PATIENT REGISTRATION

Definition of a clinical trial

A clinical trial is an investigation in human volunteers, who receive investigational treatments under supervised conditions by medically qualified personnel. The investigational treatments are developed by pharmaceutical and biotechnology companies, called the sponsor companies, the sponsor companies identify qualified investigators (doctors) to conduct the trials under conditions regulated by Regulatory Authorities and Ethics Committees in each country, with the objectives to determine the benefits of the investigational drugs. And to ensure the safety of the participants in the trial.

Clinical trials are usually conducted in four phases (I, II, III, IV). Phases I to III are the pre-registration phases during which only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers. Phase IV trials are called post registration trials during which pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life

Who qualifies for a clinical trial?

Before joining a clinical trial, a volunteer must qualify for the study according to study specific guidelines. These guidelines are all described in a study specific protocol (recipe) “Inclusion Criteria” are the factors that will allow volunteers to participate in a clinical trial and “Exclusion Criteria” are the factors that will disallow volunteers from participating in a study. These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Phase II and III studies seek participants with specific illnesses or conditions to be studied according to a study specific protocol, while phase I studies, require healthy participants. The inclusion and exclusion criteria are used to identify appropriate participants, to ensure participants’ safety and ensure the delivery of quality data and information to researchers.

How does the process work?

Once a volunteer qualifies to participate in a clinical trial, the individual is randomised (assigned) to a specific study group, who either receives the investigational drug or a placebo or a treatment already available.

A placebo is an inactive product that mimics the investigational drug to compare the effectiveness of the investigational treatment to non-treatment. The participant, investigator and research staff are blinded to which participant receives the placebo or which patient receives the active treatment. This ensures that the treating staff observes the participants objectively throughout the trial. Regardless of which treatment volunteers receive, the level of medical attention and care that each participant receives is the same.

What to expect when participating

Each volunteer must complete a consent process, and agree in writing, before the evaluation process (screening phase) can start. A detailed description of what’s expected of volunteers will be outlined during the consent process by using an Informed Consent Form in which specific clinical trial information is explained to the volunteer. After completing the consent process, the volunteer can either be accepted into the study for participation (enrolled) or participation can be denied (screen failed). Once a participant is enrolled the participant can expect that a physical exam will be done and their medical histories are documented by the participating personnel.  The participants’ well-being will be monitored during the trial conduct as well as after the trial was completed.

What is informed consent?

Informed consent is a process where information is provided to potential participants regarding the nature of the trial procedures, scientific purpose of the trial and alternative treatments to study participation. The conditions under which the potential participants are consented must be free of coercion, undue influences or incentives. The potential participants must be granted enough time to review the consent form, discuss the content with family members and the opportunity to ask questions to clear any uncertainties. The potential participants must also understand that alternative treatment will not be denied by the refusal to participate and withdrawal from the clinical trial at any time will not result in any penalties to the participant.

Benefits and risks involved?

The participation in clinical trials ensure the ongoing development of new medical therapies that may offer better treatments and cures for life-threatening and chronic diseases. However, there are always risks involved.

Benefits for participants:

  • Gain access to novel and well-regulated medical care.
  • Assist other patients by contributing to the development of new and improved medications and procedures.
  • Obtain access to proper facilities during the conduct of the trial.

Risks for volunteers:

  • Unpleasant, serious, or life-threatening side effects s could be experienced during a trial
  • The trial medication or treatment may not be effective
  • The study may require more and intense visits to the trial facility

Please note: volunteers may withdraw from a study at any time for any reason

Confidentiality

When a potential participant consents to participate in a trial, the participant agrees that personal information is available to the investigator, the research team conducting the clinical trial, the regulatory body overseeing the research and the sponsor or contract research organization coordinating the trial.  Confidentiality agreements are signed by all participating parties that no confidential information of participants will be shared with any stakeholders outside the trial environment

What occurs after the trial?

After completion of a study, all the data is collected. The objective is to get scientific confirmation whether the study drug was effective, save and to determine the side effects of the drug. which will determine whether the regulatory authorities will require more investigations on the study drug need to be conducted or whether the drug can be registered globally and in a specific country.