Phase I trials (also known as early phase trials) involve healthy participants or participants with no treatment options, such as cancer patients.
Unlike late phase trials (Phase II-IV), Phase I trials have different and unique patient recruitment challenges.
To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network.
Dr. Wood is a leader in the conduct and design of human pharmacology studies having held senior executive roles in a number of the top clinical research sites in the world.
In total, he has over 22 years of experience and has been involved with more than 200 first-in-human studies in over 2,000 studies.
After finishing his Ph.D. in Neurology and Neurosurgery, Dr. Wood worked at MDS Pharma Services, Cetero Research, Manna Research, and Altasciences as well as spending two years working at biotechnology companies.
Enjoy!
Treating sites like a partner…It’s always the best, the best way to get the results. When you have a deeper relationship and a deeper understanding, then it just everything flows so much better — Dr. Graham Wood
Sponsors:
This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. To learn more, visit slope.io
This podcast is brought to you by Florence Healthcare. More than 10,000 study sites, sponsors, and CROs in 44 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com/
Resources Mentioned:
- Adverse Events Race, Inequality, and the Testing of New Pharmaceuticals by Dr. Jill Fisher
- Interviews on Clinical Trial Podcast on Diversity in clinical trials – here and here
- Altasciences
- Stanford University Translational Research and Applied Medicine
- Verified Clinical Trials
- Outsourcing in Clinical Trials
- American College of Clinical Pharmacology
- DIA Global
- US FDA
- Australian TGA
- Australia HREC
- ICH Guidelines
Show Notes:
[3:46] How Graham started his career in Phase 1 research?
[6:02] Majority of Phase 1 studies are done with healthy participants. You’re testing the safety, tolerability, and pharmacokinetics, not the efficacy yet.
[6:57] Importance of engaging Phase 1 clinical units (sites) early in the process.
- Inclusion/exclusion criteria and concomitant medications can have a big impact on patient recruitment
- Duration of the study, number of nights
- Participants are confined to the facility to maintain safety
[9:16] Percentage of healthy volunteers versus oncology/ specialized patients in Phase 1 studies
- Nowadays researchers are able to administer oncology products in healthy participants because of the targeted nature of the compound (drug)
- 60% healthy participants, 40% in oncology/ specialized patients
- More studies are incorporating patients in early studies (proof of concept)
- Single dose → healthy population
- Multi dose → patient population with focus on symptoms or biomarker
[11:12] Studies with healthy participants almost always have one clinical site as such studies are easier to recruit and there is less variability when you have one site. Studies with patient populations tend to be multi-site
[12:36] Site selection criteria for Phase 1 studies
- Prior experience working on similar type of study
- Safety equipment
- Experience to handle what could go wrong
- Equipment for specialized testing
[15:59] Feedback from study participants
- WiFi internet connection is strong
- Food quality
- Access to the facility during the course of the study
[18:48] Considerations for healthy volunteers and patients
- Older participants are willing to stay longer
- How far are participant traveling to participate in the study
- Participant mobility
[20:52] Difference between Phase I, II, III, IV studies
Phase I → safety
Phase II f→ efficacy
Phase III → safety and efficacy
[22:40] Motivation for participation in Phase I studies
- Money/ finance
- Social
- Doing good for humanity
[25:44] Proactively building a database of nonalcoholic steatohepatitis (NASH) patients
[28:54] Phase I studies for medical devices like the COVID test
[30:43] Marketing toolkit for Phase I studies
- In-depth understanding of social media to grow database of healthy participants and patients
- Word of mouth — referrals from friends and family members
[31:51] ***Sponsor Message***
This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. To learn more, visit slope.io
[34:54] Diversity in Phase 1 research – we skew towards participants from lower socioeconomic
- Location of the site
- People with full time jobs wants to participate in weekend studies
- Study design
- Outpatient versus in-patient study
[37:10] Vast majority of studies will have few nights that need to be spent in the clinic
[39:10] Vegetarian meal options in Phase I studies
[40:50] Kunal’s personal experience participating in a healthy volunteer study at Stanford University
[42:05] How to conduct Phase 1 study?
- Marketing to participants in the site database. New potential participants call into recruiters – education and qualification
- Perform screening visit where patient signs of Informed Consent Form (ICF), medical history, blood testing, etc.
- Call patient to inform them about the outcome from the screening visit
- If a participant qualifies, reconfirm labs, ECG etc.
- Dose participants with the study drug and get started with the study. All participants come in at the same time.
[48:40] Financial compensation to participants
- Site can recommend
- Sponsor has input
- IRB makes the final determination on total compensation and compensation structure
[51:11] Site budgets build based on procedures, meals, labs, and labor
[51:59] Most common mistake sponsors make the mistake of not maintaining a feedback loop i.e. fail to involve sites early
[55:29] Using a finger printing system to check if potential study participants are in more than one Phase 1 study at a given time and/or within the washout period
[1:00:39] About Nucleus site network and the pros/cons of starting a Phase I study in US versus Australia
[1:05:23] ***Sponsor Message***
This podcast is brought to you by Slope. Slope provides an online eClinical Supply Chain Management (eCSCM) platform for sponsors and research sites collaborating on complex, sample-intensive, early-stage clinical trials. To learn more, visit slope.io
