Clinical trials – what patients should know

What do the contents of your medicine cupboard have in common with each other?  All those medicines, from the aspirin you occasionally take for a headache to the long-term treatments you may use for a condition such as diabetes, all had to go through various clinical trials before they landed on the shelves of your local pharmacy. 

Participating in a clinical trial, not only assist the medical and pharmaceutical industries to research and analyze new medicines, but it benefits the patient in many ways.  We will attempt to address all your questions about clinical trials here. 

What is a clinical trial?

Following the laboratory testing of a new medicine, it must also be tested in human beings to establish that it is in fact both safe and effective in treating the intended condition. This process of testing medicines in human beings is known as a clinical trial.

Prior to every clinical trial, the local regulatory authorities of all participating countries review and approve the proposed protocol that explains exactly how it will be carried out. In South Africa, the Medicines Controls Council fulfills this role. It also assesses the scientific merit of the clinical trial. In addition, an independent Ethics Committee must approve the protocol for the trial to ensure that human rights are respected and that the rights of participating patients are not compromised in any way.

What are the benefits?

One of the most important benefits to patients who participate in clinical trials in South Africa is that they are given the opportunity for early treatment with new medicines that are not yet sold in the country.  Patients also get a better insight to their conditions and how to treat it.  They spend much time with experts and specialists and receive additional assessments which otherwise would not have happened in a normal consultation visit.  The study medication, study visits and procedures involved in the clinical trial are provided at no extra charge to the patient or the patient’s medical aid.  Travel costs to the site are reimbursed where this is appropriate and approved by the Ethics Committee and the Medicines Controls Council. 

What happens after the trial?

All information collected in clinical trials is used in detailed applications to the regulatory authorities, which they review before allowing a new medicine onto the market. Only by keeping to the highest international standards can research conducted in any part of the world be accepted in other countries. Many of the clinical trails that are conducted at Syzygy Clinical Research Services and other centres in South Africa are simultaneously conducted in Europe, America and elsewhere.

Who pays for clinical research?

Funding for clinical research comes from both the federal government (through the National Institutes of Health) and private industry (pharmaceutical and biotech companies). The sponsor of the research hires physicians, who may work in a wide variety of health-care settings, to conduct the clinical trial. Physicians are typically paid on a per-patient basis. The medical care is often provided free to the patient. Patients may also be paid a small fee to participate in a clinical trial often to cover travel expenses for getting to the visits.

Should you participate in clinical research?

People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free.

The patient's rights and safety are protected in two important ways. Any doctor wanting to be involved in a clinical trial must obtain approval to conduct the study from an Ethics Committee and the Medicines Control Council. The Ethics Committee, which is usually composed of doctors and lay people, is charged with examining the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial is required to sign an "informed consent" form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they have a right to leave the study at any time.

Patients considering participating in clinical research should talk about it with their doctors and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study.

Your clinical trial checklist

Download this list and take it to your doctor or medical caregiver to get the right answers before signing up for a trial: 

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will patient safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• What are the alternative treatments besides the one being tested in the trial?
• Who is sponsoring the trial?
• Do I have to pay for any part of the trial?
• What happens if I am harmed by the trial?
• Can I opt to remain on this treatment, even after termination of the trial?