scholarly journals Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process

2015 ◽  
Vol 35 (7) ◽  
pp. 1063-1089 ◽  
Author(s):  
Sylwia Bujkiewicz ◽  
John R. Thompson ◽  
Richard D. Riley ◽  
Keith R. Abrams
Keyword(s):  
Drug Development ◽  
Analytical Methods ◽  
Development Process ◽  
Surrogate Endpoints ◽  
Drug Development Process

scholarly journals Biomarkers and Surrogate Endpoints: How and When might They Impact Drug Development?

2002 ◽  
Vol 18 (2) ◽  
pp. 83-90 ◽  
Author(s):  
Chetan D. Lathia
Keyword(s):  
Decision Making ◽  
Drug Development ◽  
Development Process ◽  
Surrogate Endpoints ◽  
Pharmacokinetic Data ◽  
Drug Development Process ◽  
High Likelihood ◽  
Molecular Pharmacology ◽  
Toxicity Biomarkers ◽  
The Cost

As the pharmaceutical industry starts developing novel molecules developed based on molecular biology principles and a better understanding of the human genome, it becomes increasingly important to develop early indicators of activity and/or toxicity. Biomarkers are measurements based on molecular pharmacology and/or pathophysiology of the disease being evaluated that may assist with decision-making in various phases of drug development. The utility of biomarkers in the development of drugs is described in this review. Additionally, the utility of pharmacokinetic data in drug development is described. Development of biomarkers may help reduce the cost of drug development by allowing key decisions earlier in the drug development process. Additionally, biomarkers may be used to select patients who have a high likelihood of benefit or they could be used by clinicians to evaluate the potential for efficacy after start of treatment.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

scholarly journals PRM44 Clinical and Comparative Economic Value - A Novel Pharmacoeconomic Analysis Embedded in the Drug Development Process

2012 ◽  
Vol 15 (7) ◽  
pp. A652-A653
Author(s):  
X. Fang ◽  
M. Seo ◽  
M. Standing ◽  
Z. Xu ◽  
S. Jacobson ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Pharmacoeconomic Analysis ◽  
Economic Value ◽  
Drug Development Process

scholarly journals Precision Medicine: From “Omics” to Economics towards Data-Driven Healthcare - Time for European Transformation

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-10 ◽  
Author(s):  
Denis Lacombe ◽  
Lifang Liu ◽  
Françoise Meunier ◽  
Vassilis Golfinopoulos
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Precision Oncology ◽  
Drug Development Process ◽  
Cancer Treatments ◽  
True Value ◽  
Efficient Access ◽  
Funding Agencies ◽  
Anti Cancer

There is room for improvement for optimally bringing the latest science to the patient while taking into account patient priorities such as quality of life. Too often, regulatory agencies, governments, and funding agencies do not stimulate the integration of research into care and vice versa. Re-engineering the drug development process is a priority, and healthcare systems are long due for transformation. On one hand, patients need efficient access to treatments, but despite precision oncology approaches, efficiently shared screening platforms for sorting patients based on the biology of their tumour for trial access are lacking and, on the other hand, the true value of cancer care is poorly addressed as central questions such as dose, scheduling, duration, and combination are not or sub-optimally addressed by registration trials. Solid evidence on those parameters could potentially lead to a rational and wiser use of anti-cancer treatments. Together, optimally targeting patient population and robust comparative effectiveness data could lead to more affordable and economically sound approaches. The drug development process and healthcare models need to be interconnected through redesigned systems taking into account the full math from drug development into affordable care.

scholarly journals Pharmacovigilance in Cameroon: Past, Present and Future Developments in Unlocking the Drug Development Process

2020 ◽  
pp. 21-44
Author(s):  
Estella Achick Tembe Fokunang ◽  
Bruna Njeba ◽  
Marie Jose Essi ◽  
Rose Ngono Abondo ◽  
Banin Andrew Nyuki ◽  
...  
Keyword(s):  
Drug Development ◽  
Development Process ◽  
Target Population ◽  
Human Consumption ◽  
Drug Development Process ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Development Processes ◽  
High Standards ◽  
Knowledge Attitude And Practice

The drug discovery and development processes are designed to guarantee that drugs are efficacious, nontoxic and of high standards of quality for human consumption. However, patient’s population with access to drugs at approval is only a fraction of the final target population. Therefore, a thorough understanding of the safety of medicines is generally only achieved after the marketing authorization of the drug, followed by pharmacovigilance or post marketing surveillance. Pharmacovigilance (PHV) is defined by WHO as “the science and activities that deals with the detection, assessment, understanding and prevention of the adverse drug reactions or any other possible drug-related interactions”. Health professionals, patients, drug manufacturers and drug regulatory authorities are therefore highly involved in the practice of PHV. Cameroon imports 95 % of drugs and health care products. Therefore, an effective mastery of the knowledge, attitude and practice of PHV will help to elaborate the development of our pharmacovigilance systems. This paper gives an overview of pharmacovigilance in Cameroon for unlocking the drug development process focusing on the past, present and future.

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