Clinical Trials

Weill Cornell Medicine is internationally recognized as a premier center for research and clinical care of patients with cancers of the blood (Lymphoma, Leukemia and Myeloma), and conducts more clinical research studies for these diseases than any of our regional peers. Our group is widely regarded as one of the leading lymphoma clinical and research programs2013_9_16_Weill Cornell5107 in the world. Weill Cornell physicians have been involved in and contributed to the development of the vast majority of FDA-approved lymphoma therapies.

Our clinical trial protocols include investigator-initiated (Cornell-specific) studies, pharmaceutical trials, and collaborative, multi-institutional studies. As a participant in a clinical trial, you may gain access to new research treatments before they are widely available.

Clinical Trials FAQs

What is a clinical trial?

Who oversees a clinical trial?

How are clinical trials structured?

Can anyone participate in a clinical trial?

What is informed consent?

What are the risks of participating in a clinical trial?

What kind of time commitment does a clinical trial involve?

How is patient confidentiality protected?

What is a clinical trial?

A clinical trial is a research study that uses volunteers as test subjects in pursuit of better patient care. An interventional clinical trial seeks to answer questions surrounding a new drug, new combinations of drugs, novel uses for existing drugs, new surgical procedures, or other aspects of patient care by providing an intervention and then observing the effects. An observational clinical trial seeks to answer similar questions without directly assigning an intervention to study participants.

The National Institutes of Health (NIH), divides clinical trials into natural history studies, prevention trials, screening trials, diagnostic trials, treatment trials, and quality of life trials. In the Hematology/Oncology field, clinical trials often involve the investigation of new treatment strategies seeking to improve therapy response and/or reducing side effects. Although investigators cannot guarantee whether clinical trial participants will derive any benefit from treatment, it is hoped that the information gained will improve outcomes for future patients. back to top

Who oversees a clinical trial?

Clinical trials are overseen by a principal investigator, often a physician, and supported by a research team including physicians, nurses, and other health care professionals. These trials are sponsored by the federal government, pharmaceutical and biotechnology companies, universities, or physicians groups. Their efforts are supervised by the United States Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP) and the participating organization’s institutional review board (IRB), consistent with internationally accepted standards such as Good Clinical Practice, and the Declaration of Helsinki. back to top

How are clinical trials structured?

Clinical trials are divided into four phases. Each phase answers a specific question.

In Phase I trials, researchers evaluate the safety, and identify the side effects of a particular therapy in a small number of trial participants. Researchers ask, “What dose of medication can safely be administered?” Commonly, the study begins with a low dose of the trial therapy, followed by gradual increases, until a dose that maintains an acceptable balance between unwanted side effects and desired treatment outcomes is identified.

In a Phase II trial investigators estimate the effectiveness of the trial therapy, while further evaluating its safety, in a larger group of trial participants. Researchers ask, “How well does this treatment work?”

Phase III trials are conducted to determine whether a new therapy is more effective than accepted standards of care for a specific illness. A large number of participants are assigned to receive a specific intervention (either a novel treatment or an existing standard of care) through a process termed randomization. Randomization ensures that the characteristics of the subjects in each treatment arm are as similar as possible; avoiding bias that may result from investigators assigning specific subjects to one group or another. It is ethical to use a placebo control only when there is no evidence that any other intervention improves outcomes. Placebo-controlled trials are therefore rare in Hematology/Oncology trials. Occasionally, participants and investigators are not allowed to know which intervention the participant is receiving, a process known as blinding.

Phase IV trials are performed to further evaluate the safety and efficacy of a new treatment in an everyday setting after receiving FDA approval. back to top

Can anyone participate in a clinical trial?

Contrary to popular conception clinical trials are not a last resort for patients. Rather, clinical trials are conducted wherever there is a need for better/less toxic therapies.

Each clinical trial is designed with a specific population in mind. This concept is known as eligibility. Eligibility is an important factor, as not all lymphoma patients are eligible for all lymphoma trials. For example, if a phase 2 trial asks, “How well does R-CHOP work in patients with newly diagnosed diffuse large B-cell lymphoma?”, only patients with newly diagnosed diffuse large B-cell lymphoma would be eligible to participate. Eligibility criteria exist to protect participants from inappropriate therapy and allows for a simpler interpretation of study results. Eligibility criteria typically include demographic information (including age), prior medical conditions, and factors related to the condition being evaluated, such as lymphoma subtype and prior therapy.

Eligibility can only be assessed after a patient provides informed consent. This eligibility process is termed screening. Each clinical trial requires a medical screening before enrollment. Although the scope of this screening differs from study to study, potential participants will be asked in detail about their general medical history and lymphoma-related history. Additionally, screening often involves laboratory testing, routine imaging, and verification of lymphoma subtype. back to top

What is informed consent?

Informed consent is the process by which investigators communicate with potential and enrolled participants concerning the benefits and drawbacks of clinical trials. The goal of the informed consent process is to protect participants by apprising them of all facets of the clinical trial. This is a dynamic process that is updated throughout the course of the trial.

In addition to detailed discussions about the clinical trial, investigators provide patients with an easily understood document containing the study’s important information, including expected risks, treatment options, possible costs, and contact information. Investigators, also stress the voluntary nature of a clinical trial, allowing participants to leave the trial at any time. The IRB reviews and approves the informed consent document before permitting enrollment. At Weill Cornell Medical College, potential trial participants must read, understand, and sign an informed consent document before enrolling in a clinical trial. back to top

What are the risks of participating in a clinical trial?

Just like standard therapies, study interventions may not work in everyone and may result in adverse effects to study participants. These risks may be similar to standard therapies or may be completely different. Additional risks may include extra testing or clinical visits, increased costs, or loss of confidentiality. Specific risks are discussed with participants during the informed consent process. However, there may be risks that are not yet known, and new information that is learned during the trial is often communicated with study participants. back to top

What kind of time commitment does a clinical trial involve?

The length of a clinical trial varies depending on the nature of the study. In addition, some trials require a greater investment of time than standard therapies. These details are discussed during the informed consent process. back to top

How is patient confidentiality protected?

Since personal health information is collected, there is the risk of a loss of confidentiality. No personal health information is used/disclosed unless agreed to by the study participant. Participants are not identified personally in any reports or publications resulting from any research study. Medical records of study participants are stored according to legal requirements and are only available to personnel associated with the research study. Organizations that may request to inspect research records for quality assurance may include representatives from:

• Weill Cornell Medicine and NewYork-Presbyterian Hospital
• Weill Cornell Medicine Institutional Review Board (IRB)
• The Office of Human Research Protection (OHRP)
• Department of Health and Human Services (HHS)
• National Institute of Health (NIH)
• The Food and Drug Administration (FDA)
• Trial research partners back to top

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