What Is A Clinical Trial

Clinical research or study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: observational studies and clinical trials (also called interventional studies).

Observational Studies

Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.

Clinical Trials

The first recorded clinical trial was conducted in 1747 when the scientist, James Lind, conducted his first clinical trials on the efficacy of citrus fruits curing scurvy. There was no push for clinical trials after that for new medical devices or drugs. It was in the 1960s when thalidomide use in pregnant women for alleviating symptoms of morning sickness led to multi abnormalities found in the babies delivered by those women led to a global outcry for stronger regulation of therapeutic goods including clinical trials.

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Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.

Clinical trial process

Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.

Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention).

Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment. Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.

When Clinical Trials Is Needed

Clinical trial is mandatory for the following:

1. New or relatively new drug products, herbal formulations or cosmetics for which safety/efficacy profile has not been determined especially in our population.

2 Drugs for new indications.

3. Drugs for new patient population group (e.g. Age group, race etc)

4. New combination drug products.

5. New dosage schedule/regimen.

6. New drug delivery system.

7. New medical devices.

8. New medical procedures

9. Academic clinical trials on any of the above and

10. Bioequivalence Study

Registration Of Clinical Trial

For parties interested in carrying out clinical trial in Nigeria, the two responsible regulatory authorities are:

National Agency for Food and Drug Administration and Control (NAFDAC)

The Agency is responsible for protocol review and authorization of clinical trials before it is conducted in Nigeria. It is also responsible for carrying out inspection of trial sites to monitor the conduct of authorized studies to ensure that well-being and safety of the participants is protected and credible data is obtained from the study. The public is hereby informed that there are stipulated penalties for violation of the above provisions and conduct of unauthorized clinical trials in Nigeria.

National Health Research Ethics Committee (NHREC)

The Committee is responsible for accreditation of the Independent Ethics Committee (IEC) and or the Institutional Review Board (IRB) that give ethical opinions on study protocols depending on the number of trial sites involved.

In order to reduce the processing timeline for Clinical Trial applications, the study protocol can be submitted simultaneously to NAFDAC and the Ethics Committee. However, ethical opinion must be obtained before NAFDAC issues final authorization for the conduct of the trial subject to satisfactory review.

Before the national agency for food and drug administration and control (NAFDAC) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the NAFDAC gives approval for the intervention to be tested in humans.

WHO’s International Clinical Trials Registry Platform (ICTRP) links clinical trials registers globally in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others.

Why Register a Trial

There are both ethical and scientific reasons for registering trials. People who participate in clinical trials expect their contributions to be made use of in improving health care for everyone. Open access to information about ongoing and completed trials will satisfy the ethical duty to trial participants and will promote greater trust and public confidence in clinical research. Clinical trial registration in open access registries will also reduce selective publication of trial results, because by registering a trial the researchers commit to report the findings in accordance with basic ethical principles.

Selective reporting, regardless of the reason for it, leads to an incomplete view of the trial and its results. In addition to the above, clinical trial registration will decrease wasteful duplication of research, promote international research collaboration and ensure more efficient and effective allocation of research funds.

Benefits Of Registering A Trial In The Nigerian Clinical Trials Registry (NCTR)

The benefits of the Nigeria Clinical Trial Registry (NCTR) will be felt by a wide audience including policy makers, health professionals, clinical trial funders, development agencies, researchers, and the lay public.

Read Also: Guidelines For Clinical Trial Application In Nigeria

Policy makers will benefit from the regulatory aspects of the Registry as they will be able to keep track of all clinical trial activity in the country. They will have a clearer idea of how clinical trial activity is serving the health needs of the population, as the Registry will provide them with up-to-date information on the nature and location of clinical trials being conducted. Policy makers will also benefit from the information provided by those comprehensive systematic reviews that will incorporate trial information from the Registry.

Health professionals will be able to find out information on trials in progress so that they can advise patients about appropriate trials in which to participate. Health professionals will also benefit from the evidence provided by comprehensive systematic reviews which may include information directly from the NCTR.

Clinical trial funders may obtain information on what research is being conducted, where the research is being conducted and by whom. This information will enable them to allocate their funding in a more appropriate and effective manner.

Phases Of Clinical Trials

There are 4 phases of biomedical clinical trials:

A. Phase I studies usually test new drugs for the first time in a small group of often healthy people (20 to 80) to evaluate a safe dosage range and identify side effects.

B. Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects (100 to 300) to monitor for any adverse effects and effectiveness. This has also confirmed the drug on certain diseases or conditions. Data on phase I is also monitored. Phase II can last for several years.

C. Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved. The number of subjects usually ranges from several hundred to about 3,000 people. The data are the same with phase I and II.

D. Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

Who Conducts Clinical Trials?

Every clinical trial is led by a principal investigator, who is often a pharmacist. Clinical trials also have a research team that may include doctors, nurses, social workers, and other health care professionals.

Clinical trial can be sponsored, or funded, by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations, in addition to Federal agencies. Doctors, other health care providers, and other individuals can also sponsor clinical research.

Process Of Clinical Trial

Here’s what happens in a trial

1. Study staff explain the trial in detail and gather more information about you.

2. You Ask Questions

a. What is being studied?

b. Why do researchers believe the intervention being tested might be effective?

b. Why might it not be effective? Has it been tested before?

c. What are the possible interventions that I might receive during the trial?

d. How will it be determined which interventions I receive (for example, by chance)?

e. Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?

f. How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?

g. What will I have to do?

h. What tests and procedures are involved?

i. How often will I have to visit the hospital or clinic?

j. Will hospitalization be required?

k. How long will the study last?

l. Who will pay for my participation?

m. Will I be reimbursed for other expenses?

n. What type of long-term follow-up care is part of this trial?

m. If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?

o. Will the results of the study be provided to me?

p. Who will oversee my medical care while I am participating in the trial?

q. What are my options if I am injured during the study?

3. Once you have had all your questions answered and agree to participate, you sign an informed consent form.

Read Also: Guidelines For Submission Of Clinical Trial Progress Report

4. You are screened to make sure you qualify for the trial. Eligibility criteria depends on the research protocol. Some research studies seek participants who have the illnesses or conditions that will be studied, other studies are looking for healthy participants, and some studies are limited to a predetermined group of people who are asked by researchers to enroll. They are based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Most of this information will be gathered about the participants. Those that did not meet these eligibility criteria are excluded. Those with eligibility criteria are included in the clinical trial.

5. If accepted into the trial, you schedule a first visit (called the “baseline” visit). The researchers conduct cognitive and/or physical tests during this visit.

6. You are randomly assigned to a treatment or control group.

7. You and your family members follow the trial procedures and report any issues or concerns to researchers.

8. You may visit the research site at regularly scheduled times for new cognitive, physical, or other evaluations and discussions with staff. At these visits, the research team collects information about effects of the intervention and your safety and well-being.

9. You continue to see your regular physician for usual health care throughout the study.

Clinical studies can take place in many locations, including hospitals, universities, doctors' offices, and community clinics. The location depends on who is conducting the study. The length of a clinical study varies, depending on what is being studied. Participants are told how long the study will last before they enroll.