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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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

Essential documents Deep Dive: informed consent tracking Hart’s Good Clinical Practice glossary series

Essential documents Deep Dive: informed consent tracking 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 in this portion of our glossary series.

 

Image courtesy of fda.com

Informed consent is a broad subject and we will be covering the why, what, and how of the informed consent process in future posts of our medical ethics series (additional ethics topics here and here). Today’s glossary post is about managing the informed consent document as an essential document in the trial master file (TMF).

A full history of the life of a study informed consent should be available in the TMF.  This means at a minimum, for each IRB/EC approved informed consent, the TMF should contain:

  • The version that was submitted to the site coordinator, with his or her changes tracked,
  • The version submitted to the IRB, and all submission documentation,
  • Any versions that went back and forth with the IRB/EC, with tracked changes and all correspondence between the IRB/EC and site during that process,
  • IRB/EC approval documents with the stamped and approved version of the consent, and all correspondence related to that approval.

Every change to an informed consent version should have a unique identifying name and date of revision, whether it is a draft prior to submission to the IRB/EC or during their review, or if it is a stamped and approved versions that can be used to consent patients into a trial.

The more organized and better labeled your informed consent files are, the easier it will be to find pieces of documentation in the future when an auditor is asking for them! 

Thank you for reading HCC’s glossary series! Next time we will continue to examine key essential documents by looking at advertisements used during a trial.

Hart Clinical Consultants Contact page

Hart Healthy Challenge: A tradition of caring.

Hart Healthy Challenge: A tradition of caring.

Heart disease has been the leading cause of death in the US and worldwide for several decades. In the past few years, the burden has slightly decreased, but it remains a health problem that policy makers, providers, and patients are working to prevent.

Luckily, it is also one of the most preventable diseases.  To improve awareness and education about heart disease, February has traditionally been Heart Health Month, and 2017 is no exception.

Healthfinder.gov suggests a few things to help us all raise awareness about preventing heart disease. One of those ideas is to encourage family members to make small changes in their lives, like using spices to season their food instead of salt or parking at the far end of the grocery parking lot to get a little bit more walking in during your day.

To that end, here at HCC, we are kicking off HART Healthy Month for our staff.  Each year, in honor of our healthy hearts, we encourage our team members to make changes in their eating and activity behaviors by sponsoring friendly competition during February.  Via this competition, we take steps (both literally and figuratively!) to improve our own health and strive to improve the lives of others by donating to an organization in the community. See here, here, and here for information about what we did in 2016’s HART Healthy Month and here and here for how we gave back to our communities last year.

This year, 2017, we will be having a weighted lottery competition, where team members can get bonus tickets entered into the lottery by completing a variety of food and exercise related activities aimed at helping us make incremental changes to our lifestyles.  The month will culminate with two lottery winners receiving a $250 fitness toolkit customized to each winner,  commemorative HCC schwag in the form of a workout t-shirt, and a group donation of $1500 to a charity, which we will choose by voting during the month.

If you see our HCC staff this month, ask them about what they are doing for Hart Healthy Month and consider joining them for a quick jaunt outside and be heart healthy together!!

Hart Clinical Consultants Contact page

 

Medical Ethics: The Belmont Report

Medical Ethics: The Belmont Report

This is the third in a series of articles about medical ethics.  Our previous posts in this series included covering the basics of medical ethics and the difference between utilitarianism and deontology.  Today we’ll talk about the Belmont Report and its importance in establishing modern medical ethics guidelines.

In our next post in this series, we’ll continue to explore the foundations of medical ethics by reviewing The Belmont Report, which provides us with the modern distinction between medical research and practice, and affirms the three basic ethical principles generally accepted in our culture: respect for persons, beneficence, and justice.

The 20th century saw a growing awareness of what ethical treatment of humans in research meant.  In what we would now call egregious liberties taken by U.S. state and federal governments in human experiments, as well as by physician researchers in Nazi Germany, studies were conducted on people without their consent, and which caused them harm and sometimes death.  The infamous Tuskegee syphilis study began in 1932, without the consent of the 600 black men in the study, and which allowed the men to go untreated for syphilis even after a cure had been discovered.  The study continued for forty years, until, in 1972, it was investigated and ordered to stop by an Ad Hoc Advisory Panel commissioned by the Assistant Secretary for Health and Scientific Affairs.  Reparations began after the scandal and termination of the study and on May 16th, 1977, President Clinton formally apologized to the few remaining survivors on behalf of the nation.

Partly in response to the Tuskegee study scandal and partly due to another famous scandal where medical research was conducted on prisoners of the Holmesburg prison in Philadelphia, the US government enacted the National Research Act in 1974. This law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission was charged with codifying the basic ethical principles that underlie the conduct of research involving human subjects and to consider the following things:

  1. the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
  2. the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects,
  3. appropriate guidelines for the selection of human subjects for participation in such research, and
  4. the nature and definition of informed consent in various research settings.

The Belmont Report summarizes the commission’s findings and defines the basic ethical principles that are generally accepted in our cultural tradition and are specifically relevant to human experimentation.  These principles are:

Respect for persons.  This principle is about autonomy, where an autonomous individual is capable of making decisions about their personal goals and beliefs. The tenet of respect for persons states, “Individuals should be treated as autonomous agents, and any person with diminished autonomy is entitled to protection.”  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. In the case of prisoners or soldiers, they may be under the influence of subtle coercion or undue influence.

Beneficence. Beneficence is much more than “do no harm”. It is also requires an effort to secure an individual’s well-being by maximizing the possible benefits and minimizing the possible harm to them.

Justice is about fairness or about what people deserve. This principle asks the question of who should benefit from the research and who should bear its burden.  It also requires consideration for in what respects people should be treated equally—what makes people equal or unequal?  Four frameworks for evaluating justice are used commonly:

  1. to each person an equal share,
  2. to each person according to individual need,
  3. to each person according to individual effort,
  4. to each person according to societal contribution, and
  5. to each person according to merit.

The Tuskegee experiment was a good example in our country where these three principles of ethics were not followed.

The study subjects were not informed of the experiment and did not provide voluntary and informed consent, and thus did not have autonomy under the tenet of respect for persons.

The study continued long after there was treatment for syphilis, thereby exposing the participants to undue harm and early death from the disease. There was certainly not an effort to maximize their well-being by treating their syphilis, thereby not meeting the principle of beneficence.

And last, the participants of the Tuskegee study bore the burden of the study without any expected benefit for that population.  They, nor their families, benefited from the burden of the research and the disease was not only limited to a disadvantaged, black population, resulting in an injustice for these men.

Our current use of informed consent and many other clinical trial practices flow out of the ethical principles laid out in the Belmont Report.

These principles protect all people from the injustices perpetrated in the past.  We must never forget our country’s infamous past every time we write, review, or obtain informed consent, and every time we conduct any aspect of a clinical trial.

Thank you for tuning into HCC’s ethics series.

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