General Questions

 

What is a clinical trial?

There are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

 

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

 

 

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

 

 

 

 

What are the benefits and risks of participating in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their own health care.

  • Gain access to new research treatments before they are widely available.

  • Obtain expert medical care at leading health care facilities during the trial.

  • Help others by contributing to medical research.

Risks

There are risks to clinical trials:

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

  • The experimental treatment may not be effective for the participant.

  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

  • What is the purpose of the study?

  • Who is going to be in the study?

  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?

  • What kinds of tests and experimental treatments are involved?

  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?

  • How might this trial affect my daily life?

  • How long will the trial last?

  • Will hospitalization be required?

  • Who will pay for the experimental treatment?

  • Will I be reimbursed for other expenses?

  • What type of long-term follow up care is part of this study?

  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?

  • Who will be in charge of my care?\

 

Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.


Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to governmental  agencies such as the king Abdullaziz City for Science and Technology (KACST).

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.


What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In 
Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In 
Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In 
Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In 
Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

 

 

 

 

Frequently Asked Questions

 

   

1. What are the SFDA Clinical Trial Regulations?

SFDA Clinical Trials Regulations effect in April 2010, is the legal tool that adapted from international Regulatory authority (FDA, EMA and ICH) and the SFDA Clinical trials Regulations have their own regulations in specific scientific and ethical directives according to national law.

                             

2. Are all clinical trials covered by the SFDA Regulations?

The SFDA Regulations cover all investigations/ Non-interventional studies which are undertaken to discover the efficacy or safety of a medicine in human subjects. Non-interventional trials are waived from several directive stated in the Regulations.

                                                                                                        

3. What waives that SFDA regulation stated regarding Non-interventional trials application?

Beside accelerated evaluation pathway (4 weeks) For such studies the documentation of clinical trial application should submitted with below documents:

 

1. Headed Cover Letter to VP of drug affaires. 

2. Study Protocol.

3. IRB approval.

4. C.V of Investigators.(If applicable).

5. List of names of Investigators and sites that Post Marketing Studies will conducted.

5. Consent form (English & Arabic).

6. CRF.

 

4. What steps are being taken by SFDA to deal with the concern of the individual researcher , academic institution and non government organization funded clinical trials who fear that the SFDA regulation could unnecessarily delay or stop trials?           

As well as submitting a complete Clinical Trial application file and trials involving products with a registered drug that are prescribed in the usual manner and used in accordance with the registration; SFDA  response will be accelerated with waives from several directive stated in the Regulations.

 

5.  What are the SFDA Regulations requirements for sponsorship?

The SFDA does require a sponsor to take responsibility for the initiation, management and/or financing of a trial.

 

6. How are clinical trial volunteers be protected under the Regulations?

The SFDA Regulations require that each trial has a sponsor who must obtain approval from SFDA and approval from ethics committee in clinical trial site before the trial can conduct. additionally, there are a national requirements that must followed according to Issued Royal Decree No. (321) on 9 Ramadan 1431 H and the judge approving the ethics of research on living creatures, prepared by the National Committee for Bioethics and medical King Abdulaziz City for Science and Technology. Finally, a requirement that medicines used in trials are manufactured to standards of Good Clinical Practice (GCP) to prevent subjects being exposed to unsafe medicines.

 

7. Is GMP certificate is mandatory for all study drugs?

The SFDA Regulations require that medicines to be used in a trial be manufactured to standards of Good Manufacturing Practice (GMP) to prevent participants being exposed to unsafe medicines. GMP certificate is not require for registered drug in SFDA.

 

8. What is the role of sponsor/investigator regarding Safety?

During the trial the sponsor and investigator monitor participants’ safety and notify SFDA and the ethics committee of any unexpected serious adverse reactions to the medicines used in the trial so that the effects of unanticipated risks are minimized.

 

9. What's the process should be follow to notify ADR/SE to SFDA?

 

the sponsor should report ADR to National center of pharmacovigilance and clinical trial department if the drug is registered in SFDA. For unregistered drug in SFDA reporting should sent only to Clinical trial department. The sponsor must reports (written report) the event to SFDA within 7 calendar days If the event is serious, unexpected, drug related and results in the following outcome: Death, life threatening, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect and important medical event. If the event is serious , unexpected, drug related and: non life-threatening the sponsor submits a written report of the event to the SFDA within 15 calendar days.

  

10. Are there any fees to conduct a clinical trial? And why?

 The SFDA charges fees to recover the administration costs of evaluation, authorization, and inspection. The fees charged is 15.000 SAR for one study.

 

11. I am an individual researcher without sponsorship. Is it possible to differentiate between commercial and academic research for the purpose of charging fees?

SFDA waives charging fees for individual researcher , academic institution and government organization funded clinical trials.

 

12. What are the intermediary planning for a trial that began before the Regulations were effected?

 All currently conducted clinical trials were converted to “Clinical Trial notification” without any further application. SFDA require only the Preliminary Results , final findings and PSUR. 

 

  

 

13.   Are there any documents required  to conduct study on approved drugs for approved indication but with new dosing regimen.

 

Yes. For such case interventional studies, the sponsor or researcher should apply for Clinical Trial authorization, the application should include:

 

ü  Headed Letter to SFDA.

ü  Bank Transfer Payment. (If applicable, Only for Clinical Trial sponsored by Pharmaceutical Company)

ü  Confidentiality Agreement between the sponsor and the Principle Investigator.

ü  Trial Application Form.

ü  Trial Protocol.

ü  Informed Consent Form (English & Arabic)

ü  IRB/EC Approval.

ü  Investigator Brochure.

ü  Financial Disclosure of Principal Investigator.

ü  GMP Certificate. (For unregistered drug in SFDA)

ü  Certificate of Analysis of Study Drug. (For unregistered drug in SFDA)

ü  Label of Trial Drugs.

ü  Investigational Medicinal Product (IMP) Labeling & Packaging. (For unregistered drug in SFDA)

ü  Clinical Trial Agreement between the sponsor and the Principle Investigator.

ü  CVs of Principal Investigator & Sub-investigator.

ü  Samples of Trial Drugs (For unregistered drug in SFDA and Registered drug packaged differently from the registration application).

Also, when final findings showed a significant result , the sponsor should apply to register the new dosing regimen in SFDA. 

14.   Is approval required for approved drugs currently already on the Saudi Market in which the investigator wishes to study this drug for its approved indication in the Saudi population.

 

Yes. In case of (non-interventional) , the sponsor or researcher should apply for Clinical Trial authorization, but with different requirement .The application should include:

 

ü  Headed Letter to SFDA.

ü  Trial Application Form.

ü  Trial Protocol.

ü  Informed Consent Form (English & Arabic)

ü  IRB/EC Approval.

ü  Clinical Trial Agreement between the sponsor and the Principle Investigator.

ü  List of investigators and sites of trial.

 

15.   Who is responsible for registering the trial?

The sponsor of the clinical trial; - OR - The principal investigator (PI), so long as the PI is responsible for conducting the trial and has sufficient data rights.

 

16.       What do I need to do to start a clinical Trial within the Saudi Arabia?
The requirements of the Clinical Trial Regulations must be fulfilled (Sponsor or PI); in general this means that a clinical trial sponsor must be identified and  approval from IRB/EC in clinical trial site and approval from SFDA .

More information on the details required to complete the clinical trial application file (clinical trial application for approval) and procedures for submitting an application to an ethics committee can be found on:

                            

www.sfda.gov.sa

 

17.   What are SFDA requirements regarding research team qualifications?

The SFDA Regulations  state that all members involved  in clinical trial should have relevant education and experience in medical research and receive training in Good Clinical Practice commensurate with their roles and responsibilities. In order to demonstrate the training has occurred, documentation should be maintained and retained.

 

  

 

18.   What documentation needs to be maintained relating to clearance of drug used in clinical trials?

SFDA regulation state the importance of such requirements but are not limited to the following:

  • Headed letter from the agent to VP of drug affaires.

  • Approval of clinical trial department to conduct the trial

  • Sponsor name, Study drug name, quantity and port of clearance.

More information on the details required to finalize drug shipment  used in clinical trial can be found on:

                

www.sfda.gov.sa

 

 

19.   Do we need to notify the SFDA of protocol amendments?

 

The SFDA does require protocol amendments to be notified by sponsors where the amendments seek to clarify the use of, and/or monitoring of treatment. Also, SFDA require the ethics committees approval for such amendment.