1)What is a Phase 1 Trial?
This is when potential new medication, or health products, is tested on healthy volunteers. Investigators look at the best way to administer new treatment to measure the levels to which the medications reach in the body - after one or more doses, and to see how quickly the medication is eliminated
2) What is a Phase 2 Trial?
This is when medications are considered safe for testing on patients, and that its clinical activity may be beneficial against a particular disease, or condition. At this phase a larger group of patients are enrolled, and condition/ disease specific rating scales, are used to record data.
3) What is a Phase 3 Trial?
This is an important turning point for drug manufacturers. The medication has already passed the rigorous testing and review process required by the authorities, and now it is ready to be studied in larger populations. In this phase patients are monitored for improvement in their lifestyles. Most medications that make it to Phase 3 will at least be considered for approval by the appropriate authorities.
4) What is a Phase 4 Trial?
This is when medications have been approved by the authorities, and have been released on to the market, but are testing the medication for new applications. Phase 4 studies are often conducted through BioTrax or your General Practitioner.
5) What is a Non-Systemic Trial?
This is when the potential new medication is not absorbed into the bodies system, and therefore represents little, if no internal side effects. These treatments are usually topical - such as Anti-scarring, Wound Healing or Skin trials.
6) Is there a shortage of placements for volunteers?
Definately not! Volunteers and panellists are in great demand and where BioTrax recruits for clinics you will be given first priority!
7) Why should I participate in a Clinical Trial?
There are many reasons why people take part in research studies. Often it gives you a chance to access a medicine that is not available for the market for prescription. Often the process for collecting information in the study will allow your doctor to find out more about your disease, and the effects it has on you. This may allow you to benefit from better treatments after you have completed a Trial. For Phase 1 Trials, a trial may not benefit you directly, but the information gathered may be of help to patient volunteers. Many healthy volunteers, and also patient volunteers, derive satisfaction from knowing that they are part of the effort to potentially reduce the suffering of other people.
8) Who will I interact with whilst on a Clinical Trial?
There is often the opportunity to mix with nurses, and/ or trained clinical research associates. There is also the opportunity to interact with other volunteers
9) How long do studies last?
This varies depending on the particular clinical trial. This can be anything from 1 day to 5 months or more. There are many trials that take place on just outpatient visits, or weekend studies. Biotrax will inform you of the details of each study and its requirements.
10) Is my study participation confidential?
Your medical information at Biotrax is kept strictly confidential, however in all circumstances, after you have been accepted on a trial, the clinical trial houses, or their sponsor, may use the data to seek approval from the Food and Drug administration, in the USA , the Medicines control agency in the UK or the European Medicines Evaluation Agency in Europe anytime during, or after the study.