Policy of the Investigational Drugs in the Clinical Trial

Yousef Ahmed Alomi*, BSc. Pharm, MSc. Clin Pharm, BCPS, BCNSP, DiBA, CDE Critical Care Clinical Pharmacists, TPN Clinical Pharmacist, Freelancer Business Planner, Content Editor, and Data Analyst, Riyadh, SAUDI ARABIA. Amal Hassan Al-Najjar, BSc, MSc, Drug and Poison Information Center, Security Forces Hospitals, Riyadh, SAUDI ARABIA. Hamidah Qasim Ali Abushomi, BSc, MSc. Clin Pharm Dammam Medical Complex, Dammam, SAUDI ARABIA. Maha Hussein Almadany, BSc, Pharm, Health Care Quality Management Professional Diploma (HCQM), Pharmacy Quality Department, King Salman bin Abdulaziz Medical City, Al Madina Al Monwarah, SAUDI ARABIA.


INTRODUCTION
There are numerous research designs, including case reports, case series, case-control studies, and cohort studies apart from randomized clinical trials, systematic reviews, and meta-analyses. [1,2] The design strength ranged from a low of one such case report to a high of meta-analysis. [1,2] In the pharmacy practice, each design should have policies and procedures. The clinical trial had the most complex design with numerous and extensive procedures. Clinical trial performance standards were established nearly a century ago. [3] However, the entire picture was not clear until the International Council for Harmonisation released the first guideline in the 1970s and then regularly updated it. It is now referred to as good clinical practice guidelines. [3] Several studies discussed the guidelines in great detail. [4][5][6][7][8][9][10] However, detailed reviews of practical policy and procedures are rare or not found in biomedical publications. The majority of healthcare organizations kept their policies and procedures as their copyright throughout the institutions. Thus, the authors are unfamiliar with comprehensive publications on practice policy and procedures for conducting medication clinical trials. [11,12] However, there are reporting guidelines for clinical trials. [13][14][15] The current topic's goal is to declare the research policy and procedures, focusing on medication clinical trials.

MATERIALS AND METHODS
It's a narrative review of pharmacy research. Litterateur searched for specific topics related to research in pharmacy practice in a variety of databases, including PubMed, Medline, and Google Scholar. The time frame for the search is from the 1960s to October 2021. The terms used were in English and included narrative review, systemic review, Meta-analysis, and guidelines. The policies were limited for the previous ten years. In a search term, all hospital or community pharmacy services are included. Inpatient pharmacy, outpatient or ambulatory care pharmacy, satellite pharmacy, extemporaneous preparation, repackaging units, pharmacy store, drug information center, and clinical pharmacy services were among the pharmacy services available. Furthermore, the National and international guidelines for general research in hospital practice. [3][4][5][6][7][8][9][10][16][17][18][19][20][21] The Saudi Food and Drug Authority (SFDA), [5,16] the European Medicine Agency, [9] the American Society of Health-System Pharmacists (ASHP), [10] and the World Health Organization (WHO), [7] and other literature. [11,12,22,23] Aside from that, the Equator Network is a library of health research guidelines based on observational studies. This includes the Consolidated Standards of Reporting Trials (CONSORT); the Guidelines for Reporting Parallel Group Randomized Trials, which are guided by writing policy and procedures [13][14][15] which a committee of pharmacy researchers developed. Clinical pharmacists, drug information pharmacists, and clinical research specialists are among those who work in this field. One member's policy draft guidelines were reviewed and corrected by a second member, and the research specialist completed the third revision. Pharmacy research practice, research and ethical committee, data collection and organizations, quality of pharmacy research services, competency of pharmacy research services, and pharmacy research education and training were among the topics covered. The current reviews were reported in accordance with the adopted international Appraisal of Guidelines, Research, and Evaluation (AGREE). [24] The search term methodology was done as follows:

RESULTS AND DISCUSSION
The clinical drug study is a type of interventional clinical trial in which "Any investigation in human subjects with the purpose of determining or verifying the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), identifying any adverse reactions to an investigational product(s), and/or studying the absorption, distribution, metabolism, and excretion of an investigational product(s) to establish its safety and/or efficacy. Therefore, the terms clinical trial and clinical study are interchangeable. " [8,9,16] The clinical study's advantages included the following: Blinding is more likely, randomization facilitates statistical analysis, and the best experimental design is a Randomized Clinical Trial (RCT). [25,26] On the contrary, the disadvantages were prohibitively expensive, time-consuming, volunteer bias, occasionally ethically problematic, more difficult to conduct, and bias (selection/ allocation/observer/attrition/measurement/ compliance). [25,26] To avoid bias, a clinical trial is "blinded, " and the participants are unaware of whether they are in the experimental or control arm of the study. [16,27] The blinding could be single, double, or triple. Due to single blinding, the patient is oblivious to the treatment he is receiving. Due to the double-blinding, neither the subject nor the investigator knows which treatment is being planned. Thus, double-blinding ensures that all patient or therapy groups are treated and observed in the same manner. A method for maintaining blinding in a clinical trial in which the two treatments cannot be similar. Supplies are prepared for Treatment A (active and placebo) and Treatment B (active and placebo); patients are then randomly assigned to one of two treatment groups, either A (active) and B (placebo), or A (placebo) and B (active). [16,27] A standard trial against which experimental observations can be evaluated can be used to control controlled trials. [28] As far in clinical trials, one group of participants is given an experimental drug. In contrast, another group (the control group) is given either a standard treatment for the disease or a placebo. Therefore, a control group serves as a standard against which experimental results are measured. For example, one group of subjects will be given experimental medications or treatment, [28] and the control group, on the other hand, is given either a standard treatment for the illness or a placebo, a therapy with no significant efficacy. The control group must be ethically justifiable and capable of answering the study's most critical questions. The term "historical control" refers to an individual or group for whom data were collected prior to the study set. [29,30] There is a substantial risk of bias in studies that use historical controls due to systematic differences in the comparison sets caused by changes in risk, prognosis, and health care over time. [30] The suggested general policy for investigational drugs in the clinical trial is as follows [4,5,7-10,13-16,

Terms Definition
A clinical trial Human volunteers were used in a research study to answer particular health questions. Under controlled conditions, interventional studies establish whether experimental medicines or novel ways of employing existing therapies are safe and effective.

Control group
Participants are similar to the experimental group (for example, they are in the same age range) but are not given the experimental treatment. To compare the effect of the new drug, medical device, operation, changes are measured in both the treatment group and this group.

Experimental group
The group of individuals who got the new, well-researched treatment. This group is usually compared to a "control group, " or individuals who don't seem to be given the treatment.
Institutional Review Board, "IRB" A committee that has been officially assigned to safeguard individuals associated with research. This board should audit and approve each clinical study with the aim to ensure each person's safety, rights, privacy, and welfare.

Case Report Form (CRF)
A document records all protocol-required information on each trial subject for reporting to the sponsor.

Investigator Brochure
A collection of all known information about the test product to date includes chemistry and formulation data and preclinical and clinical data. It is at least once a year update. Once the product has been marketed, it's labeling (package insert) takes its position.
Informed Consent Form A document outlines a study participant's rights and information on the study's objective, duration, needed procedures, and essential contacts. The informed consent statement explains the risks and potential benefits.

Placebo
A chemical with no therapeutic effect is given to a patient who believes it is medicine but isn't. Placebos are also known as 'dummy pills' or 'sugar pills. '

Investigational drug
The trial's drug; this meaning is interchangeable with "investigative novel drug" or "investigative medical product. "

Medication number
Each experimental drug package has a unique number on the label used to dispense and track drugs in a trial. In addition, the number is used to ensure that the medicine is delivered in the correct quantity to various research facilities.
Adverse Event Any negative experience associated with using a pharmaceutical in a patient is referred to as an adverse event, also known as a side effect. Adverse reactions can be moderate or severe. Serious adverse events can result in impairment, are life-threatening, require hospitalization or death, or result in birth abnormalities.
Serious adverse event A life-threatening adverse event that necessitates hospitalization or an extended hospital stay causes continuous or substantial disability, causes congenital anomalies or congenital disabilities, or results in death.

Study completed date
The date of the last trial participant visited the research location for the final time (that is, "last partcipart, last visit") and the last samples or tests were gathered.

Sponsor
The Sponsor is the organization or person in charge of the clinical trial's many sites.

Principal Investigator
The person in charge of the clinical trials. He or she had scientific and technical guidance at a specific clinical site. Most of the time, the chief investigator will be a well-known physician in the field of research.

Study Coordinator
A crucial member of the research team; who works for the primary investigator or chief researcher. They are the individual who is generally in charge of the clinical study's daily operations.
Sub-Investigator Any member of an investigational team other than the investigator.

Protocol
The clinical trial is based on a written study design. A protocol outlines subjects eligible to participate in the trial, the tests, procedures, medications, and dosages that will be administered, the outcome measures that will be analyzed, and the study's duration.

Subject
During a clinical study, an individual's reactions or responses to various therapies are assessed (either as a healthy volunteer or as a patient volunteer). A trial participant is another term for this person.
Double-blind research A study in which neither the participant nor the researcher knows the treatment or control group is known as a double-blind study.
Double-blind, randomized, controlled clinical trial A double-blind, randomized, controlled clinical trial is one in which study participants are evenly divided into two groups: one receiving the experimental intervention and the other receiving standard or no care. Neither group is aware of how they were assigned. This method decreases the risk of a "placebo effect, " which occurs when a treatment that contains no active ingredient produces the same results as a treatment that includes an active component.
Blinding A sort of clinical trial design in which one or more trial participants, such as the research team, are unaware of which treatments have been assigned to them.

Randomization
Refers to the technique of assigning clinical trial participants to treatment or control groups based on a chance factor to eliminate bias.

Recruitment Plan
The recruiting plan lays out how people will be recruited for the study and how the study will meet its enrollment objective.
Standard Operating Procedure (SOPs) Detailed written instructions for ensuring consistency in the performance of a specific function among trials and patients at a single facility.

CONCLUSION
Clinical trial policies and procedures are essential in the practice of pharmacy. Patient safety is enhanced in any setting within a healthcare organization using this approach. Healthcare professionals, including pharmacists, review and update the entire policy and procedure regularly to ensure that it complies with new local regulations and international standards of good clinical practice. Clinical trial governance is strongly recommended for Saudi Arabia's new vision 2030.