ABOUT CLINICAL TRIALS

The medicines available today in pharmacies are the outcome of medical research. Medical research has tremendously evolved over the last 50 years, contributing through new therapies and innovative medicines to cure many diseases and therefore prolonging lifespans.

Researchers predict that every second child born today is likely to live beyond the age of 100 years, due to the progress of medical research!

Each medicinal product, before being sold in a pharmacy and being used for the treatment of countless diseases, goes through a long process of research, testing, efficacy confirmation, identification of possible side effects, and eventually being approved for marketing.

Clinical research adheres to very strict national and international regulations, which are carried out based on the ICH-GCP (International Conference of Harmonization - Good Clinical Practice) Guidelines and the Helsinki Declaration, adopted by the General Assembly of the World Medical Association.

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf

All the European states, USA, Canada, Japan and most countries throughout the world adhere to these international regulations in order to facilitate the progress of medical science for the good of mankind.

Clinical trials are conducted in many different locations such as hospitals, universities, medical practices, or medical clinics, all certified for research activities by the competent health authorities.

A clinical study may be single centre (taking place at one single centre/clinic, i.e., in one single country) or multicentre (taking place at multiple centres in several countries). Most clinical trials involving human volunteers are multicentre and are conducted simultaneously in European Union countries, the United States, Canada, Japan, the Russian Federation, Australia, New Zeeland, etc., whose volunteers contribute together to international clinical research.

Countries with a long-standing tradition in pharmaceutical clinical research are also the undisputed leaders regarding the number of clinical trials conducted per capita. The USA holds the first place in this respect, followed by European Union countries.

Good Clinical Practice (GCP) Guidelines are internationally accepted, ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve volunteer participation of human subjects to ensure:

For additional information on clinical trials, please visit the websites of:

PHASES OF CLINICAL TRIALS

Medical research sets out to understand the disease mechanism. Therefore, researchers usually identify a way to influence this mechanism: block harmful molecules, kill germs, stimulate a favourable process. At this stage researchers create new compounds (molecules) that, theoretically, could act in a beneficial manner to disrupt the disease mechanism.

Subsequently, the compound goes through multiple stages to confirm its safety and efficacy. Firstly, computer models select potential molecular candidates (in silico), then appropriate lab testing is performed (in vitro). Tests are then conducted on laboratory animals selected as they show a reaction pattern similar to that of humans (in vivo or pre-clinical trials). In the late phases of the drug development process, clinical trials are finally implemented, and the medicinal product is administered to humans.

Only a small proportion of the compounds created by researchers reach this phase of clinical trials, most of them getting lost on this lengthy pathway as they do not prove to be as effective as expected.

Clinical research is divided into two main categories:

Clinical trials go through the following phases, in chronological order:

Phase 0

It is a relatively recent form of optional exploratory trials. Phase 0 trials are called micro-dosing studies in humans as well and are intended to accelerate the development of promising medicines or imaging agents, establishing much faster whether the drug or agent works in humans as expected based on pre-clinical studies. Distinctive features of phase 0 studies include the administration of single sub-therapeutic doses of the investigational medicines to a small number of subjects (10-15) to collect preliminary data on the pharmacokinetics of the agent.

A phase 0 trial does not provide data on safety or efficacy, the dose being by definition too low to determine any therapeutic effect. Based on the data obtained during these trials, a decision is made whether to proceed or not with the drug development, based on relevant human models, instead of exclusively relying on sometimes inconsistent animal data.

Phase I

Usually, the number of participants in such a trial varies from 20 to 100 healthy volunteers or volunteers with a certain illness/condition. The study lasts for several months. Investigational medicine is given to a small number of healthy volunteers to see which dose is safe, starting with a single dose administration. Different participants receive different doses to determine which dose is safer, then either multiple doses are administered to healthy volunteers and/or single/multiple dose(s) in volunteer patients with a condition (disease) possibly targeted by the investigational medicinal product. The information is useful for the design of phase II studies.

Phase I studies can be further divided as follows:

Phase II

In Phase II trials, the investigational medicinal product is administered to a group of patients having the condition (disease) for which it has been developed. Typically involving several hundreds of patients, these studies are not large enough to show whether the investigational medicine is going to be beneficial. Instead, Phase II studies provide investigators with additional safety information. This data is used to design new Phase III research protocols.

Phase II studies can be further divided as follows:

Some studies combine Phase I and Phase II and test both efficacy and safety and tolerability.

Phase III

The investigational medicinal product is administered to a much larger number of people (thousands of patients) over several years, in order to determine whether it continues to be effective or causes side effects, which only occur after a longer period of time and/or compare this investigational medicinal product to others already in use. If an investigational medicinal product is successful at this time, it could be approved for large scale use.

Phase IV

A treatment is often studied even after it has been authorized; these are called “post marketing studies”. These studies monitor the side effects or problems that could occur only after several years of use or test the treatment in different prevention or therapy settings.

RELEVANT TERMS

The document that governs the conduct of a clinical trial and establishes all the activities carried out within is known as the Study Protocol. The Protocol provides information on the research purpose, criteria for including volunteers in the study, the schedule of activities, methods and treatments, dosages, the study period and the reporting methods. Another important document is the Investigator's Brochure (Ib), made available to researchers/investigators by the Sponsor, which includes pharmacology data and pre-clinical and clinical experience (beneficial effects and adverse events) accumulated in previous studies with that test product.

Before a patient is included in a clinical trial, he/she signs a document called Informed Consent Form (ICF). Prior to the decision to participate in a clinical trial, patients spend more time with one of the investigators who explains what the study is about (what tests will be done, how often the patients will have to come to the clinic, what the patient will have to do at home, what discomforts or risks may occur). Patients will be informed about the medication they will receive. The patient is then encouraged to ask questions to make sure he or she understands all the implications of study participation. The patient also receives this information in a written document, through the informed consent form.

During informed consent process, investigators will need to:

The purpose of the informed consent process is to protect the participants. It begins when a potential participant first requests information about a study and continues throughout until the end of the study. The investigator and potential participant have conversations that include answering the participant's questions regarding the research. All important information about the study should also be provided to the potential participant in a clear and easy-to-understand written document. The informed consent form is reviewed and approved by regulatory authorities, respectively independent ethics committee, before the document is given to potential participants. A person has to sign an informed consent form to be enrolled in a clinical trial.

The confidentiality of study participants’ personal data will be strictly protected, and only the investigation team will have access to such data.

All data referring to the study will use only the initials of the participants.

The investigator (researcher) is a highly experienced and qualified medical doctor. He/she requires scientific knowledge and clinical experience in patient care. Investigators are usually specialists trained in clinical trial practice. The investigator is responsible for conducting the clinical study at an investigation site, and in case the study is performed by a team at that site, the team leader is appointed Principal Investigator (PI).

The legislation governing the conduct of clinical trials is based on a set of recommendations called "Good Clinical Practice - GCP - Guidelines".

The Good Clinical Practice Guidelines are a standard for the clinical trial design, management, development, monitoring, auditing, recording, analysis, and reporting, which guarantees both the reliability and accuracy of the reported data and results, and protection of patients’ rights and integrity as well as the confidentiality of their personal data.

The investigational medicinal product (IMP) is the pharmaceutical form of a drug substance or placebo that is tested or used as a reference in a clinical study.

Clinical trial Sponsors are usually pharmaceutical companies or governmental agencies that perform research and manufacture medicines. These Sponsors design the strategy and ensure financial support to conduct the clinical trials. If the Sponsors do not have adequate internal resources to organize clinical trials, they outsource (contract) the implementation of clinical trials to specialized companies called Contract Research Organizations (CROs).

Clinical trials are conducted in many different locations, such as hospitals, physician practices, medical clinic or teaching hospitals, all certified for research activities by the competent health authorities.

In order to conduct a clinical trial in any country, the approval of two regulatory authorities is needed: the Health Authority (HA) and the Ethics Committee (EC) in the given country. The clinical trial can only start after obtaining the approvals of these authorities based on the legislation in force.

CONTACT US

This website uses cookies

We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We also share information about the traffic in our site with our social media, advertising and analytics partners who may combine it with other information that you’ve provided to them or that they’ve collected from your use of their services. Detailed information about the use of necessary cookies, which are essential to browse this website, and optional cookies, which you can select below, and how you can review or withdraw your consent at any time can be found in our Privacy Statement.

Always ON Essentials

Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.

  • cookiePreference

    This essential functionality ensures that your choices regarding data privacy and personalization are respected and consistently applied during your visits. You can seamlessly navigate our website with the confidence that your selected settings are in place, providing a tailored and secure user experience.

    Expiry: 1 year Type: Local
  • cookiePreference-*

    This cookie is an advanced component of our website, meticulously designed to track and manage the specific categories of cookies you allow. This innovative functionality ensures that your customized cookie settings are precisely implemented, offering a seamless and personalized browsing experience that aligns with your privacy preferences.

    Expiry: 1 year Type: Local
Statistics

Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting information anonymously.

  • Google Analytics

    We create pseudonymous user profiles with the help of Google Analytics in order to design our websites in line with requirements. Google Analytics uses targeting cookies that are stored on your end device and can be read by us. In this way, we are able to recognize and count returning visitors and find out how often our websites are accessed by different users. Data processing is carried out on the basis of Art. 6 para. 1 lit. a) GDPR (consent) and § 25 para. 1 TDDDG. The information generated by the cookie about your use of our website is usually transmitted to a Google server in the USA and stored there. However, since we have activated IP anonymization on our website, your IP address will be shortened by Google beforehand within member states of the European Union. Only in exceptional cases will the full IP address be transmitted to a Google server in the USA and only shortened there (further information on the purpose and scope of data collection can be found, for example, at https://policies.google.com/privacy?hl=de&gl=de). We have also concluded an order processing contract with Google LLC (USA) in accordance with Art. 28 GDPR. Google will therefore only use all information strictly for the purpose of evaluating the use of our websites for us and compiling reports on website activity.

    _ga_

    This cookie is used by Google Analytics to persist session state.

    Expiry: 1 year 1 month Type: Third-party
    _ga

    This cookie name is associated with Google Universal Analytics - which is a significant update to Google's more commonly used analytics service. This cookie is used to distinguish unique users by assigning a randomly generated number as a client identifier. It is included in each page request in a site and used to calculate visitor, session and campaign data for the sites analytics reports.

    Expiry: 1 year 1 month Type: Third-party
  • Hotjar

    We use Hotjar Observe, a service provided by Hotjar Ltd, 3 Lyons Range, 20 Bisazza Street, Sliema SLM 1640, Malta, on our website. This is a software for the analysis and optimization of online offers on the basis of pseudonymous measurements and analyses of user behavior, which may include in particular A/B tests (measurement of the popularity and user-friendliness of different content and functions), measurement of click paths and interaction with content and functions of the online offer (so-called heat maps and recordings). The legal basis is your consent in accordance with Art. 6 para. 1 lit. a) GDPR and Section 25 para. 1 TDDDG.

    _hjSessionUser_*

    Set when a user first lands on a page. Ensures data from subsequent visits to the same site are attributed to the same user ID. Persists the Hotjar User ID which is unique to that site. Hotjar does not track users across different sites.

    Expiry: 1 year Type: Third-party
    _hjSession_*

    Holds current session data. Ensures subsequent requests in the session window are attributed to the same session.

    Expiry: 1 hour Type: Third-party
  • Zoom Info

    We use the advertising services of ZoomInfo for our website. The service provider is the Canadian company ZoomInfo Technologies LLC, 805 Broadway, Suite 900, Vancouver, WA 98660, Canada. Your data may also be processed in Canada and thus outside the scope of the GDPR. The European Commission has decided that there is an adequate level of protection for commercial offers from Canada in accordance with Art. 45 para. 1 GDPR. This means that data transfer to this country is permitted.

    __cf_bm

    This cookie is used to distinguish between humans and bots. This is beneficial for the website, in order to make valid reports on the use of their website.

    Expiry: 30 minutes Type: Third-party
    _zitok

    First-party cookie set by ZoomInfo to identify unique visitors.

    Expiry: 1 year Type: Third-party
    _cfuvid

    The _cfuvid cookie is used to allow the Cloudflare WAF to distinguish individual users who share the same IP address. Visitors who do not provide the cookie are likely to be grouped together and may not be able to access the site if there are many other visitors from the same IP address.

    Expiry: Session Type: Third-party
Marketing

Marketing cookies are used to track visitors across websites. The intention is to display ads that are relevant and engaging for the individual user and thereby more valuable for publishers and third party advertisers.

  • Linkedin

    Our website uses the “LinkedIn Insight Tag” conversion tool from LinkedIn Ireland Unlimited Company, Wilton Place, Dublin 2, Ireland.This tool creates a cookie in your web browser, which enables the following data to be collected: IP address, device and browser characteristics and page events (e.g. page views). This data is encrypted, anonymized within seven days and the anonymized data is deleted within 90 days. LinkedIn does not share any personal data with us, but offers anonymized reports on the website target group and display performance. LinkedIn also offers the option of retargeting via the Insight Tag.

    AnalyticsSyncHistory

    Used to store information about the time a sync with the lms_analytics cookie took place for users in the Designated Countries.

    Expiry: 1 month Type: Third-party
    li_gc

    Used to store guest consent to the use of cookies for non-essential purposes

    Expiry: 6 months Type: Third-party
    lidc

    Facilitates data center selection.

    Expiry: 1 day Type: Third-party
    UserMatchHistory

    This cookie is used to track visitors so that more relevant ads can be presented based on the visitor's preferences.

    Expiry: 1 month Type: Third-party
    bscookie

    Used for remembering that a logged in user is verified by two factor authentication and has previously logged in.

    Expiry: 1 year Type: Third-party
    bcookie

    Browser Identifier cookie to uniquely identify devices accessing LinkedIn to detect abuse on the platform .

    Expiry: 1 year Type: Third-party
    li_sugr

    Used to make a probabilistic match of a user's identity.

    Expiry: 3 months Type: Third-party