Sam Salek

Sam Salek
Cardiff University | CU · School of Pharmacy and Pharmaceutical Sciences

PhD

About

226
Publications
45,486
Reads
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5,677
Citations
Additional affiliations
June 2006 - present
Cardiff University
Position
  • Chair in Pharmacoepidemiology
Education
June 1990
University of Wales
Field of study
  • Pharmacy
June 1978
University of Oklahoma
Field of study
  • Pharmacy

Publications

Publications (226)
Article
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Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspec...
Article
Objectives: The current study is aimed at proposing a standardized regulatory model for biosimilar development and approval for adoption by BRICS-TM agencies, based on evaluation of regulatory guidelines and potential solutions to challenges. Methods: An established validated questionnaire was used and the recommendations were collated. Proposit...
Article
Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems of comparable size provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients' access to medicines. The aim of this study was to compare the medicines registration process of the M...
Article
Core outcome sets (COSs) are an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. Tsekhe aim of our position paper by the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life and Patient Oriented Outcomes was to identify the chall...
Article
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Background: The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) on the different criteria used for biosimilar development and marketing authorisation process. Methods: A semi-quantitative ques...
Article
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The original article [1] contained several typos which were mistakenly incorporated by the production team that handled this article. All errors have since been corrected.
Article
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Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern Afric...
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Background A person’s chronic health condition or disability can have a huge impact on the quality of life (QoL) of the whole family, but this important impact is often ignored. This literature review aims to understand the impact of patients' disease on family members across all medical specialities, and appraise existing generic and disease-speci...
Article
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Objectives: The aim of this study was to identify, compare and evaluate regulatory requirements for the biosimilar development and review processes in BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, Mexico) countries with mature regulatory systems of Australia, Canada, Singapore and Switzerland. It is hoped that this benchmark study p...
Article
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Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development C...
Article
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Background Biosimilars are expected to emerge as a rapidly growing segment of the biopharmaceutical industry. However, the biosimilar industry faces multiple challenges and obstacles in developing and marketing these complex products. Divergent regulatory framework in emerging countries adds to repetitive trials and increased cost of biosimilar dev...
Article
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Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulatory review processes and the good review practices...
Article
e18615 Background: It is recommended to include patient-reported outcomes (PROs) in cancer trials to ensure clinical benefit based on patients’ perceptions. For multiple myeloma patients, PRO measurement is essential to understand the impact of treatment on their physical and psychosocial functional behaviour. However, it is unclear which PRO instr...
Article
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The Cardiff Acne Disability Index (CADI) is a questionnaire designed to measure the quality of life (QoL) of teenagers and young adults with acne. It has been used clinically and within therapeutic research globally. This review aims to appraise all published data regarding the clinical and research experience of CADI, its psychometric properties a...
Article
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Purpose The aims of this study were to assess the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate the overall performance from 2017 to 2019, identify good review practices, evaluate the quality of decision-making processes, and identify the challenges an...
Article
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Background: National regulatory agencies of various sizes and maturity levels, including the South African Health Products Regulatory Authority (SAHPRA), have had to revise systems and re-engineer processes in order to adapt to the new regulatory environment and increase the effectiveness of regulatory operations. This study aimed to develop a new...
Article
Background The Acute Leukemia Advocates Network (ALAN) conducted a multi-country survey to gather information on the experiences, quality of life (QoL) and symptoms of adults (16+) with acute leukemia [acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and acute promyelocytic leukemia (APL)]. Aims To examine which factors are most ass...
Article
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Background: Patients' experience of symptoms often goes undetected during consultation in an outpatient clinic, and the use of a patient-reported outcome measure (PRO) in such a setting could be useful to aid treatment decision-making. A new PRO measure, the HM-PRO (Hematological Malignancy Specific Patient-Reported Outcome Measure) has been recen...
Article
The pharmaceutical approach to skin disease has been hugely successful, but despite effective drugs being available and used, there are still vast numbers of people who continue to have some level of persisting skin disease and continue to experience quality of life (QoL) impairment. So the question that needs to be answered, while we await further...
Article
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Background: Validity is the ability of an instrument to measure what it claims to measure. It means the degree to which the empirical evidence supports the trustworthiness of interpretations based on the calculated scores. The hematological malignancy (HM) specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use...
Article
The European Academy of Dermatology and Venereology (EADV) has started the ‘Healthy Skin @ Work’ campaign aimed to raise awareness among the public and EU authorities on the frequency and impact of occupational skin diseases (OSDs). The EADV Task Forces (TFs) on Quality of Life and Patient Oriented Outcomes (QoL/PO) and on OSD present their mutual...
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Background: The development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionma...
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Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as a tool to communicate the basis for the decision. The Universal Methodology for Benefit-Risk Assessment (UMBRA) has also been used to effectively communic...
Article
The pandemic of COVID‐19 is a global challenge for health care and dermatologists are not standing apart from trying to meet this challenge. The European Academy of Dermatology and Venereology (EADV) has collected recommendations from its Task Forces (TFs) related to COVID‐19. The Journal of the EADV has established a COVID‐19 Special Forum giving...
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The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, reflects on what has been realized in six years of operation and what still needs to be achieved. Statistics...
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Background The quality of life of patients at all stages of hematological malignancy is greatly affected by the disease and its treatment. There is a wide range of health-related quality of life (HRQoL) issues important to these patients. Any new instrument developed to measure HRQoL of such patients should be content valid, i.e., the items should...
Article
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Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations for the implementation of an abridged review process in South Africa based on good reliance practices (GRelP).MethodsA questionnaire was...
Article
Introduction The aim of this study was to explore patients’ knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to patients’ access to new medicines. Methods For the purpose of this study a tailored made paper-based questionnaire, Patient Perspective Questionnaire (PPQ)...
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The link between acne and psychiatric morbidities has been demonstrated in many studies; however, large scale studies aiming to reveal the psychosocial impact of acne are rare. The aim of this study was to assess the psychological burden of adult acne patients. This analysis was based on a multicenter study including 213 acne patients and 213 contr...
Article
Background:To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process by health technology assessment (HTA) agencies.Methods:Two questionnaires were developed and subsequen...
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Background Timely access to new medicines may be addressed through strengthening of registration efficiencies and timelines by establishing and refining value-added registration processes, resources, and systems. The aims of this study were to evaluate the timelines of the milestones of the South African review process and the overall approval proc...
Article
Itch is a highly prevalent and multidimensional symptom. We aimed to analyze the association between itch and mental health in dermatological patients. This multicenter study is observational and cross-sectional and was conducted in dermatological clinics across 13 European countries. A total of 3,530 patients and 1,094 healthy controls were includ...
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Individuals who rely on public health payers to access new medicines can access fewer innovative medicines and must wait longer in Canada compared to major markets around the world. New medicines/indications approved by Health Canada and reviewed for eligibility for reimbursement by the Common Drug Review or the pan-Canadian Oncology Drug Review (C...
Data
Time to First Provincial Listing, in number of days, (all provinces, excluding Quebec), for oncology and non-oncology products, as segmented based on the following timelines: from NOC to HTA submission; from NOC to HTA recommendation; and from HTA recommendation to listing (source: CADTH reviews, excluding resubmissions).
Data
Time to first provincial listing for non-oncology (CDR) and oncology (pCODR) product HTA submissions made pre-NOC vs. post-NOC, 2013–2014 and 2015–2016.
Article
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Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move toward achieving their regulatory goals and stakeholders’ demands. The aims of this study we...
Article
Background:: To evaluate the quality of the decision-making processes of pharmaceutical companies during medicines development for evidence generation to support reimbursement of new medicines and the appraisal recommendation decision-making process by health technology assessment (HTA) agencies. Methods:: Two questionnaires were developed and s...
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Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality of their decision-making processes and is considered the most promising tool for such purpose. This study aimed to further establish the...
Article
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The drive for improved regulatory systems and the establishment of a more effective regulatory framework in South Africa has been evident for the past two decades but despite political intentions and legislative revisions success has been limited to date. Efforts to address the increasing volume of applications that have been received have to date...
Article
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Itch is an unpleasant symptom, affecting many dermatological patients. Studies investigating the occurrence and intensity of itch in dermatological patients often focus on a single skin disease and omit a control group with healthy skin. The aim of this multi-centre study was to assess the occurrence, chronicity and intensity (visual analogue scale...
Article
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Background: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practi...
Article
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Purpose: The Dermatology Life Quality Index (DLQI) and the European Quality of Life-5 Dimension (EQ-5D) are separate measures that may be used to gather health-related quality of life (HRQoL) information from patients. The EQ-5D is a generic measure from which health utility estimates can be derived, whereas the DLQI is a specialty-specific measur...
Article
Background/aims: The decision to discharge is a critical and common outpatient consultation event. However, little guidance exists over how discharge decision-making can be taught. We aimed to provide educational recommendations concerning outpatient discharge decision-making. Methods: Recommendations were drawn from prior interviews with 40 con...
Article
Aim: To develop and validate a dermatology-specific quality of life (QoL) instrument for adolescents with skin diseases. Methods: Qualitative semi-structured interviews were conducted with adolescents with skin disease to gain in-depth understanding of how skin diseases affect their QoL. A prototype instrument based on the themes identified from...
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Background An understanding of the daily life impacts of hyperhidrosis and how patients deal with them, based on qualitative research, is lacking. This study investigated the impact of hyperhidrosis on the daily life of patients using a mix of qualitative research methods. Methods Participants were recruited through hyperhidrosis patient support g...
Article
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Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those or...
Article
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Objective To observe the influences on clinicians when discharging patients, to explore patients' perspectives concerning their discharge or follow-up decision and to identify what patients think is important for clinicians to consider when taking a discharge decision. Design Qualitative study involving observations of consultations and semistruct...
Article
Background: The use of patient-reported outcome measures in electronic format has been increasing. However, these formats are usually not validated or compared to the original paper-based formats, so there is no evidence that they are completed in the same way. Objectives: The aim of this study was to compare the conventional paper version and a...
Article
Aims: The impact of haematological malignancies (HM) on patients' health-related quality of life (HRQoL) is still not well understood. The aim of this study was to identify HRQoL issues and symptoms in patients with HM to be included in a new patient-reported outcome measure for use in routine clinical practice. Methods: In a multicentre observatio...
Article
Objectives: To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA recommendations with the initial decisions of the other HTA agencies, and to identify factors for differing national HTA recomme...
Article
Background: Generic instruments measuring health related quality of life (HRQoL), like EQ5D, enable comparison of skin diseases with healthy populations and non-dermatological medical conditions, as well as calculation of utility data. Objectives: The aims were to measure HRQoL in patients with common skin diseases and healthy controls across Eu...
Article
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Background: Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery of new products, there appears to be no suitable instrument to assess QDM in this area. The aim of this study was to assess differences in QDM using a validated instrument, the Quality of Decision-Making Orientati...