Clinical Trial Laboratories - where are we now?

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• tkwahli 17 Jan 2011

  Good topic and some helpful comments. We would like to put a set of lab SOPs together can anyone share there's with us?

• jhagarwal 14 Dec 2010

  We have recently had some training on lab QA and SOPs this has helped our site and I am now reassured that it is not some complicated and that most aspects can be met by simple steps. Are documentation has now improved and there is less paperwork than we expected. We do still need more of our staff to receive training

• jhagarwal 26 Nov 2010

  This discussion is very helpful and has guided our progress with our lab it would be good to have some templates and training material if others could share those

• stevequanza 24 Oct 2010

  I do understand your frustration with the CRO visits but you know what? These visits are mandatory and here to stay for now unless they change in the future. Despite the fact that you have previous experience with the CROs does not mean that there is waiver of certain procedures. Studies are different and even though it be on the same disease area, study protocols vary. Remember, they are very important partners in the process and can pull the plug out of us (some studies are stopped courtesy of their reports). I would suggest that when you expect their visits, you work out a schedule that allows room for lab operations to go on. Try and develop QA systems internally that can ensure you are heads up with international and regulatory requirements.

• stevequanza 24 Oct 2010

  QA systems are very easy to put in place, the real daunting task is maintenance of the momentum and commitment of team members to the same. We started by identifying one person who fitted into the criteria (keen to detail, assertive, team player, up to the task etc). You can even hold an interview if there is time or use other approaches but then after identification of this person comes the work of developing systems and coordination (of writing of SOPs, tracking systems for trainings, samples received, samples processed, results issuance, equipment calibration and maintenance, temperature monitoring, inventory for stocks in the lab such as reagents and expiry dates etc). You realize QA does rest with this individual but it is team effort. I hope this helps to enlighten you.

• stevequanza 24 Oct 2010

  I totally agree with Palma on the elaboration above. We need to avoid re-inventing the wheel especially where we have systems however rudimentary they may be as at now. Our effort and focus should lean more towards to strengthening them as platforms that can be used in the future as clinical trials increase. There are templates that can be used to mirror where you are now (pre-test) and then as you take steps to make changes then you can later perform a post test to see to what extent the gaps in the lab are being resolved. In addition to training, the other requisite is creation of a culture for quality in the lab to achieve compliance with GLP/GCLP and other applicable standards.

• mbwinga 28 Sep 2010

  What is a clinical trial laboratory? This was a good question placed by our colleague from Ghana. A trial laboratory is a normal clinical laboratory with some extra training for the staff and some further procedures for the laboratory. Let me give Jake some reassurance, a trial lab should have processes that are built into the day to day activities so there is no need for last minute scrambles to fill paper work for the auditor. We run trial samples through our hospital lab. We now have a special area for the trial and the staff that work on this are trained and pround to be working on research samples. We have found that training and the recognition of what these new steps are important have made these steps a normal part of working practicies, in this way they are not noticed as being 'extra' paperwork - which is what we need to work to acheive, or it does not get done. So my advice is to bring the team together and get everyone involved in setting standards and making these new systems. We do not need expensive 'research' labs, just well trained and motivated trial staff

• jpry 15 Sep 2010

  *quantity of 'paperwork'
  sorry, post does not make so much sense without that that bit.

• jpry 15 Sep 2010

  Greetings from Southern Africa. I suspect that an over-whelming quantity is commonplace to all clinical trials labs and that most of wish that an entire team could be committed to seeing that it is completed in full. The reality is that we all scramble a week or so before the audit visit to get things in order. The truth is that lab operations do not 'require' the paperwork to be filled out and so we tend to save it to the last. I am fairly new to the lab here but, I have seen this trend already. I am keenly interested in finding ways to ensure that the appropriate forms are filed and the SOPs are followed and up-to-date. I have found many old checklists around the lab that are either obsolete or just ignored (auditors do not like posted checklists that are not utilized). The problem is finding a way to keep the checklist from just being another intermediary step in seeing that a task is done, (e.g. manual temp checks, SOP review, competency/training review, etc.). I do not know that a simple checklist is possible given all of the monitoring requirements but, then I have not been at it long enough to say for sure. I can appreciate the fact that the clinical trials do seem to "mushroom" that is appear manageable at first and then quickly stretch your already lean staff too thin to see anything done well. Priority setting paramount.

• jagarwal 13 Sep 2010

  Yes this is a good point. We all benefit from externally sponsored trials, we do run many trials with drug companies. However we want to increase the research that we conduct ourselves and the capacity that we now have in our laboratory is very advantageous for this. Before we ran trials with sponsors we did not calibrate our equipment - or at least did not write down that we had! We also did not keep training records or maintainance logs. I think these are the main simple systems that bring a laboratory up to a standard that can work on research samples. The problem comes when people see how industry trial run big trials and labs and this seem to set a high goal that can not be reached by most academic researchers. I would offer the advice of not being put off and reassurance that the steps are not complicated and can be acheived. A simple check list and guidance would be helpful? Does anyone have this?

• Palma Romero 27 Aug 2010

  Thank you for the two contributions from India. interesting to see we experience the same issues in Brazil. We have learnt much from running sponsored studies with the development agenies and pharma companies. They bring good training and many of the system and organisation we have for our trial I think is because we have worked on these sponsored programmes. We would like to do more of our own trial but we do not have all the capabilities we need. So yes it is a burden and difficult when we have too many monitors here and we seem to have too much paper but we have also learnt.

• jchandra 26 Aug 2010

  I just wanted to share the experience I have had this week. We are running two trials for different sponsors, but both are for public health not-for-profit area, so using funds from charitable organisations. We are, of course, running the trials to the best international regulatory standards. Our lab in particular is very good and very experienced, although not large and as is typical very stretched and could do with more staff. This week we had two visits from CRO to our labs. They were each sent by the sponsors of these studies. They both conducted the same type of visit checking off the same things. Both visits took up so much time and had the lab staff filling out endless forms for what seemed pointless reasons as we had worked with both these sponsors before. My concern is that the CRO is making good money from these visits but they are not necessary. The lab team have most of the week taken up by these visits and this is not unusual. I am highlighting it as I think public and charity money is being spent needlessly often on these expenesive CRO visit. Of course we need to maintain standard and we agree with all the requirements but this is over the top and distracts us from doing our work. What do others think? Does any other groups have similar experiences?

• achapal 21 Jul 2010

  Good Day from India. We use the hospital laboratories for our studies and this works very fine. We needed to put in place some processes and systems but not too bad and they work well. For our drug company studies there was more paperwork and files, but still OK and we did learn from this. We think this is the best way and special research labs for most trials are not needed. We want to run more of our own studies and need to put some QA systems in. Please can anyone share how they do this? Thank you.

• Palma Romero 13 Jul 2010

  Hello David. This is a very good discussion that I would be interested to see what others think. Personnally it seems obvious that you do not need a separate lab and we should be trying to encourage more research and so not be making it harder by this idea that a special lab is needed. Is this what you are saying? The actual requirement for lab assays for clinical trials are pretty straight forward. There needs to be training, and this needs documenting. The equipments need to be working and have a service record. Fridges and freezers need to have temperature monitoring. None of this needs specialist equipment as long as documented and done properly. Samples need tracking and labelling. All sensible and quite easy to acheive. We do not all need to have expensive companies come and set us up as trial laboratories, but we can do some good systems and quality management and create a complient enviroment. What do others think?