Investigator Resources

A Principal Investigator (PI) is the physician who leads the conduct of a clinical trial. The leadership role of the PI is the foundation that creates the successful clinical trial. The doctor who chooses to be a PI can offer his/her patients the possibility of receiving unapproved yet promising treatments, while assisting drug companies to evaluate the efficacy and safety of these treatments. The PI is responsible for all clinical research activities at the center. The FDA mandates the PI to sign a form 1572 that outlines the specific responsibilities a doctor must accept as leader of the clinical investigation. These responsibilities are defined as "Good Clinical Practice" (GCP). GCP is outlined in the Code of Federal Regulations (CFR) in sections 50, 56, 312, and 314. Please refer to the link below for more information regarding GCP.

To successfully run a clinical trial, certain ancillary staff are typically required to support the PI. Most clinical trials employ a "study coordinator", a clinically oriented person involved in the daily operations of a study mandated by a protocol under the supervision of the PI. This person will often schedule patients, perform minor assessments and laboratory work (depends upon level of clinical skills), and organize the data for transfer into Case Report Forms (CRF). CRFs are the official records that drug companies use to house the data collected by the Investigator. It is critical that the information contained in a CRF is accurate, as it is the final information used by statisticians to analyze the safety and efficacy of an investigational medication. As a PI, your responsibilities are twofold: to assure that your patients receive the best medical care, and to assure that all study related activities follow the FDA guidelines of GCP.

Conducting clinical trials requires a number of resources. The more resources a PI can provide, the more likely he/she will be invited to participate in a study. Here are some of the most common resources:

• Examination Rooms for conducting physicals and patient interviews.
• Office equipment such as a computer, fax machine, and telephone for patient scheduling and study correspondence.
• Phlebotomy and laboratory shipping materials storage area.
• A locked storage area for study materials and study medication.
• A locking calibrated refrigerator and freezer for lab samples (and potentially study medication).
• Adequate working space for on-site visits from sponsor representatives or regulatory authorities.
• A secure storage area for archiving study records as required by the FDA.

The PI and ancillary study staff should be available to the sponsor company to review study issues and answer pertinent study related questions.

There are many avenues by which physicians may enter the clinical research field.

• Contact pharmaceutical or biotechnology companies, and Contract Research Organizations (CRO's) directly at their web sites or main phone numbers.
• Advertise your services on the internet and/or industry publications.
• Attend annual meetings for organizations such as the Drug Information Association (DIA) and the Associates of Clinical Research Professionals (ACRP).
• Contact a Site Management Organization (SMO). An SMO is a centralized organization sponsoring the activities of several clinical sites under one umbrella. SMO's provide physicians an excellent opportunity to gain research experience.

It is important to be versed in the regulatory requirements involved in the conduct of clinical trials. Classes and seminars are offered by organizations like DIA, ACRP, and Barnett International.

Nektar Therapeutics is always seeking talented experienced physicians to become Principal Investigators. We encourage physicians who are interested in clinical research and would like to join forces with Nektar to look at the therapeutic areas currently in development posted on this site. If you are a specialist in one of these areas, you may submit your contact information into the online questionnaire listed on the link "Investigator Survey". Should a study arise that matches your expertise, you may be contacted by a Nektar representative for further evaluation of your experience and site facilities. A member of the Nektar clinical staff will travel to your site and collect information about you and your staff's industry experience, inspect your medical facilities, assess staff experience and availability, and assess overall ability to successfully conduct the clinical investigation effectively. Based upon the results of the meeting, you will be notified in writing if you have been chosen to participate in the study.

Working as a Principal Investigator for Nektar is an exciting endeavor. We look forward to hearing from you soon. For more information about clinical research, please click here: FDA Consumer.

Nektar is registering investigators/sites who are interested in conducting our clinical trials. Completing the survey will help Nektar learn about your past experience, qualifications of your site and site staff and your research interests. This information resides in our investigator registry and is used only by Nektar as a primary resource for site selection for current and upcoming studies. If you are interested, please access and complete the Investigator Survey.

When Nektar is conducting a study that matches your therapeutic area of expertise, you may be selected from our registry as a potential investigator for the study. If so, you will receive a screening questionnaire or a telephone survey outlining the particulars of the trial as well as questions to assess your interest, experience, patient population and qualifications. If your site meets the criteria and specifications for the study, you may be selected as a principal investigator for a Nektar clinical research trial.

Thank you for your commitment and interest!

Please read the following statements carefully:

1. When completing the Investigator Survey, you will be asked to furnish your contact information, your primary specialty, indications in which you have conducted clinical research, and your primary research site institution and network affiliation.
2. Please be sure to review your entries prior to submitting your information as the accuracy of this data is critical for Nektar to contact you regarding potential participation in upcoming clinical studies.
3. This survey will "time-out" after 1 hour and does not have a save function. Please be prepared to complete this survey in one sitting to ensure your data is accepted into the system.

Investigator Survey »

The mission of the Nektar IIR Program is to provide support for investigator-initiated research that advances medical and scientific knowledge of NKTR-102. The program is available to researchers interested in receiving Nektar support (funding or drug substance) for conducting research with NKTR-102 including:

• Clinical studies of NKTR-102
• In vitro or animal studies with NKTR-102

Submitting an Investigator-Initiated Research (IIR) Request

Nektar accepts both concept submissions and full submissions for IIR grant requests. If a concept submission is of interest, a follow-up request for a full Submission will be issued. A full submission must be received in order for a request to be considered for approval. Requests are submitted to Nektar via e-mail. Please e-mail your submission to IIR@nektar.com for consideration.

Concept Submission

A concept submission must contain an adequate amount of information for Nektar to determine interest in receiving a full proposal. When submitting a concept proposal, the following information will be requested:

• Principal Investigator contact information
• Study Type: Clinical or Pre-Clinical
• Grant Request: Funding, Drug or both
• Research Setting: Single- or Multi- site
• Total Funding Requested
• Outside Support
• Non-Nektar drug(s) as part of the study
• Preliminary Study Title
• Brief Study Synopsis
• Brief Study Rationale/Objectives

Detailed Submission

A full detailed submission must contain enough detail about the research study and the grant request to enable Nektar to make a final evaluation regarding support. It should include:

• Principal Investigator contact information
• Study Type: Clinical or Pre-Clinical
• Grant Request: Funding, Drug or both
• Research Setting: Single- or Multi- site
• Total Funding Requested
  • Direct Labor Costs subtotal
  • Direct Study Costs subtotal
  • Institution Overhead subtotal
  • Indirect Costs subtotal
• Outside Support
• Non-Nektar drug(s) as part of the study
• Preliminary Study Title
• Brief Study Synopsis
• Primary Endpoints
• Statistical Methods
• Inclusion/Exclusion Criteria
• Target Enrollment
• Treatment Plan or Dosing Regimen
• Study Duration
• Target Start or End Dates
• Publication Plans
• Current Curriculum Vitae or brief Bio
• Itemized Budget

Review Process

Nektar will acknowledge receipt of all grant submissions. The review process is conducted by a Nektar Grant Review Committee and decisions are made based upon medical and scientific merit as well as available resources and research priorities. A formal notification on the status of your application will be sent once a decision is reached.