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Clinical Trials

Randomized clinical trials or clinical studies are prospective biomedical studies on human volunteers designed to answer specific scientific and healthcare related questions about a potential novel – investigational – biomedical intervention including vaccines, drugs, treatments, functional foods, and medical devices.

These studies generate safety and efficacy data to help regulatory authorities (the Food and Drug Administration or FDA in the United States, European Medicines Agency or EMA in Europe as well as many other agencies around the world) to verify the effects of one or more investigational medicines should be approved for wider use in the general population.

The European Union (EU), including the European Commission and the European Medicines Agency (EMA), has a number of confidentiality arrangements with a number of regulatory agencies, including the United States FDA. These arrangements allow the exchange of confidential information between the various agencies as part of their regulatory and scientific processes.  Information includes advance drafts of legislation and regulatory guidance documents, as well as non-public information related to ensuring the quality, safety and efficacy of medicinal products for human use.

Satisfactory information
To protect and ensure the rights, safety and well-being of human trial subjects are protected and the results of clinical trials are credible, clinical trials involving human volunteers  are conducted only after satisfactory information has been gathered that satisfies regulatory authority in the country where approval of the therapy is sought. Before a potential novel treatments can be tried in people, it must be studied in laboratory animals first to determine potential toxicity. If a potential treatments has an acceptable safety profile it can then be moved into clinical trials.

Clinical trials are an integral part of new product discovery and development and are required by the FDA and other regulatory authorities before a new product can be brought to the market.

Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.

Good Clinical Research Practice
What we know today about the safety and efficacy of available products and treatments comes from randomized controlled clinical trials . These randomized controlled clinical trials assign trial subjects to either treatment or control groups using an element of chance to determine the assignments in order to reduce bias.  This approach, in which neither the researchers nor the participants can choose which group, forms the foundation of what is known as evidence-based medicine.[1]

Using chance to assign people to groups means that each groups in a randomized trial will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. In clinical trials patients receive either current standard of care or the new investiagtional drug. This research can only be relied upon if it is conducted according to principles and standards which the World Health Organization or WHO referred to as Good Clinical Research Practice (GCP).[2]

Overview of Clinical Trials

Purpose Number of Participants
Phase I 15 – 30 patients
Dose finding (safe dose)
How to administer the treatment
How does the agent affect the human body
Phase II Less than 100 people
Does the proposed agent have an effect on the selected target (cancer)
How does the agent affect the human body
Phase III From 100 to several 1,000 of people
Compare proposed agent/treatment to existing standard of care therapies (or to compare an existing agent to a new use/therapy)
Phase IV (post marketing) From 100 to several 1,000 of people
Assess long term safety and effectiveness of a new treatment

This overview provides updated information about clinical trials involving antibody-drug conjugates.

Clinical Trials

Last Editorial Review: December 23, 2018

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