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Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison to Traditional Paper-Based Methods

WEBINAR RESCHEDULED FOR 26.10.2023, 08:00 AM PDT | 11:00 AM EST | 17:00 CET | 20:30 IST
Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison to Traditional Paper-Based Methods
    Session Overview: During this webinar, we will discuss new data findings showing that the implementation of electronic consenting via telemedicine, from the patient and oncologist experience, works well for complex early-phase clinical trial (Phase I-II) and clinical genetic consent discussions when compared to in-person clinical research consent encounters.

Telemedicine (TM) disparities in the US during the pandemic are well-reported; however, its use by diverse participants providing electronic informed consent (eIC) for clinical trials in oncology remains unexplored. Our previous research found eIC comparable to in-person paper-based visits across participants: stress, technology burden, comprehension, and agency for complex clinical genetic and Phase I-II clinical trial discussions. Based on this work, we hypothesized that our implementation of eIC via TM would be well received, and we evaluated participant characteristics associated with their consent method preferences.

Oncologist experiences to date have shown that TM works well for uncomplicated clinical scenarios, but its performance alongside increased care complexity is less clear from the patient perspective. 

Our Goal
Determine whether electronic informed consent via TM would be received as well as, better than, or worse than in-person clinical research consent encounters for complex early-phase clinical trial (phase I-II) and clinical genetic consent discussions by patients. Additionally, research participants with in-person clinic and TM eIC visits from Aug 2021- Jan 2023 received anonymous, uncompensated surveys electronically. We assessed age, sex, primary language, ethnicity, race, and 3 groups of survey questions generated from factor analysis:
1) TM usability, 2) TM satisfaction and 3) eIC process comfort (comfort using TM for eIC). A multivariable multinomial regression model evaluated associations between factors and eIC preference, a survey item assessing overall preference for eIC via TM or in-person or no preference.

Our findings suggest electronic consent and electronic consent via telemedicine should be offered as an option for patients throughout their treatment continuum, and for patients presented with complex clinical trials.

  What You'll Learn
  • The implementation of electronic consenting via telemedicine in complex early-phase clinical oncology trials is the preferred method of consent when compared to traditional paper-based in-person clinic methods when all visit factors are considered, and performs as well across 6 key patient agency domains:
    1) saying a clinical trial is not right for me,
    2) requesting more time to decide about clinical trial participation,
    3) looking information up online,
    4) sharing a concern about taking part in a clinical trial,
    5) asking for more information to better understand a clinical trial,
    6) including friends, family, or care givers to join the clinical trial discussion.
  • Electronic consenting via telemedicine does not contribute additional stress to consent appointments for most patients when compared with traditional in-person clinic visits, and performs well across complex clinical genetic and Phase I-II clinical trial discussions.
  • There a broader call for organizations to offer electronic consenting and telemedicine platforms for oncology clinical trial discussions to increase overall patient satisfaction and potentially increase participation.
Who Should Attend
This webinar is accessible by all: beginner, intermediate, and advanced level.

Meet the Speaker
Michael Buckley
Associate Director, Product Management, Clinical Research Administration, Clinical Research Informatics and Technology
Memorial Sloan Kettering Cancer Center
Michael is the Associate Director of Product Management in the Clinical Research Informatics and Technology Division of the Clinical Research Administration at Memorial Sloan Kettering Cancer Center in New York, NY since October 2022. In this role, Michael leads diverse teams who translate user needs into transformative digital products that improve the quality, cost, and experience of healthcare for MSK clinical research customers. Prior to this role, Michael joined MSKCC in 2008 as the Manager of the Department of Medicine Clinical Trials Office, and in 2014 served as the Manager of Enterprise Clinical Research Innovation.

Prior to joining MSKCC, Michael was the Associate Research Scientist and Manager of the Clinical Core Laboratories of The NYU School of Medicine’s Cancer Institute; which included the radiochemistry, pharmacokinetics, and pharmacodynamics core facilities. Michael holds a BS in Chemistry from Allegheny College, an MS in Biology from NYU, and an MBA, with a specialization in high technology, from Northeastern University. Michael has more than 20 years of experience in oncology research.
Earn CEUs
SCDM is authorized by IACET to offer 0.2 CEUs for this program. Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.

SCDM members: $50
Non-members: $175

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