Research

CPCE ANNOUNCES FALL 2013 PILOT GRANT AWARD RECIPIENTS

Beatriz Larru, MD
Fellow, Division of Infectious Diseases
Project Title: "Combination Antibiotic Therapy for Definitive Treatment of Gram-Negative Bacteremia in Hospitalized Children"

Erik Jensen, MD
Fellow, Neonatal-Perinatal Medicine
Project Title: "Pilot N-of-1 Multiple Crossover Randomized Trial of Gastric and Transpyloric Feeds in Infants with Severe Bronchopulmonary Dysplasia"

Congratulations to Drs. Larru and Jensen! Thanks to all who submitted proposals for consideration. We encourage all interested investigators to submit their proposals to the CPCE Pilot Grant Program in the future.

Click here to see past CPCE Pilot Grant Award recipients

Pilot Grant Program

CPCE offers awards twice each year through its Pilot Grant Program. The purpose of this program is to promote and support CHOP investigators in clinical effectiveness pilot research studies that will attract external support for large-scale studies. Investigators from all CHOP departments and divisions, including fellows in their final year of fellowship transitioning to a faculty position at CHOP, are encouraged to apply. Selected proposals will be supported for up to a maximum of $10,000 for one year. Projects should be able to be completed within one year.

Important Eligibility Notes:
1) Only proposals meeting the following definitions will be reviewed and considered for award.

Clinical Effectiveness Research is research designed to produce evidence of what works best for treating, diagnosing and preventing disease.

A Pilot Study is a small study, conducted in preparation for the larger research study, in which study feasibility is tested and preliminary data are collected.

2) Studies already in progress or partially funded will not be supported.

3) Re-submissions are by invitation only. We will notify you if your submission qualifies to be resubmitted for a future funding cycle.

4) The review process will consist of two rounds. Round one will determine if proposal meets the definition of clinical effectiveness pilot study and is of sufficient quality for further review. ONLY PROPOSALS THAT QUALIFY FOR THE SECOND ROUND WILL BE CRITIQUED AND SCORED.

Application and Submission Process:

  • Please submit proposals in NIH format to include project summary/abstract, specific aims, and a research strategy section which includes significance, innovation and approach. (5 page maximum)
  • Proposals must also include a cover page, an investigator biosketch in NIH format and project budget, budget justification, and references. (not included in 5 page maximum)
  • Budgets must be reviewed by your business manager prior to submission.
  • Funding may not be used for investigator salary support. Staff salaries are allowable budget items.
  • There are two submission deadlines per year. The 2014 deadlines are Tuesday, April 1 (awards announced in early May) and Wednessday, October 1 (awards announced in early November).
  • Selected applications must show documentation of IRB submission within 30 days of award notification.
  • Proposals submitted for other awards (e.g., Foerderer) are not eligible for CPCE pilot grant consideration.
  • Please submit the proposal as a single Word document via email to Megan Foley, at foleym@email.chop.edu no later than 4:00 p.m. on the deadline date.

For a submission template, please click here.

Review Process and Selection Criteria

As detailed above, the review process will consist of two rounds. Applications meeting the definitions (above) for pilot clinical effectiveness research studies, and judged by the Pilot Grant Steering Committee to be of sufficient quality for further review, will be assigned to a reviewer, critiqued and scored. Reviewers will meet in a study section to discuss the merits and limitations of the competing proposals and to determine the awardee(s). All applicants whose proposals qualify for round two will receive a copy of reviewers' comments and score. Those applications that do not qualify for round two will be returned to the applicant without further review, critique or score.

The following criteria will be used to score the proposals. They are adapted from NIH Study Section Criteria.

  • Significance of Study: Does the project address an important problem or a critical barrier to progress in the field?
  • Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
  • Likelihood of Impact of Clinical Effectiveness: If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
  • Appropriateness of Budget: Is the proposed budget and period of support appropriate in relation to the proposed research?
  • Likelihood of Future Research: If the aims of the project are achieved, will the results lend themselves to future research?
  • Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

The above criteria will be scored on a scale from 1 (high impact) to 9 (low impact).

Common Pitfalls of Past CPCE Pilot Grant Applications:

  1. Failure to anticipate difficulties or address limitations
  2. Uncertainty regarding future direction or funding
  3. Incomplete significance section; failure to adequately describe rationale
  4. Overambitious for pilot study; unrealistic timeline
  5. (Budget) Underestimate of biostatistical support needed to complete aims

Although projects may be funded up to a maximum of $10,000 priority will be given to those projects that include a prudent spending plan. CPCE will attempt to fund all requested budgets in full, but may elect to partially fund certain protocols in order to increase the number of funded proposals.

Reports:

  • Principal investigators must submit a report at the end of the grant period for review by the Pilot Grant Program steering committee. The reports should include progress, expenditures and plans for disseminating results. Subsequent reports will be requested to include publications and extramural funding resulting from the research.
  • Funds unspent at the end of the one-year grant period will be returned to CPCE. However, requests for rollover of funds for an additional year will be considered with adequate justification. We are very excited about the opportunity to support fellows and junior faculty who are interested in advancing CPCE's goals.

Questions?

Contact Megan Foley at foleym@email.chop.edu with any questions about the CPCE Pilot Grant Program or submission process.

The Healthcare Analytics Unit is a service unit of CPCE and PolicyLab. The HAU serves as a resource for investigators who want to use administrative or other existing data to answer research questions. HAU offers the services of programmer/analysts to pull, clean, manage, model and analyze data. The unit provides access to and expertise in the use of PHIS, KID, Medicaid, Premier, NHDS, NAMCS and other databases.

Examples of databases to which the HAU provides access and expertise:

  • Pediatric Health Information System (PHIS)
  • Kids' Inpatient Database (KID)
  • Medicaid
  • NAMCS (National Ambulatory Medical Care Survey)
  • NHDS (National Hospital Discharge Survey)
  • Premier Perspective Database

To see samples of articles published using PHIS data, click here

To see samples of poster presentations using PHIS data, click here

For PHIS Data Use Forms, click here

HAU Staff

Xianqun Luan MS, Director
3535 Market Street, Rm 1545
267-426-8729
luan@email.chop.edu


Mr. Luan has expertise in clinical trial studies (Phase I-III), biomedical research, and outcomes research. As a biostatistician, he has experience in clinical trial design and analysis, sample size estimation, implementation of statistical methods, statistical modeling for longitudinal, categorical, time to event and outcome data, and analysis of measurement agreement. Mr. Luan has extensive experience in statistical programming, statistical graphics, and statistical report presentation (SAS, Splus, and R). He has comprehensive knowledge about utilization and analysis of regional and national survey datasets, and he has strong database (Oracle, SQL server, Access, Filemaker, and Excel) integration, research data modeling, and analysis data generation skills.

Dingwei Dai, PhD
Programmer/Statistical Analyst
3535 Market Street, Rm 1405
267-426-5485
daid@email.chop.edu

Wu Gong, MS, MPH
Programmer/Statistical Analyst
3535 Market Street, Room 1409
267-426-9445
gongw1@email.chop.edu

Vera Huang, MS
Programmer/Statistical Analyst
3535 Market Street, Room 1404
267-426-7748
huangys@email.chop.edu

Yang Liu, MS
Healthcare Data Scientist
3535 Market Street, Room 1494
267-426-6359
liuy6@email.chop.edu

Jin Long, PhD
Programmer/Statistical Analyst
3535 Market Street, Room 1406
267-426-9837
longj2@email.chop.edu

Lanyu Mi, MS
Programmer/Statistical Analyst
3535 Market Street, Room 1406
mil@email.chop.edu

Zeinab Mohamad, MS
Programmer/Statistical Analyst
3535 Market Street, Room 1404
267-426-5638
mohamad@email.chop.edu

William Quarshie
Programmer/Statistical Analyst
3535 Market Street, Room 1406
267-590-8748
quarshiew@email.chop.edu

Lihai Song, MS
Programmer/Statistical Analyst
3535 Market Street, Rm 1405
267-426-2885
songL@email.chop.edu

Requesting Data Services from the HAU

Contact us via email at luan@email.chop.edu We will contact you to schedule an appointment to discuss your project's feasibility and cost.

IRB APPROVAL FOR STUDIES THAT UTILIZE HAU SERVICES

The IRB has increasingly judged large datasets, such as those obtained from PHIS, to contain data that is not readily identifiable and therefore, outside the requirements for prospective IRB review and approval. Regulatory statements have made clear that "readily identifiable" does not mean possibly or potentially identifiable. This lowers the barriers for receipt and use of these datasets.

HIPAA does apply to the receipt/use of these datasets.
- If the dataset is a limited dataset, then all that is required to obtain and use it would be a data use agreement (no IRB approval required) with the data source (e.g. CHCA for PHIS data).

For research that utilizes datasets containing identifiable PHI, or for which data will be prospectively collected, IRB review/approval will continue to be needed.

It is the responsibility of the investigator to obtain IRB review and approval for those studies that require it, and to complete any data use agreements required by the data source.

For more complete information regarding what must be reviewed by the IRB, the use of registries/repositories for research, and other related topics, please see these sections of the research intranet site (authentication may be required):

https://intranet.research.chop.edu/pages/viewpage.action?pageId=25854699

https://intranet.research.chop.edu/pages/viewpage.action?pageId=29427527

https://intranet.research.chop.edu/pages/viewpage.action?pageId=26477172

https://intranet.research.chop.edu/display/cmtirb/Sharing+Data

SUBMITTING MANUSCRIPTS BASED ON RESEARCH UTILIZING DE-IDENTIFIED OR LIMITED DATASETS

When submitting a manuscript for publication, for a study that utilized PHIS or a comparable large and not readily identifiable dataset, and which therefore did not require IRB review/approval, the following boilerplate text can be used when needed during the journal's submission process. There are two versions, please choose the appropriate one, depending on the nature of your dataset.

1) In accordance with the Common Rule (45 CFR 46.102(f)) and the policies of the The Children's Hospital of Philadelphia IRB, this research, which utilized a de-identified dataset, was determined to not meet the definition of human subjects research.

2) In accordance with the Common Rule (45 CFR 46.102(f)) and the policies of the The Children's Hospital of Philadelphia IRB, this research, which utilized a limited dataset according to the terms of a valid data use agreement, was determined to not meet the definition of human subjects research.

HAU Tools

Sample Table To help define your population and measures, inclusion/exclusion criteria, etc

ICD 9 codes -- Use ICD 9 codes in your table to define population of interest

CTC codes (©2008 Thomson Healthcare) please use the appropriate PDF from the list below:

  1. Pharmacy
  2. Medical Supplies
  3. Laboratory Services
  4. Imaging Services
  5. Clinical Services
  6. Other Transacted Services

Questions?

If you have questions about HAU services, please contact:
Xianqun Luan, MS
HAU Director
267-426-8729
luan_AT_email.chop.edu

CPCE Grants Database

In order to further support our goal of facilitating the performance of clinical research at CHOP, CPCE aims to support researchers in their grant writing endeavors by providing good examples of successfully funded grants. These samples help all to benefit from good ideas about grant formatting, methods, content and organization. We have created a central repository of grants by and for center members. The searchable listing is categorized and includes a complete document library for each grant.

Access to the Grants Database

Faculty who are center members and have a USER ID and password can click here to access the CPCE grants database.

Center members who do not have a USER ID/password for the database can request one by emailing hillman@email.chop.edu.

Those interested in becoming center members can also contact hillman@email.chop.edu.

Contribute to the Grants Database

We hope you will find this to be a useful tool. If so, we would greatly appreciate if you can support it by contributing one or more of your grants. This will give CPCE members a greater variety of examples of successfully funded grants. To submit a grant for uploading, simply e-mail the grant (no need to include the budget or budget justification) to center manager, Deb Hillman at: hillman@email.chop.edu.

Word documents are preferred, but other formats (e.g. pdfs) are also accepted.