Download International Clinical Trials

International Clinical Trials
Dr. Luis A. Salicrup
Senior International Cancer Research Specialist
Center for Global Health
National Cancer Institute
National Institutes of Health
Importance of Clinical Trials
• Clinical trials are part of clinical research and at the heart of all
medical advances. Clinical trials look at new ways to prevent,
detect, or treat disease. Treatments might be new drugs or new
combinations of drugs, new surgical procedures or devices, or new
ways to use existing treatments. The goal of clinical trials is to
determine if a new test or treatment works and is safe. Clinical trials
can also look at other aspects of care, such as improving the quality
of life for people with chronic illnesses.
• People participate in clinical trials for a variety of reasons. Healthy
volunteers say they participate to help others and to contribute to
moving science forward. Participants with an illness or disease also
participate to help others, but also to possibly receive the newest
treatment and to have the additional care and attention from the
clinical trial staff. Clinical trials offer hope for many people and an
opportunity to help researchers find better treatments for others in
the future
Clinical Research
• Clinical research is conducted according to a plan known as
a protocol. The protocol is carefully designed to safeguard
the participants’ health and answer specific research
questions. A protocol describes the following:
• Who is eligible to participate in the trial
• Details about tests, procedures, medications, and dosages
• The length of the study and what information will be
gathered
• A clinical study is led by a principal investigator (PI), who is
often a doctor. Members of the research team regularly
monitor the participants’ health to determine the study’s
safety and effectiveness.
Clinical Trials Protocol
• Each clinical trial in the United States must be
approved and monitored by an Institutional Review
Board (IRB) to ensure that the risks are minimal and are
worth any potential benefits. An IRB is an independent
committee that consists of physicians, statisticians, and
members of the community who ensure that clinical
trials are ethical and that the rights of participants are
protected. Federal regulation requires all institutions in
the United States that conduct or support biomedical
research involving people to have an IRB initially
approve and periodically review the research.
Types of Clinical Trials
• Natural history studies provide valuable information about how
disease and health progress.
• Prevention trials look for better ways to prevent a disease in people
who have never had the disease or to prevent the disease from
returning. Better approaches may include medicines, vaccines, or
lifestyle changes, among other things.
• Screening trials test the best way to detect certain diseases or
health conditions.
• Diagnostic trials determine better tests or procedures for
diagnosing a particular disease or condition.
• Treatment trials test new treatments, new combinations of drugs,
or new approaches to surgery or radiation therapy.
• Quality of life trials (or supportive care trials) explore and measure
ways to improve the comfort and quality of life of people with a
chronic illness.
Phases of Clinical Trials
• Phase I trials: Researchers test an experimental drug or treatment
in a small group of people (20–80) for the first time. The purpose is
to evaluate its safety and identify side effects.
• Phase II trials: The experimental drug or treatment is administered
to a larger group of people (100–300) to determine its effectiveness
and to further evaluate its safety.
• Phase III trials: The experimental drug or treatment is administered
to large groups of people (1,000–3,000) to confirm its effectiveness,
monitor side effects, compare it with standard or equivalent
treatments, and collect information that will allow the experimental
drug or treatment to be used safely.
• Phase IV trials: After a drug is approved by the FDA and made
available to the public, researchers track its safety, seeking more
information about a drug or treatment’s risks, benefits, and optimal
use.
Clinical Trials at NCI
• The Cancer Therapy Evaluation Program
(CTEP) supports organizations conducting
cancer treatment trials through the Clinical
Trials Cooperative Group Program. Emphasis is
placed on the development and conduct of
large, multicenter, randomized phase 3
studies. The program’s mission encompasses a
wide variety of investigational efforts.
NCI’s Clinical Trials Cooperative Group
Program
• Is designed to promote and support clinical trials
(research studies) of new cancer treatments, explore
methods of cancer prevention and early detection, and
study quality-of-life issues and rehabilitation during
and after treatment.
• Cooperative groups include researchers, cancer
centers, and community physicians throughout the
United States, Canada, and Europe.
• Efforts to include more LMICs
• They work with NCI to identify important questions in
cancer research and to design clinical trials to answer
these questions
Clinical Trials Working Groups at
NCI/NIH
– COG - Children's Oncology Group
– ECOG-ACRIN Cancer Research Group
– NRG Oncology Group
– NCI-CCTG - National Cancer Institute of Canada,
Clinical Trials Group
– SWOG - Southwest Oncology Group
Interactions with Industry
• The goal of the Cancer Therapy Evaluation
Program (CTEP) is to facilitate the process of
bringing promising, novel, investigational
anticancer and anti-HIV agents to the public as
quickly and as safely as possible.
• CTEP offers a unique combination of resources
and expertise to assist an Industry Collaborator in
clinical development of new therapeutic agents
and the ability to evaluate investigational agents
in a wide variety of tumor types and disease
settings.
Important information about NIH
Clinical Trials
• www.clinicaltrials.gov
Useful Information about Clinical Trials
• For those of you who want to learn about the
policies and procedures involved in clinical drug
development, CTEP has developed the
Investigator's Handbook (now available online!).
• If you want to find information on research and
funding by NCI for AIDS-related malignancies, we
have developed the Office of HIV AIDS
Malignancy (OHAM) site for basic and clinical
research.
For more information:
• DCTD Links
• Division of Cancer Treatment and Diagnosis (DCTD)
Homepage
• Biometric Research Branch (BRB)
• Cancer Diagnosis Program (CDP)
• Cancer Imaging Program (CIP)
• Developmental Therapeutics Program (DTP)
• Radiation Research Program (RRP)
• Office of Cancer Complimentary and Alternative
Medicine (OCCAM)
• Clinical Trials Working Group (CTWG)
ASCO Clinical Trials Workshops
•
International Clinical Trials Workshop Application ICTW
•
•
To be held outside of the United States
Description: ICTW supports clinical cancer research by developing the research
skills of
clinicians in emerging economy countries. The two-day intensive workshops are
organized and taught in conjunction with a national or regional oncology society.
Target audience includes young clinicians who have prior research experience but
limited research training and their supportive research staff (nurses, data
managers, CRAs, etc.).
The program focuses on best practices in the implementation of a clinical study
and includes an overview of clinical trial design, roles and responsibilities of the
research team, patient accrual strategies, ethical considerations, promoting clinical
trials, and regulatory issues. Content is delivered through a combination of
presentations and break-out sessions. The size of the workshop is small and
interactive.
•
•
•
•
•
•
•
•
•
•
•
ASCO-ICTW
•
•
•
•
•
•
•
•
•
•
•
•
Goal: Deliver education in globally accepted standards of conducting
clinical cancer
research while remaining grounded in and relevant to the needs and
interests of
the local audience and their setting.
ICTW Objectives:
Further best practices in the implementation of research programs
(patient
safety, global standards of GCP, promoting research, etc.)
Increase understanding of local regulatory practices
Increase understanding of roles and responsibilities of research team
members
Increase ability to communicate with patients the values of clinical
research
Enhance networking opportunities among researchers
Increase participation in clinical trials long term (researchers/patients)
Increase published research (long term)
ASCO ICTW
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
1. Develop and list clear educational objectives for the workshop. Changes to the agenda after
approval is granted must be forwarded to ASCO International Affairs for review.
2. Clearly define the target audience, sponsors, purpose and objective, program description,
agenda, and faculty. The local workshop director and members of the planning committee
must be identified.
3. Submit a letter of support by an active ASCO member from the host country of the
conference. The letter must clearly state the goals of the workshop and reasons for which
the applicant organization is seeking collaboration with ASCO.
4. Signatures of the local Workshop Director and Workshop Coordinator are required to apply
for ASCO ICTWs. These can be sent to ASCO by post, email, or fax for consideration.
5. Following approval of the application by the International Affairs Steering Committee, an
ASCO member will be appointed to serve as ASCO Workshop Director and will be actively
involved in the content selection for the workshop. Applicant is encouraged to make
suggestions for ASCO members to serve in this capacity. ASCO may provide financial support
for the workshop, which will be determined on a case‐by‐case basis.
6. If applying for financial support, a “Funding Request Form” must accompany this
application.
ASCO Clinical Trial Workshops ICTW
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Please detail speaker airfare and honoraria requests for funding. Also specify on this
application if funds are being requested from additional organizations other than ASCO.
7. Applicant must comply with all the Legal Terms and Conditions Governing ASCO Advanced
Cancer Workshops attached to this application. Conference organizers will convey all criteria
to organizing committee members and faculty to insure full compliance.
8. Submit original evaluation forms and a summary of the workshop within 45 days after the
conclusion of the program. These should include statistics on participants, feedback, and a
list of participant names and email addresses.
9. Applicant may be granted permission to use the ASCO logo on promotional materials upon
request. All materials must be in accordance with the ASCO guidelines for logo use and
include the standard disclaimer found in the Legal Terms and Conditions Governing ASCO
International Clinical Trials Workshops. All materials must be pre‐approved by ASCO in
writing prior to their release.
10.Organizers agree to comply with ASCO policies governing reproduction of ASCO content.
11.ASCO adheres to the Council of Medical Specialty Societies (CMSS)
•
Please send the completed application and all required attachments listed in the
application form to [email protected].
ASCO staff are available at [email protected] to explain the application process
and to answer any questions.
•
•
•
•
•
•
•
Dr. Luis A. Salicrup
International Cancer Research Specialist
Center for Global Health
National Cancer Institute (NCI)
National Institutes of Health
[email protected]