Submited on: 05 Oct 2010 07:35:18 AM GMT
Published on: 05 Oct 2010 07:44:59 PM GMT
 

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? No
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? Yes
7 Can you suggest any reductions in the paper, or deletions of parts? Yes
8 Is the quality of the diction satisfactory? No
9 Are the illustrations and tables necessary and acceptable? No
10 Are the references adequate and are they all necessary? No
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    The focus of the paper brings to light a relevant issue with regards to use of CROs in monitoring trials. Coming up with alternative solutions to CROs is important especially if this solution works across different trials sites and in different countries.  This will greatly assist in bringing down the costs of conducting trials and concurrently potentially improve the quality of the data gathered.   I believe that this in-house monitoring strategy is very timely and the mentoring over monitoring strategy is highly commendable especially in the current setting where involvement of CROs are cost limiting.

    Would like to request the authors to clarify and suggest some items to the authors.

    1)     Would recommend that the authors clarify the concept of central statistical monitoring.

    2)      While the concept is interesting, it would have been more fascinating if the manuscript focused more on the suggested new approach since this is the main topic under discussion and lessen the background details which though essential, can still be shortened.

    3)     In some practices, clinical monitoring is different from quality control or quality assurance though there is some overlap. It is recommended that the authors elaborate whether they used a distinction between the 2 or considered both as one and the same in the manuscript.

    4)     The new method of mentoring is very interesting and it would have been good if the authors described in more detail the actual approach, design, and implementation of monitor training as well as presenting/ outlining the specific steps, the curriculum or an equivalent course outline if this are being used. This can ensure standardization across sites during implementation. It is understandable though that the specific approach depends on the study being monitored.

    5)     Presenting data comparing costs incurred vis-a-vis data quality of trials monitored by CROs versus the in-house approach would also lend an objective and quantifiable aspect to the manuscript.

    Specific comments:

    1)     Under Case Report(s), Mentoring – the essentials.  6th sentence, there seems to be a missing word.  This is worrying as new ___? and changes to treatments…

    2)     Under current monitoring practices subheading – page 3;2nd to the last sentence; Here we come back to the point about making the role a more intelligent and “think” one. Reconsider changing the “think” one phrase since this seems to be a non-standard/ non-formal English grammar.  (i.e. role which involves intelligent and critical thinking)

    3)     Under current monitoring practices, page 4; We need to be assured that the number {unsure what number is being referred to, is this supposed to be data?} is correct and the mechanism by which “it” {missing word} is obtained has been consistent.

    4)     For the references, please make the format uniform. #3 reference does not follow a standard format, #5 capitalization of last name of author, #4 different format from the others.

    5)     For illustration 1, this comment is minor but it seems this was cut and pasted from the paper by Wademan,2006. If raw data is available would recommend that the raw data be inputted and another graph be made to make it more uniform with the font and font sizes of the other parts of the manuscript. This will also have the added benefit of making the manuscript more presentable.

    Again, the paper is very interesting and relevant especially in resource constrained trials. It would be more interesting if more specific details and resources about the new approach are presented. Kudos to the authors for coming up with this approach in monitoring.

     



  • Competing interests:
    None
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    Line of work involves the conduct of commercial and non-commercial safety and efficacy clinical trials for drugs and vaccines in the Philippines and currently also a WHO-TDR CCTC clinical monitor.




     

  • How to cite:  Velasco J .A Sensible Approach To Monitoring Trials: Finding Effective Solutions In-house (Review)[Review of the article 'A Sensible Approach to Monitoring Trials: Finding effective solutions in-house ' by Lang T].WebmedCentral 2010;1(11):WMCRW00182
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  • Other Comments: This is a timely article on an affordable and innovative in-house solution for the readers to the strategic quality management systems of clinical trials in resource-limited settings which promotes mentoring of staff involved in clinical trials whilst sharing best practices in a reciprocal manner. This approach is highly commendable and as members of the East African Consortium for Clinical Research (EACCR) plan to embrace it wholeheartedly. The approach will be expanded to 17 multi-centre sites in the region which are conducting clinical trials on multiple diseases (Malaria, TB and HIV/AIDS). The article is well-written, structured and clear to a reader. There is value addition to the existing scientific literature and the benefits of this novel approach are clearly mentioned. A typo has been identified in the sub-title which is written as "Has is it worked?" It should be corrected to "Has it worked?" Evaluation of the health economics aspects to this strategy will further guide the decision-makers on its wider implementation especially when compared to the cost implications of CROs.
  • Competing interests:
    None but I currently work with the EDCTP-sponsored regional network of excellence in Eastern Africa where we plan to roll out the reciprocal clinical monitoring scheme.
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:
    I have background training as a Medical Doctor and currently working as a clinical epidemiologist with special interest in infectious diseases, clinical trials, strategic quality management systems and patients' safety in health research. I have been working in a resource-limited setting on a couple of clinical trials and other epidemiological studies for at least 10 years, especially on HIV/AIDS and related infectious diseases such as TB, pneumococcal disease and bacteraemias.
  • How to cite:  Miiro G M.A Sensible Approach To Monitoring Trials: Finding Effective Solutions In-house [Review of the article 'A Sensible Approach to Monitoring Trials: Finding effective solutions in-house ' by Lang T].WebmedCentral 2010;1(11):WMCRW00125
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  • Other Comments: Dear Editor, This paper comes with a very good timing. Several voices have been addressing in recent years the problem of implementation of GCP standards in resource-poor settings and/or in academic research, sometimes arguing that standards have been set too high and could become an obstacle to independent, public health-driven research (1, 2). To address these concerns, there is an urgent need of guidance to distinguish between GCP ?essential requirements?, which are not negotiable, and ?procedural requirements?, which may and should vary depending on the contexts. In other words, the principles underlying GCP must be translated into patient-centered processes and procedures, which ensure the protection of research subjects and the reliability of research data, while maximizing the rationale use of available resources. For instance, trials must be monitored in order to ensure and document compliance with ethical and methodological standards: however, the frequency of monitoring and the way it is organized and conducted can vary, provided that the ultimate goals are achieved. In this perspective, this paper proposes a concrete and pragmatic approach to monitoring of clinical trials, by addressing the main problems faced by independent research group: - How to ensure adequate frequency of monitoring, with small research budgets? - How to ensure that monitoring results in actual support to the study team to ensure quality and reliability of data as well as protection of patients? - How to ensure that the monitor acts as the main line of communication between the sponsor and the investigator (3), so actively contributing to the good conduct of a trial on a continuous rather than ?spot? basis? The proposed ?in house monitoring scheme? could adequately address these major questions: by bringing monitoring ?within? the research team, it will allow a decrease in monitoring-related costs, while creating the pre-conditions for a qualified, motivated and continuous involvement of the monitor through all the phases of clinical study. I would like to make a few additional comments only: - When talking of GCP standards, in addition to the 2006 ICH Guidelines (3), I would always mention the 2005 WHO Guidelines (4). To date, most Donors are based in the EU or US and therefore refer to ICH Guidelines, however comprehensive international standards would better be agreed, adopted and when needed updated at WHO level. - The WHO TDR approach of training young African investigators so that they can also serve as clinical monitors is surely very positive and constructive, but it could still fail to address the requirement of ?continuity? of contacts between the monitor, the investigator(s) and the sponsor between two consecutive visits, e.g. for follow-up of findings and for timely support on problems that arose after the last monitoring visit. The approach proposed in this paper can represent a further step in this direction. - The perspective of extending the in-house monitoring scheme, by opening to interested research networks (moving from ?in house? to ?reciprocal? monitoring scheme) represents a logical step forward. However, care should be put to ensure the uniformity of standards applied by different groups, as well as to ensure that the monitor will still play an active communication role between two consecutive visits, even if he/she belongs to a different research group. (1) WHITE N. (2006). Editorial: Clinical trials in tropical diseases: a politically incorrect view. Tropical Medicine and International Health : Vol. 11, no 10: 1483?1484 (2) STEWART P et al (2008). Regulation: the real threat to clinical research. BMJ; 337: 1085-1087 (3) International Conference of Harmonization (1996). ICH Tripartite Guideline for Good Clinical Practices E6 (R1), 10th June 1996 (4) WORLD HEALTH ORGANIZATION (1995). Guidelines for Good Clinical Practices for trials on pharmaceutical products. WHO Technical Report Series No. 850, 1995, Annex 3. WHO, Geneva
  • Competing interests:
    No. However, I wish to remind that my institution participates in the Global Health Clinical Trials, in whose website I am quite active as well as the Authors of this article.
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    Yes
  • References:
    In press in the Italian Journal of Tropical Medicine
  • Experience and credentials in the specific area of science:
    Pharmacist by background Experience as clinical research scientist in the private sector in Europe Experience in NGOs mdical programs in developing countries Since 2006, head of the clinical trials unit of the ITM (carrying out non commercial trials in developing countries)
  • How to cite:  Ravinetto R M.In-house monitoring scheme: a promising fay forward for non commercial clinical research[Review of the article 'A Sensible Approach to Monitoring Trials: Finding effective solutions in-house ' by Lang T].WebmedCentral 2010;1(10):WMCRW0078
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