Early phase drug development pathways may seem rigid, but there can be some flexibility when it comes to the steps you take in certain phases. Some studies often associated with Phase 1 do not necessarily have to be done before starting Phase 2. The reverse is also true, in that some elements of Phase 2 can actually be performed by you or your contract research organization during Phase 1. This can help you access vital bioanalysis data earlier in the drug development process. As Phase 1 studies have become increasingly complex, early access to trial results and comprehensive data related to safety and drug pharmacology can help better inform decisions. This information can also help support funding opportunities and solidify your overall program. Here are four things you need to know about the flexibility you have during Phase 1 clinical trials.
Early and Clinical Pharmacology Study Timing
During a drug development program, exploratory therapeutic studies are required milestones, and clinical pharmacology studies include both conditional and mandatory studies. You will only need conditional studies when specific safety data is required for regulatory approval. These can sometimes be conducted at different stages of your program. Human Abuse Potential studies might be part of CNS clinical trials, for example, and may be done in Phase 1 or later. They are likely needed for the end of Phase 2. In some cases, these studies may be waived, thanks to supporting data.
Combining Protocols in Phase 1
Combining protocols requires planning for and conducting multiple analyses. It might include multiple cohorts in a Phase 1 trial. For instance, you may need to assess the food effect for a small molecule, and this step can be incorporated into your first in human clinical trials. You might include a special population cohort at the beginning of the study to help you gain a deeper understanding of PK/PD or early proof of concept within those groups.
Flexible protocol language is also necessary when combining protocols and different assessments. Deep knowledge of the molecule, applicable regulatory guidance, and clearly defined assessments are also required. Combining protocols means earlier access to data, helping eliminate certain clinical pharmacology studies, obtaining waivers for specific analyses that usually occur later, and reducing requests for additional information.
Special Population Trials
Another way to strengthen the data collected in Phase 1 and optimize your submission package is to include a special population cohort. This special population should be made of those likely to be treated by the investigational drug. This additional cohort should be studied after SAD and MAD cohorts. Special populations could include pediatric or elderly patients and individuals with a concomitant chronic disease or medication regimen such as hypertension, diabetes, or depression.
Allocating Resources
Resource availability frequently influences decisions regarding the acceleration of study timing. If your organization has multiple drugs in development, you may opt to balance those timelines to maximize revenue streams. Funds from approved drugs can be used to fund discoveries. If there is little need for supplemental analysis based on early preclinical and clinical signals, you may choose to wait until later in the development process to perform specific assessments.
About Altasciences
As a mid-sized contract research organization, Altasciences understands all the intricacies of the complex drug development process. This CRO with pharmaceutical CDMO capabilities uses their proprietary communication database to quickly share data across teams, helping streamline your drug development program. Biotechnology and pharmaceutical organizations rely on Altasciences’ integrated, innovative approach for preclinical studies, clinical trials, and manufacturing. When partnering with Altasciences, you gain the team’s expertise in various therapeutic indications and study types. These include first-in-human clinical trials and CNS clinical trials. This dynamic CRO/CDMO offers partners access to a wealth of resources, including Phase 1 clinical trial units with more than 580 beds, a recruiting database of more than 400,000 potential participants, and trained and experienced staff.
Learn how Altasciences can help accelerate your drug development program at https://www.altasciences.com/
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