Patient Studies

Preclinical research is the stage of new treatment development required before promising therapeutics can move into clinical trials. The FDA and other medical authorities evaluate important preclinical information before approving a new treatment for use in patients. Completing essential preclinical research with time-sensitive efficiency can be the difference between an innovative treatment advancing to earlier patient access and a promising treatment that is held-up in preclinical delays.  

In blood-based preclinical research, medical scientists rely on patients diagnosed with the targeted disorder or disease to donate samples of white blood cells (immune cells), red blood cells, platelets, and whole blood.  Researchers perform extensive tests on these blood samples – which act as a ‘stand in’ for patients – to identify the effectiveness and safety of a new treatment.  Determining a drug’s safety profile is perhaps the most critical stage of new treatment development.Until it is completed, even the most promising drug cannot advance.  

In bone marrow, body fluids, and tissue-based preclinical research, scientists also rely on patients to donate select cell samples necessary to evaluate a treatment’s effectiveness and safety before moving into clinical trials. While patient blood and bone marrow donation for research is performed in our clinics, other types of sample donations are often arranged at partner medical clinics that treat the disease being studied.

Selectivity in patient and healthy donor participation also helps scientists focus on creating precision treatments for groups most commonly diagnosed with a disorder or disease.  Researchers often require age and sex representation in preclinical studies to ensure the blood and tissue samples being donated ‘stand in’ as accurately as possible for patients most likely to need the future treatment. 

Preclinical research studies differ from clinical trial studies in several important ways.

Patients in preclinical studies:

• Receive no experimental drugs or treatments. 
  • They give blood, bone marrow, or tissue samples to accelerate new therapeutics development.
• Keep their own physician and personal medical care arrangement. 
  • The Study Medical Director will evaluate the patient for participation and oversee their well-being but does not provide medical care.

• Benefit by receiving compensation for time and effort.

  • Blood, bone marrow, or tissue samples are donated.

  • Financial compensation for activities is explained in detail.

  • Patients may participate multiple times, if eligible.

  • Each participation is separately compensated.

Preclinical research study activities:

• Preclinical studies generally involve 2-4 study visits.

  • Introductory, Consenting, and Screening Appointments (which may be combined).

  • Blood, bone marrow, or tissue sample donation procedure (the longest appointment).

• Study participants are screened for general health status and specific study eligibility.

  • A health history is completed, and general wellness and infectious diseases blood tests are done.

  • These screenings, required by law for the protection of researchers handling body fluids and tissue, are similar to those done for regular whole blood donation.

• Patients provide consent to their physician(s) to provide documentation confirming their diagnosis.
  • Medical Team representatives may communicate with patients’ physicians to confirm patients’ health stability.
• Blood, bone marrow, and tissue sample donation procedures are done to collect the needed cell samples.
  • All procedures involve the use of syringes, IVs, or swabs.
  • Risks associated with collection procedures are explained in detail.

Patient protections and support:

• Patient well-being and privacy are paramount.
  • Patient welfare is protected through compliance with international, federal, state, and local laws; regulatory oversight authorities; ethics experts; and an external Institutional Review Board (IRB).
  • All federal, state, and local protections are exercised to safeguard identity.
  • Patient samples are de-identified and the process explained in detail.
• Patients are provided 24/7 telephone access to the Medical Outreach Coordinator, the Medical Director, and/or other Medical and Patient Care Team members.
  • Patients’ physicians also are provided 24/7 access for questions.

For two-and-a-half decades, Lanu Stoddart, MD has been treating patients in blood-based therapeutics and facilitating key research in innovative treatments that are transforming lives.  A multi-faceted professional, Dr. Stoddart has experience treating a breadth of diseases including autoimmune disorders, hematologic and infectious diseases, and transplant rejection. She has served in multiple directorships across leading medical institutions in the Northeast and the Southwest; published peer-reviewed research articles across diverse medical topics; and presented at national conferences. Dr. Stoddart also serves as a university educator in health care sciences dedicated to empowering the next generation of scientific leadership that will carry the torch advancing breakthrough medical discoveries.

Dr. Stoddart’s expertise in clinical management, transfusion medicine, clinical pathology, and research is reflected in the meticulous oversight she brings to patients’ care in our preclinical studies. Patient advocacy and accessibility to study participants and their personal physicians is a commitment. Her focus on providing a secure and satisfying patient experience inspires many of our patient donors to return for additional study participation. 

Together with our physicians, physician associates, clinical professionals, and support personnel, Dr. Stoddart ensures excellent care of the patient research champions with whom HemaCare is honored to work.

Our Patient Care Team specialists bring deep experience across nearly every major area of health care, specialized therapeutic intervention, and medical research. Our medical experts include hematology/oncology, bone marrow, and stem cell transplant specialists. Our registered nurses and patient advocates bring decades of knowledge from outpatient and in-patient settings, including oncology, hematology, rheumatology, cardiac care, critical care, tissue donation, transfusion services, and therapeutic apheresis.  Our dedicated phlebotomists bring an expert touch to donor care. Our Patient Care Support Team members value and support patient study donors as individuals whose life stories now include a new chapter.

Our study participants consistently rate the care they receive as “Excellent”. We look forward to meeting you if you’d like to learn more about helping to advance life-saving treatments.