ATTENTION:

Please note that the form must be filled out completely and submitted in a single session. Partially completed forms cannot be saved for completion at a later time.

Clinical and preclinical ISR submissions are currently being accepted for all IMPs; however, please check below for specific submission details for certain IMPs. Nektar support may be available in the form of funding and/or drug supply.

To submit a study proposal through our online system, please review the following checklist for information you will need to provide for your submission. Please note that the form must be filled out completely and submitted in a single session. Partially completed forms cannot be saved for completion at a later time.

  • Primary investigator information: first name, last name, email address, phone number
  • Institution Information: institution name, address, city, state, postal code, country
  • Study Information: study type, subtype, phase, short title, therapeutic area, disease area, planned start date, number of sites and site names, participating countries, planned trial duration, planned number of patients enrolled, local Nektar contact name (if applicable), requested resource, projected costs, primary compounds, primary indication, funding from other sources, government review
  • Study details: study rationale, primary objective, primary endpoint, hypothesis, study assessments, secondary objective, data and statistical plan, preclinical/clinical data supporting study, correlative studies (i.e. translational/biomarker), target patient population, specify dose, schedule, duration, and any pre-medications, etc., estimated contract review time, IRB/IAC meeting frequency, sample size calculation and justification, secondary endpoint, planned publication information, if any.
  • Unexpected Serious Adverse Reaction (SUSAR) Contacts: SUSAR contact name, SUSAR contact email, SUSAR contact country
  • Related documents: Curriculum Vitae (CV), study design schematic (if available), key exclusion/inclusion criteria, references/relevant Literature, supporting documents (if applicable)


Confidential, Proprietary or Confidential Information Excluded

Please do not submit any information to Nektar that is considered confidential, proprietary or private. Submission of a concept does not imply or guarantee endorsement by Nektar. Ultimately, any support provided by Nektar is contingent on an executed research agreement.

Primary Investigator

Institution Information

Study Information

Up to 999

List sites here one per line.

Up to 99

Up to 999

If applicable.

Upload your budget file. File size must be less than 25mb preferably in .docx, .xlsx format

Download budget template here.

1000 characters remaining.

1000 characters remaining.

Study Details

1000 characters remaining.

Provide a brief description of the medical question and the rationale of how this trial addresses the question. Provide a rational for the dose schedule outlined for all treatment arms. Reference any non-labeled indication.

1000 characters remaining.

Provide the main goal of the study and the study population. Provide a detailed definition that is directly linked to the primary objective. In some cases, the detailed description may be more appropriate in the statistical section.

500 characters remaining.

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Specify type and frequency of safety, efficacy, and outcome measures. Also, indicate the method(s) used to assess measures.

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Describe the planned statistical analysis including timing of the primary and secondary measurements and sample size calculation. The range of sophistication will depend on a number of factors, including the size and complexity of the study.

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Specify age, gender, and other demographic information for the trial population.

1000 characters remaining.

Provide this in number of months. Up to 99.

500 characters remaining.

1000 characters remaining.

The sample size must reference the primary endpoint.

1000 characters remaining.

Unexpected Serious Adverse Reaction (SUSAR) Contacts

Related documents

In addition to the required files, you can also include any other supporting documents that you wish to be considered. Compress multiple files into one archive or zip file.

On Windows:
  1. Locate the files or folder that you want to zip.
  2. Press and hold (or right-click) the file or folder, select (or point to) Send to, and then select Compressed (zipped) folder. A new zipped folder with the same name is created in the same location.

On Mac:
  1. Locate the items to zip in the Mac Finder (file system)
  2. Right-click on a file, folder, or files you want to zip.
  3. Select “Compress Items”
  4. You will find the newly created .zip archive in the same directory.

You must complete the "Please read and consent" item above before submitting.