Clinical Trials

What is a Clinical Trial?

  • Clinical trials involve research using sick or healthy humans that allows us to get more information on how the body reacts to certain diseases and/or treatment
  • They are designed by investigators who are highly qualified in the diagnosis and treatment of a certain disease, and subject to evaluation and approval by the Sanitary Authorities (this being the Spanish Agency of Medication and Sanitary Products, AEMPS) and the Ethics Committee before they can be conducted
  • The drug research Ethics Committee consists of at least ten members. One of them must not be involved in biomedical research or clinical assistance, so they can represent the patients’ interest. This committee must be formed of doctors, a pharmacist and a nurse; at least two members that are not medical professionals and a graduate in law. Also, one of its members must have bioethical training
  • Trials and other clinical research studies are governed by ethical and legal standards at both a national and international level. Their protocol, which must be followed strictly, describes what to do and how often, explaining the importance of each part of the study. It also provides the requirements to be met by individuals in order to participate in the study
  • Patient safety must be always guaranteed, as well as their freedom to participate in or withdraw from the investigation at any time, without this decision conditioning their further medical assistance
  • Patient data must be processed with privacy and confidentiality

Phases of clinical development of a drug

  • Every new drug must show its safety and effectiveness during its developement process in order to be approved by health authorities and subsequently marketed
  • Before conducting human trials, it is necessary that the drug is tested on cell cultures and animals in order to obtain the first safety and effectiveness data. This step is called preclinical phase. After this, the drug goes into clinical phase, where it is tested on patients and healthy volunteers
  • Traditionally, there have been considered four phases in the development of a drug:
    • On PHASE I, its safety and the way it behaves on the body (pharmacodynamics and pharmacokinetics) is tested on a small group of people. The dose to be used and preliminary efficacy data can also be obtained at this stage
    • On PHASE II, its efficacy is evaluated on a group of patients with a specific disease, and additional safety data are obtained
    • On PHASE III, the effectiveness of the drug must be proved on a bigger group of patients considered extrapolated to all patients suffering from this disease and in a similar moment. At this stage, clinical trials are performed to compare the drug that is subject to investigation against the usual medicine used for the treatment or against placebo
    • On PHASE IV, safety is still tested on long term patients that are treated within clinical practice

Phases of clinical development

Why are Clinical Trials important?

  • Clinical trials can help investigators progress in their searching of new therapies and aspects of a disease
  • People participating in clinical trials can benefit from treatment, and help others benefit in the future
  • Participating in a clinical trial also implies assuming there may be some risk, as some information about the treatment is still unknown
  • Patients suggested to participate in clinical trials must be properly informed about every possible risk and benefit so they can make a conscious decision when signing the Informed Consent Form
  • Participants may decide to withdraw from a clinical trial at any time, without this decision conditioning their further treatment or care

Informed Consent

The doctor lets the patient know of their chance to participate in a clinical trial

What implies to participate in a Clinical Trial?

  • Patients participating in a clinical trial will be closely monitored by the medical and nursing team so their safety is looked after
  • This means that patients will also be tested more frequently and continuosly monitored, and will have to visit the doctor more often
  • They will have to inform their doctor about any incident or symptom experienced, even if they seem insignificant, as they could be a side effect
  • Doctor- patient communication must be continuous and effective in order to get all the relevant data for the investigation and guarantee patient safety

Other kinds of Clinical Trials: Observational Studies/Registry

  • They are studies in which the investigator is limited to gathering information about the patient population disgnosed with a specific disease, without any intervention beyond daily clinical practice
  • It is useful to have data that allow us to have a global vision of diagnosis, evolution and treatment of a certain disease and that is helpful to identify possible improvement areas in order to improve its natural evolution
  • These studies chase different kinds of goals, the most frequent including completing security data on drugs and patients’ preference and adherence to treatment, as well as any situation experienced by patients that may offer information about the treatment when used in clinical practice
  • If the patients’ data are to be included in a study of this characteristics, they must be informed and may have to give consent to their data to be part of the investigation