Clinical Studies

General

The different phases

Clinical studies are conducted in three successive phases, of varying lengths, at research sites.

Phases I

Phase I studies are the first studies on humans, and take place before the efficacy of a treatment is evaluated. They are conducted on a small group of healthy volunteers. The main aim of this phase is to evaluate the tolerability, the absence of side effects and the way in which the product is absorbed, distributed and metabolised by the body. This phase may, in exceptional cases, not need to be carried out.

Phases II

Phase II studies are conducted on a larger group than phase I studies, comprised of volunteers suffering from the disease targeted by the test product. The aim of this phase is to study whether the expected beneficial effects are observed in the population affected by the targeted disease, as well as the side effects of the test product at the doses associated with beneficial effects.

Phases III

Phase III studies involve a much larger group of patients. The aim is to formally test the nature and extent of the benefits of the new treatment versus a comparator in terms of safety and efficacy. From phase II, but more generally during phase III, the treatment is compared to a standard treatment, called a “reference” treatment, and/or a placebo treatment, that is, with no pharmacological properties.

At the end of phase III, the treatment may be submitted to the competent authorities and reimbursement authorities in order to obtain marketing authorisation. The competent authorities may be, for example, the European Medicines Agency (EMA) or the American Food and Drug Administration (FDA)

Veterinary medicines

The development of a veterinary medicine follows a rigorous process comparable to that for human medicines, but adapted to the specific characteristics of animal species and veterinary regulations (in Europe, supervised by the European Medicines Agency (EMA) and in France by the National Agency for Veterinary Medicines (ANMV)).

What is a clinical study?

A clinical study is a study which is designed to evaluate the safety and efficacy of a new treatment in humans.

Before reaching the clinical study stage, the hypothetical treatment is first tested in the laboratory – in vitro and in vivo (on animal models) – to confirm the relevance and safety of the hypothesis. If the results are satisfactory, it is then tested on human subjects during clinical studies.

The key players

The sponsor

The sponsor initiates and finances the clinical trial and handles the organisation and execution thereof. The sponsor may be a legal person (non-governmental organisation, laboratory or business) or a physical person.

The investigator

The investigator is a doctor who supervises the conduct of the clinical trial. He/She is the link between the sponsor and the patient who is participating in the study. The patient is, therefore, never in direct contact with the sponsor. The investigator supervises the clinical study in a hospital centre, or in a private or public establishment, which is called the investigating site.

The patients

The patients are the participants in the clinical study. They must meet certain eligibility criteria in order to be enrolled in the study.

Advantages and disadvantages

The patient may benefit from several advantages by participating in a clinical study:

Possibility of receiving a promising treatment before it is marketed.
Close medical follow-up by a highly qualified team.
Contribution to the advancement of medical research in the clinical study field.

There are also some constraints and disadvantages:

Strict protocol of visits with which the patient must comply in order to monitor disease progression.
Possible administration of a placebo instead of the test treatment.
Possible adverse side effects.
Uncertainty with respect to the efficacy of the treatment.

Who can participate?

In order to participate, patients must meet the eligibility criteria (also called inclusion criteria) required for the study in which they want to participate. These criteria may, for example, be based on age, diagnosis or the stage of progression of the treated disease.

Patients must be able to understand the requirements of the study and read and sign the informed consent document.

There are also exclusion criteria which exclude some patients from participating in the study. These may, for example, be associated with a list of particular treatments or diseases.

The informed consent

Choosing to participate in a study is an important personal decision. Patients should first talk it through with their doctor and family members in order to discuss the state of their health and different treatment options. If the patient is interested in the study, his/her doctor will then be able to redirect him/her to their nearest clinical trial site.

BioSenic is not authorised to refer patients to clinical study sites or respond to their requests for information regarding participation in ongoing trials.

If you are a physician and you would like to receive information regarding a BioSenic study or you have an eligible patient interested in a study, you can contact BioSenic

During the process of obtaining informed consent, the doctor ensures that the potential patient has received the necessary information regarding the trial (the aim, the treatment given, the duration and the protocol) and regarding the risks involved. Once the patient has received this information and if he/she is still interested in participating in the study, he/she will sign an informed consent document as proof of his/her consent.

Once the document has been signed, the patient can still withdraw from the study at any time, without having to give a reason or being subject to damages as a result of his/her withdrawal.

4P004v

Phase I

BioSenic is co-developing, with the French company 4Moving Biotech, 4P004v, a veterinary drug for dogs recovering from surgery after ligament repair. The aim is to modify the course of the disease for better post-operative recovery and long-term joint quality after cranial cruciate ligament (CCL) surgery. Each year, more than 750,000 dogs undergo this type of surgery in the United States and Europe. With the drugs currently available treating only the symptoms, 4P004v could meet a major unmet need.

With its unique anti-inflammatory, anti-catabolic, and regenerative action, 4P004v is positioned as the first-in-class candidate in veterinary orthopedics. 4P004 is a GLP-1 analog designed for intra-articular use in human knee osteoarthritis. The current objective is to demonstrate clinical proof of concept in dogs following ligament repair. The Phase I clinical study is ongoing.

Medical devices

A medical device is a healthcare product intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of a disease, injury, or disability.

This extremely broad field covers everything from bandages to screening tests and prostheses. Medical devices nevertheless have one thing in common: they have a mechanical or physical action. For example, a bandage acts as a barrier between an injury and the ambient air, while a prosthesis can replace a natural joint.

Medical devices are classified into four classes (from lowest to highest risk), each corresponding to specific regulatory compliance requirements.

More

In Europe, medical devices are divided into classes I to III.

Class I (lowest risk class) E.g., corrective eyeglasses, vehicles for disabled persons, crutches, compresses, compression bandages.
Class IIa (moderate/measured potential risk) Ex. contact lenses, ultrasound devices, dental crowns, skin staples, hearing aids.
Class IIb (high/significant potential risk) Ex. condoms, lens disinfectants, infusion pumps.
Class III (highest risk class) Examples: breast implants, stents, hip replacements, pacemakers.

In vitro diagnostic medical devices (IVDs) are classified separately into classes A to D.

Class A (low individual risk and low risk to public health) General laboratory products intended by the manufacturer for in vitro diagnostic procedures. E.g., specific cleaning solutions, certain dyes.
Class B (moderate individual risk and/or low risk to public health) E.g., pregnancy detection, cholesterol level determination.
Class C (high individual risk and/or moderate public health risk(s)) E.g., detection of certain sexually transmitted agents (Chlamydia, Herpes, Human Papilloma Virus, etc.), cancer screening or diagnostic tests, most self-tests.
Class D (high individual risk and high risk to public health) E.g., HIV, SARS-CoV-2, or hepatitis C screening tests, blood group marker (ABO).