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The Clinical Research Training Institute (CRTI) offers trainees the opportunity to:

• Discuss the principles of clinical research design and execution, including clinical trials with correlative science objectives.
• Recognize the ethical and regulatory issues of clinical research.
• Examine the fundamentals of competitive grant writing, abstract presentation, and manuscript preparation.
• Demonstrate improvements in the quality of their own research proposals through input from faculty and peers.
• Formulate strategies for pursuing and developing successful careers in hematology research.
• Discuss approaches to forming and sustaining a multi-disciplinary clinical research team.
• Practice preparing research results and presenting their work to diverse audiences.
• Develop contact with other trainees to facilitate future collaborations.
• Develop relationships with leaders in clinical research who can enhance professional networking opportunities.
• Formulate strategies for maximizing the benefits and avoiding potential pitfalls in mentor-mentee relationships.

Workshop Curriculum

During the mandatory summer workshop, participants are matched with faculty members and small groups, which provide intensive exposure to mentorship and networking resources. Each day is divided into didactic sessions and small group meetings, with mornings dedicated to lectures on patient-oriented clinical research methodology and related topics. In the afternoons, participants meet with their small groups, 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.

Throughout the week, participants develop their own proposed patient-oriented clinical research projects, refining and revising their plans through interaction with faculty and peers.

Highlights of the 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 the 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 the National Institutes of Health (NIH) and foundations that support hematology research
• Introduction to skills necessary for presenting 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 or K08 application or a similar award application
• Methods and consultation for effective and efficient literature searches
• Overview of patient-reported outcomes in clinical trials

Webinars

Watch the following webinars designed to help you prepare for CRTI and enhance your experience in the program.

Eligibility Requirements

CRTI is geared toward trainees and early-career faculty in hematology-related programs at academic medical centers. Applicants must meet the following criteria to qualify for CRTI:

• Be trainee or early-career faculty with a commitment to hematology or blood-related research and hold an MD and/or PhD or biomedical PhD, PharmD, DNP degree (or equivalents) 
• Be an ASH member in good standing. To verify your membership status, please . Not an ASH member yet? Take the first step. Your membership application must be pending at the time of CRTI eligibility form submission and approved by the application deadline.
  • For ASH Active or International membership, apply by August 1.
  • For ASH Associate or International Associate membership, apply at least three weeks prior to the eligibility review deadline.
• Be fluent in English
• For North American applicants: Be in hematology-related fellowship training, or be a junior faculty member who has completed his/her 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 position is defined as the first job in a hematology-related discipline irrespective of whether the applicant has held a previous position in a field unrelated to hematology.
• For international applicants: Be a fellow who at the time of application has received his/her MD within the past 15 years if from a low- or middle-income country,* or within the past 12 years if not from a low- or middle-income country; or be a faculty member who at the time of application has completed his/her fellowship training within the past five years.

  *Please review ASH's list of low- and middle-income countries.

Research Project Requirements

CRTI is intended to foster the development of a real project that the participant will move forward throughout the year-long program. All applicants must submit a research proposal as part of the application process. Completion of the proposal within the year of CRTI is not necessary; however, a clear plan for the timeline of the study and data analysis is essential.

• The project submitted to CRTI cannot be under consideration for or have been presented at any other similar clinical research development workshops.
• 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 should not have obtained Institutional Review Board approval by the date of the CRTI workshop.
• Studies that are exclusively laboratory based are not appropriate.

Diversity Equity & Inclusion (DEI) is a priority for ASH and the Society is committed to supporting scientists and clinicians from all backgrounds including those underrepresented in hematology and elevating diverse voices across the patient and healthcare communities. ASH’s CRTI curriculum is dedicated to addressing the advancement of health equity by giving consideration for how principles of diversity, equity, and inclusion should be incorporated throughout the clinical trial life cycle. This includes providing support to CRTI participants by incorporating these principles in their respective study designs. As participants develop their research protocols, they are encouraged to review these DEI in Clinical Trials resources that ASH has collated and work with their institutions’ Clinical and Translational Science Centers to determine ways to ensure that the trial protocol will recruit and engage a participant population that is representative of the relevant patient population.

Home Mentor Expectations

The support of home mentors are a valuable component not only to the participant, but also to the program. The home and CRTI mentor will take a team-based approach to supporting the CRTI participants journey throughout the program.

Before the CRTI program begins, home mentors are expected to:

• Assist with the development of the CRTI project and application.
• Provide a letter of support for CRTI applicant.

During the CRTI year, home mentors will be expected to:

• Meet regularly with the mentee (at least once a quarter) to discuss the CRTI project and career development.
• Assist the mentee with refinement and execution of the CRTI project.
• Connect with the CRTI mentor at the beginning and the end of the CRTI year.
• Complete a brief survey at the end of the CRTI year so that ASH can gain their perspective of the program.
• Attend the Monday Night Career Development Awards Reception (highly encouraged, but not required) at the ASH Annual Meeting to meet with the mentee and CRTI mentor.

Application Process

The CRTI application, as well as all supporting documents outlined below, must be submitted through the . Only those who have fulfilled the eligibility review requirements will be invited to apply.

All applications must include the following:

• Applicant NIH Biographical Sketch
  • Please see the Please see the required documents PDF for specific details. for specific details.
• Applicant Career-Development Plan
• Research Proposal and References
• Research Mentor NIH Biographical Sketch
  • The applicant’s Research Mentor must be an active ASH member. The applicant may have two mentors (one primary mentor and one co-mentor), as long as the primary mentor is an active ASH member. The co-mentor is not required to be an ASH member.
  • During the Letter of Intent (LOI) phase, only one mentor can be added. The applicant should add the information for their primary mentor only. The applicant should add the information for their co-mentor during the Full Application phase.
• Research Mentor Letter of Support
  • Please see the required documents PDF for specific details.
• Institutional Commitment Letter
  • Please see the required documents PDF for specific details.
• For applicants in their final year of training who plan to transition to another institution: A support letter from the new institution must be provided in addition to one from the current institution. The applicant must also state the feasibility of completing his/her proposed research project at the new institution.
• For applicants with K-type grants who have access to or involvement in educational programs that cover material included in CRTI: The applicant will need to describe the ways in which CRTI participation would provide him/her with further benefit and training.

For more information about the required materials, please see the required documents PDF.

All eligibility review and application submissions will be sent a confirmation email. If you do not receive a confirmation email, please contact the ASH Training Coordinator at [email protected] or 202-552-4928.

ASH works to ensure a diverse applicant pool and participating cohort in the CRTI program. This includes having representation of the diverse perspectives, talents and experiences of individuals, including but not limited to, those from centers who have not had trainees or mentors in CRTI, individuals from communities underrepresented in hematology, and applicants who focus on classical hematology.

In support of this goal, ASH is offering application mentors who are ASH members knowledgeable in the CRTI application process. Mentors will work with candidates to help strengthen the application in advance of submission. Please contact [email protected] if you are interested in this opportunity and meet the above program goals.

Evaluation, Selection, and Notification

Each application will be reviewed by a primary, secondary, and tertiary reviewer. Applications will be evaluated on the following criteria:

• The applicant’s personal qualifications, as assessed by the biosketch, and potential for academic success, as assessed by the career-development plan.
• The proposal’s originality, feasibility, and clinical importance. Preference will be given to proposals with greater involvement of clinical observations.
• The mentor’s experience and plans for supporting the applicant, as evidenced by the mentor’s biosketch and letter of support. As mentorship is considered a critical component of a successful CRTI experience, the mentor’s letter of support will be carefully examined and contribute substantially to the applicant’s score.
• The institutional support, as evidenced by the institutional commitment letter.

Finalists selected to participate in CRTI will be notified in June and will receive a written review and critique of their proposal. If an applicant is accepted and knows that the original proposal is no longer feasible (i.e., lack of drug access, etc.), the individual must resubmit another possible project no later than two weeks before the start of the summer workshop. The co-directors will review the new proposal and determine if the individual is still eligible to attend. If the revised application is not approved, the next applicant on the rank list will be invited to attend.

Terms and Conditions

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

• Maintain ASH membership throughout the duration of the program (from the time the eligibility review form is due through the final project update meeting).
• Adhere to all required deadlines.
• Attend all parts of the three-part program:
  1. The week-long summer workshop held in August in La Jolla, California. (Due to the intense nature of the workshop, participants are not allowed to bring guests, family, or significant others to the workshop.)
  2. Small group meeting and CRTI reception at the ASH annual meeting in December.
  3. All-day final class meeting held in May at ASH Headquarters in Washington, DC. At the final meeting, participants will present progress reports on their projects and personal development as clinical/translational investigators.

Please note: ASH will pay for participants’ travel and hotel expenses to attend the summer workshop and spring meeting; however, travel, hotel, and incidental expenses associated with attending the ASH annual meeting are the responsibility of the participant and/or the participant’s academic institution.

• Make airline reservations through EWA Travel, ASH’s official travel agent.
• Attend and participate in each small group meeting during the summer workshop.
• Give a PowerPoint presentation on your submitted research proposal on the first and last day of the CRTI and at the final class.
• Have scheduled status updates with your CRTI mentor
• Complete the ASH Conflict-of-Interest (COI) form and abide by the ASH COI policy.
• Execute a confidentiality agreement.
• Cite support from the 91¹ú²ú¾«Æ· in any publications resulting from the CRTI project.
• Respond to future inquiries from ASH regarding your career progression.

Acceptance into CRTI cannot be transferred or deferred.

Questions?

If you have any questions or require additional information regarding the ASH Clinical Research Training Institute, please contact [email protected].