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FDAMA Section 113: Status Report on Implementation

~ Appendix ~

Appendix A: Acronyms & Definitions

Appendix B: CDER Letter Template

SPONSOR'S NAME
Attention: NAME OF CONTACT PERSON, TITLE
SPONSOR'S ADDRESS

Dear NAME:

Please refer to your Investigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for NAME OF DRUG.

We also refer to your amendment(s) dated DATE(S), serial number(s) NUMBER(S), containing information about a new protocol.

The purpose of this letter is to inform you about the Clinical Trials Data Bank available to the public through the Internet at http://clinicaltrials.gov. The National Institutes of Health (NIH) through its National Library of Medicine (NLM), and with input from the FDA and others, developed the Clinical Trials Data Bank, as required by the Food and Drug Modernization Act of 1997 (Modernization Act).

Section 113 of the Modernization Act amends 42 U.S.C. 282 and requires the establishment of a public resource for information on studies of drugs for serious or life-threatening diseases conducted under FDA's Investigational New Drug (IND) regulations (21 CFR part 312). It directs the Secretary of Health and Human Services, acting through the Director of NIH, to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.

The Clinical Trials Data Bank is intended to be a central resource, providing current information on clinical trials to individuals with serious or life-threatening diseases, other members of the public, healthcare providers, and researchers. Specifically, the Clinical Trials Data Bank will contain 1) information about clinical trials, both federally and privately funded, of experimental treatments for patients with serious or life-threatening diseases; 2) a description of the purpose of each experimental drug; 3) patient eligibility criteria; 4) the location of clinical trial sites, and 5) a point of contact for those wanting to enroll in the trial. This information must be submitted if the clinical trial concerns a serious or life-threatening disease or condition and if the trial tests effectiveness.

FDA has made available a final guidance to implement Section 113 of the Modernization Act. The guidance describes the type of information to submit and how to submit information about clinical trials for serious or life-threatening diseases or conditions to the Clinical Trials Data Bank.

The guidance entitled "Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions" was made available on March 18, 2002. It is accessible through the Internet at http://www.fda.gov/cder/guidance/4856fnl.htm

The data fields and their definitions are available in the Protocol Registration System at http://prsinfo.clinicaltrials.gov/. Protocols listed in this system will be made available to the public on the Internet at http://clinicaltrials.gov.

Please review the referenced protocol to determine if it is a trial for a serious disease or condition and if it is a trial to test effectiveness. If the protocol meets these criteria, you must submit information about the trial to the Clinical Trials Data Bank, unless you provide detailed certification to FDA that such a disclosure would substantially interfere with the timely enrollment of subjects in the investigation (42 U.S.C. 282(j)(3) and (j)(4)). You can also submit information about clinical trials under IND that do not meet the criteria described in the Modernization Act.

We appreciate your cooperation. This project is a collaborative effort by the FDA Office of Special Health Issues, the FDA Center for Drug Evaluation and Research (CDER), and NLM/NIH. You will receive a similar letter for each new protocol submitted to a CDER IND during 2002. If you have any questions, contact Theresa Toigo or Janelle Derbis in the Office of Special Health Issues at (301) 827-4460 or e-mail at 113trials@oc.fda.gov.

Sincerely,

{See appended electronic signature page}

Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research

{See appended electronic signature page}

Theresa Toigo, R.Ph., M.B.A.
Director
Office of Special Health Issues
Office of Communications and Constituent Relations
Office of the Commissioner

Appendix C: CDER Education Program

• OSHI staff photocopied the FDA Form 1571 for each IND. This form contains the most current mailing address for the sponsor or sponsor's authorized representative.
• Letters were created no sooner than 37 days after the stamp date (the date FDA received the submission) recorded on the paper IND to ensure after 30 days the protocol was not subject to clinical hold. Letters were created electronically on a weekly basis using COMIS PE, a CDER management information system.
• OSHI created a standard letter template containing protocol-specific fields. (see appendix B). COMIS PE electronically input the protocol-specific information into the letter template. Information such as the sponsor's name, address, and drug name was verified and updated as needed using a paper copy of FDA Form 1571.
• Letters were sent via U.S. mail to sponsors by the CDER division document room.

OSHI made two attempts to obtain all paper INDs. A total of 24 paper INDs were not received. If the paper IND was not received, a letter was not sent to the sponsor.

Appendix D: CBER Letter Template

SPONSOR
Attention: FIRST_NAME, MIDDLE, LAST_NAME, CREDENTIAL
TITLE
Addess1
Adress2
Address3, City, State, Country

Dear Sponsor:

Please refer to your Investigational New Drug Applications (INDs) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act referenced in the enclosure.

The purpose of this letter is to inform you about the Clinical Trials Data Bank available to the public through the Internet at http://clinicaltrials.gov. The National Institutes of Health (NIH) through its National Library of Medicine (NLM), and with input from the FDA and others, developed the Clinical Trials Data Bank, as required by the Food and Drug Modernization Act of 1997 (Modernization Act).

Section 113 of the Modernization Act amends 42 U.S.C. 282 and requires the establishment of a public resource for information on studies of drugs for serious or life-threatening diseases conducted under FDA's Investigational New Drug (IND) regulations (21 CFR part 312). It directs the Secretary of Health and Human Services, acting through the Director of NIH, to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions.

The Clinical Trials Data Bank is intended to be a central resource, providing current information on clinical trials to individuals with serious or life-threatening diseases, other members of the public, healthcare providers, and researchers. Specifically, the Clinical Trials Data Bank will contain 1) information about clinical trials, both federally and privately funded, of experimental treatments for patients with serious or life-threatening diseases; 2) a description of the purpose of each experimental drug; 3) patient eligibility criteria; 4) the location of clinical trial sites, and 5) a point of contact for those wanting to enroll in the trial. This information must be submitted if the clinical trial concerns a serious or life-threatening disease and if the trial tests effectiveness.

FDA has made available a final guidance to implement Section 113 of the Modernization Act. The guidance describes the type of information to submit and how to submit information about clinical trials for serious or life-threatening diseases or conditions to the Clinical Trials Data Bank. The guidance entitled "Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions" was made available on March 18, 2002. It is accessible through the Internet at http://www.fda.gov/cber/gdlns/clintrial.pdf.

The data fields and their definitions are available in the Protocol Registration System at http://prsinfo.clinicaltrials.gov/. Protocols listed in this system by industry sponsors will be made available to the public on the Internet at http://clinicaltrials.gov.

Please review your protocol(s) to determine if it is a trial for treatment of a serious disease or condition and if it is a trial to test effectiveness. If the protocol(s) meets these criteria, you must submit information about the trial to the Clinical Trials Data Bank, unless you provide detailed certification to FDA that such a disclosure would substantially interfere with the timely enrollment of subjects in the investigation (42 U.S.C. 282(j)(3) and (j)(4)). You can also submit information about other clinical trials under IND.

We appreciate your cooperation. If you have any questions, contact Theresa Toigo or Janelle Derbis in the Office of Special Health Issues at (301) 827-4460 or e-mail at 113trials@oc.fda.gov.

Sincerely,

Kathryn C. Zoon, Ph.D.
Director
Center for Biologics Evaluation and Research

Theresa Toigo, R.Ph., M.B.A.
Director
Office of Special Health Issues
Office of Communications and Constituent Relations
Office of the Commissioner

Appendix E: CBER Education Program

• CBER provided OSHI with a database containing information on all active IND holders. Information included IND number, sponsor's name and address, and name of the biologic.
• Contact information from the CBER database was merged into the letter template (see appendix D).
• Each letter contained an attachment referencing each active IND held by the sponsor.
• Letters were sent via U.S. mail to sponsors.

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Appendix F: Compliance Evaluation Program I: Data Collection Process

Each week OSHI received an electronic file containing all new commercial protocols submitted to CDER the previous week. The file averaged 50 protocols per week. The following protocol information was contained in the electronic file:

• IND number
• Serial number
• Stamp date (indicates the date FDA received the submission)
• Sponsor
• Drug name
• Indication
• Review division

• The file was downloaded into a Microsoft Access™ database OSHI developed for the project, hereafter referred to as the OSHI database.
• Each week the CDER document room staff delivered copies of the paper INDs corresponding
• The receipt date for the paper document was entered into the database using the Document Check-In Form. (see appendix Q)
• Paper documents were placed in individual folders labeled with corresponding IND number. Documents were filed numerically by IND number.
• OSHI made two attempts to obtain all paper INDs. A total of 24 paper INDs were not received. If the paper was not received, a letter was not sent to the sponsor.

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Appendix G: Protocol Form 2

Appendix H:

The seriousness of a disease is often a matter of judgment and can vary by protocol. For purposes of this project we made a determination as to whether the disease was serious or non-serious and used this one determination for the entire project to ensure consistency. (See Chapter 7-- Limitations)

* For purposes of this project, FDA's Office of Special Health Issues classified diseases as serious or non-serious. Each CDER Division Director and the Director, Office of Medical Policy were consulted to produce the final list. This list does not have official status for any purposes other than this project.

Appendix I:

Appendix J:

Appendix K: Office of Women's Health Data Entry Form

Appendix L: Letter Results Data Entry Form

Appendix M: Thank You Letter

Dear ___________,

Thank you for listing information about your protocol in the ClinicalTrials.gov Data Bank. ClinicalTrials.gov provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. ClinicalTrials.gov receives over 2 million page views per month and hosts approximately 7,200 visitors daily.

We appreciate your support of the Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. If you have any questions or comments, please do not hesitate to contact Janelle Derbis, Pharm.D. or me by phone at (301) 827-4460 or email at 113trials@oc.fda.gov. Thank you for your cooperation.

Sincerely,

Theresa Toigo, R.Ph., M.B.A.
Director
Office of Special Health Issues
Office of Communications and Constituent Relations
Office of the Commissioner

Appendix N: Compliance Evaluation Program II: Data Collection Process

• OSHI received from CDER two electronic Microsoft Excel™ spreadsheets: one containing original INDs and one containing new protocols for existing INDs submitted to the Division of Oncology Drug Products (DODP). The following protocol information was contained in the electronic file:
  • IND number
  • Serial number
  • Submission date (indicates the date the sponsor filed the submission)
  • Stamp date (indicates the date FDA received the submission)
  • Sponsor name
  • Drug name (brand and generic)
• The Excel spreadsheets were downloaded into a Microsoft Access™ database OSHI developed for Compliance Evaluation Program II.
• OSHI received copies of the paper INDs from the CDER document room staff.
• OSHI filed the paper documents in individual folders labeled with corresponding IND number. Documents were filed numerically by IND number.

Appendix O: Submissions Form

Appendix P: Trial Site Location Letter

Dear __________,

We have received inquiries from trial sponsors about the trial location and contact data element fields when submitting clinical trial information to ClinicalTrials.gov.

The purpose of ClinicalTrials.gov is to inform members of the public about potential trials for which they may be eligible. Some patients are willing to travel anywhere to participate in a study and others want to restrict their travel. The latter group limits their searches to locations to which they are willing to travel. For example, a patient who has relapsed with metastatic lung cancer may be unable to travel more than ten or fifteen miles from their home. On the other hand, a newly diagnosed relatively healthy stage three kidney cancer patient may be willing to travel anywhere to be in a clinical trial. Please include the city, state, and country for each clinical trial site so that visitors to ClinicalTrials.gov may search for clinical trials by location. We also ask that you consider including the name of the facility conducting the trial.

We require contact information in the form of a phone number or email address so visitors to the site can call or e-mail to obtain additional information about the trial. The contact can be a central contact such as Clinical Trial Coordinating Center,1-800-123-1234 or a specific contact such as Dr. Mary Jones, mjones@institution.org for each site.

The protocol records (NCT 00000001, NCT 00000002, NCT 00000003) do not provide visitors to ClinicalTrials.gov with sufficient location and/or contact information.

Because you are currently omitting the location and/or contact information when you enter your protocol into the Protocol Registration System (PRS), patients will not find your trial as a potential option when searching by location. We ask that you make the necessary changes through the PRS at https://register.clinicaltrials.gov/ and re-release the record.

If you have any questions, please call me at (301) 827-4460. Thank you in advance for your understanding and support.

Sincerely,
Theresa Toigo, RPh, MBA
Director, Office of Special Health Issues
Office of External Relations
Food and Drug Administration

Appendix Q: Document Check-In Data Entry Form

FDAMA 113 Report

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