groups » Clinical Trial Laboratories » July Issue of the Month: Clinical Research Laboratories - Ask our Expert!
this month, we are discussing Research Laboratories, and we have on hand our expert Innocent Ali, of the University of Yaoundé I's Biotechnology Centre, to answer any questions you might have.
Innocent and his colleagues, Dr Nji and Professor Mbacham, have kindly provided a fascinating article about how the Biotechnology Centre at Yaoundé was initiated and equipped, and how they revised staff training. The Biotechnology Centre is now an extremely well known and well respected laboratory, so this account of how it begun from scratch will, I hope, be of great use and interest to other members: you can read the account here: http://globalhealthtrials.tghn.org/articles/clinical-research-laboratories-trials-global-health-central-africa/ (and you'll also find a link to the WHO's GCLP guidance).
Please feel free to ask Innocent anything you like about research laboratories: his personal experiences, how one should go about developing laboratory training, lab career development, what needs to be put in place to make sure certain equipment is not affected by power surges - anything you like! We look forward to your questions.
I'd like to kick-start the questions this time by asking about accreditation. Innocent, we've heard a lot about accreditation of laboratories becoming more popular in the States, for example, but I think this could be an interesting problem for developing countries. Did you feel a lot of pressure to have your lab accredited, and what are your thoughts about accreditation in general? Is it a useful idea, and which organisations (perhaps none?) would actually be 'qualified' to accredit a laboratory over any other?
It is true that the requirement for quality management systems in clinical laboratories has become an overarching theme in global health today. Production of quality data on which clinical decision is based lies at the very heart of ethical practice enshrined in the ICH guidelines and other international conventions. The second reason for this popularity and requirement stems from paradigm revolutions in science itself and technological developments in global health care with the increasing challenges associated with implementing these innovations into the practice of daily clinical care for the patients. This poses unique challenges to health care systems and laboratory systems in particular in low middle income countries the bear the burden of infectious and increasingly comorbidities with non-communicable diseases. Thirdly, limited resources allocated to health care and donor funds that require proof of effectiveness and resource accountability only means that health programs that receive more funding are those that are able to demonstrate the former and the untility in meeting the health challenges of populaions.
Laboratory accreditation is a widely accepted process of evaluation of a lab's quality, its efficiency, its effectiveness in delivering the clinical solutions it claims by reason of its identity with the goal of improvement. It is common therefore to hear of accreditation process rather than full accreditation due to the audit and reaudits required and the need for sustainability. The accreditation process, seen in this light has to do with the lab's sustainable capability to perform quality testing, calibration/measurement activities. with this blanket defintion, the laboratory assessment process include domains of quality performance such as personnel and organisation, quality management system, Equipment and reagents, Supplies and sample management, records and systems management etc. Standards used for the accreditation process are internationally accepted and harmonised albeit slight differences relating to type of international organisation and context.
The value of accreditation lies in the in the delivery of reliable results for patient management or generation of reliable data for critical public health interventions, but also on the reliability of acceptable quality across different health providers, systems strengthening, cost effectiveness, credibility, etc.
The elaborate and nature of the accreditation process gives the impression of a police officer finding a fault in your system and labelling the system as bad. This view is prohibitive, and contradicts with goal of improvement to be accomplished by the accreditation process. Cognisant of this, the WHO/TDR and WHO-AFRO promotes a process of quality improvement towards accreditation known as Good Clinical Laboratory Practice(GCLP)and the Step-wise Laboratory Improvement Process Towards Accreditation scheme(SLIPTA/SLAMTA) respectively.Other accreditaation bodies exist such as the College of American Pathologists (CAP), the International Standardisation Organisation (ISO), South African National Accreditation Scheme (SANAS)as well a regional initiatives such as the East African Public health Laboratory Networking Project and other initiatives widely promoted by the Centers fo Disease Control and Prevention throught in collaboration with the recently created African Society for Laboratory Medicine.
The Laboratory for Public Helath Research Biotechnologies is recognised by WHO/TDR for full implementation of good clinical laboratory practices, a vital step towards professional accreditation. While we were hesitant for the above reaons at the very outset, the encouragement and support of the WHO/TDR capacity Strengthening team combined with the leadership of the lab director, Pr Wilfred Mbacham led us to engage in this process that is proving very useful to all of us and the wider public in general. We have been able to carry out trials of antiimalarial medications for the past ten years to generate data to support treatment policy decisions. This process of recogntion for GCLP has proven extremely helpful in improving the qualty of data and malaria research in general.
Thanks Innocent, very interesting answer!
That was an elaborate writeup. However for the beginner,what are the required skills and training to participate in such clinical trials? I wanted to know how a clinician qualifies to work in a laboratory setting?
The required skills to participate in clinical trials is not different from those required to be a good lab technician, good physician, good pharmacist, good nurse etc. But because there are many different roles in the operation of a clinical trial, different roles need different levels of training and skills. A principal investigator for example must be qualified by training, competence and experience as mentione din the ICH guidelines found here http://ichgcp.net/4-investigator. Aduequate training for all staff must be documented, and this also relates to the nature of the trial and type of clinical and biological evaluations to be made.
Most medical training programs do have residency programs in clinical biology where physicians can train. While running a clinical trial is not strictly a laboratory setting, physicians can develop a team of both clinical, laboratory, data management staff, clerical officers etc to run a trial. physicians themselves can also take a training on clinical trials. An example is run by the London School of Tropical Medicine and Hygiene where suitably qualiied individuals from developing countries can also get trained (with scholarship from EDCTP or self sponsor). Post graduate programs in clinical research also train physicians who become trial investigators. Keep and eye on this site as many of such trainings and scholarhsip opportunities are often advertised.
Thank you very much Innocent Ali for the well-presented view on Clinical Laboratory Accreditation. I think you have provided the details with an emphasis on what is currently taking place in Africa.
The approach to Laboratory Accreditation in Africa should not necesarily follow the Western Countries approach. It has taken United States more than 65 years to build their Laboratory systems and for them to be where they are now.
Laboratory Accreditation process in Africa is not going to be an overnight affair. Thus, I absolutely agree with the approach recommended by WHO popularly known as Step-wise Laboratory Improvement Towards Accredition (SLIMPTA). This simply means that each Clinical Laboratory will improve their systems at a pace which they are comfortable with, using the locally available resources. They should not necessarily have to conform to the Laboratory Standards prescribed by the Western countries. Although it will be nice if they follow the same standards if they can and have the resources to do it.
Secondly, it also means that lack of Laboratory accreditation should not be used as an excuse by any sponsor or pharmaceutical firms, in supporting the Clinical Trials conduct in Africa. The Clinical Trials can be undertaken by any Laboratory which is not accredited for as long as they follow the principles of Good Clinical Laboratory (GCLP) principles and practices.
Thank you for your contributions to the discussion. I agree that the lack of accreditation should not stop any laboratory that strictly follows the guidelines of GCLP to perform a clinical trial. The second point you made with respect to Western standards is also pertinent, as not every aspect will be comparable between systems here and overseas. So long as the commitment is there to keep acceptable lab standards sustainable, there is no problem. In naddition, Western standards can be looked upon as benchmarks for continuous quality improvement, until such a time where quality standards in developing countries will be producing the same credible outcomes like it is for those Western countries and lab systems that adhere to their laid donw standards.
I am a resident of the Nigerian FELTP, a two-year MPH degree programme in field epidemiology. I am writing my dissertation research proposal on the evaluation of the performance and quality of Romanowsky stains and RDT kits used for malaria diagnosis in Plateau State, Nigeria. Please can someone provide me detailed information on methods for analysis of the active substance (antigen or antibody) in a malaria RDT kit? What laboratory methods can be used to assay the histidine or LDH or aldolase component of a malaria RDT kit? I also need information about chromatographic and spectrophotometric methods for analysing biological stains. There is this rapid thin layer chromatographic method for analyzing blood stains by Marshall and Lewis, 1974a, I have not been able to get the details of it. Can somenone help here please?
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