A Manual for Participants in Clinical Trials of Investigational Agents ...

4.2.2 Other Phase 1 Investigators
Qualified investigators with peer-reviewed expertise in the conduct of early clinical trials
are also eligible to conduct unsolicited phase 1 trials. Investigators are usually selected
because of unique expertise or research experience relevant to the agent or the
availability of certain patient populations or laboratory facilities to perform special
studies. These clinical studies are usually performed as investigator-initiated research
using the R21, R01 or P50 grant funding mechanisms. Grants can be submitted as
investigator initiated research applications or in response to a Program Announcement
(PA) or Funding Opportunity Announcement (FOA). These opportunities may be found
at either http://grants.nih.gov/grants/guide/index.html or
http://www.grants.gov/applicants/find_grant_opportunities.jsp.
In all cases, such investigators must have demonstrated competence in conducting
phase 1 studies with anticancer agents. Ad hoc phase 1 investigators must fulfill all
CTEP requirements for trial conduct, as defined in this section, and for reporting of data
as described in Section 10.
4.3 Which Organizations Can Conduct Phase 1 Studies
Phase 1 trials are most commonly conducted by single institutions. Multicenter trials with
a new single agent having an unknown adverse event profile are usually conducted most
safely in a single center. In unique situations, phase 1 trials may require multiple
institutions, such as with many pediatric phase 1 studies (see Appendix III), and with
agents that are targeted specifically for a single disease or limited subpopulation of
cancer patients.
4.4 Who Is Eligible to Administer Phase 1 Agents
All phase 1 agents must be administered only at institutions listed on the approved
protocol’s cover page and must be administered under the protocol chair’s supervision.
Investigators must not send these agents to referring physicians, except with CTEP’s
written permission. The protocol must describe any part of the treatment that will be
administered at a site other than the study center in detail.
4.5 How to Obtain Information about Phase 1 Agents
4.5.1 Investigator’s Brochure
This document contains all relevant information about the agent, including animal
screening, preclinical toxicology, detailed pharmaceutical data, pharmacology and
mechanism of action. The brochure also contains information about the clinical adverse
events observed in clinical trials. CTEP has an Investigator’s Brochure for each
investigational agent it sponsors. CTEP provides these routinely to investigators who
are approved to conduct a clinical trial of the agent at the time the LOI is approved, and
when the Investigator’s Brochure is updated. When necessary, investigators with
approved LOIs or protocols may obtain the Investigator’s Brochure from the
Pharmaceutical Management Branch (ibcoordinator@mail.nih.gov).
4.5.2 Investigational Drug Branch (IDB) Physicians
Each CTEP investigational agent is assigned to an IDB staff physician, who prepares the
solicitation for initial clinical trials and coordinates its clinical development under DCTD
sponsorship. Phase 1 investigators are advised to discuss a proposal with this physician
Section 4 - Investigator’s Manual 2009 16