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Before a drug, a diet, or a procedure becomes available for the general population to use, they go through specific steps to make sure they are safe and effective.

1. Doctors or researchers have an idea they would like to test.
2. They write a detailed plan called a protocol.
3. Other doctors check the plan through peer review.
4. The research team get funding to run the trial and a sponsor.
5. An ethics committee approves the plan.
6. Trial authorisation and trial sites.
7. Participants join the trial.
8. The research team analyse the results.
9. Licensing and prescribing the use of treatment if it is proven effective.

1. Idea Generation in Clinical Trials

The first step starts with an idea researchers or doctors want to test. This could come from laboratory work, patient groups, or other trial results.

The idea could involve:

• A new treatment (or diets, procedures or any new investigations).
• A new combination of treatments.
• Using an existing treatment for another condition.
• Testing a new way of giving a current treatment.

2. Developing a Detailed Protocol

The team interested in doing the trial writes a detailed plan (protocol) that everyone involved will use. 

The protocol contains essential information, including:

• why do researchers want to do the trial;
• who will be able to take part (the eligibility criteria);
• how many people do they need to take part;
• what the treatments are;
• what tests and appointments will people have to go through before, during and after treatment;
• how and when do they plan to analyse the results to know if their idea worked.

Quite often, the protocol lists all the existing treatments, if there are any. For the researchers, it will also list information such as what they need to do when contacting participants, what procedures they need to perform, and the data they want to see to understand if their idea worked, etc.

3. Peer Review of the Clinical Trial Plan

Doctors, researchers, and statistics experts who are not involved with the trial but are experts in the field will then check the protocol to ensure it's valid. 

Peers look at all aspects of the trial, including:

• how important the research question is;
• how easy will it be to find people to take part;
• if the plan to analyse the results is suitable;
• if there are any possible difficulties not listed;
• is there anything that they have not written down;
• is the statistical plan suitable, and is it going to give the results needed to progress to the next stage.

4. Securing Funding for Clinical Trial

The research team needs funding to run the trial. This usually comes from a sponsor. Common funders are charities, governments, and pharmaceutical companies.

Sponsors can be organisations, individuals, or multiple sponsors (co-sponsors) and can also manage trials.

The sponsor ensures the researchers follow regulations, such as protocol and ethical guidelines. This ensures the safety of the study's participants and that the researchers get the data they need.

5. Ethics Committee Approval

The Committee or REC will consist of up to 15 people not directly involved with the trial. Some medical and scientific people will be on the Committee, but most will include people who do not work in that area.

The REC's role is to protect participants' rights, safety and dignity.

The Ethics Committee checks:  

• The aim of the trial is important to patients.
• The way patients will be recruited.
• The benefits are greater than the risks.
• The trial research team are adequately qualified.
• The peer review has been completed.
• All information facing participants will be easy to understand.

If the protocol is altered during the trial, the Committee must re-approve any changes. The research team will inform the Committee of any unexpected severe side effects, and REC can stop the trial at any time if they have concerns.

6. Clinical Trial Authorisation and Site Selection

In the UK, this is done by the Medical & Healthcare Products Regulation Agency (MHRA), in Europe by the European Medicine Agency (EMA) and in the US, by the Food and Drug Administration (FDA). 

Trials can take place in various settings, such as hospitals, general practitioner (GP) offices, and Clinical Research Organisations (CROs). Hospitals participating in trials must obtain approval from their Research and Development (R&D) department.

All trial centres must ensure they have the necessary staff, time, equipment, and expertise to conduct the trial safely.

Hospitals taking part in trials must get approval from their R&D Department.

Before the trial can commence, the trial team must undergo training, which may involve doctors, research nurses, pharmacists, and radiographers.

7. Participant Recruitment and Enrollment

Before joining the trial, participants must meet specific criteria to ensure they are as similar as possible in age, health, diet, previous or current treatment, symptoms, and diagnosis. This is important for the investigators to guarantee the participants' safety. Some criteria will be exclusionary because of safety factors, such as certain health conditions or medications.

Eligibility Criteria may include the potential participants':

• current diagnosis and symptoms;
• previous or current treatments;
• diet;
• age;
• general health;
• other medical conditions.

8. Data Analysis and Result Interpretation

Analysis of the Results

Data analysis continues throughout the study. Sometimes, researchers receive interim data analyses, where the team evaluates whether the trial should continue. In some cases, if the trial is not working as expected or if there are unforeseen safety concerns, the team may decide to stop the trial early.

Once the trial is over, the research team will look at and analyse the results.

They will draw some conclusions about the treatments in the trial and may make recommendations for future research. Many research teams publish the results in a medical journal or present them at a conference. This is to share what they have learnt.

Sometimes, the results show that the new treatment isn't better than the existing treatment. Even so, it adds to our knowledge and understanding of certain diseases and how to treat them.

The results also help decide what should be done in the next trial.

9. Licensing and Prescribing New Treatments

The last step is approving the use of new treatments and devices. They can be licensed if the trial results are positive for treatment, diet, or intervention and show benefits. 

Licensing new treatments is quite a long and complicated process. It might take 4-5 years before the drug receives a license because of all the data analysis that needs to happen before that point. It often depends on the results of multiple trials in different places with different populations for the same treatment.

In the UK, this is done by the Medical & Healthcare Products Regulation Agency (MHRA), in Europe by the European Medicine Agency (EMA) and in the US, by the Food and Drug Administration (FDA). 

Treatments require a further recommendation from the NICE before the NHS can prescribe them.

NICE looks at multiple factors such as benefits for that particular population, cost, other treatments available, and the suitability of prescriptions on the NHS.

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Navigate to other pages about clinical studies:

1. Clinical Trials Explained: Learn the basics

2. Clinical Trials Process: Start to Finish

3. Types of Clinical Trials

4. Accuracy and Safety in Clinical Trials

5. Phases Of Clinical Trials

6. Clinical Trial: Key Participant Information

7. Clinical Trials Community Questions