The ASH Clinical Research Training Institute is a unique year-long education and mentoring program for hematology fellows and junior faculty at academic medical centers and offers a broad education about clinical research methods, research collaborations, stastical analysis, and managing the demands of family and career. The goal of ASH’s Clinical Research Training Institute is to produce a group of researchers armed with ideas for clinical hematology research and the tools and access to resources to make their ideas a reality.

The Clinical Research Training Institute begins with a mandatory week-long summer workshop, to be held from August 3 through August 9, 2013 in La Jolla, CA. The workshop focuses on the foundation, methodologies, and application of patient-oriented clinical research. Participants are matched with workshop faculty members and a small group, which provide participants with intensive exposure to mentorship and networking resources. Throughout the week, participants further develop their own proposed patient-oriented clinical research projects, refining and revising their plans through interaction with faculty and peers.

Each day of the summer workshop is divided into didactic sessions and small group meetings. The mornings are dedicated to lectures on patient-oriented clinical research methodology and related topics, while in the afternoons participants meet with their workshop mentors and other faculty, including biostatisticians, to work on protocol development. Informal presentations by leaders in hematology clinical research take place in the evenings.

In addition to the summer workshop, two subsequent mandatory sessions, the first at the ASH annual meeting and the second on the third Thursday in May at ASH Headquarters in Washington, DC, provide an opportunity for further interaction and mentoring throughout the year. By applying for the Clinical Research Training Institute, you agree to participate in all three segments of the program, if accepted.

There is no fee to apply to the program, and ASH will pay for the participants’ travel expenses to the summer workshop and spring meeting. Travel to and expenses at the annual meeting are the responsibility of the participant and/or their academic institution.

Watch a short video about the Clinical Research Training Institute.

Read more about the 2012 ASH Clinical Research Training Institute participants in this ASH press release.

• Proposed Curriculum
• Timeline
• Eligibility Requirements
• Letter of Intent Requirements
• Application Requirements
• Evaluation, Selection, and Notification
• Terms and Conditions
• Past Participants and Faculty
• Questions

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Proposed Curriculum

Highlights of the 2013 summer workshop curriculum include:

• Advantages and disadvantages of observational studies and meta-analysis
• Advice for forming and sustaining a multi-disciplinary clinical research team including basic science colleagues
• Tools for assessing the quality of clinical research in your field
• Advice on using mentoring and networking to your advantage
• Overview of the design, conduct, analysis, and interpretation of epidemiologic studies of diseases in humans
• Strategies for securing research funding from NIH institutes and foundations supporting hematology research
• Introduction to skills necessary for presenting your work to diverse audiences
• Advice on preparing research results for publication
• Overview of basic statistical terms, sample size calculation, and interpretation of results in clinical trials
• Advice on successfully interfacing with industry while maintaining research independence
• Application of translational laboratory studies to facilitate early phase I/II clinical trials
• Overview of regulatory rules governing clinical trials
• Advice on strategies for successful collaborative research in cooperative groups by junior faculty
• Formal planning of career development and aims for a successful K23, K08 application, or similar award application
• The ABCs of the genome for clinical researchers

DRAFT: 2012 Clinical Research Training Institute Summer Workshop Curriculum

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Timeline

All letter of intent and application submissions will be sent a confirmation email. If you do not receive a confirmation email, please contact the ASH Training Associate at training@hematology.org, or at 202-552-4928.

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Eligibility Requirements

The CRTI is geared toward trainees and early career faculty members in adult and pediatric hematology, hematology/oncology and hematology-related programs at academic medical centers. Eligibility criteria include:

• CRTI applicants are required to be members of ASH in good standing at the time of Letter of Intent submission, and for the duration of the CRTI program. If your 2013 dues have not been paid by 11:59 pm, Eastern, March 1, 2013, your application will be deemed ineligible. To verify your membership status, please log on to the membership section of the ASH website.*
• North American (United States, Canada, Mexico) applicants who at the time of their application AND for the duration of the CRTI program are in hematology-related fellowship training OR are junior faculty who have completed their fellowship training within the past three years. Fellowship training is defined as any sub-specialty training in hematology irrespective of whether this training is concurrent with another training program. The first faculty position is defined as the first position as an instructor (or equivalent) or assistant professor in a hematology-related discipline irrespective of whether the applicant has held a previous faculty position in a field unrelated to hematology.
• International fellow applicants who at the time of the application have received their MD within the past 12 years. OR international faculty applicants who at the time of the application have completed their fellowship training within the past five years.
• Agreement to participate in all of CRTI. Those who are chosen for CRTI are required to attend all parts of the three-part program: 1) the 2013 Summer Workshop; 2) the follow-up program that takes place at the 2013 ASH Annual Meeting; and 3) the one-day Final Class meeting held on May 15, 2014 in Washington, DC.
• Fluency in English.
• Applicants who have been accepted to the Translational Research Training in Hematology (TRTH) program are not eligible to apply for the CRTI program until after the TRTH term has been completed.
• Applicants who have been granted an ASH Scholars Award are not eligible to apply for CRTI during the research period of the awarded project.
• Applicants in their final year of training who plan to transition to another institution the following year are eligible to apply for CRTI but must state the feasibility of completing their proposed research project at the new institution. A support letter from the new institution must be provided in addition to one from the current institution.
• Studies submitted to CRTI must directly involve clinical observation of human subjects. Research projects must include the development or study of new diagnostic methods, therapies, and/or outcome measures that ultimately will benefit patients with hematologic disorders.
• Studies that will be open to enrollment before September 2013 are not eligible as are studies which will have obtained Institutional Review Board approval by the date of the CRTI.
• Studies that are exclusively laboratory based are not appropriate.

* If you need assistance with your username and password, please contact an ASH Customer Relations Representative at membership@hematology.org.

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Letter of Intent Requirements

Letters of intent for the 2013 application cycle will be due by 11:59 pm Eastern on January 8, 2013. Those who have fulfilled the letter of intent requirements will be invited to submit a full application. Any letter of intent that does not follow the requirements below, is not formatted correctly, is lacking information, has incorrect information, or is lacking required documents will be deemed ineligible and will not be reviewed by the study section.

Letters of intent must include the following:

• Letter of intent form (completed)
• Applicants NIH Biosketch (4-page limit). You MUST use the NIH template (sample biosketch)
• A 350-word (maximum) abstract describing the proposed research project (tables, figures and references are not necessary at this stage)
• Letters of intent must be submitted electronically to training@hematology.org by 11:59 pm Eastern on January 8, 2013.
• Only electronic submissions will be accepted.
• All submissions MUST include the required documents listed above, in the order above, and be submitted as one PDF file. Resubmissions or separate e-mails will not be considered.
• The file should be named in the following format: CRTI Lastname-Firstname 2013 LOI.pdf

Please Note: Any letter of intent that does not follow the letter of intent requirements, is not formatted correctly, is lacking information, has incorrect information, or is lacking required documents will be deemed ineligible and will not be reviewed by the study section.

There are no appeals or consideration for additional or further review once a letter of intent has been determined to be ineligible.

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Application Requirements

• Only those who have fulfilled the Letter of Intent requirements will be invited to submit an application.
• Applications must be submitted electronically to training@hematology.org by 11:59 pm, Eastern, March 1, 2013.
• Only electronic submissions will be accepted.
• All submissions MUST include the required documents listed below, in the order below, and be submitted as one PDF file. Resubmissions or separate e-mails will not be considered.
• The file should be named in the following format: CRTI Lastname-Firstname 2013 Application.pdf. It is highly recommended that you use Adobe Acrobat to complete the application.
• Applicants from the same program of an institution are eligible to apply; however, no more than one applicant from any one program at any one institution will be selected.
• In addition to the summer workshop there are two subsequent mandatory sessions, the first at the ASH annual meeting, and the second on the third Thursday in May of 2013 at ASH Headquarters in Washington, DC. By applying for the Clinical Research Training Institute, you agree to participate in all three segments of the program, if accepted.

Required Documents
Those invited to apply will be responsible for submitting the following eight required documents.

The following two forms are supplied by ASH:

1. CRTI Application Form
   ASH provides this form. Please answer all questions.
2. CRTI Demographic Survey
   ASH provides this form. Although the applicant is not required to provide demographic information for consideration for the CRTI, the survey must be returned indicating whether or not you care to participate in the survey. See instructions on survey document.

The following documents must be created by the applicant and formatted with 1'' margins on all sides and a minimum font size of 12 pt.

3. Applicant’s NIH Biosketch (4-page limit)
   You MUST use the NIH template (sample biosketch)
   Please provide a biosketch that includes contact information, present position, training (including training in clinical research), publications, and other relevant information.
4. Applicant’s Career-Development Plan (2-page limit)
   Please detail your career goals (and relate to your prior experiences), systematic plan to obtain experience and skills for an independent career in clinical research, and available resources (such as courses, workshops, etc.) at your home institution. A description of those courses and experiences that the applicant intends to pursue should be clearly identified.
5. Research Proposal & References (5-page limit for proposal; tables and figures are included in the five-page limit; 1 additional page for references is allowed) The proposal should, at a minimum, include:
   • Introduction
   • Specific Aims/Objectives
   • Relevance to Hematology
   • Study Description
   • Statistical Considerations
   • Timeline for Completion and Data Analysis

The following documents must be created by the applicant’s mentor and formatted with 1'' margins on all sides and a minimum font size of 12 pt.

6. Mentor’s NIH Biosketch (4-page limit)
   Please provide either a biosketch detailing present position, training (including training in clinical research), publications, mentoring experience, and research support.
7. Mentor’s Statement of Support (2-page limit)
   Please carefully review the "Instructions to Mentors" below with your proposed mentor. Mentorship is considered a critical component of a successful CRTI experience, and the Mentor’s Statement of Support will be carefully examined and contribute substantially to the applicant’s score. The "Instructions for Mentors" outlines how to complete the Mentor’s Statement of Support. If the applicant has co-mentors, the statement of support must be written and signed by both mentors.

Instructions for Mentors
Please include a letter of support that outlines your experience with the applicant and details your qualifications in your research area, previous experience in mentoring junior investigators, plans to mentor the applicant and support the proposal during the award year, and commitment to providing a productive environment for him/her to pursue the project.

If the proposal requires funds, drugs, or data/tissue from another organization, please outline whether: (1) funds/drugs/data/tissue have already have been received; (2) a written agreement is in place to supply funds/drugs/data/tissue; (3) a proposal to obtain funds/drugs/data/tissue is in process or has been submitted; or (4) not yet sure of how funds/drugs/data/tissue will be secured. If funds/drugs/data/tissue are not yet secured, please outline in your letter a contingency plan for the trainee if the required materials ultimately cannot be obtained.

If the applicant’s project has co-mentors, only ONE statement of support should be included (2-page limit). The statement should be written, and signed, by both mentors.

The following documents must be created by the applicant’s division chief, or similar institutional official, and formatted with 1'' margins on all sides and a minimum font size of 12 pt.

8. Institutional Commitment Letter (1-page limit)
   The division chief, or similar institutional official, should provide a description of the institutional commitment to the investigator applicant. The narrative should include a statement regarding “protected” time for the execution of research and a description of the available environment and resources for the applicant to conduct research and to gain experience and training relevant to his/her career development. A commitment of time and resources for the applicant to attend all three (3) required meetings should be clearly stated.
   
   This letter must be separate from the mentor letter of support and be on official institutional letterhead with an original signature of the division chief (or similar institutional official). If the mentor is also providing the institutional commitment letter two distinct letters must be submitted.

Additional Items
If the trainee has made plans to move to another institution prior to the start of CRTI in August, a letter of support from the mentor and a letter of support and commitment from the division chief (or similar institutional official) at the new institution must be sent as part of a completed application. These documents do not count towards the page limits discussed previously. These letters should be formatted similarly to those discussed above.

For those protocols using agents from a pharmaceutical company that are not FDA approved for the disease under study, the review committee suggests that a letter of support from the collaborating company (companies) be included in the application. Such documentation provides reviewers with important information regarding the feasibility of the proposal. However, we recognize that many concepts are in a developmental stage at the time of application, and such proposals may also be appropriate for CRTI participation. In such cases where a pharmaceutical company letter of support is not included in the application, it is strongly suggested that statements as to the status of company collaboration be included by the applicant.

Please Note: Any application which does not follow the application requirements, is not formatted correctly, is lacking information, has incorrect information, or is lacking required documents, will be deemed ineligible and will not be reviewed by the study section.

There are no appeals or consideration for additional or further review once an application has been determined to be ineligible.

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Evaluation, Selection, and Notification

Each application is reviewed by a primary, secondary, and tertiary reviewer and reviewed based on the following criteria:

1. The applicant’s personal qualifications, as assessed by the biosketch, and potential for academic success, as assessed by the career development plan.
2. The proposal’s originality, feasibility, and clinical importance. Completion of the proposal within the year of the Clinical Research Training Institute is not necessary, but a clear plan for the timeline of the study and data analysis is essential. Preference will be given to proposals with greater involvement of clinical observations.
3. The mentor’s experience and plans for supporting the applicant, as evidenced by the mentor’s biosketch and statement of support and the institutional letter of commitment.

Finalists selected to participate in the Clinical Research Training Institute will be notified in June 2013. A written review and critique of the proposal will be provided to each applicant.

Only one individual per program per medical school/institution will be accepted.

Acceptance into CRTI cannot be deferred.

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Terms and Conditions

As a condition of acceptance to the Clinical Research Training Institute you are required to:

• Maintain membership in ASH throughout the duration of the CRTI program (letter of intent through project update meeting).
• Adhere to all required deadlines.
• Attend all parts of the three-part program:
  1. The week-long Summer Workshop held from August 3 through August 9, 2013 in La Jolla, CA. (Due to the intense nature of the workshop, participants are not allowed to bring guests, family or significant others to the Summer Workshop.)
  2. Small group meeting, lunch, and CRTI reception at the ASH Annual Meeting.
  3. All-day final class meeting held on May 15, 2014, at ASH Headquarters in Washington, DC. At the final meeting, participants will present progress reports on their projects and personal development as a clinical/translational investigator.

PLEASE NOTE: ASH will pay for the participants’ travel expenses and hotel to the Summer Workshop and Spring Meeting. Travel, hotel, and incidental expenses at the annual meeting are the responsibility of the participant and/or their academic institution.

• Make airline reservations through EWA Travel, ASH’s travel agent.
• Give a PowerPoint presentation on your submitted research proposal on the first and last day of the CRTI.
• Attend and participate in each small group meeting during the Summer Workshop.
• Have quarterly telephone status meetings with your CRTI mentor.
• Send 1-2 page quarterly updates to their CRTI mentor(s) and ASH.
• Complete the ASH Conflict-of-Interest form and abide by the ASH COI policy.
• Execute a confidentiality agreement.
• Cite support from the American Society of Hematology in any publications resulting from the CRTI project.
• Respond to future inquiries from ASH regarding your career progression.

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Past Participants and Faculty

Past participants and faculty of the Clinical Research Training Institute.

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Questions

If you have any questions or require any additional information regarding the ASH Clinical Research Training Institute, please contact training@hematology.org.

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