SCRCM

Society for Clinical Research Coordination and Management

Upcoming Sessions

Month:

Day

Time

Session Type:

Topic:

June

8th

1200-1300

SCRCM

Informed Consent: Who, What, Where, When, How

July

13th

1200-1300

SCRCM

Compassionate Use: Streamlining FDA and IRB Submissions

July

19th

1200-1300

RAES

Financial Incentives and Clinical Trial Participation

August

10th

1200-1300

SCRCM

Introduction to the Clinical Trial Protocol: How to Approach Reading the Document

September

14th

1200-1300

SCRCM

Online applications for Participant Contact and Recruitment

October

12th

1200-1300

SCRCM

Sharing Data and Biological Samples with Third Parties

November

9th

1200-1300

SCRCM

Protocol Noncompliance: Determination of Reportability and Submission

November

16th

1200-1300

RAES

Prospective Deviations: IRB & FDA Consideration Differences

December

14th

1200-1300

SCRCM

Investigator Essentials: Delegation of Authority and 1572

 

NOTE: 

  • SCRCM = Society of Clinical Research Coordination and Management
  • RAES = Regulatory Affairs and Ethics Series

July 13th, 2022 - SCOOPS

SCRCM SCOOPS: Compassionate Use: Streamlining FDA & IRB Submissions

Session Overview:

Single Patient Treatment (Compassionate) Use protocols are not research studies; rather, these activities are an extension of clinical care. Under FDA regulations (21 CFR 312.300), single patient ‘expanded access’ pathways allows for the treatment use of unapproved product outside of a clinical trial for a specific type of patient with ‘serious diseases or conditions’ only when ‘there is no satisfactory alternative therapy’ to treat the patient’s disease or condition. The primary purpose is to diagnose, monitor or treat a patient’s disease or condition. These extensions of clinical care, however, fall under the same compliance requirements and documentation obligations as FDA-regulated clinical trials given the manufacturer/sponsor of the product to be used as treatment has not yet received FDA authorization for commercial marketing in the United States.  Use of a product for clinical treatment prior to formal market authorization remains an ‘experimental’ use.  What is the process for requesting a treatment use of an unapproved product?  How long does the process take?

 

This session will provide a review of fundamental regulatory and operational concepts for physicians/administrative teams interested in pursuing treatment use of an unapproved product for their patient.  Experience based suggestions for timely and effective communication with manufacturers and internal stakeholders will be provided.  Best practice for streamlining submission through the IRB and FDA will be discussed.  The lifecycle of the treatment plan with associated minimum documentation and reporting expectations will be described. 

 

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Define ‘single patient treatment use,’ and the key stakeholders involved with accuracy
    • Compare/contrast obligations for providing clinical care involving approved products and unapproved products
    • Describe the submission processes for obtaining IRB & FDA approval for a treatment use of an unapproved product in detail
  • Skill
    • Develop a baseline understanding of the timeline for providing care with an unapproved product
    • Align expectations in the communications provided to patients regarding unapproved treatment plans for improved clinical interactions
  • Behavior
    • Advocate for best care including unapproved options with confidence
    • Adjust current practice to meet minimum regulatory and institutional expectations

 

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July 19th, 2022 - REAS

RAES: Paying Patients to Participate in Clinical Trials: Undue, Unjust, or Understudied?

Session Overview:

For decades, providing patients with financial incentives for research participation has been controversial and variably regulated due to uncertainty regarding whether financial incentives serve as undue inducements by blunting peoples’ sensitivity to research risks, or unjust inducements by preferentially increasing enrollment among disadvantaged persons. Emerging normative analyses and a small number of empirical studies of how hypothetical offers of payments influence trial enrollment decisions have increasingly suggested that concerns with incentivizing research may be overblown. But without evidence of how real incentives influence participation in real trials, investigators, research sponsors, and regulatory bodies have rarely modified their practices or norms.

 

This talk will briefly overview of those early studies and conceptual points, and then describe the methods and results of two randomized trials of real incentives for participating in two real parent trials that were published in 2021.

Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Understand the designs and results of the only trials of real financial incentives in real clinical trials
    • Interpret these findings in the context of prior knowledge and theory
    • Identify the remaining unanswered questions

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