What are Clinical trials

Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease. These clinical trials may also show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce high-quality data for healthcare decision making. 

The purpose of clinical trials is to answer scientific questions. Therefore, these studies follow strict, scientific standards which protect patients and help produce reliable clinical trial results. Clinical trials are one of the final stages of a long and careful research and development process. The process often begins in a laboratory, where scientists first develop and test new ideas. 

Clinical trials related to drugs are classified into four phases. The trials at each phase have a different purpose and help scientists answer different questions: 

Phase I trials test an experimental drug, vaccine or device in a small group of people to evaluate safety, possible side effects, and to determine how the drug should be used or delivered. 

Phase II trials involve more people than Phase I and they are designed to assess the safety and efficacy of an experimental treatment. This phase can last several years. 

Phase III trials are usually large studies with many participants. This phase compares the experimental drug or vaccine to a placebo or standard treatment, to evaluate safety and efficacy. Some side effects that were not identified in Phase II may be identified in a Phase III trial because many more people are evaluated. The regulatory health authority, such as the U.S. Food and Drug Administration, will consider the results of clinical trials up to and including Phase III trials when determining whether to approve a new drug or vaccine. 

Phase IV trials take place after a regulatory health authority, such as the U.S. Food and Drug Administration, has approved the use of the drug or vaccine. A drug's effectiveness and safety are monitored in large, diverse populations. 

Every clinical trial has a protocol or study plan that describes what will be done during the clinical trial, how the clinical trial will be conducted, and why each part of the clinical trial is necessary. The protocol or study plan also includes guidelines called eligibility criteria for who can and cannot participate in the clinical trial. 

Common eligibility criteria may include:

• Having a certain type or stage of disease
• Having received (or not having received) a certain kind of therapy in the past
• Being in a certain age group
• Medical history
• Current health status

Criteria such as these help to reduce the medical differences among people taking part in the clinical trial so that researchers can be more certain that the results are due to the treatment being tested and not to another reason. 

In addition, because some people who want to take part in a clinical trial have health problems outside of the disease being studied which could be affected by the treatment being evaluated, anyone interested in joining a clinical trial will receive medical tests to confirm their eligibility.

Heparin: Mechanism, Uses, Side Effects, Dosage

Heparin belongs to a group of medications known as anticoagulants. Anticoagulants work by reducing coagulability and helping Stop clots to form in blood vessels. Anticoagulants are sometimes referred to as “blood thinners,” although they do not actually agitate the blood. Heparin does not dissolve the already formed blood clots, but could prevent the formation of formed clots, which increase and cause serious problems.

It is used during dialysis, blood transfusions and blood sampling. It is also given prior to surgery to reduce the risk of blood clots.

It was approved in 1939 by the Food and Drug Administration (FDA).

HEPARIN USES

Prevention of peripheral artery thromboembolism

Prophylaxis of deep vein thrombosis and pulmonary embolism

Prevention of blood clot in the lung

Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion.

Heparin Mechanism of Action

Heparin interacts with the natural plasma protein antithrombin III to induce a
Conformational change that significantly improves the activity of the antithrombin III serine protease,
As a result, the activated coagulation factors, in particular Xa, are involved in the coagulation sequence
and IIa. Small amounts of heparin inhibit the Xa factor and larger amounts inhibit thrombin (Factor IIa).
Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of fibrin

Stabilizing factor. Heparin has no fibrinolytic activity. Therefore, the existing lumps will not lyse.

Heparin reversibly binds to antithrombin III (ATIII) and leads to an almost immediate inactivation of factors IIa and Xa. The heparin-ATIII complex may also inactivate factors IX, XI, XII and plasmin. The mechanism of action of heparin is ATIII-dependent. It works primarily by accelerating the neutralization rate of some antithrombin-activated coagulation factors, but other mechanisms may be involved. The antithrombotic effect of heparin correlates well with the inhibition of factor Xa. Heparin is not thrombolytic or fibrinolytic. Prevents the progression of existing blood clots by inhibiting further coagulation. The lysis of the existing clots is based on endogenous thrombolytics.

Pregnancy and Heparin

It is not known if heparin can harm an unborn child. However, this drug is sometimes used alone or with aspirin to prevent loss of pregnancy or other problems in pregnant women. Talk to your doctor about the risks of using heparin during pregnancy.



This drug doesn’t cross the Breast milk but Do not use this medicine during breast-feeding without first consulting your doctor.

FDA Expands Use of Breast Cancer Drug to Men

The US Food and Drug Administration (FDA) has extended the indication of the breast cancer drug palbociclib (Ibrance, Pfizer) to include male patients.

Palbociclib capsules are used in combination with specific endocrine therapies for hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced or metastatic breast cancer. The drug was initially approved in 2015.

The indication was expanded on the basis of data from postmarketing reports and electronic health records that show that the safety profile for men treated with palbociclib is "consistent with" the safety profile for women, said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research in a press statement.

Pazdur added that "some approved indications for breast cancer treatments do not distinguish by gender, but in certain cases, if there is a concern that there may be a difference in efficacy or safety results between men and women, then further data may be necessary to support a labeling indication for male patients."

Breast cancer is rare in males. It is estimated that only 2670 cases will occur in 2019, which is fewer than 1% of all cases of breast cancer, said the FDA. However, the majority of breast tumors in male patients express hormone receptors; such tumors are typically treated with endocrine-based therapies, which, in advanced cancers, may include palbociclib.

The FDA pointed out that although some breast cancer therapies have been approved only for women, these drugs are often prescribed for male patients too, and that in general, males are treated similarly to women, per clinical practice standards.

The most common side effects of palbociclib are infections, leukopenia, fatigue, nausea, stomatitis, anemia, hair loss, diarrhea, and thrombocytopenia. Other common side effects include rash, vomiting, decreased appetite, asthenia, and fever.

Healthcare providers should monitor patients for neutropenia. Such monitoring should be undertaken before the start of therapy, at the beginning of each cycle, and on day 15 of the first two cycles.

Use of palbociclib is associated with a risk for genotoxicity. Male patients with female partners of reproductive age should be warned of that risk and should use effective contraception during treatment and for 3 months after taking the last dose.