The Role of Phase 1 CRO Clinical Trials in Pharma Testing

Once a drug is cleared in pre-clinical or Phase zero testing, the next stage is to evaluate its potential effectiveness and any potential side-effects. Phase 1 CRO clinical trials are first-stage trials that CRO companies conduct on people. Several drugs in this phase carefully test how they act on specific targets and are a lot less risky than they were in the past.

Objectives of Phase 1 Clinical Trials

Phase 1 CRO clinical trials are conducted to determine if a drug that has been tested in a lab or on animals is safe to be tested on humans. Preclinical tests are exhaustive. Only after significantly positive results have been found can a drug be approved for human testing.

In Phase 1 CRO clinical trials, clinical trial companies usually test the drug on a small sample of people to determine its safety, right dosage, and method of administration. Volunteer patients may be divided into groups where one group receives a higher dosage of the drug than the other.

In trials involving cancer patients and similar life-threatening conditions, CRO companies can also test whether the cancer decreases or stabilizes.

Monitoring of Phase 1 CRO Clinical Trials

Considering that Phase 1 CRO trials test a drug and its safety for humans for the first time and carry higher risks, patients enrolled in the study are carefully monitored by CRO drug development companies.

Although the sample size of volunteer patients is very small in this phase, only if the drug is considered safe to be administered to humans can it go to the next stage of testing. 

Trials at the Phase 3 phase and beyond comprise a much larger sample size. This makes it even more important to ensure clinical trial companies ensure that drugs tested in Phase 1 are safe, otherwise the testing will have to be completely abandoned.

Advances in modern medicine have made it a lot more likely that drugs tested in Phase 1 CRO clinical trials are likely to be approved for further trials. This gives new hope to thousands of patients facing a life-threatening disease.

Participation in Phase 1 CRO Trials

Patients who volunteer to participate in Phase 1 clinical trials hope that this new drug will help in overcoming an illness when other drugs don’t seem to help.

The other reason is that they hope the study will help other people who may have the same disease sometime in the future. 

While these are the two main reasons why people volunteer to participate in a Phase 1 trial, not everyone is suitable for Phase 1 Clinical Trial.

Participants seeking to enroll in CRO clinical trials should carefully evaluate the benefits and risks before enrolling. Eventually, it is up to an individual to decide if they would like to participate in a clinical study.

Phase 1 clinical trials may have more to offer than just the hope that a volunteer’s life will improve in a few months. While in Stage 3 clinical trials drugs which have already been tested are compared, in Phase 1 trials, a new drug or category of drug is tested which could be of more help than anything else which has been available

Cost Considerations of Phase 1 CRO Trials

With proper planning and intelligent design, the cost of a Phase 1 CRO clinical trial can be controlled to fit the allocated budget.

Using statistical designs, Phase I clinical studies can be significantly improved.  With incomplete block designs, for example, where the volunteer patients receive a subset of the treatments making it possible to test more treatments within a cross-over study. This could arise in a situation where a few different formulations of a compound need to be tested.

Designs can also help in exploring multiple factors simultaneously in the same study such as ascertaining optimal dosage levels for a combination product. In the case of compounds with a high expected variability of pharmacokinetic parameters which requires a  large sample size, using sequential designs or interim analysis gives an opportunity to complete the study faster and with fewer subjects.