Clinical Trials

A research participant with a magnetic sensor attached to their tongue is testing tongue-controlled technology. In front of them, a laptop screen displays charts and a diagram of a mouth. A red prompt on the screen reads: Freeze your tongue! You have 5 seconds left.

Shepherd Center participates in United States Food & Drug Administration (FDA) regulated clinical trials to test the effectiveness and safety of new drugs and medical devices, as well as to expand scientific and medical knowledge.

The clinical trials team at Shepherd Center supports research studies that allow patient volunteers to receive treatment with a drug or device currently under research testing. Typically, the drug or device being tested is not yet approved by the FDA for use by prescribing by physicians and the general public.

About research studies at Shepherd Center

Sponsorship

Clinical trials are sponsored by pharmaceutical and biotechnology companies. Sponsorship may also come from a physician inventor/investigator. All clinical trials have a qualified Shepherd Center physician who serves as the principal investigator (PI) to oversee the study and incorporate the drug or device being tested into clinical care.

Effectiveness

Clinical trials are a type of research study designed to answer specific questions. Studies help to determine whether an experimental new drug or new device is safe and effective in humans. Studies may be designed to test different ways of using currently available drugs and devices alone and/or in combinations.

Volunteer safety

Each clinical trial is reviewed and approved by the Shepherd Research Review Committee prior to initiation. The committee consists of scientists, healthcare professionals and lay people from the community. They protect the rights and safety of research volunteers. They also monitor potential risks to research volunteers throughout the study and provide oversight so that applicable regulations are followed.

Volunteer opportunities

Shepherd Center offers many opportunities for individuals to volunteer for research studies. The rights, safety and welfare of research participants is always our primary concern. Research volunteers are seen regularly by the physician investigator and the research team to monitor health outcomes.

Volunteering for a research study is an important personal health decision. Ask your healthcare provider about research studies that may apply to your situation and discuss your options with your family and friends.

Clinical trials services

The clinical trials team manages the entire clinical trial cycle including: assessment, initiation, incorporating study protocol into clinical operations; subject recruitment and retention; data collection; monitoring; and study close-out. Close collaboration with corporate teams ensures that mutual goals are met. The Principal Investigator provides leadership to the clinical trials team, and is supported by the clinical trials team in every aspect of trial conduct.

The following are examples of services the clinical trials team provides to industry sponsors, contract research organizations (CROs) and Principal Investigators.

  • Review and processing of confidentiality disclosure agreements (CDA)
  • Study feasibility assessments
  • Clinical and protocol consultation services
  • Operational impact review and approval
  • Coordination of site qualification visits
  • Completion of sponsor/CRO preselection documents

  • Preparation and submission of regulatory documents
  • Completion of sponsor specific documentation
  • Preparation of the informed consent form (ICF)
  • Study submission to the Institutional Review Board (IRB)
  • Contract review and processing, including clinical trial agreements, master service agreements, work orders and professional services agreements
  • Budget development and negotiations
  • Staff training on good clinical practice (GCP)
  • Staff training on human subjects protections training
  • IRB training
  • Development of source documents
  • Staff training on study protocol

  • Research mentorship for clinicians
  • Maintenance of regulatory documents
  • Training on study procedures and assessments
  • Data entry, management and query resolution
  • Drug/device accountability
  • Pharmacy assistance and monitoring
  • Support of recruitment activities
  • Research account set-up
  • Sponsor invoicing
  • Reconciliation of research accounts
  • Reporting of expenditures and staff effort
  • Review of study compliance
  • Quality assurance
  • Monitoring sessions
  • Staffing audits from the sponsor, FDA and other regulatory bodies

  • Return/destruction of investigational agent (if applicable)
  • Completion of final report
  • Communication with IRB
  • Storage of study documents

Current clinical trials

Purpose

Shepherd Center is starting a new clinical trial under the leadership of John Lin, M.D., Erik Shaw, D.O., and Angela Beninga, M.D. The iovera° device is FDA-approved to treat pain by applying cold to specific nerves of the body. This study will determine how iovera° affects shoulder and/or arm spasticity in people who have had a brain or spinal conditions. Study participants will come to Shepherd Center for five visits over approximately four months for assessment and treatment with iovera° or placebo.

Participation eligibility

  • Be 18 years or older
  • Have upper extremity spasticity due to a brain or spinal condition more than six months ago
  • Be stable on oral anti-spasticity medications for at least four weeks
  • Not have had a neurotoxin injection within the past three months
  • Not have a baclofen pump

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