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Decentralized Clinical Trials: A New Paradigm for New Medical Product Development and Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Isaac R. Rodriguez-Chavez, Greg Licholai
If the DCT involves an IMP, individual state laws should be reviewed to assess direct-to-trial IMP delivery implications as supply and dispensing regulations vary depending on state statutes and federal regulations. The process should be clearly outlined for investigators in the Investigator Brochure (IB) and institutional review board (IRB) documents, as well as to participants in the Informed Consent Form (ICF). International jurisdictional laws and regulations should also be reviewed and complied with when shipping IMPs globally in DCTs; e.g., sponsors in Europe (EU) need to comply with the General Data Protection Regulation 2016/679 (GDPR), which is a regulation in EU law on data protection and privacy. IMP supply suitability in a DCT needs to be determined based on its safety profile. IMPs with toxic safety profiles will not be suitable for remote administration in DCTs. Other factors that impact IMP supply are stability and shelf-life, shipping via special curriers, handling, storage conditions, and mode of administration.
The Role of the Medical Department
Published in Peter Holden, Marketing Communications in the Pharmaceutical Industry, 2018
Externally, the many contacts of the medical department may remain an under-utilized resource. Members of the department may be the first contact a potential prescriber has with the company, and the investigator’s brochure the first written information he gets about a compound. This is often forgotten, to the detriment of the company. Carefully managed, these initial early contacts are extremely important in order to generate feedback, as a source of influence and information, and to nurture a group of product champions.
The Evolution of MAbs from Research Reagents to Mainstream Commercial Therapeutics
Published in Maurizio Zanetti, J. Donald Capra, The Antibodies, 1999
A typical IND would have the following format: Introductory statement and general investigational plan (description of the drug, rationale for the therapeutic use of the agent in humans, previous human experience, proposed indication, and clinical studies). Investigator’s brochure (condensed overview of the background, rationale, clinical protocol, and supportive preclinical data for review by participating clinicians). Clinical protocol (detailed plan of the dosing, schedule, endpoint measurements and safety precautions). Chemistry, manufacturing and control information (see below). Pharmacology and toxicology (cross-reactivity studies, toxicological evaluation in animals).
Risks of molecular targeted therapies to fertility and safety during pregnancy: a review of current knowledge and future needs
Published in Expert Opinion on Drug Safety, 2021
Elena Lorenzi, Matteo Simonelli, Pasquale Persico, Angelo Dipasquale, Armando Santoro
As easily conceivable, data for the newer second-generation Bcr-Abl-I nilotinib and dasatinib are sparse. In a case report by Abruzzese and colleagues, a 33-year-old male patient with CML who was enrolled in the GIMEMA NILIM trial (alternated nilotinib/imatinib), conceived after 40 days of nilotinib treatment and had a healthy boy born at term [36]. The investigator brochure (issued on 8 June 2012) refers to a total of 36 cases of drug exposure via the father. One of these cases presented with fetal abnormalities and ended with a therapeutic abortion [36]. Considering maternal exposure, nilotinib investigator’s brochure reported 45 cases of drug exposure during pregnancy [36]. There was only one case with fetal abnormalities. In addition, there was one pregnant female carrying twins who was exposed; one twin experienced congenital transposition of great vessels and resulted in death, and the other twin experienced a non-serious heart murmur [36].
Anti-EGF antibodies as surrogate biomarkers of clinical efficacy in stage IIIB/IV non-small-cell lung cancer patients treated with an optimized CIMAvax-EGF vaccination schedule
Published in OncoImmunology, 2020
Xitlally Popa, Beatriz García, Karla P. Fuentes, Vivian Huerta, Karen Alvarez, Carmen E. Viada, Elia Neninger, Pedro C. Rodríguez, Zuyen González, Amnely González, Tania Crombet, Zaima Mazorra
A total of 405 advanced unresectable NSCLC patients were enrolled in a randomized phase III clinical trial (National Public Registry of Clinical Trials: RPCEC00000161) with CIMAvax-EGF from June 2006 to January 2012.19 Histologically confirmed stage IIIB or IV NSCLC patients with at least stable disease after first-line chemotherapy treatment were included. Other eligibility criteria were an Eastern Cooperative Oncology Group (ECOG) performance status index ranging from 0 to 2 and adequate organ function, as previously described.18 The trial protocol, informed consent and investigator brochure were approved by the ethics boards from all participating institutions and by the National Regulatory Agency. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practices guidelines. All patients provided a written informed consent.
What to consider for a good quality PDE document?
Published in Pharmaceutical Development and Technology, 2019
Claudia Sehner, Markus Schwind, Gregor Tuschl, Ester Lovsin Barle
Accessibility of the primary datasets leads to a better evaluation of toxicological and clinical information since there is less uncertainty with respect to the potential data gaps. For drugs in development, a summary document like an Investigator’s Brochure (IB) may also be considered a reliable source of preclinical data in earlier versions of the document. Later versions will continuously incorporate advanced clinical information and reduce the preclinical data set. Therefore, access to the earlier version of an IB will be beneficial to get a clear preclinical hazard understanding. This document will however not be available to an external consultant, who may have to resort to the use of publicly available information. Therefore, the PDE assessments done by the originator companies, that generate preclinical and clinical information, should be of better quality by default. Once a drug is on the market, patient insert leaflet (PIL) or summary of product characteristics (SMPC) will be publicly available. These documents may provide a good overview; however, they have their limitations. One major limitation is the brief information about potential non-clinical adverse effects that could represent the critical effects. The assessor must always keep in mind that the target patient population for a PDE is not likely to benefit from the drug that is the potential source of contamination. Having not all data available may lead to lower PDEs due to higher adjustment factors or also higher, unreliable ones due to missing critical data (in particular pharmacological).