1 in 3 US adults is at risk for kidney disease and that it can go undetected for a very long time? Did you also know that chronic kidney disease or CKD affects 26 million American adults?  Main risks for CKD are diabetes and high blood pressure, which are responsible in approximately two-thirds of all cases.

Although symptoms of CKD may go unnoticed, doctors recommend watching out for these symptoms:

  • Being more tired and having less energy
  • Trouble concentrating
  • Poor appetite
  • Trouble sleeping
  • Muscle cramping at night
  • Swollen feet and ankles
  • Puffiness around your eyes in the morning
  • Dry, itchy skin
  • Increased urination

At your annual physical, talk to your doctor about any symptoms you may be experiencing.  Your doctor can prescribe a few simple tests to determine how well your kidneys are functioning.  He or she can order a urine test to evaluate your Albumin Creatinine Ratio (ACR), which tests for the protein albumin in your urine. Albumin should be in your blood, so its presence in your urine means that your kidneys may not be filtering properly.  Your doctor can also order a simple blood test to evaluate your Glomerular Filtration Rate (GFR), which estimates how well your kidneys are filtering out creatinine, a muscular waste product, from your blood.

             

In March this year, the American Kidney Fund will be offering free kidney health screenings, and other nutrition, fitness, and medical referral services around the country to help people keep their kidneys healthy and to identify disease earlier.  Check here to find a screening location near you!  Check here to find out more about National Kidney Month!

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Hart Healthy Challenge continued: happy eating

Hart Healthy Challenge continued: happy eating

We are just about three-quarters of the way through our Hart Healthy Month and wanted to share some of our activities with you! 

Along with our physical activity goals, our team is engaging in nutritional goals as well. Here is a sampling of those goals:

  • Reducing food intake by 25%
  • Eating more veggies
  • Eating less junk food
  • Reducing sugars and caffeine
  • Drinking more water
  • Eating dinner earlier

Some additional tips for healthy eating come from the American Heart Association webpage for Happy, Healthy Eating for Kids, which applies to kids of ALL AGES!

Eat the Rainbow – try to get as many different colored vegetables and fruits as you can in each meal.  Make it fun for you and your family!

Choose fruits and vegetables instead of French fries in the cafeteria and at restaurants.

Stay hydrated with water so you aren’t tempted to eat to satisfy your thirst.

Our team is also putting together an e-book of our favorite healthy recipes.  Yummy options like this Green Soup with Yams and Sage  from EatingWell and others abound! Check out these links as well for tasty and healthy options:  allrecipes and foodnetwork

Stay tuned for the results of Hart Healthy Month early in March!  In the meantime, stay active and make incremental changes to improve your heart health!

Hart Clinical Consultants Contact page

Essential documents Deep Dive: Advertisements Hart’s Good Clinical Practice glossary series

Essential documents Deep Dive:  Advertisements

Hart’s Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents that are typically generated before the clinical phase of the trial begins. We have looked specifically at the Investigator brochure  and clinical protocol/protocol amendments and informed consent tracking in this portion of our glossary series.

The Good Clinical Practice (GCP)  guideline states that an advertisement in a clinical trial is used for subject recruitment. These documents must be reviewed by the IRB/EC and filed in the Investigator’s portion of the trial master files.  Thorough review and documentation of these files is required “to document that recruitment measures are appropriate and not coercive.”

Another guidance from FDA regarding recruiting study subjects provides direction on direct media advertising of potential research participants as well as receptionist scripts. Direct advertising is any form of communication that is intended to be “seen or heard by prospective subjects” for soliciting their participation in a study. As long as these materials are accurate and are not coercive, this type of recruitment is not objectionable.  Advertisements include things like flyers, posters, and bulletin board postings, but also may include newspaper, radio, or television ads.  Recruitment materials for health professionals, like “dear doctor” letters or articles intended for the general public, like news stories, do not fall under the description of study recruitment “advertisements”. 

Any communication with a prospective study participant is required to be reviewed by an IRB in order to confirm that the wording does not unduly influence the individual. Undue influence can include leading the subject to believe they will be receiving a newly approved drug, by using words like “new treatment” instead of “investigational treatment” or by making promises of “free medical treatment”, when the actual scenario is that the subject won’t be charged to participate in the study. Another regulatory no-no is to make any claim about the investigative product, either implicitly or explicitly, that the treatment is safe or effective for the purposes used in the study or that it is the same or better than any other treatment.

Generally, an advertisement should contain the following types of information:

  • Name and address of the clinical investigator and of the research site
  • Purpose of the research
  • Study eligibility criteria
  • Benefits of participation
  • Commitment required of the subject
  • Location of the research
  • Who to contact

This guidance provides general information on internet advertisements, but we will address the use of social media in clinical trials in an upcoming post (stay tuned!). Until then, look here for some tips on social media in clinical studies.

Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at insurance requirements for a trial in the US.

Hart Clinical Consultants Contact page