Clinical trials

CHILDREN'S ONCOLOGY GROUP

Clinical Studies

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We Take Research Seriously

It is scientifically proven that children who take part in clinical trials have a much higher rate of survival. That’s one reason research is so important to us and why we encourage and participate in those trials. However, they are expensive. They also require additional diagnostic work, monitoring, and education. Sadly, the most vulnerable type of cancer patient, the uninsured, has limited access to these life-saving clinical trials. We believe every child is entitled to the best treatment options that modern science has to offer. This is why we also place a great emphasis on raising money to support access to these trials for all children. 

Learn More About our Active Clinical Trials

Hematology

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Oncology

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Rare Diseases and Disorders

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Clinical Studies

What is Clinical Research?

A clinical study involves research using human volunteers that is intended to add to medical knowledge. There are two main types of clinical studies: Interventional Studies (also called Clinical Trials) and Observational Studies.

Clinical research is the way doctors and scientists learn about new ways to prevent, treat, diagnose or relieve symptoms of disease in people. It can help determine the safety and effectiveness (efficacy) of medications, devices and other treatments intended for human use. Clinical research is the fastest way to find answers to the many questions about health and disease. Clinical research differs from standard of care clinical practice. Generally, in clinical practice the most established treatments are used, while in clinical research, evidence and data is collected to establish a treatment. Nonetheless, the line is often blurred and research and practice can occur simultaneously.

Clinical Studies

What happens if I think I want to participate in clinical research?

If you think you might want to volunteer for a clinical research study, contact our staff and notify them that you are interested in learning more. Someone from the research team will explain the details of the study to you.

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During pre-screening, the study team may ask some questions to identify if you are an appropriate candidate for a full screening visit. Questions asked are based on the eligibility criteria of the study. Common eligibility criteria include: age, sex, health condition, duration of illness, medical and treatment history, medication use, pregnancy, and ability to undergo certain procedures or tests.

If you are found to be a suitable candidate, a full screening visit may be conducted. This involves a visit to our center where your eligibility will be more comprehensively assessed. No study procedures will be performed without obtaining your informed consent.

What is Informed Consent?

Informed consent is the process by which a patient voluntarily confirms willingness to participate in a clinical study. The willingness is confirmed after the patient has been informed of all aspects of the trial that are relevant to their decision to participate. The informed consent form will be made available to take home and includes the elements outlined in the gray section to the right.

As someone considering participating in a clinical study, you always have the opportunity to ask questions to your satisfaction and have adequate time to process information and discuss with family, friends or other health professionals.

If the individual has the capacity to consent, it is the individual who should give consent along with the research team member who went through the informed consent process, usually the principal investigator. In situations where the individual is unable to consent on their own behalf, consent must be obtained from a legally authorized representative who can consent on behalf of a prospective patient. No clinical study procedures will be performed without obtaining consent. You may be asked to take part in screening tests and procedures to ensure you qualify for the research study.

  • Purpose and duration of study
  • Description of procedures and identification of which are experimental
  • Randomization and whether the study involves assignment and the probability of random assignment to each group
  • Risks or inconveniences to the subject and, when applicable, to an embryo, fetus or nursing infant
  • Benefits and when there is no intended clinical benefit to the subject, the patient should be made aware
  • Confidentiality of records statement
  • Compensation for injuries and whether there will be any medical treatment offered and who will bear the financial responsibility for treatment if injury occurs
  • Person to contact for answers to questions regarding subject’s rights, research study and/or for a research-related injury
  • Voluntariness and right to withdraw
  • Responsibilities the subject will have as a research subject
  • Payment and expenses, if any, for participation
  • New information will be informed in a timely manner that may be relevant to the patient’s willingness to continue participation
  • Early termination from study including foreseeable circumstances and/or reasons under which the patient’s participation in the trial may be terminated
  • Alternative procedures or treatments, including their risks and benefits
Cure 4 The Kids Foundation

Children’s Consent (Assent)

Children are not able to give true informed consent until they reach the age of majority (18 years old). Those under 18 are asked to provide their assent to take part if they are old enough to understand what the study about. The research team will explain the trial to the child in language they can understand, and the child is encouraged to ask questions. The child’s parent or guardian needs to give permission for their child to participate.

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Hematology Studies

Title: ATLAS-PPX: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in patients with hemophilia A and B previously receiving factor or bypassing agent prophylaxis.

Protocol: EFC15110

Study Type: Interventional Studies (Clinical Trial)

Status: Open for enrollment

Condition/Disease: Hemophilia A or B

Principal/Investigator: Joseph Lasky III, MD

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Title: Prospective, Randomized, Crossover Trial Comparing Recombinant Von Willebrand Factor (rVWF) vs. Tranexamic Acid (TA) to Minimize Menorrhagia in Women With Type 1 Von Willebrand Disease: The VWD Minimize Study

Protocol: PRO15070638

Study Type: Interventional Studies (Clinical Trial)

Status: Open for enrollment

Condition/Disease: Von Willebrand disease (vWD)

Principal/Investigator: Joseph Lasky III, MD

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Title: Prospective, multinational, non-interventional post-authorisation study to document the long-term immunogenicity, safety, and efficacy of Human-cl rhFVIII (simoctocog alfa) in patients with haemophilia A treated in routine clinical practice

Protocol: GENA-99

Study Type: Observational

Status: Opening for enrollment

Condition/Disease: Hemophilia A

Principal/Investigator: Joseph Lasky III, MD

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Title: An Open-label, Non-investigational Product, Multi-center, Lead-in Study To Evaluate At Least 6 Months Of Prospective Efficacy And Selected Safety Data Of Factor Ix (Fix) Prophylaxis Replacement Therapy In The Usual Care Setting Of Moderately Severe To Severe Adult Hemophilia B Subjects (Fix:c≤2%) Who Are Negative For Neutralizing Antibodies (Nab) To Adeno-associated Virus Vector (Aav)-spark100

Protocol: C0371004

Study Type: Observational

Status: Open for enrollment

Condition/Disease: Hemophilia B

Principal/Investigator: Joseph Lasky III, MD

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Title: A prospective, multi-national, non-interventional study in hemophilia A and B patients with or without inhibitors treated according to routine clinical treatment practice (explorer™6)

Protocol: NN7415-4322

Study Type: Observational

Status: Open for enrollment

Condition/Disease: Hemophilia A or B

Principal/Investigator: Joseph Lasky III, MD

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Title: ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

Protocol: ALN-AT3SC-004

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Condition/Disease: Hemophilia A or B

Principal/Investigator: Joseph Lasky III, MD

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Title: ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

Protocol: ALN-AT3SC-003

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Condition/Disease: Hemophilia A or B

Principal/Investigator: Joseph Lasky III, MD

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Title: ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with Hemophilia A or B, with or without Inhibitory Antibodies to Factor VIII or IX

Protocol: LTE15174

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Condition/Disease: Hemophilia A or B

Principal/Investigator: Joseph Lasky III, MD

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Title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII SingleChain, CSL627) in Subjects with Severe Hemophilia A

Protocol: CSL627_3001

Study Type: Interventional (Clinical Trial)

Status: Open for enrollment

Condition/Disease: Hemophilia A

Principal/Investigator: Joseph Lasky III, MD

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Title: Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years

Protocol: 1160.108

Study Type: Interventional (Clinical Trial)

Status: Closed for enrollment

Condition/Disease: Venous Thromboembolism, Secondary Prevention

Principal/Investigator: Alan Ikeda, MD

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Title: A randomised, double-blind, parallel-group, multicenter, phase III study to evaluate the effect of ticagrelor bid versus placebo in reducing the number of VOCs in paediatric patients with sickle cell disease.

Protocol: D5136C00009

Study Type: Interventional (Clinical Trial)

Status: Closed for enrollment

Condition/Disease: Sickle Cell Disease

Principal/Investigator: Alan Ikeda, MD

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Oncology Studies

Rare Diseases and Disorders Studies