Clinical trials are health related research studies using human volunteers or participants that are intended to contribute to medical knowledge.
There are two main types of clinical trials: Interventional and Observational.
Interventional Trials: In an interventional clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. Interventions may be medical drugs or devices, changes in medical procedures; or participants’ behaviour, such as diet. They may compare a standard approach to a newly available one, a known drug to a placebo or may involve no interventions at all. When investigating a new product, it is not usually known whether it will be helpful, harmful, or no different than available alternatives. Investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.
Observational Trials: In an observational clinical trial, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
To learn more about clinical trials: visit here: https://clinicaltrials.gov/ct2/about-studies/learn
Participant Benefits in Clinical Research:
Benefits in participating in clinical trials may include (but are not limited to):
- Playing a more active role in your own health and healthcare
- Gaining access to new treatments that may otherwise not yet be available
- Helping others by contributing to medical research
Clinical studies have specific “eligibility” criteria outlining who can participate. “Inclusion criteria“ outline the factors that allow participation while “exclusion criteria“ outline the factors that disallow participation in clinical trials. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek:
- participants who have the illnesses or conditions that will be studied
- healthy participants for a control group
Participant Safety in a Clinical Research Trial: Informed Consent
Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical research trial. It is intended to protect participants and should provide enough information for a person to understand the purpose, duration, risks, potential benefits and alternatives to the study. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
Participant Safety in a Clinical Research Trial: Data Protection and Confidentiality
In Beacon Hospital your privacy is of utmost importance to us and we take that responsibility
very seriously. The law on data protection means we have to protect your data to a very high standard.
The General Data Protection Regulation 2018 is Article 6: 6 (1)(e) Public Interest and Article 9: 9 (2) (j) Scientific Research Purpose state that you have the following rights as a data subject to:
- Request access to your data and ask for a copy of it
- Restrict or object to processing of your data
- Have any inaccurate information about you corrected or deleted
- Have your personal data deleted
- Have a right to data portability, meaning you have a right to move your
- data from one controller to another in a readable format
- Object to automated processing including profiling if you wish
- Lodge a complaint with the Data Protection Commissioner
Participant Safety in a Clinical Research Trial: Regulation and Monitoring
In order to ensure participant safety, clinical research trials are tightly regulated and monitored by several ethical and legal standards. They must first pass a stringent independent ethical review process before commencing. Throughout the duration of the trial they must adhere to strict guidelines in a controlled study protocol and report any adjustments to this protocol to the ethics review board.