Search for Trials

From Research Labs to Pharmacy Shelves

“Before a medication is available in pharmacies, it has come a long way. In all, it takes approximately 12 years and a total spending of £600 million.”

Before researchers develop new ways to use known pharmaceutical substances, or before they discover new combinations of pharmaceutical agents, they first choose the most promising substances and test them in a research lab.

This test gives researchers the first round of data concerning tolerability, safety and dosage. Using this data, researchers determine how and in which form a substance might potentially be used for treating diseases in humans. These laboratory tests are called 'pre-clinical testing'. This phase can take up to a decade.

Only those substances that show therapeutic potential and that have proven to be safe in pre-clinical testing are allowed to be tested using human participants in a clinical trial. These substances are called 'investigational substances'. During the clinical trial, the investigational substances and the comparison substances are administered either in drops or in capsules.

A detailed study protocol documents the most up-to-date scientific knowledge about the investigational substance. This protocol, patient education materials and patient consent forms are all presented to an ethics committee.

An ethics committee is a committee that approves, monitors and reviews biomedical research involving humans. Ethics committees perform critical oversight on research conducted on human subjects to ensure that they are scientific, ethical and regulatory. Clinical trial doctors (called 'investigators') are obliged to conduct every trial according to the prescribed guidelines set out by these ethics committees.

Clinical trials are divided into 4 phases:

Phase 1- Trials with Healthy Volunteers: Phase 1 trials are usually conducted using healthy volunteers. This trial gathers information on absorption, distribution, metabolism and excretion of the drug. These types of trials are called 'pharmacological studies'. The results of this trial describe what is called the 'pharmacokinetics' of the drug. Phase 2 trials are only allowed to follow if the phase 1 trial has proven that the drug’s side effects are not too severe.

Phase 2- Trials with Patients: Phase 2 trials are conducted with patients. This controlled clinical trial gathers information on the drug’s therapeutic efficacy. Therapeutic efficacy describes a drug’s capacity for beneficial change in the treatment of an illness. Some phase 2 trials also aim at determining the proper dosage. This may vary from study to study, depending on the indication and other factors. Phase 2 trials are called 'therapeutic exploratory studies'. The results of these trials let investigators assess the 'pharmacodynamics' of the drug. They also identify common short-term side effects and other risks. Phase 3 trials are only allowed to follow if the phase 2 trial has proven that the drug’s side effects are acceptable.

Phase 3- Trials with Large Patient Groups: Phase 3 trials are conducted with large groups consisting of 200 to 5000 patients. During this phase, the investigational drugs are often compared with the current 'gold standard' treatment. They are assessed in long-term tests to provide information on long-term use and safety. Phase 3 trials are called 'therapeutic confirmatory studies'. They must demonstrate or confirm therapeutic benefit and efficacy.

Phase 4- Post-Market Surveillance: After a drug is authorized for, phase 4 studies are conducted. These studies are performed to gain additional knowledge about a product's safety, efficacy, or optimal use.

Case or Clinical Series: In addition to the 4 phases of clinical trials, pharmaceutical companies also perform 'case series'. The objective of the case series is to review drug effects after its introduction on the market by observing and documenting how the approved drug or medical device is used in clinical practices and in everyday life.

Review of Effectiveness: In a clinical trial, the efficacy and tolerability of a new drug is compared to existing authorized drugs or treatments (standard therapy). If there is no alternative standard therapy, the drug is tested against a placebo to differentiate real drug reactions from independent effects (due to placebo, self-healing, etc.). However, because patients cannot be denied effective treatments within a clinical trial setting, all placebo-controlled clinical trials are carefully examined in advance to determine whether administering the placebo is ethical. During a clinical trial, patients regularly see their investigator in the hospital or medical practice. During these appointments, they are examined by a doctor and interviewed about the efficacy and potential side effects of the drug. Sometimes the study participants are asked to keep a journal documenting their state of health. After completion of the study period, the results of the treatment groups (efficacy and safety) are compared with each other, analysed, evaluated and published.