Learn about Phase 2 clinical studies and trials

Clinical trials are done to test new diagnostic, treatments and prevention methods to treat any health condition. The main aim of a clinical trial is to test whether a treatment of diagnosing method is safe and effective or not. Clinical trials evaluate variety of things that include medications, medical devices, medical combinations and how an existing medication can be used in new way. The preclinical trials are done on animal models or human cell cultures by the investigators.Phase 2 clinical studies

If the result of preclinical trial is good then further trial is done to show its effectiveness on humans. There are several phases of a clinical trial. Every phase depends on the previous phase and its results. Let us understand phase 2 clinical studies and other phase as well to know what happens in each phase during the clinical trial process.

Phase 0

The trial begins with phase 0 where only few humans are given a small dose of medication. If the expected results are achieved then phase 1 will be started otherwise few more preclinical research will be conducted.

Phase 1

The trial is done on more than 50 people for few months and checks its effectiveness. The people tried under trials have no serious health conditions. Here the higher dose a human can take without getting any negative effect is checked. Close observation on their bodies is done to check their reaction. Moreover, they also check for the best way in which a drug can be consumed by the human. This phase yield only general result.

Phase 2

In phase 2 clinical studies the large group of participants is tested. These participants are those having conditions for which the medication or drug is developed. The same dose from previous phase is given to them for months or years. During this time they study about their side effects and effectiveness.

However, the safety of drug is still hard to demonstrate as large number of participants is involved. The data collected is used to conduct further investigation. Few key points of this phase are as follow.

Key points of phase 2 clinical studies

  • A group of patient with same medical condition participates in this phase
  • Same dose of drug found to be safest in phase 1 is given to them
  • Few patients can be assigned different treatments to be invested for phase 3 trial with different dose of drug
  • No inactive treatment is used
  • Phase 2 clinical studies are usually done on patients with major conditions and even done in offices of doctor or hospital

Since large number of patient are involved thus there are better chances of getting any side effects.

Phase 2 clinical studies and trials

Phase 3

Safety and effectiveness is compared with existing medications. A random participant is chosen to test the new medication.

Phase 4

This phase is done after the approval of new medication where thousands of participants are involved. Long term safety and benefits of medication is found here.

Every phase is important of clinical research before the drug reach to public for use.

How To Write A Report for Medical Purposes?

The doctors and the legal system have a method of communication, and this is usually done by making a report. A medical report helps in the process of communication but there are a lot of things that you must keep in mind. The format has to be an organized one. Things to be included are background information, physical examination, medical history, treatment details etc.

The report creates a bridge between the doctors and the legal system. Now you might ask why that is necessary. This does not always happen in the case of any and every patient. This is applicable for unique cases where the law might get involved.  A medical report must be generated in case of an accident victim or an assault victim where without a report the legal proceedings cannot continue.

Medical Report

Structure

As mentioned above the report must follow a proper structure so that it is easy for the legal practitioners to find out the necessary points.

  1. First of all you must provide a proper background information, or data. This data must include the basics like the date, time and place and also the examination reasons. A medical report should also include a report on the kind of offence committed. Also if there are any medical conditions that the patient is suffering from that should be mentioned too.
  2. There should be a detailed account of the different states of the patient as per seen though examinations conducted on them. The states include physical and psychological states. These things are especially noticeable in rape victims. If there is any lack of co operation on the part of the patient then that to should be included in the medical report.
  3. There are lots of specimens that are usually involved with a report and those details should most definitely be a part of the report as well. These work as evidence in court and are extremely important for the proceedings to be conducted properly. There should be general information report provide on the specimen that has been collected, like where it has been found and also when.
  4. The facts that you provide can be backed up by your own opinion as a medical examiner but there should be a clear demarcation between the two. However you must know that it will not be taken as a given and will undergo a lot of scrutiny. Make sure that the opinion is at par with the facts provided, so that they do not sound too farfetched.

The end result should ideally be a well organized and informative medical report that has all the required materials and that can be produced in court as substantial evidence. The drafts of the report that you have made need to be destroyed so as to avoid confusion on the part of the reader.

You can get your report reviewed by some expert or some experienced colleague so that you find out any mistakes before it is sent out to court. But proper flawless organization of the reports is of utmost importance.