Early Phase Clinical Trials

There are many developmental therapeutics programs conducted regarding the study of the combination of drugs treating cancer and promising new medicines. Over the past few years, the patients suffering from cancer has witnessed a huge success in the field of medications and improved treatment quality. The research is the only way to bring a massive revolution in the field of treatments of serious chronic diseases. A new approach named early phase clinical trial is carried out by the scientists and physicians to bring a revolution. The early phase clinical trial works on the step by step approach of the clinical trial. It constitutes the series of few steps called phases. The early phase trials are mainly divided into 2 phases, i.e., Phase I and Phase II. The phases refer to the steps in understanding the effect of medicines and drugs or the specific clinical treatment at any stage. The early phase prefers the involvement of a few people for the trial. If the treatment works fine within the patient population at Phase I, then only the further processes are executed and moved to Phase II.

The Early phase clinical trial is the most preferred way for the safety and treatment for the new drug or conditions. At the time of the early phases (Phase I and Phase II), the researchers study about the safety of the new treatment, effectiveness of the new medicine, the absorbing, circulation and elimination rate of new drug, side effects of the drugs and treatment, the best dosage and timings for the new treatment. It ensures one site laboratory facilities and highest patient safety standards. The early phase clinical trial is especially for the patients who are suffering from fatal diseases like cancer which are not responding to the standard therapies. Rather than just positively affecting the patients, it will also lay a great impact for the curing of future cancer patients with suitable medications. The early phase clinical trial may study the immune-based therapies, nanotechnology, targeted therapies and combinations of chemotherapeutic drugs.

 

Phases of early phase clinical trial

Phase I

Phase I is the initial phase of the clinical trial which is carried out to find the effectiveness of the new treatment on the human body. The trial focuses on getting knowledge about the working of the new treatment along with the safety limits of the respective treatment. In the following phase, the researchers observed for the best way to facilitate the new treatment via mouth or injection along with the frequency and amount of best dosage without any side effects. To execute the phase I, the volunteer patients are divided into small groups. Every different group will be supplied with the increasing dosage with the varied routes. The patients are carefully watched upon for the harmful side effects of any corresponding medication. Normally, group one receives one dosage, and another group receives a different dosage by a different route. The observed effects are recorded to find out the highest and safest dose with no harmful side effects. The phase I trial is concluded with the observance of the safe dosage and the way to deliver the dosage. The following study usually involves a small number of patients who would eventually not be helped by the other standard known treatments. The tumor stabilization and shrinkage is the primary goal of therapy which normally occurs to only a few numbers of patients.

 

Phase II Trials

If the volunteer patients pass in phase I, then only they are promoted to phase II of the early stage clinical trial. Phase II is continued to test the safety of the respective drug and evaluate the working of the drug. It primarily focuses on the specific type of cancer. The phase II trial work on the learning of the new treatment such as will the tumor shrink? Only a few people are willing to participate in the subsequent trials due to the unknown risks and side effects involved. In order to study specific cancer responding to the treatment, various studies are carried out in the form of a group of volunteer patients with a similar type of cancer. To be eligible in the Phase II trials, all the patients shall have measurable disease, i.e. at least tumor should be present in the body and must be seen on the physical study or examination (MRI scan, X-Ray, CT scan). For the phase II clinical trials, the size of the tumor and condition of the tumor is tracked and measured to see the feedback of the treatment:

  • If there is no detectable tumor present in the body, then it is said to be Complete Response or CR.
  • If the measurable disease decreases by at least 50%, then it is inferred that cancer has shown a response to the following treatment.
  • If the noticeable tumor shrinks from more than 50% but still remain inside the body is known as positive response or PR.
  • If there is neither a partial response nor a complete response, then cure is said to take place. However, there is always a possibility of the returning of cancer. The time span of the returning of the cancer cells can vary from different bodies and treatment they received. Usually, the response of the regular treatments lasts for a few months, whereas the new innovative treatments can also result in the years of effectiveness.

The early phase clinical trial is very effective yet a great initiative for the safety of future generations. It can help those people who are genuinely in need and have no hope left due to pathetic cancerous conditions. The trials may find a cure for them as well as the hundreds of people going through the same road. It strictly concerns with the safety of future generations. However, not every person is eligible to volunteer in the early phase clinical trial. If in case the patient has few better ways or hope for the cure with the standard treatments, then he/she is encouraged to pursue those methods.

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