What is it like to Join a Clinical Trial?

What is it like to Join a Clinical Trial?

The idea of participating in a clinical trial can make people feel anxious or uneasy. Patients often come into the trial with worries about what they may be asked to do, what the side effects of new medicines are, and what effect the treatment may have on their bodies. Regeneris Medical cares about patient concerns and safety above all and want to make sure that all of our patients concerns are addressed before beginning the trial.

 

Why clinical trials are important

Clinical trials are essential research tools for advancing medicine. Clinical trials provide a framework to study new developments in the healthcare field in a systematic manner.  Serving as stepping stones of a regulated pathway, these trials study the safety and efficacy of medicinal or biologic treatments, medical devices, surgical procedures and approaches to care which were created to combat disease.  Finding answers to commonly asked medical questions along with the knowledge to apply this data in a meaningful way are gained as a result of the process of conducting clinical trials.  

 

Process of joining a clinical trial

If you are interested in and eligible to participate in one of our clinical trials, the Clinical Research team at Regeneris Medical will invite you in for a screening visit.  At this visit and informed consent will be provided which will explain the study process of the particular clinical trial that you are a good fit for.  Whether or not you are comfortable signing the form at the visit, you will be able to take a copy the form home with you should you so choose to seek a second opinion or for your reference.  This form contains information relating to the following points:

  • A statement that the study involves research
  • An explanation of the purposes of the research
  • The expected duration of participation
  • A description of the procedures to be followed
  • Identification of any procedures which are experimental
  • A description of any reasonably foreseeable risks or discomforts
  • A description of any benefits to the subject or to others which may reasonably be expected from the research
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous
  • A statement describing the extent, if any, to which confidentiality of records will be maintained
  • For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
  • Research, Rights or Injury: An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
  • A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
  • Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
  • Any additional costs to the subject that may result from participation in the research
  • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
  • A statement that significant new findings developed during the course of the research, which may relate to the subject’s willingness to continue participation, will be provided to the subject
  • The approximate number of subjects involved in the study

 

Learn more about our clinical trials and how to join by calling Regeneris Medical at (855) 357-0916

 

How Clinical Trials Change the Face of Medicine

How Clinical Trials Change the Face of Medicine

Clinical Research and Clinical Trials seem to come with an ‘experimental’ vibe. Although that’s the literal perception, being apart of a clinical trial is incredibly important in the advancement of modern medicine. At Regeneris Medical , we believe that this stage of discovery is the foundation for all advancements in healthcare. 3 key reasons below explain just how important your participation in clinical trials are for the continued improvement and change of medicine.  

 

Discover new or evaluate the existing intervention

One of the biggest recognitions for the purpose of clinical trials is the discovery of new medications. For any medication on the market, at one point, it had to undergo the ‘step’ of a clinical trial. In order for a drug to even be available for prescribers and users, the FDA has a grueling 5 step process by which any new medication must pass. Step 3 is clinical research. Before the drug is even considered to be tested with humans, it has to pass both In Vivo and In Vitro testing to determine if the drug is too toxic to be tested on people. The discovery of new medications isn’t the only breakthrough for Clinical Trials; medical devices and therapies for the pre-existing condition are also at the top of the list. For instance, Chemotherapy was morbidly discovered by two Pharmacologists who were called upon by the United States government in response to Germans using chemical warfare (mustard gas in particular) in World War I. Although quite the long story, you can see how the evolution of medicine is truly and highly dependent on clinical research.

 

Uncover new or evaluate the existing ways of prevention

Besides pills or therapies, major breakthroughs for prevention techniques, like vaccines, also have a dominance in the forever changing face of medicine. The first vaccine was performed by Edward Jenner in Berkeley, England in the 1770’s for Smallpox. Back in those times, Smallpox was today’s cancer. Being a brilliant man that he was, Jenner tested the “vaccine” by exposing an 8 year old boy to an opened, smallpox wound on a milkmaid’s hand. The 8 year old boy was then exposed again to an opened, smallpox wound, 6 weeks later, and was unaffected. Nowadays, clinical trials aren’t as barbaric. One of the most recent vaccines to hit the market was Gardasil, or the HPV shot. The vaccine was created on behalf of Harald zur Hausen, a German researcher who helped prove that a genital HPV infection can lead to cervical cancer. At the University of Queensland, Australia the vaccine was then developed and in 2006 the FDA approved it’s use for prevention. Of course, like mentioned above, the FDA has a multi-step process, including the use to test on human subjects, prior to a vaccine’s approval.

 

Bring to light new ways to improve the quality of life

Without the use of medicine, therapies or preventions, we can assume the quality of life would be pretty poor. Remember the last time you had the flu? Think of what you took to help ease the symptoms or reduce the fever. Although it’s hard to visualize a world with no medicine, it’s not all that difficult to imagine how miserable we would be. The human body can only combat so much without the help of another agent. Improving the quality of life is as simple as taking an over the counter medicine, like Ibuprofen, to rid a headache or as complicated as radiation therapy for a brain tumor. At the beginning of each lies clinical trials that harvest valuable results in order to improve your health and well-being.

 

Regeneris Medical’s Clinical Research Division is devoted to make strides against various conditions. We have a vast list of disorders that we are proud to be apart of in the fight against. If you are interested in our current clinical studies, contact us at 855-734-3678 to learn more and potentially be apart in the changing face of medicine.  

Checking for Tick Bites: How To Prevent Lyme Disease

Checking for Tick Bites: How To Prevent Lyme Disease

Summer is right around the corner, and for those who spend more time in suburban or rural areas this blessing always comes with the curse of checking for tick bites. Blacklegged ticks––also known as deer ticks––are infamously known for their ability to spread Lyme Disease- an illness that can cause a multitude of symptoms such as joint inflammation and body aches, nausea, fever, headaches, and swollen lymph nodes. (more…)

Clinical Research at Regeneris Medical

WELCOME TO REGENERIS MEDICAL & OUR NEW WEEKLY BLOG!
Our blog will provide you with information about Regeneris Medical and its innovative cellular therapies that can improve quality of life for patients with a range of conditions, from cosmetic, hair loss, orthopedic injuries and arthritis to autoimmune disorders and more! We will also cover general health advice provided by our expert health care providers.


Clinical Research

This week we’d like to introduce you to our Clinical Research Division, who are currently at the forefront of clinical testing for cellular therapies. Clinical testing includes volunteer patients and is managed by Gabrielle Lewis, our Director of Clinical Research, under the leadership of Dr. Ryan Welter.
(more…)

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