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

 

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