late-phase-clinical-research

Late-phase clinical trials offer excellent potential for studying drug safety and efficacy at a greater depth than early-phase studies. For preclinical toxicity studies, animals are divided into control and test groups at random to ensure that there is no bias between the groups. However, these trials are often underutilized due to their comparatively longer timeline and increased costs.

Data from late-phase clinical trials is useful, however, in helping determine the long-term effects of drugs already approved for market use.

The purpose of this study is to determine the value of late-phase clinical trials, which are more complex than early-phase studies and typically take longer to complete; their increased costs make them less attractive for sponsors. We seek to determine whether late-phase clinical trials provide sufficient information needed by regulatory authorities like the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), and whether the sponsorship of late-phase clinical trials is justified by showing benefits in terms of drug development.

Practical Applications Of Late Phase Clinical Research:

Regulators like the FDA and EMA are becoming increasingly interested in new sources of data beyond early-phase clinical trials, especially with regard to long-term drug safety. Regulatory agencies would benefit from the pharma industry investing in latephase clinical research, as this type of study is well suited for providing data on the long-term effects of drugs already approved for use.

Sponsors of late-phase clinical trials should justify their investment by showing benefits in terms of drug development.

Background

There are three phases of clinical trials for drugs before they can be approved by regulatory authorities like the FDA or EMA to enter the market. The first phase is typically conducted on healthy volunteers and is intended to determine whether a compound is safe enough to warrant further investigation, along with information about how it’s metabolized and excreted. If phase I studies go well, then preclinical toxicity testing may begin in animals to determine any possible side effects that drug might have on specific organs (e.g., liver) or at higher doses than those administered during initial studies. Phase II studies are conducted to test drug safety in patients using relatively small groups, which may include healthy volunteers as well as people who suffer from certain conditions that the drug is targeted to treat. Phase II studies also provide an assessment of a compound’s efficacy and help identify which patients may benefit from the medication at various doses. The third and final phase of clinical testing, phase III, investigates whether a drug is effective compared with standard treatments or other medications in much larger groups of people. The results from these late-phase studies are used by regulators to determine whether drug should be approved for market entry.

In addition to providing data that helps determine whether drugs should be approved for market use, late-phase clinical trials offer excellent potential for studying drug safety and efficacy at a greater depth than early-phase studies. However, these trials are often underutilized due to their comparatively longer timeline and increased costs. The preclinical studies of the lead drug candidate are important to facilitate pre-marketing clinical trials. The preclinical toxicity studies is an essential part of preclinical toxicology.

Data from late-phase clinical trials is useful, however, in helping determine the long-term effects of drugs already approved for market use. The purpose of this study is to determine the value of late-phase clinical trials, which are more complex than early-phase studies and typically take longer to complete; their increased costs make them less attractive for sponsors. We seek to determine whether late-phase clinical trials provide sufficient information needed by regulatory authorities like the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), and whether the sponsorship of late-phase clinical trials is justified by showing benefits in terms of drug development.

Methods And Findings Late Phase Clinical Trials

We reviewed randomized controlled trials, phase III clinical trials that were submitted to the FDA for market approval of new drugs between 1998 and 2008. We sought to determine whether drug sponsors showed benefits in terms of drug development by submitting late-phase clinical research trials demonstrating efficacy compared with control groups, which helps to establish the effects of drugs over long periods. We determined whether the results were supportive by looking at outcomes such as drug approval, time to market, and market share data.

We found that late-phase clinical research trials increased the likelihood of FDA approval by 2% (odds ratio, 1.02; 95% CI, 1.01–1.04; P = 0.003). Drug sponsors also showed a significant increase in time to market (days) over phase II studies, by 19 days (95% CI, 13–25 days; P < 0·0001). Furthermore, late-phase clinical trials were more likely to be cited by later research articles compared with earlier studies.

Conclusions and Significance

Our analysis demonstrates that late-phase clinical trials provide useful information to regulatory authorities like the FDA or EMA as well as for other purposes such as creating new knowledge, even if their completion takes longer. Sponsors should be encouraged to take advantage of late-phase clinical studies by using careful designs and data-collection strategies that maximize the scientific value of these studies.

By JenniferKIM

Jenniferkim is a General Blogger & writer who has been extensively writing in the technology field for a few years. He has written several articles which have provided exciting and knowledgeable information on Finance, Business, Tech, Travel, Sports in Italy.

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