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A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice.

ABSTRACT: The success of targeted and immune therapies in other malignancies has led to an exponential increase in the number of active and pending clinical trials using these therapeutic approaches in patients with gynecologic cancers. These novel investigational agents are associated with unique and potentially life-threatening toxicities and many require special multidisciplinary logistical considerations. The objective of this review is to describe a practical approach for the safe implementation of targeted and immune therapies in academic gynecologic oncology practices based on our experience at M.D. Anderson Cancer Center.

SUBMITTER: Jazaeri A

PROVIDER: S-EPMC6235625 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice.

Jazaeri Amir A Coleman Robert L RL Sood Anil K AK Frumovitz Michael M MM Soliman Pamela T PT Shafer Aaron A Cutrera Jeffry J JJ Klinger Marlana M Sharafi Sara E SE Johnson Cynae A L CAL Villanueva Valerie F VF Hinchcliff Emily M EM Dickens Andrea A Cain Katherine E KE Anderson Jaime E JE Lu Karen H KH Westin Shannon N SN

Gynecologic oncology 20180910 2

The success of targeted and immune therapies in other malignancies has led to an exponential increase in the number of active and pending clinical trials using these therapeutic approaches in patients with gynecologic cancers. These novel investigational agents are associated with unique and potentially life-threatening toxicities and many require special multidisciplinary logistical considerations. The objective of this review is to describe a practical approach for the safe implementation of t ...[more]

PMID: 30213435

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Project description:Considerable efforts have been exerted to implement Pharmacogenomics (PGx), the study of interindividual variations in DNA sequence related to drug response, into routine clinical practice. In this article, we first briefly describe PGx and its role in improving treatment outcomes. We then propose an approach to initiate clinical PGx in the hospital setting. One should first evaluate the available PGx evidence, review the most relevant drugs, and narrow down to the most actionable drug-gene pairs and related variant alleles. This is done based on data curated and evaluated by experts such as the pharmacogenomics knowledge implementation (PharmGKB) and the Clinical Pharmacogenetics Implementation Consortium (CPIC), as well as drug regulatory authorities such as the US Food and Drug Administration (FDA) and European Medicinal Agency (EMA). The next step is to differentiate reactive point of care from preemptive testing and decide on the genotyping strategy being a candidate or panel testing, each of which has its pros and cons, then work out the best way to interpret and report PGx test results with the option of integration into electronic health records and clinical decision support systems. After test authorization or testing requirements by the government or drug regulators, putting the plan into action involves several stakeholders, with the hospital leadership supporting the process and communicating with payers, the pharmacy and therapeutics committee leading the process in collaboration with the hospital laboratory and information technology department, and healthcare providers (HCPs) ordering the test, understanding the results, making the appropriate therapeutic decisions, and explaining them to the patient. We conclude by recommending some strategies to further advance the implementation of PGx in practice, such as the need to educate HCPs and patients, and to push for more tests' reimbursement. We also guide the reader to available PGx resources and examples of PGx implementation programs and initiatives.

Dataset Information

A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice.

Publications

A practical guide for the safe implementation of early phase drug development and immunotherapy program in gynecologic oncology practice.

Similar Datasets

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