Clinical Trials Unit
Rehman Clinical Trials Unit
RMI has established Clinical Trials Unit with the goal to streamline, govern and promote clinical trials activities. CTU’s aim is to develop a centre of excellence dedicated to advance research at RMI following the ICH, and GCP guidelines. Our research endeavors will include observational studies and surveys ensuring full compliance, with Good Clinical Practice (GCP) endorsed by Drug Regulatory Authority of Pakistan (DRAP) and international regulators as required.
RMI is committed for conducting high quality clinical trials working in collaboration with health professionals, faculties, research alliances and centres of excellence (COE), innovating to improve processes, aiming to build capacity, ensuring the efficient use of resources and with a strong focus on ethical and good clinical practices compliance.
Research generation through knowledge, technology and innovation under GCP, DRAP and international guidelines to evaluate medical, surgical or behavioural intervention.
To perform clinical trials research under the supervision of regulatory authorities to contribute in the area of study, innovate and produce knowledge, strengthen cooperation and collaboration between industry, academia and government and establish trainings that will produce next generation of clinical researchers and clinical trials personnel.
To be updated soon...
Rehman Clinical Trials Unit is responsible for conducting all types of clinical trials under the supervision of regulatory authorities. All trails will be conducted as prescribed by the guidelines and Good Clinical Practices including:
- Rehman Clinical Trials Unit prepares and submits ethical application with transparency and patient data security
- Developing alliance with stakeholder and other study members
- Maintaining trial master, site and pharmacy files for the record
- Safety and data management as per national and international guidelines and protocols
- Managing financial records to ensure compliance with financial agreements and drafting financial expenses
- Maintaining liaison with investigators, regulators and sponsors to ensure timely submission of reports and statements
- Highly professional and academically distinguished investigators
- Ethical and participant safety considerations
- Investigational drug/ investigational product development and regulation
- Study and safety management defined by the regulatory authorities
- Data management and transparency
- Dedicated pharmacy for drug storage at different temperatures
- Protocol development
- Internal audit of quality assurance by the Quality Assurance Department
- Management of drug/ investigational products
- Regular safety and data monitoring with regards to the specified guidelines
- Workshops on Good Clinical Practice training, protocol writing and standard operating procedures
- Procurement, storage and disposal of drugs used for study
- Preparation and maintenance of trial file
Rehman Clinical Trials Unit takes full responsibility in training and developing staff competencies in different areas of a clinical trail by delivering training workshops on different national and international guidelines of a clinical trials unit.
- ICH-GCP Guidelines
- Storage of Investigational study medications
- Storage, Tracking and Shipment of biological samples
- Reporting and managing Adverse events, Serious adverse event
- HIMIS use for Study protocol compliance
- Clinical trials documentation and Quality Assurance
- Clinical trials Designs and implementation
- Selection, recruitment, and retention of study Subject
- Site imitation, Ongoing monitoring & evaluation, and closeout
- Randomization techniques, Masking (Blinding) and Allocation concealment
RMI Pathology department is privileged to declare to be the only facility in the province to have in-house state of art and latest equipment. The department can perform more than 400 different tests in different fields of pathology. Doctors and scientists are working in the labs assisting all departments in identification of disease and illness.
Our lab services are following
- Blood Bank
- Molecular biology, PCR Lab
- Chemical Pathology
- Centre for genomic sciences
- Hematology Day care
- Infection control department
- Myco bacteriology
Click below link for further details
- Vaccine phase III double blind randomised controlled clinical trial
- Treatment of Chronic Cough randomised controlled Phase III clinical trial
A clinical trial is a research study conducted in human beings with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. Clinical trials are used to determine whether new drugs, diagnostics or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that help people.
After researchers test investigational new therapies or procedures in the laboratory and in animal studies, those with the most promising possibilities are moved into human clinical trials. Clinical trials are broken down into different phases. During a trial, more and more information is gained about the potential treatment, its risks and how well it may or may not work, along with aspects related to quality of life.
Clinical trials are categorized as Phase I to IV trials. They are generally described as follows:
Phase I (small number of participants, normally between 6-10 healthy volunteers, or very sick patients for whom treatment options are lacking)
Phase I studies are designed to allow scientists and medical doctors to understand what effects an investigational compound has in human subjects. The goal is to study what happens to the compound in the body from a safety and tolerability point of view after it is swallowed, injected or infused. .Study participants are monitored for the occurrence and severity of any side effects that they may experience.
Phase II (once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups of patients, generally 20-300 depending on the type of disease)
Phase II studies are designed to begin to evaluate the safety and efficacy of an investigational medicine in patients, and often used to determine if different dosages of the treatment have different effects. The patients are given various doses of the compound and closely monitored to compare the effects and to determine the safest and most effective dosing regimen. In many instances, multiple Phase II studies are conducted to test the compound in a variety of patient populations or indications.
Phase III (carried out on large patient groups, 300–3,000 or more depending upon the disease being studied)
Phase III studies are designed to confirm the safety and efficacy of an investigational medicine. Large numbers of patients are generally involved in order to adequately confirm benefit and safety. These studies, as in the earlier phases, may involve one or more ‘treatment arms’, which allow for the safety and efficacy of the new investigational drug to be compared to other available treatments, or to be tested in combination with other therapies. Information obtained from Phase III studies is used to determine how the compound is best prescribed to patients in the future.
Phase IV (also known as Post-Marketing Surveillance Trials)
Phase IV studies take place after the medicine has received regulatory approval (market authorization) and are designed to provide broader efficacy and safety information about the new medicine in large numbers of patients, subpopulations of patients, and to compare and/or combine it with other available treatments. These studies are designed to evaluate the long-term effects of the drug. Under these circumstances, less common adverse events may be detected.
Ethical clinical research is guided by the principles of nonmaleficence, respect, beneficence and justice.
• Nonmaleficence is the duty to cause no harm. This principle has its roots in the Hippocratic Oath. The ethical issue at the core of clinical research is whether the outcome of the research can be reasonably expected to provide benefit to society without doing any harm to the individuals enrolled in the trial.
• Respect for persons is embodied in informed consent, dictating that information is exhaustive and provided in a manner that is understandable, that the subject’s cooperation is voluntary, and that all information pertaining to the subject is held in confidence.
• Beneficence is demonstrated by a thorough risk/benefit assessment, recognizing that benefits can be direct, collateral, and/or altruistic. Similarly, risks are considered in physiologic, psychological, and socioeconomic terms. For a clinical trial to be considered ethical, there must exist a sufficient body of scientific/medical evidence to justify exposure of individuals to the risks of the trial. There must be clear medical need, and the potential benefits to be gained by the research must be weighed against the possible risks to the participating person in both safety and effectiveness of the drug or intervention being studied.
• The principle of justice takes into account all the processes by which populations are selected for study to ensure that the results benefit the community, avoid exploiting vulnerable populations, and include individuals who may be likely to benefit.
Rehman Medical Institute respects human rights, human dignity, patient safety, and ethical principles. The organization is committed to act ethically and to provide the highest standards of care to individuals participating in any kind of clinical trials. RMI commits to protect the privacy of all individuals participating in trials. This commitment aims at safeguarding all personal data protection rights and will ensure that no patients suffer any emotional or physical harm because of having participated in a clinical trial.
Consequently, the institute welcomes external controls of its clinical trials. The concept of independent oversight requires the review of proposed clinical research projects by qualified individuals independent from the investigators and sponsors.
Independent review boards approve and provide oversight to studies involving human beings. In the US, these are known as Institutional Review Boards (IRBs), and in other parts of the world, they are called Independent Ethics Committees (IECs). These boards are composed of researchers, ethicists, legal experts, and community members. Such independent oversight helps ensure the integrity of the clinical research, both from the standpoint of scientific validity and the protection of participating individuals. Thus, there is a system in place that strives to provide scientific validity while protecting patients’ interests through meaningful informed consent, justice and independent oversight and review.
RMI has developed internal standards and systems to ensure that we comply with or exceed all guidelines, regulations, and legal requirements. All RMI employees who work on clinical trials are required to strictly adhere to local laws and international guidelines, conduct their research with integrity, and apply the highest standards of medical care and respect for patients at all times.
To ensure this compliance, RMI will ensure that Good Clinical Practice (GCP) training is provided to employees working in clinical research and related areas. In addition, RMI has established internal processes to facilitate early discussion of and consultation on issues. This support mechanism allows employees to obtain independent advice if they need it. In addition, RMI staff is obligated to report any suspected issue of noncompliance with regulatory or ethical standards.
RMI has also established a process for discussing and resolving potential ethical issues that may arise during the course of everyday work in drug development. This framework incorporates a central point of contact for RMI staff and an escalation process to facilitate the consideration of alternative perspectives when appropriate.
Any RMI employee, who is faced with an ethical dilemma or question can contact Institution ethics committee and National bioethics committee and internationally the Science and Ethics Advisory Group (SEAG) which is independent of the clinical teams. The SEAG will help clinical teams to find an appropriate answer or will escalate the issue, first, to an internal committee of experts. If need be, advice may be requested from an independent external advisory group composed of ethicists and experts from academia and the patient community.
There is a deep understanding of, and belief in high ethical standards by all members of the RMI community. This translates into the practical application of these high ethical standards by each employee in his or her daily work responsibilities.
Participants are entitled to a clinical trial that adheres to all legal and ethical standards. In addition, participants have a right to:
• A clear, transparent Informed Consent process before they agree to join the trial
• Withdraw from the trial at any point in time
The Informed Consent process aims at answering any and all questions that might be relevant to a participant’s decision to agree or decline to join a trial. Only participants who, after having all their questions answered, sign an Informed Consent form can enter the trial. With their signature, participants confirm that they believe they have been given all the important facts about a trial, that they understand them, and that they decided to take part in the trial of their own free will.
An Informed Consent document is not a contract. Therefore, a participant may change his or her decision – any participant has the right to withdraw at any point of the trial. A withdrawal will not affect the participant’s relationship with their doctor nor will it result in a loss of benefits to which the participant is otherwise entitled. Potential medical risks of a sudden withdrawal from the trial should be detailed in the Informed Consent document.
If a patient agrees to join a trial, some people will need to be told about the participation. These people are:
• The patient’s primary physician who is responsible for their healthcare on a day-to-day basis
• The doctor and research team looking after the patient in the trial.
The fact that someone is taking part in a trial will be written in that patient’s medical notes. Investigators cannot tell anyone else about a participation in a trial unless the patient gives his or her permission.
During the trial, all of the information collected about the participants will be kept confidential, as with any other medical records. When investigators publish the results of a trial, they are not allowed to include any information that would identify people – a patient’s name will not be used in any reports or publications.
The clinical trial protocol will define what is to be done with samples and information of participants. Specific sections within this document will detail for how long samples and information must be kept before they are destroyed. If samples and/or information are to be used further, then this will be either:
• included in the original trial protocol.
• be part of the informed consent a patient signs prior to his participation in the trial.
• be written up in a specific informed consent which the patient will also be asked to sign.
Firstly, we will provide, upon request, clinical study reports (CSRs), periodic safety reports, and clinical trial summary reports, either through regulatory bodies such as the Drug Regulatory authority of Pakistan, relevant Healthcare commission in each province of Pakistan and EMA, or directly. CSRs contain summaries of data and trial results regarding the safety and efficacy of the medicine but will not include any information that allows the identification of individual patients.
For requests for patient-level anonymized data (rather than CSRs), RMI will ask an independent panel of experts to review such requests. Access will be based on good scientific merit that will help patients and doctors in using our medicines.
All of trial protocols are posted along with the results of trials once they are completed on website that are available to the public: clinicaltrials.gov. Finally, we are also committed to publishing all of our l studies in RMI medical journals.
What does the end of a clinical trial mean for participants?
RMI is obliged by Good Clinical Practice (GCP) international quality standard, regulations and laws to store the records of its clinical trials for a certain period of time (e.g.15 and more years). The end of a clinical trial has no impact on the confidentiality of those records; they will still be protected from disclosure to third parties.
We are committed to a high standard of quality and ethical conduct in all aspects of conducting clinical trials. For sponsored trials, Sponsors usually commits to provide the investigational medicinal product free for the duration of the study, as required by GCP and in accordance with the regulatory requirements of Pakistan. As part of this commitment and in accordance with the Declaration of Helsinki, Sponsors offers patients who participate in clinical trials continued access to the investigational medicinal product that they received after trial completion, when appropriate.
RMI will work with qualified Contract Research Organizations (CROs) and other types of contractors whenever needed.
How do you select sites for your clinical trials?
We collaborate in clinical trials at multiple investigational sites (e.g. hospitals) and in many different countries.
We consider several factors when collaborating sites for a trial:
o Infrastructure – the site should demonstrate experiences in clinical trial management activities which include independent ethics committees and a strong regulatory framework.
o Facilities and training – Healthcare Professionals (investigators and their staff) selection criteria should be based on scientific expertise, training (clinical trial management and applicable laws and regulations) and qualifications as well as site-specific competency and feasibility.
o Patient availability – adequate patient population should be available and willing to participate in the clinical trials.
Mr. Umar Farooq
Associate Director Clinical Research
Phone: 091 5838 000 (Ext 1582)
Mobile: +92 346 555 1852