If you are developing a new medicine, medical product, therapy or healthcare intervention then at some point along the way you will hear the term clinical trial used. But what does that mean and why do we need one in the development process?
In simple terms a clinical trial is a structured research study with human participants to assess the effects of an intervention on health related outcomes. Depending on the research question, this intervention could be a medicine, vaccine, medical device, procedure, behavioural intervention or another healthcare approach.
Pharmaceutical, biotechnology and healthcare companies need to understand what a clinical trial entails before deciding how to plan, manage and support a clinical development program.
At FrontroPharma we work with organisations who need professional support for clinical research and clinical trial activities in India. We start by understanding the product, development objectives and research requirements before deciding what support is required.
What Is a Clinical Trial?
A clinical trial is a prospective research study involving human subjects that measures the effect of an intervention on health-related biomedical or behavioural outcomes.
The NIH uses four questions to help determine whether a study fits their definition of clinical trial:
- Does the study involve human participants?
- Are participants prospectively assigned to an intervention?
- Is the study intended to test whether that intervention works? Is it intended to measure the effect of that intervention?
- Is the effect being evaluated biomedical or behavioural health-related?
If these conditions are met then the study may be considered a clinical trial by NIH.
The U.S. FDA defines clinical trials as research studies in human volunteers that evaluate medical products (medicines, vaccines or devices) for safety and effectiveness. Put simply — a clinical trial is how researchers get structured evidence on how an intervention performs when studied in people.
Why Are Clinical Trials Conducted?
Clinical trials are an important part of medical research and product development.
A promising intervention may show promise in the lab or other pre-clinical work but human studies are needed to know how it works in people.
Clinical trials can be used to investigate questions about:
Clinical trials are often used to test a hypothesis. A hypothesis is an idea that you want to test. The question is what do we actually want to find out? What will happen if we do something? A hypothesis could be “if I heat up this material it will expand.”
- Safety.
- Effectiveness.
- Tolerability.
- Appropriate use.
- Side effects.
- Health outcomes.
- How an intervention performs in a population.
NIH says that clinical trials can be done on new drugs or drug combinations, surgical procedures, medical devices, behavioural interventions and new ways of using existing treatments. So what does this mean? A clinical trial isn’t just about proving that a product “works.” It is a structured way of answering specific scientific and medical questions.
Clinical Trial vs Clinical Research: Are They the Same?
Not exactly. Clinical research is a broad term for research about people. It can include patient-oriented research, epidemiology, behavioural research, outcomes research and health services research.
A clinical trial is one type of clinical research where participants are prospectively assigned to an intervention in order to study its effects on a health-related outcome.
This distinction is useful for companies because a research programme may include several activities but not every human research study qualifies as a clinical trial under every regulatory or institutional definition.
For a given project the definition used may be different depending on the regulatory framework and organisation.
What Happens in a Clinical Trial?
While the exact design of a study will vary from study to study, a clinical trial generally follows a structured research process.
The study starts with a defined research question.
For example:
Does this investigational treatment provide meaningful benefit to people with a condition while having an acceptable safety profile?
The research team then develops an appropriate study approach for answering that question.
This can involve planning around:
- Study objectives.
- Participant population
- Eligibility requirements
- Intervention
- Outcome measures
- Data collection
- Safety monitoring
- Study procedures
- Documentation
- Statistical analysis
The study is then conducted according to its approved requirements and data collected and analysed to help answer the research questions.
The exact operational requirements may differ according to the intervention, population studied, study design and regulations.
Who Is Involved in a Clinical Trial?
A clinical trial is rarely the responsibility of one person or organisation.
Depending on the project different stakeholders can be involved in research.
Sponsor.
Sponsor can be a pharmaceutical company, biotechnology company, medical device company, academic organisation or other entity that initiates and supports the study.
Investigators.
Clinical investigators conduct the study at the research site or sites (or sites) and oversee participant-related activities.
Clinical Research Teams.
Clinical research professionals can support study planning, coordination, monitoring, documentation, data related activities and other operational needs.
Research Sites.
Hospitals, clinics, universities and specialist research facilities may carry out clinical trial activities involving participants.
Participants.
Human volunteers are the backbone of clinical research. Depending on the study, participants can be healthy volunteers or people with a disease or medical condition. The FDA says participation in clinical trials is voluntary.
Regulatory and Ethics Bodies.
Clinical research also takes place within regulatory and ethics bodies that protect participants and ensure that research is conducted properly.
Why Participant Safety Matters?
A clinical trial is not an experiment done on people. Participant safety and ethical conduct are central concerns.
Before and during a clinical trial safeguards are put in place to protect the participants and their rights.
For example, informed consent is part of ethical clinical research. Participants should be told about the study before they decide whether to take part.
The FDA says people volunteer to participate and can leave a clinical trial when they want. Regulatory and ethics oversight is also an important part of clinical research too. Depending on jurisdiction and study appropriate review and approvals may be required before research involving participants begins.
For organisations developing a new healthcare product these requirements need to be factored into clinical development planning not treated as an afterthought.
What Types of Products Can Be Studied?
Depending on the research question, clinical trials may include:
- recruitment and screening
- testing of treatments
- follow-up testing of treatment effects
- Investigational drugs.
- Vaccines
- Medical devices
- Biological products
- Surgical procedures
- Behavioural interventions
- New uses of existing treatments
- Other healthcare interventions
The NIH specifically states that clinical trials can investigate drugs, treatments, devices and behavioural interventions (National Institutes of Health). For a pharmaceutical or biotechnology company the specific clinical research strategy should therefore be developed around the product and the evidence that needs to be generated.
Clinical Trials Are About Generating Reliable Evidence
One of the biggest reasons clinical trials matter is the quality of evidence they can generate when properly designed and conducted.
A company may have laboratory findings or preclinical data that are promising but those findings don’t tell researchers how an intervention will perform in humans.
Clinical research is an opportunity to systematically gather information from participants within a defined research framework.
This can help answer questions such as:
- Is the intervention tolerated?
- What safety information emerges?
- Does it produce the intended health outcome?
- How do participants respond?
- Are there important adverse events?
- Does the intervention merit further development?
The answers can be used to make decisions about future development of the product.
Clinical Trial Planning Requires More Than Finding Participants
One common misconception for businesses entering clinical development is that a clinical trial is all about recruiting participants and collecting data.
In reality there are many activities that are interconnected with a study.
A well-designed programme may take into account:
- Scientific objectives — What question does the study need to answer?
- Study population — Who needs to participate?
- Study design — What approach fits the research question?
- Operational planning — How will the study be carried out?
- Data management — How will study information be captured and managed?
- Data processing (how) — how will study information be processed (what)?
- Data storage (where) — where will study information be stored?
- Data transfer (who) — who will transfer study information?
- Data security (why) — why must study information be protected?
- Safety oversight — How will participant safety information be monitored?
- Documentation — What records and reports need to be kept?
- Regulatory and ethical requirements — What approvals and compliance requirements apply?
So that’s why companies often hire clinical research professionals instead of trying to do it all in-house.
When Should a Company Start Thinking About Clinical Trials?
Clinical trial planning should not begin only when a company is ready to recruit its first participant.
For pharmaceutical and biotechnology companies clinical development planning can start long before operationalisation.
Early planning can help organisations understand:
- What evidence needs to be produced.
- What resources might need to be available.
- Who needs to be involved?
- What regulatory issues may arise?
- What operational capabilities are needed?
- What timelines and milestones need to be considered.
The earlier these questions are answered the easier it is to see what challenges there might be before the study becomes operationally complex.
The requirements are different for each product, indication, study design and jurisdiction.
Where Does a Clinical Research Organisation Fit In?
Companies that are developing healthcare products may choose to work with a clinical research organisation (CRO) or other specialist research partner for some activities.
A CRO can support professional work in different areas of clinical research depending on its capabilities and the scope of engagement.
This can be useful for companies that:
- Do not have a large internal clinical research team.
- Need additional research expertise.
- Are new to clinical development (first time round).
- Need operational support in India.
- Want specialist support for an ongoing programme.
- Need additional resources for specific clinical research activities.
The right partner should be selected based on the requirements of the programme, not just based on how many services are listed on their website.
Choosing a Clinical Trial Partner in India
If your organisation is planning clinical research in India then the choice of research partner needs to be carefully considered.
Look for a team that can understand your:
- Product.
- Research goals.
- Development stage.
- Target population.
- Study requirements.
- Operational needs.
- Documentation expectations (you may also want to talk about the partner’s experience, communication process, project management style and ability to support your research requirements).
When companies are looking for a clinical trial company, the first thing they should do is find a partner that understands the scientific and operational requirements of the project and can support it appropriately.
Choosing a Clinical Trial Partner in India
At FrontroPharma, we work with organisations who need clinical research and clinical trial support in India.
What we do starts with what you are developing and what you need to achieve.
We don’t treat every project exactly the same way so we consider your product, goals, development stage and study needs before discussing support.
Our clinical trial services can help organisations that need professional assistance with clinical research activities and study execution .
If you are right now asking “what is a clinical trial?” because your company is thinking of moving a pharmaceutical, biotechnology or healthcare product into human research then this is the time to start talking about what you need with an experienced team.
Choosing a Clinical Trial Partner in India
Understanding what a clinical trial is only the starting point. The next step is understanding what your particular product, research question and development objectives need.
You don’t have to know every detail before calling a clinical research partner.
If you are developing a product and need to know about the clinical research requirements talk to FrontroPharma’s experts about your project. We can discuss your objectives with you and help you figure out what next steps for your clinical research programme in India.
Planning a clinical trial? Contact FrontroPharma to discuss your project and clinical research requirements.
