Investigator Initiated Study Development
Developing a protocol is a process that should be started early and given significant thought and consideration. When designing the study initially, it is important the protocol is well-designed from a scientific standpoint, the research question is well-formulated and the data gathered will be reliable, valid and will address the hypothesis.
The Biostatistics team can assist with study design and feasibility and should be contacted early on in the process.
Biostatistics resources are available to all Hackensack Meridian Health team members who would like to design their own research projects, analyze their research data, or interpret the statistical results.
Our team assists investigators in identifying important scientific and clinical outcomes, major characteristics of study subjects, and treatment options and processes. We will propose the best possible study design to appropriately answer the clinical questions.
We also guide investigators in writing statistical analysis plans for new research projects (including the sample size estimation), assessing/modeling the collected research data, generating the statistical analysis report, writing the “Statistical methods” and “Results” sections for presentation or publication, and interpreting statistical results.
Because of the support that we offer at various stages throughout the research, investigators will gain the most benefit if they contact the Office of Research Administration at the onset of a project.
Providing some basic information when requesting our services will enable our team to better prepare for the initial meeting and enable us to make it as efficient and productive as possible.
Investigators are asked to provide the following information when requesting Biostatistics services:
- Research questions, research objectives, or research hypothesis
- Background information
- Clinical or scientific importance
- Key references (more than 3 peer-reviewed articles)
- Protocol Draft (if applicable)
To request assistance with a new project, please complete the request form. It will be reviewed, and a team member from the Office of Research Administration will reach out to you to schedule a call or a meeting within three to five (3-5) business days.”
A clinical trial is defined as any research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
All eligible clinical trials need to be registered prior to the first patient being enrolled.
Information about clinical trials and required registration can be found here.
If you think your study could be a clinical trial or if you have questions regarding the registration process, please contact Elli Gourna Paleoudis, Ph.D. To access the registration system, please go to Protocol Registration and Results System (PRS). To look for registered clinical trials, please go to ClinicalTrials.gov.
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. An IND is required when an investigator would like to conduct a study with an approved drug that will be used off-label (different indication) or a drug not FDA-approved.
A similar process is required for investigational devices. Before a study can be conducted with an investigational device, an Investigational Device Exemption Application (IDE) must be submitted and approved by the FDA. Approval of the application allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data
Another element of the protocol development process is writing the protocol and developing the tools and processes to carry out the research. It is important to ensure that the protocol is very clear. Another researcher should be able to replicate the exact same experiment by referring to the protocol document. The protocol also needs to be compliant with the relevant federal and local regulations. Protocol writing support is available to assist with this process.
Protocol Development resources are available to all Hackensack Meridian Health investigators who would like to develop their own research projects. Our team guides investigators through the conception, design, implementation, and manuscript preparation of novel clinical and basic research, including Phase I-IV clinical trials, translational research studies, and outcomes research projects.
First-time investigators are encouraged to contact the Office of Research Administration in the very early stages, regardless of the status of the project at the time. Our team is experienced in working with researchers to transform an idea into a well-designed research protocol that is consistent with local and federal regulations. We also provide assistance with the design, conduct, or analysis of an existing study.
Providing some basic information at the onset will enable our team to better support the investigator and expedite the study initiation, so it is encouraged to have the following information at the first consultation:
- Type of project (e.g. clinical trial, retrospective chart review, etc.)
- Research area of interest
- Research question, research objectives, and/or hypothesis (if applicable)
- Study Overview (if applicable)
- Protocol Draft (if applicable).
To facilitate the process, investigators are advised to utilize the protocol templates.
To request assistance with a new project, please complete the request form. It will be reviewed, and a team member from the Office of Research Administration will reach out to you to schedule a call or a meeting within three to five (3-5) business days.