Scientific misconduct is a recognized problem which needs to be addressed-Prof. Khalid Saeed Khan


Clinical Trials conference at UHS-II
Scientific misconduct is a recognized
problem which needs to be
addressed-Prof. Khalid Saeed Khan
Pakistan is an ideal country for Clinical
Research operations-Dr. Masud Ur Rehman

By Mubarak Ali

LAHORE: Knowledge creation process should have integrity for it to be embedded within health care. Integrity ensures trustworthiness, scientific misconduct is a recognized problem which needs to be addressed. This was stated by Professor Khalid Saeed Khan from University of Granada, Spain, while conducting a Workshop during the three-day international conference on clinical trials held at the University of Health Sciences (UHS) Lahore from March 25-27th, 2022. The conference was organized jointly by the University of Granada Spain, Drug Regulatory Authority, National Institute of Health Islamabad, Pakistan Society of Internal Medicine, and University of Child Health Lahore. The main purpose of the conference was to highlight the importance of clinical trials in scientific discovery and to explore its future prospects.

Prof. Khalid Saeed Khan

Two workshops were held on the first day of the conference. Dr. Masood Ur Rehaman, Dr. S. Anwar and Prof. Tayyaba Wasim were the panelists in the first workshop which was facilitated by Prof. Khalid Saeed Khan who discussed “Transparency in Clinical Trials”. Importance of clinical trials in medicine and scientific discovery, proper education and training are required for their registration. Value of any clinical trial depends primarily on the quality of the information and data it generates and which shuld be declared publicly, he added.

Prof. Khalid Saeed Khan pointed out that so far over two hundred papers concerning COVID19 have been retracted by many well reputed journals. He was of the view that beliefs without a correct knowledge basis are very dangerous. Informed Consent is an important issue in research and it must be free of coercion with no intentional threat of harm to obtain compliance, free from undue influence. Honesty and integrity is required throughout research. Research based practice is the most ethical way to provide care. Research should generate the highest level of evidence which must minimize bias. Informed consent must respect individuals approached to participate and the whole publication process needs to be transparent. Taking part in clinical trial is most safe for patients, we have to promote research culture in randomized trials, we could not force anybody, we do not have to force patients but must create awareness because research needs collaboration, he concluded.

Prof. Sidrah Saleem and Dr. Shahnoor Azhar conducting workshop on “Preparing Laboratories as
per Good Clinical Practice” during the 1st Clinical Trial Conference held at UHS Lahore recently.

Dr. Masood Ur Rehman in his concluding remarks said that six months back DRAP has established Medical clinical Trial Registry. Prof. Tayyaba Wasim stated that it is good and challenging task to do a research and to run it transparently is a daunting task.

The second workshop was facilitated by Prof. Sidrah Saleem. Head of Microbiology Department at UHS. The theme of her workshop was “Preparing Laboratories as per Good Clinical Practice”. The main idea of the workshop she stated was that the laboratory staff must be fully trained and certified before the commencement of clinical research because protocols may necessitate the collection, processing, storage, and transport of various biological samples and specimens.

Talking about development of vaccines, she stated that exploratory stage, pre-clinical stage, clinical development regulatory review and approval, manufacturing and quality control are the other important stages of development of vaccine. Clinical development is a three phase process. She discussed in detail the process of Regulatory review and approval, ethical approval of the clinical trial, preparation of laboratory as per Good Clinical Lab Practices (GCLP) and Organizational and personnel role, trial staff responsibilities, trial facilities, waste disposal, standard operating procedure, Laboratory Accreditation, storage and retention of records. Conduct of the work should be in accordance with the Trial Protocol and the analytical plan. All data generated during the conduct of the analytical phase should be recorded directly, promptly accurately and legibly. These entries should be signed or initialed and dated. Each material used in the analysis of trial material should be appropriately documented, validated, controlled and approved, she added.

Masood Ur Rehman

Dr. Shahnoor Azhar in his remarks said that Preparing Laboratories as per Good Clinical Practice is extremely technical subject, it is not a simple scenario. We have to follow SOP’s to come up to the requirements of the Regulatory Bodies, meeting standards is priority, After COVID other trials will follow. COVID-19 has provided us an opportunity that at least clinical research has been started which will help to improve the quality of research in Pakistan.

Dr. Masud Ur Rehman, Chairman, Clinical Studies Committee & Director, Pharmacy Services, Drug Regulatory Authority of Pakistan discussed the Country Situation in Clinical Trials and stated that these are experiments designed to evaluate new interventions for diagnosis, treatment and prevention. The interventions evaluated can be drugs, diagnostic tests, vaccines, devices etc. Results of randomized clinical trials are usually considered vital for determining the efficacy of an intervention. Research studies on drugs involving human subjects under strict set of criteria, to explore new treatment options which can assure tolerability and effectiveness of that particular drug and can benefit in long term to majority of population.

DRAP Dr. Masud Ur Rehman stated was established under DRAP Act, 2012. Under Bio-Study Rules, Division of Pharmacy Services, DRAP is responsible for Regulatory Control of the Clinical Studies in Pakistan. Composition of Clinical Studies Committee is consisted of One Professor of Pharmacy, One Clinician or Physician or Medical Specialist, one Statistician, one Representative of Pakistan Pharmaceutical Manufacturer Association and the Pharma Bureau, Co-Opted Member to be nominated by the Committee for therapeutic goods or any other specific matter.

Group Photograph of the participants of the workshop on “Preparing Laboratories as per Good Clinical Practice”
along with Facilitator Prof. Sidrah Saleem and Dr. Shahnoor Azhar during the 1st Clinical Trial
Conference held at UHS Lahore recently.

He discussed in detail the Role, Responsibilities & Functions of CSC, Minimum Divisions or departments required to work as a CRO’s. Recently DRAP, he said, has developed software for Clinical Trials application submission & tracking & its user manual is also available on official website DRAP:

Talking about the challenges Dr. Masud Ur Rehman mentioned that Lack of awareness in the country regarding Clinical Research & regulations, lack of research culture in Pakistan, lack of qualified Personnel besides acute shortage of human resources & logistic support at regulatory body. Clinical Research is a 70 billion dollar industry in the World & expanding rapidly. Major share of Clinical Trials is taken by India, Bangladesh, Vietnam and Philippines. Pakistan share in clinical trial is a just few millions dollars. Pakistan is the 5th populous country in the World with diverse ethnic groups. It makes Pakistan an ideal country for Clinical Research operations. DRAP has adopted International Guidelines & at the moment Pakistan is the new market for Clinical Research with lot of opportunities.

Continuing Dr. Masud Ur Rehman said that enormous funds are available which is 1% being contributed by Pharma companies which can be obtained for research. COVID was an opportunity to request for funding for research. We developed COVID Kits, Ventilators were manufactured, we have very good labs, and everybody did his best to do whatever one can do. We have forty thousand deaths due to COVID in Pakistan which was very low as compared to other countries, he concluded. Mr. Ahasun ul Haque, Assistant Director DRAP also assisted Dr. Masud Ur Rehman in his presentation.

Earlier Dr. Shahnoor Azhar Chief Organizer of the First Clinical Trials conference in his introductory remarks said that purpose of the meeting was to get benefit from different peoples working in this field. Most important person in the clinical trial is patient or volunteers. COVID era has provided us an opportunity to work under pressure, develop and implement specified standards for research. To convince and mobilize people to get involve for the study, recruitment and transparency were the more challenging tasks. he added.

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