If your organization is developing a drug for the first time, you may not know the required regulatory phases. Each is essential to the drug development cycle and regulatory acceptance prior to taking a drug to market. If this is the first time your organization is on its way to first in human clinical trials, whether you are partnering with a contract research organization or not, here is all the most important information you need to know.
The Preclinical Phase
The preclinical phase occurs before clinical trials can begin. Researchers must conduct laboratory research and present results to the FDA. The FDA then evaluates and potentially approves the results, paving the way for the clinical trial to begin in earnest. In this phase, regulatory approval is key. If your organization has not submitted results and procedures for regulatory approval in the past, partnering with a CRO with experience may be worthwhile.
Phase 1: Safety
The first phase of a clinical study is designed to assess the safety of the proposed drug and treatment. The first test is usually small, with researchers testing between 20 and 80 participants. Researchers may even conduct these tests on healthy participants instead of those who are intended for the treatment. This phase can identify potential side effects and puts the bioanalysis of the preclinical phase to the test. More bioanalysis will help refine the formulation, and as the clinical trials continue, it could result in the need for a new version of the drug to be manufactured.
Phase 2: Efficacy
The second phase answers the question of whether the treatment works effectively or not. Efficacy tests the treatment under ideal conditions, while effectiveness deals more with real-world results. While Phase 1 is fairly short, Phase 2 can last months or even years. There are generally between 100 and 300 participants in this stage. Therefore, this phase further examines the safety of the drug. A CRO with experience can help your organization meet all these requirements, addressing any issues prior to IRB submission and minimizing the risk of amendments—for example, if you know your drug development project will need to include CNS clinical trials, there are specific regulatory complexities to navigate.
Phase 3: Comparison
Is the new treatment or drug comparable or better than what is already available or standard? That is what the third phase tests. If it is not as good or better than what is currently available, there is little or no value in the new treatment. The outcome, cost, and side effects of the treatment are compared in studies that can last several years. Typically, between 1,000 and 3,000 participants are used in this phase. Successfully completing this phase means the study sponsor can seek FDA approval for marketing the treatment.
Phase 4: Post Marketing Surveillance Trials
Finally, Phase 4 monitors the effectiveness and safety of the drug or treatment over a long period of time in the general population. This can lead to more information about the drug’s benefits and its optimal uses, thanks to long-term data. For example, some side effects may only appear after this much time. Claims and labeling of the drug may need to be modified as a result.
About Altasciences
As a mid-sized contract research organization, Altasciences understands drug development is a complex process. The Altasciences team can help make the process smooth and streamlined for their partners. Altasciences is an integrated CRO with pharmaceutical CDMO services and more than 25 years of research experience. Pharmaceutical and biotechnology companies can count on the innovative, integrated approach Altasciences uses for preclinical studies and clinical trials. When your organization partners with Altasciences, it gains the team’s expertise in a variety of therapeutic indications study types, including experience in first-in-human clinical trials and CNS clinical trials. The CRO/CDMO offers access to resources including highly trained and experienced staff, more than 580 beds, and a recruiting database of over 400,000 potential participants.
Get help moving through clinical trial phases from Altasciences at https://www.altasciences.com/
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