About Clinical Trials
A clinical trial is a human research study which aims to improve health outcomes in specific population groups. They are used to determine the safety and effectiveness of a potential treatment, as well as address health issues in large groups of people. Potential treatments can include a drug (a new drug or an old drug with a new use), new procedures, surgical techniques, medical devices, complementary or alternate medicines, behavioural treatments, dietary interventions, exercise, and more. Clinical trials are generally conducted by doctors and other research professionals known as investigators. Potential treatments can be developed by pharmaceutical companies, biotechnology companies, universities and research institutes. There are different types of clinical trials. Most spinal cord injury clinical trials focus on are treatment and quality of life.
Clinical trials are carried out using a predefined study plan known as a clinical trial protocol. This study plan not only ensures the safety and health of the participants but allows investigators at different locations (for multicentre trials) to all perform the trial in the same way on participants with the same characteristics so the data can be combined and clear conclusions can be drawn. The information included in this plan is what will be done in the study, how it will be conducted, and why each part of the study is necessary.
Before a human clinical trial can begin, the treatment must go through extensive preclinical testing, where it has been shown to have a strong and repeatable effect. Potential treatments need to be assessed for adverse effects in animals, dosage, preliminary effectiveness, toxicity, pharmacokinetic (how the body processes the treatment) and pharmacodynamic (how the treatment works in the body) information. Functional outcome measures that could also be used in human clinical trials should be used in preclinical studies. Upstanding preclinical research is published in scientific journals and reviewed by other scientists, and is repeated several times in more than one laboratory.
Sponsors are groups that plan, fund and initiate clinical trials. These are often drug companies and have a contractual say in whether the results are published. In 2005 the International Committee of Medical Journals members agreed that they would not publish the results of any clinical trials that had not been registered on a public database before the trial commenced. This registration includes detailed information about the trial’s author, sponsor, design and anticipated outcome. Registration may prevent unnecessary duplication of research and provide an insight to trial information before it is published.
Scientists and doctors around the world are searching for innovative ways to treat spinal cord injury and improve functional outcomes, as well as quality of life after spinal cord injury. Preclinical spinal cord injury studies must be investigated in animals with spinal injuries and must show clear improvement without toxic side effects. Different types of experimental spinal cord injury must be studied and especially those that mimic those that are found in humans, such as contusion or compression types of injury. Ideally spinal cord injury studies involving cellular treatments would follow what happens to the implanted cells or tissues. However, they may be difficult to trace.
Individuals considering participating in a clinical trial should talk about it with their doctors and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study. Individuals should only participate in properly designed and conducted clinical trials of treatments for which there is compelling evidence of effectiveness from animal experiments. If you ask investigators for information you should receive a detailed account of the preclinical work or any clinical trials that have already been undertaken.