The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs
Abstract Background The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-09-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2877-z |
| _version_ | 1830442263651549184 |
|---|---|
| author | Aviv Ladanie Benjamin Speich Florian Naudet Arnav Agarwal Tiago V. Pereira Francesco Sclafani Juan Martin-Liberal Thomas Schmid Hannah Ewald John P. A. Ioannidis Heiner C. Bucher Benjamin Kasenda Lars G. Hemkens |
| author_facet | Aviv Ladanie Benjamin Speich Florian Naudet Arnav Agarwal Tiago V. Pereira Francesco Sclafani Juan Martin-Liberal Thomas Schmid Hannah Ewald John P. A. Ioannidis Heiner C. Bucher Benjamin Kasenda Lars G. Hemkens |
| author_sort | Aviv Ladanie |
| collection | DOAJ |
| description | Abstract Background The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant information required to systematically analyze and assess this early evidence in meta-epidemiological research. Methods We designed a modular and flexible database of systematically collected data. We identified all novel cancer drugs and therapeutic biologics approved by the FDA between 2000 and 2016, recorded regulatory characteristics, acquired the corresponding FDA approval documents, identified all clinical trials reported therein, and extracted trial design characteristics and treatment effects. Herein, we describe the rationale and design of the data collection process, particularly the organization of the data capture, the identification and eligibility assessment of clinical trials, and the data extraction activities. Discussion We established a comprehensive database on the comparative effects of drugs and therapeutic biologics approved by the FDA over a time period of 17 years for the treatment of cancer (solid tumors and hematological malignancies). The database provides information on the clinical trial evidence available at the time of approval of novel cancer treatments. The modular nature and structure of the database and the data collection processes allow updates, expansions, and adaption for a continuous meta-epidemiological analysis of novel drugs. The database allows us to systematically evaluate benefits and harms of novel drugs and therapeutic biologics. It provides a useful basis for meta-epidemiological research on the comparative effects of innovative cancer treatments and continuous evaluations of regulatory developments. |
| first_indexed | 2024-12-21T05:35:11Z |
| format | Article |
| id | doaj.art-bd4a3c8c1c0f4d999380a0596958963c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T05:35:11Z |
| publishDate | 2018-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-bd4a3c8c1c0f4d999380a0596958963c2022-12-21T19:14:26ZengBMCTrials1745-62152018-09-0119111310.1186/s13063-018-2877-zThe Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugsAviv Ladanie0Benjamin Speich1Florian Naudet2Arnav Agarwal3Tiago V. Pereira4Francesco Sclafani5Juan Martin-Liberal6Thomas Schmid7Hannah Ewald8John P. A. Ioannidis9Heiner C. Bucher10Benjamin Kasenda11Lars G. Hemkens12Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of BaselBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of BaselUniv Rennes, CHU Rennes, Inserm, CIC 1414 [(Centre d’Investigation Clinique de Rennes)]Department of Medicine, University of TorontoHealth Technology Assessment Unit, Institute of Education and Health Sciences, Oswaldo Cruz German HospitalDepartment of Medicine, The Royal Marsden NHS Foundation TrustCatalan Institute of Oncology (ICO) Hospitalet, Melanoma, Sarcoma and GU Tumors UnitSt. Clara HospitalBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of BaselMeta-Research Innovation Center at Stanford (METRICS), Stanford UniversityBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of BaselBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of BaselBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of BaselAbstract Background The available evidence on the benefits and harms of novel drugs and therapeutic biologics at the time of approval is reported in publicly available documents provided by the US Food and Drug Administration (FDA). We aimed to create a comprehensive database providing the relevant information required to systematically analyze and assess this early evidence in meta-epidemiological research. Methods We designed a modular and flexible database of systematically collected data. We identified all novel cancer drugs and therapeutic biologics approved by the FDA between 2000 and 2016, recorded regulatory characteristics, acquired the corresponding FDA approval documents, identified all clinical trials reported therein, and extracted trial design characteristics and treatment effects. Herein, we describe the rationale and design of the data collection process, particularly the organization of the data capture, the identification and eligibility assessment of clinical trials, and the data extraction activities. Discussion We established a comprehensive database on the comparative effects of drugs and therapeutic biologics approved by the FDA over a time period of 17 years for the treatment of cancer (solid tumors and hematological malignancies). The database provides information on the clinical trial evidence available at the time of approval of novel cancer treatments. The modular nature and structure of the database and the data collection processes allow updates, expansions, and adaption for a continuous meta-epidemiological analysis of novel drugs. The database allows us to systematically evaluate benefits and harms of novel drugs and therapeutic biologics. It provides a useful basis for meta-epidemiological research on the comparative effects of innovative cancer treatments and continuous evaluations of regulatory developments.http://link.springer.com/article/10.1186/s13063-018-2877-zUS Food and Drug Administration (FDA)Drug regulationMarketing authorizationApproval packageDrugs and biologicsClinical trials |
| spellingShingle | Aviv Ladanie Benjamin Speich Florian Naudet Arnav Agarwal Tiago V. Pereira Francesco Sclafani Juan Martin-Liberal Thomas Schmid Hannah Ewald John P. A. Ioannidis Heiner C. Bucher Benjamin Kasenda Lars G. Hemkens The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs Trials US Food and Drug Administration (FDA) Drug regulation Marketing authorization Approval package Drugs and biologics Clinical trials |
| title | The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs |
| title_full | The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs |
| title_fullStr | The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs |
| title_full_unstemmed | The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs |
| title_short | The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs |
| title_sort | comparative effectiveness of innovative treatments for cancer ceit cancer project rationale and design of the database and the collection of evidence available at approval of novel drugs |
| topic | US Food and Drug Administration (FDA) Drug regulation Marketing authorization Approval package Drugs and biologics Clinical trials |
| url | http://link.springer.com/article/10.1186/s13063-018-2877-z |
| work_keys_str_mv | AT avivladanie thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT benjaminspeich thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT floriannaudet thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT arnavagarwal thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT tiagovpereira thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT francescosclafani thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT juanmartinliberal thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT thomasschmid thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT hannahewald thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT johnpaioannidis thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT heinercbucher thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT benjaminkasenda thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT larsghemkens thecomparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT avivladanie comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT benjaminspeich comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT floriannaudet comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT arnavagarwal comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT tiagovpereira comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT francescosclafani comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT juanmartinliberal comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT thomasschmid comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT hannahewald comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT johnpaioannidis comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT heinercbucher comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT benjaminkasenda comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs AT larsghemkens comparativeeffectivenessofinnovativetreatmentsforcancerceitcancerprojectrationaleanddesignofthedatabaseandthecollectionofevidenceavailableatapprovalofnoveldrugs |