secondary response
write 2 secondary responses
1. Since the completion of the human genome project, genetics have played more and more significant part in drug development process. Understanding the underlying genetic mechanism has brought about greater understanding for development of more specific and personalized therapies. These advancement in genetic studies has helped in identifying target mediated intended and adverse effects for the drug and its therapeutic class. Since clinical trails have an inclusion criteria and the data collected through these trials in specific to the trial population. In my opinion instead of restricting the sale to specific trial population the focus should be more on the extension of phase 3 trials. Phase 3 trials being pivotal should encompass a broader genetic population to better understand the effects of the drug. There should be adaptive randomization, where the newly signed participant of the trials are assigned to either treatment arm or control arm based on the interim data collected. This would help in identifying the arms in which there are reported target mediated adverse effects ad thus could be dropped. Analyzing this data would help in broader understanding of the target market.
Restricting the trials would just hinder the collection of data. The drug therapy should not be completely restricted to the population in which through genetic analyses has been performed but should also be given to patients since the drug class is same and safety and efficacy is established. There should be provisions to collect the genetic data in phase 4 of the trial and post market analysis should be done on the population that is genetically differing from the trial population. So in a case when there is potential risk or benefit identified in phase 4, then drug can be accordingly navigated in the industry. Unless there is no significant improvement to be made the data collected in phase 4 could be used further such as real world data and be submitted as real world evidence. Supposedly if all the trials undergo genetic data requirements in phase 4 there would be tremendous data generated and therapies going ahead will have a shorter development time line.
References:
Holmes, M. V. (2019). Human genetics and drug development. New England Journal of Medicine, 380(11), 1076-1079. https://doi.org/10.1056/nejme1901565
2.About 73% of clinical trials used to evaluate oncology products take into account biomarkers and genetic data. In fact, more than 50% of all conducted trials consider genetic variability. Though taking genetic data into consideration helps to create efficacious therapies, it creates complications. For example, it affects the inclusion criteria and makes recruiting of participants difficult, it necessitates the involvement of genetic counselors. Having said that, I think the genetic composition of patients should be taken into keen consideration. From a drug discovery standpoint, this information helps to identify better drug candidates and targets, as mentioned in the article Drug development in the era of precision medicine.
Biogen conducted a trial for their novel therapeutic agent for Alzheimers. The trial included patients who contained a susceptibility allele. Although the primary objective of the trial was not met, it had a positive effect on the patients. The high dose of the therapeutic agent showed slowed disease progression in patients with a genetic predisposition to the disease. From this, it can be learned that though the therapeutic agent may not be indicted to treat a specific genetic cause of the disease, genetic differences need to be taken into consideration. Putting restrictive inclusion criterias will hinder trial success, but comparative trials can be conducted to check the difference the therapeutic agent has on volunteers without a genetic predisposition.
Reference
Parmar, A., Baum, S., DeArment, A., Dietsche, E., & Truong, K. (2018). Adding genetics to the clinical trial ecosystem – MedCity News. Retrieved 5 August 2020, from https://medcitynews.com/2018/12/adding-genetics-to-the-clinical-trial-ecosystem/?rf=1
Sarah A.Dugger et al.(2017) Drug development in the era of precision medicine.
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