INDUSTRY DAYPARTICIPANT RECRUITMENT SUPPORT

SERVICES FOR THE NIDA-IRP

October 2, 2019

Carolina Smith, MSContract Officer’s RepresentativeNational Institute on Drug Abuse (NIDA)Intramural Research Program (IRP)Biomedical Research Center 251 Bayview Boulevard, Baltimore, Maryland 21224

GOALS FOR THE DAY

Goal 1. Learn about the current best practices in the fields of research participant recruitment, advertising, and screening services for clinical research studies;

Goal 2. Obtain recommendations from industry experts on processes and procedures to achieve the project requirements discussed;

Goal 3. Identify specific metrics that can be used to measure the success and effectiveness of targeted advertising and recruitment campaigns

WELCOME

Clinical Director, NIDA-IRP

Karran Phillips, M.D., M.Sc.

ACQUISITION LIFE CYCLE

Identify Needs

Market Research

Acquisition Plan

Request for Proposals

(RFP)

Evaluations

NegotiationsContract

Award

Performance

Closeout

MARKET RESEARCH – FAR 10.001 - POLICY

Agencies shall conduct market research as appropriate;

Before developing new requirements;

Before soliciting offers for acquisitions;

On an ongoing basis, to identify the capabilities of small businesses and new vendors in the marketplace.

MARKET RESEARCH – FAR 10.001 - POLICY

Identify sources capable of satisfying the requirements;

Determine if commercial services are available;

Identify the practices of capable vendors;

Determine whether consolidation or bundling of services is necessary and justified

MARKET RESEARCH – FAR 10.002 - PROCEDURES

Contacting Government and industry experts regarding market capabilities.

Publishing formal Requests for Information.

Querying the Governmentwide databases and commercial databases.

Participating in interactive communications with industry, acquisition personnel, and customers.

Conducting meetings to engage potential offerors early in the acquisition process.

MARKET RESEARCH GOALS

Learn about the current best practices from Vendors;

Obtain recommendations to inform the planning processes;

Identify new ways to measure the success and efficacy of performance;

Encourage industry involvement and participation; and

Identify interested and capable vendors.

ACQUISITION LIFE CYCLE

Identify Needs

Market Research

Acquisition Plan

Request for Proposals

(RFP)

Evaluations

NegotiationsContract

Award

Performance

Closeout

IMPORTANT NOTICES & DISCLAIMERS

This forum does not obligate the Government to award a contract.

The Government reserves the right to use information as deemed necessary and legally appropriate.

Information provided may lead to the development of a solicitation.

IMPORTANT NOTICES & DISCLAIMERS

The Government is under no obligation to acknowledge receipt or provide feedback to respondents with respect to any information provided or submitted.

Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5.

Attendance at this forum is voluntary.

IMPORTANT NOTICES & DISCLAIMERS

Any information provided up to this point shall not be considered an adequate response to a solicitation.

Any proprietary or confidential information disclosed must be expressly identified as such, to avoid disclosure.

Upon completion of the Market research phase vendors shall only communicate procurement sensitive information to the Contract Specialist and Contracting Officer.

Discussing procurement sensitive items with other Government Stakeholders may be grounds for exclusion from competition.

NIDA-IRP HUMAN SUBJECTS RESEARCH

NIDA’S MISSION

The mission of the Intramural Research Program (IRP) of the National Institute on Drug Abuse is to conduct cutting edge research on basic mechanisms that underlie substance use disorders (SUDs), and to develop new methods for the treatment of SUDs.

The IRP’s Human Subjects Research (aka Clinical) Program conducts various studies with human volunteers to better understand, treat, and prevent SUDs.

NIDA-IRP HUMAN SUBJECTS RESEARCH

Six Principal Investigators who write the protocols

Regulatory process in-house: scientific review, IRB review, and FDA review (as needed).

Approximately 10-20 studies that are actively recruiting at all times.

Most studies are conducted on-site.

Each study has unique Inclusion/Exclusion Criteria resulting in studies that range from quick/easy to recruit to those that may require innovative and very targeted recruitment strategies in order to meet target enrollment goals.

NIDA-IRP HUMAN SUBJECTS RESEARCH

Sensitive/Unique populations: active SUDs: seeking treatment or not seeking treatment

(SUDs include alcohol, cocaine, marijuana, nicotine, opioids), those who are occasional users, and healthy controls.

We also have studies with HIV+ populations.

Many protocols require that participants with SUDs are otherwise healthy and do not have other comorbidities.

Special Considerations:

IND/IDE studies

Imaging studies

NIDA-IRP HUMAN SUBJECTS RESEARCH

Interactions with IRP Staff:

The Principal Investigator (PI) is responsible for the study, including scientific integrity and safety.

In addition to the PI, each study includes a Medical Accountable Investigator (MAI) and a Lead Associate Investigator (LAI).

The Office of Clinical Director (OCD) is overall responsible for the safety of all studies and also provides clinical support personnel to complement research personnel.

Clinical Research Nurses, Research Associates, Research Pharmacists, and Physician Assistants.

NIDA-IRP HUMAN SUBJECTS RESEARCH

Clinical Program Resources includes the following:

Space for in-person screening, call center, and waiting areas

Specialized study rooms (including ventilated smoking chambers, nursing stations, Pharmacy, dispensary, drug treatment rooms)

An addiction treatment outpatient research clinic (capacity 45)

MRI facility, TMS facility, mock scanner

Access to an on-campus overnight facility

Internally developed and maintained electronic medical record system which is on a secure network and allows for research related data to be entered in real-time.

GOVERNMENT FURNISHED EQUIPMENT AND PROPERTY

Office space, computers, telephones, desks, chairs,

lights, and an electronic medical records system

IT support

For this contract, the IRP staff is limited to Physician

Assistants to perform H&Ps

PROGRAM NEEDS

1) Advertising/Recruitment

2) Screening

3) Remuneration Services

4) Flexible staffing expertise

1) ADVERTISING &RECRUITMENT NEEDS

Grassroots community outreach is needed to provide awareness and establish trust within the community regarding research studies in general and NIDA specifically.

Participants with SUDs may have unique lifestyles that can make recruitment particularly challenging

Other outreach: treatment clinics, community healthcare institutions, etc.

Development of Creative Materials and Creative Strategies

Traditional and digital media advertising techniques with real-time monitoring and optimization plans.

1) ADVERTISING &RECRUITMENT NEEDS

Highly targeted methods to ensure we selectively reach qualified individuals in a timely and cost effective manner

Urgency: 1) Society Demands 2) Scientific Productivity

Tracking of participant disqualifications and using those data to better develop recruitment strategies

A software platform for integrating and monitoring outcomes of advertising and enrollment data (either developed or modified from existing software).

2) SCREENING NEEDS

Objective of screening: assessing Inclusion/Exclusion criteria, unique to each study

Maintain sensitivity to population

Maintain privacy and confidentiality

Streamline the process to be efficient and cost-effective

The better targeted the advertising is, the better the recruitment is, which leads to improved time and cost effectiveness of the screening process.

Candidate often qualifies for multiple studies

Candidate Convenience

2) SCREENING NEEDS (CONT).

Provide expertise in assessing protocol eligibility.

E.g. obtaining psychiatric and other medical information via interviews and basic medical assessments such as obtaining vital signs, drawing blood, performing ECGs, assessing breath for alcohol and carbon monoxide, and testing urine for pregnancy and for drugs of abuse.

MAI ultimately evaluates data and clears the subject for enrollment

Pre-screening

Level 1: online screen – brief, flexibility in modification

Level 2: phone screen – in-depth assessment of basic I/E criteria

Approximately 20 minutes per candidate, IRB approved script

Screening

In-person screening is done on-site

Depending on the protocol, screening can take up to 6-8 hours per candidate.

3) REMUNERATION NEEDS

Each protocol specifies the amount and method of remuneration per NIH policy

Methods of remuneration include: cash, checks, have bills paid on their behalf, gift cards, online payments.

A system for chain of custody is needed and must reconcile with remuneration tracking with our electronic medical record.

Travel and Hotel accommodations – as needed.

Travel includes reimbursement for mileage, public transport or we will provide transportation (bus, train, taxi, Uber, Lyft, airfare, etc.).

4) FLEXIBLE STAFFING NEEDS

Load Demand Management

Flexible staffing to conduct screening is needed to handle variations in phone screens as well as in-person screens.

Flexible Hours

Q & AYou have heard our needs, now your questions and answers will help

us better frame our requirement and achieve these goals:

Goal 1. Learn about the current best practices in the fields of research participant recruitment, advertising, and screening services for clinical research studies;

Goal 2. Obtain recommendations from industry experts on processes and procedures to achieve the project requirements discussed;

Goal 3. Identify specific metrics that can be used to measure the success and effectiveness of targeted advertising and recruitment campaigns;

THANK YOU

Thank you for attending

Break (Noon – 1pm) – Room Open

Closed One-on-one sessions as scheduled

Additional Questions?

Joshua Lazarus Carolina Smith, MS, COR

Josh.Lazarus@nih.gov smithcaro@mail.nih.gov

301-443-6677 443-740-2624

INDIVIDUAL VENDOR SESSIONS

1. Based on what you know of NIDA’s needs, what strategies would you use to target our research populations?

a) those with active SUDs, seeking treatment (OR NOT).

b) occasional users and healthy (matched) controls.

c) No comorbidities in conjunction with the SUD.

d) IND/IDE studies OR imaging studies have other exclusions for safety reasons

2. How do you define a successful advertising campaign or strategy?

3. Across various ad platforms, how would you propose to monitor and assess success and how would you then use that information in developing future advertising strategies?

4. What strategies would you propose in order to screen potential research candidates in a cost-effective and timely fashion?