Revised_TechnicalEvalCriteriaSectionM_HHSNIHNIMH10024_121610.pdf

REVISED Section M

4. Technical Evaluation Criteria

RFP#: HHS-NIH-NIMH-10-024

December 16, 2010

C. TECHNICAL EVALUATION CRITERIA

Proposals submitted in response to this RFP will be evaluated based on the following factors, which are weighted in order of their relative importance. Proposals will be judged solely on the written material provided by the Offeror.

WEIGHT CRITERIA (TOTAL 100 POINTS)

1. TECHNICAL APPROACH (40 Points)

Note: The evaluation of the technical approach itself should not include any discussion of the personnel/investigators that developed the approach – PERSONNEL are evaluated separately under criterion 2, below.

The proposal should demonstrate the soundness and practicality of the technical approach(es) for executing the entire set of requirements specified in the Statement of Work, with adequate justification for and substantiation of the recommended methods. A sound technical approach itself will demonstrate the Offeror’s understanding of the scope and purpose of this work.

The evaluation will assess:

a. Scientific value of the proposed study protocol for the first recommended intervention to be tested.

The Offeror should develop and fully elaborate the key elements of the study design, addressing the study objectives in the Statement of Work. The Offeror should present a detailed protocol including, but not limited to, the following aspects:

• Elaboration/discussion of the underlying rationale for the choice of the proposed FIRST intervention and clearly outlining the proposed experimental methodology for accomplishing the stated objectives;

• Discussion of any previous data and literature;

• Power analysis of the first clinical trial;

• Feasibility of recruiting a sufficient number of subjects to complete the clinical trial and accomplish the objective(s) of the study;

• Plans for ensuring consistent and replicable administration of the protocol both within and across sites, during the duration of the trial;

• Plans for ensuring consistent and replicable assessment of the clinical variables of interest, both within and across sites, during the duration of the trial;

• Plans for ensuring quality control of the data collection;

• A comprehensive data analysis plan.

b. Procedures and experience obtaining necessary FDA approvals and access to study interventions.

The Offeror should outline the necessary procedures in obtaining FDA approvals, and provide evidence of previous experience working through the FDA regulatory processes (including applying for INDs and/or HDEs), previous experience(s) of productive interactions with pharmaceutical and/or device companies, and success in obtaining access to drugs and/or medical devices. The Offeror should demonstrate that there is minimal risk in gaining all approvals and final access to the first proposed intervention so as to not delay performance under this contract.

The NIMH reserves the right to exclude an offeror from award where access to the first recommended intervention may be delayed.

c. Scientific value of proposed additional interventions to be tested (i.e., the second and subsequent interventions). The Offeror should discuss additional novel interventions to be tested (beyond the recommended first intervention trial) with a rationale for each and a ranking order based upon scientific merit. The Offeror should also provide a plan for identifying other promising interventions for testing in the network, and describe any relevant previous experience collaborating with pharmaceutical companies using 3rd party compounds. THE GOVERNMENT

CONSIDERS AN OFFEROR WITH ACCESS TO, AND THE CAPABILITY

TO CONDUCT, BOTH DRUG AND NON-DRUG INTERVENTIONS AS

SCIENTIFICALLY DESIRABLE BECAUSE A WIDER RANGE OF

POSSIBLE INTERVENTIONS MIGHT BE TESTED. HOWEVER, THE

QUALITY OF THE IDENTIFIED INTERVENTIONS IS PARAMOUNT

ABOVE THE DIVERSITY OF INTERVENTIONS.

d. Proposed milestone schedules and timelines for timely completion of study trials.

These should be realistic and satisfactory for achieving contract objectives while maintaining quality control.

e. Plan for management and analysis of study data. The Offeror should detail the quality control procedures to ensure reliable, well-monitored, and efficient studies with an effective data management system. The procedures for handling data from multiple clinical sites and for interfacing with NIMH and the study sites should also be described. The Plan for providing statistical analysis should be sound.

Discuss possible adaptations to data management that might be necessary to test different interventions, other than the first proposed intervention.

f. Potential difficulties. Based upon the Offeror’s experience, discuss any potential difficulties which may arise in performance of this contract and how they will be mitigated.

2. PERSONNEL AND MANAGEMENT PLAN (35 Points)

The proposal should demonstrate the quality and experience of the team, including previous collaborations and past experiences of similar work, for the successful accomplishment of the Statement of Work.

The evaluation will assess:

a. Quality and experience of the Contract Principal Investigator (Contract-PI). The Contract-PI should be an established researcher in depression, actively publishing in the field, and have both strong leadership experience and substantial expertise in managing and providing scientific oversight for multi-center clinical trials. The Contract-PI should be able to devote sufficient time (at minimum 15% of her/his full time effort) to this project and should provide evidence that she/he is not over-committed with regard to other duties. RESEARCH EXPERIENCE OR

KNOWLEDGE WITH BOTH DRUG AND NON-DRUG INTERVENTIONS IS

DESIRABLE.

b. Quality and experience of the Site Principal Investigator(s) (Site-PIs). The Site PIs should be established researchers in depression, actively publishing in the field, and have substantial expertise in providing scientific oversight of clinical studies/trials. The Site-PIs should be able to devote sufficient time (at minimum 15% of their full time effort) to this project and should provide evidence that they are not over-committed with regard to other duties. RESEARCH EXPERIENCE

OR KNOWLEDGE WITH BOTH DRUG AND NON-DRUG

INTERVENTIONS IS DESIRABLE.

c. Quality and experience of the other personnel. For all sites, documentation of the medical and scientific qualifications and required expertise in adult psychiatry (especially mood and anxiety disorders), clinical psychopharmacology AND/OR non-pharmacological interventions. Evidence that key staff is adequately available to this project and is not over-committed with regard to other duties. The business office and other administrative personnel should be familiar with providing budgetary expertise in managing multiple subcontractors.

d. Quality and experience of the Data Management Center Principal Investigator (DMC-PI) and other personnel, if applicable. The DMC-PI should be an established researcher with experience in multi-site clinical trials data management. The computing staff should possess documented expertise in computer methods for data management and statistical analysis of clinical data, electronic connections to remote systems (if proposed) and proficiency with software and operating system(s) proposed to accomplish the Statement of Work, including some proficiency with standard commercial software as necessary.

e. Management plan for conducting multiple, concurrent trials. The organizational experience and capability of the proposed Network to collaboratively work together in this regard. The management plan should demonstrate the level of commitment and priority the organization will give to this research and the adequacy of the administrative framework with clear lines of authority and responsibility.

3. QUALITY OF SUB-SITES (25 Points)

The proposal should include a list of potential collaborative sites, with letters of support, from quality research organizations, which have available the necessary facilities, resources, equipment, and management/administrative/organizational personnel to provide support for this research and promote the successful accomplishment of the Statement of Work. The Offeror should provide documentation of their ability to recruit an adequate number of subjects for all sites (e.g., past experience on similar trials).

Note: this evaluation focuses on “organizational” experience (i.e., the quality of the site organization itself), and its history of conducting related research; do not evaluate the site organization/institution based upon the quality of the proposed investigators – this is a separate evaluation under PERSONNEL, above.

The proposed sites will be evaluated for:

a. Adequacy and availability of the facilities and resources. All sites should have available adequate facilities and resources to perform the Statement of Work, including optimal conduct of both Proof of Concept and Larger Scale (i.e., Phase IIb/III) studies. This includes organizational experience conducting similar studies, inpatient and outpatient capability, experience in securing regulatory approval for clinical trials, access to an IRB, evidence of adequate patient flow and ability to recruit patients in a timely manner, a pharmacy (AS APPLICABLE) experienced in the preparation of materials for randomized clinical trials, staff with experience in training, following and conducting research protocols, etc.

b. (AS APPLICABLE) SITES WITH EXPERIENCE IN DIFFERENT TREATMENT MODALITIES WHICH EXPAND YOUR (The Offeror/Prime Contractor’s) OWN CAPABILITIES

c. Availability of computer hardware, software and other equipment. The Offeror should demonstrate the availability of necessary equipment to successfully implement the requirements of this contract.