AHPPI Attending the HRA Phase 1 Advisory Group Meeting, London, 09-Feb-2016

NHS-logoThe National Health Service Health Research Authority (HRA) has a special interest group focusing on Phase 1 clinical trials.

An excerpt from their web site:

The Phase 1 Advisory Group is established by the HRA as a forum to discuss issues relating to the ethical review of Phase 1 trials in the UK. The Phase 1 Advisory Group meets twice a year.

The membership of the Advisory Group comprises representatives of the following:

  • HRA Operations and Approval staff
  • NHS/HSC RECs with Type 1 recognition to review phase 1 trials
  • Phase 1 trials units
  • Association of the British Pharmaceutical Industry (ABPI)
  • Bio-Industry Association (BIA)
  • Contract Clinical Research Association (CCRA)
  • Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI)
  • Medicines and Healthcare Products Regulatory Agency (MHRA)

The Phase 1 Advisory Group (P1AG) meeting minutes can be found on their site (link).

The next meeting will take place in London on 09-Feb-2016.

Representatives from the AHPPI, the UK’s early phase trials membership association, have been attending these meetings since their inception in order to put forward the interests of it’s members.

Further, general information on conducting Phase 1 trials in the UK can be found on the HRA’s site (link).

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Club Phase 1 to hold it’s next meeting in Paris on 22-Mar-2016

ClubPhase1Club Phase 1, the AHPPI’s French sister human pharmacology organisation, will be holding it’s next meeting in Paris on 22 March.

The draft outline of the programme is included below:

  • Regulatory– Update on early phase clinical trial approval & on new EU regulation implementation – ANSM –Cecile Delval
  • Immunogenicity … How to deal with it? Nathalie Mace –Sanofi
  • Prediction of patient placebo response: from myth to reality. Impact on Proof of
  • Concept clinical trials. Alvaro Pereira -Tools4Patients
  • Use of modelling & simulation approaches in Clinical Development Speaker to be confirmed
  • Definition of ”adversity” in toxicologic pathology – Results of the ESTP expert workshop – Practical considerations for NOAEL definition and first into human studies Xavier Palazzi- Sanofi
  • Drug Drug Interactions & drug transporters: what’s new? Professor Jean Michel Scherrmann– Université Paris Descartes
  • Translational medicine from animal to human : oncology models Patricia Vrignaud –Institut Gustave Roussy
  • Translational medicine from animal to human : panic disorders Philippe Danjou – Biotrial Neurosciences

Use the following links to download the full draft Flyer and Registration Form.

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Statement on the Recent Serious Adverse Events During a Clinical Trial in Europe

Logo Eufemed 10-6-'15The European Federation for Exploratory Medicines Development (EUFEMED) yesterday posted a statement about the widely reported death and serious illnesses occurring in an exploratory clinical trial in Europe (link PRNewswire).

EUFEMED is headquartered in Brussels and constitutes the federated member associations of professionals working in Early Phase clinical trials from Belgium (BAPU), France (Club Phase 1), Germany (AGAH) and the United Kingdom (AHPPI).

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Survey Results for AHPPI’s Annual Meeting

Steffan Stringer, published 23-Dec-2015. Correspondence steffan.stringer@alwynconsulting.co.uk.

©2015 Steffan Stringer, Alwyn Consulting, www.alwynconsulting.co.uk


This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A survey methodology showed the meeting to be well organised, and good value for money. The venue was good but the facilities were not sufficient for the breaks. A longer meeting would improve networking opportunities and allow more time per speaker. Most attendees (63.64%) supported the AHPPI (Net Promoter Score loyalty metric).

Background

The Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) held its annual meeting on 29-Oct-2015. The meeting was titled Risk Management in Early Phase Clinical Trials and took place at the Academy of Medical Sciences in London. The meeting cost £35 per person, started at 12:30 and finished at 17:00 and was followed by a drinks reception. A survey was sent to the attendees the day after the meeting. Links to the presentations and an attendance certificate were provided to the attendees by follow-up emails.

Methods

A 10 question survey was constructed prior to the meeting using SurveyMonkey. The survey was intended to determine the level of satisfaction the attendees experienced and to solicit feedback for the planning and development of future meetings. The questions were all pulled from an existing library of questions and were either Eventbrite or SurveyMonkey certified.

The questions were as follows:

  1. Overall, how would you rate the event?
  2. What did you like about the event?
  3. What did you dislike about the event?
  4. How engaging were the speakers at the event?
  5. How organized was the event?
  6. Was the event length too long, too short, or about right?
  7. How would you rate the value for the money of the event?
  8. How could future events be improved? Select all that apply.
  9. Is there anything else you’d like to share about the event?
  10. How likely is it that you would recommend the AHPPI to a friend or colleague?

Questions 2, 3 and 9 collected free text responses. All other questions required the selection of a single or multiple predefined responses or a rating upon a 10-point scale. Questions and answers were not edited and were presented verbatim from the library of question/answer combinations. The survey did not collect any identifying data from the respondents. The survey remained editable until it was submitted. Upon completion of the survey, a respondent was able to see the aggregated and summarised data of previous respondents. The survey was issued to the 57 attendees at approximately mid-day on 30-Oct-2015 and closed on 08-Nov-2015. The recipients included the speakers, AHPPI committee members and the organising committee for the meeting.

The full survey page can be seen here (link to SurveyMonkey Web site).

Results

Twenty responses were received on the first day the survey was opened and the last response was collected 04-Nov-2015, approximately four business days after it was opened. A total of 33 responses were collected from the 57 invitations to participate (57.9%), 32 in response to an email invitation and one in response to a link to the survey. Questions 1, 5, 6 and 10 show results compared to SurveyMonkey global benchmarks. Where available, box and whisker plots have been chosen to display the numerical data rather than frequency histograms.

For free text responses, the verbatim responses are presented below. Each bullet point represents the complete response of one individual. Some typographical errors have been corrected and minor formatting changes made.

The full results dataset can be found here (link to SurveyMonkey Web site).

1. Overall, how would you rate the event?

The score was 1.67, better than the Global Benchmark median (1.73).

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

  1. What did you like about the event?

Twenty-eight respondents answered this question. Five skipped the question.

  • Variety of content
  • All speakers provided clear, concise and relevant information. Meeting was also well organised with good professional and time for social interactions
  • Risk Management for Early Trials in biological -the speaker was very good balancing science and information
  • High quality presentations. Interesting mix. Nice venue, it had a professional feel to it
  • High standard of presentations. Wine & snacks afterwards!
  • Topical theme. Speakers from differing backgrounds
    Length of time for talks. Good opportunity for networking. Good quality of food and drinks
  • Topics, speakers, organisation
  • Engaging, knowledgeable speakers. Good venue as ever. Kept to time
  • The members- very friendly and knowledgeable. The presentations – very interesting and informative. The venue- small but cosy. The drinks reception – nice touch!
  • Talks were interesting and good networking opportunities
  • There was a variety of talks; it was relatively small which made networking easier; well organised and kept to time.
  • Nice mix of people, good presentations, people open to networking
  • Updates related to regulatory environment and new trends or changes in standard of practice (e.g. TQT). Meeting point
  • Good attendance, agenda shared ahead of the meeting, most presentations were well thought out and informative
  • It was good to see that the organization has positive plans for the future.
  • In a half-day, some of very important topics in clinical trials are discussed.
  • That there was a range of topical items discussed
  • Opportunity to network – great topics discussed – brilliant organisation
  • Good talks, nice to meet some old friends
  • Topic content of risk management.
  • Very relevant to my current job
  • Chance to network. Interesting presentations
  • Very well organized, good location and great facilities
  • The agenda – the theme was very relevant and the talks all very informative and excellent. The name badges were good and big so they were easy to read!
  • Talks were interesting the presenters were good (especially the second talk)
  • The focus on updates on a number of essential topics relevant to drug development.
  • The talks were well prepared, relevant and very engaging.
  • The breadth of topics discussed and the active participation. The speakers were excellent, I thought in detailing the important issues.

3. What did you dislike about the event?

Twenty-five respondents answered this question. Eight skipped the question.

  • Over run of some talks
  • Meeting room limited in space although adequate
  • The room was too dark during presentation – difficult to write notes. General concern with proposal of using other social media for sharing information and especially accessing the presentations
  • A little crammed. The meeting format (n=50) and the relatively small room did not go well with the high level talks. Also some presentations would have warranted more time – for discussion
  • Use a more comfortable space to host the event
  • Room too hot
  • Nothing, except perhaps biscuits at the start!
  • Slides not given as notes to annotate
  • Nothing!
  • Nothing
  • When the focus of a presentation is more business related rather than knowledge sharing
  • Very much a lecture style, not the environment to network (it appeared most ppl were speaking with prior connections), very phase 1 unit focused (not a bad thing but perhaps more input from the Sponsor side would’ve been good)
  • I thought it a pity that the speakers had too little time to present their slides, or too many slides to present in the short time, i.e. didn’t prepare too conscientiously. The result was that the pace was pretty hurried.
  • Nil
  • Too short
  • Nothing
  • Timing of presentations the speakers could keep to time better so that all slides can be seen. Suggestion – one speaker per presentation 15 mins.
  • None
  • Finishing when the queue to get into Oxford Circus tube station tailed back onto the street, and for Piccadilly tube station filled the station. I guess walking to Waterloo was good for me but I missed the train I was after!
  • The coffee room got a bit hot before the presentations started. Lecture theatre was fine.
  • Nothing. Central London location was good for me, half day was perfect as I got 4 hours work done first, drinks afterwards were very pleasant.
  • The room with coffee, etc was a bit small for the number of attendees
  • The narrow lounge where colleagues had a tea/coffee. It felt too cramped in there.

4. How engaging were the speakers at the event?

All respondents answered this question. Thirty respondents (90.91%) felt that the speakers were extremely or very engaging. Three (9.09%) felt the speakers were somewhat engaging.

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

5. How organized was the event?

All respondents answered this question. The result, a score of 1.64 compares with a median of 1.78 in the Global Benchmark indicating that the meeting was well organised.

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

6. Was the event length too long, too short, or about right?

All respondents answered this question. The result, a score of 4.24 compares with a median of 4.00 in the Global Benchmark indicating that the meeting was shorter than the attendees would have liked.

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

7. How would you rate the value for the money of the event?

All respondents answered this question. The event cost £35. 31 (93.94%) felt that the event was either Excellent or Very Good value for money. One respondent (6.06%) felt the event was Good value for money.

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

8. How could future events be improved? Select all that apply.

Twenty-one respondents answered this question. Twelve respondents skipped it.

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

9. Is there anything else you’d like to share about the event?

Seventeen respondents answered this question. Sixteen respondents skipped it.

  • None
  • I had hoped to get some more update on the regulatory view on the update of E14 or S7B
  • If the event expands in size the venue would not suffice
  • Appreciate the committee members hard work in organising a good event.
  • Good to have representatives from Regulatory and ethic bodies
  • It was really great. Above comments are no criticism just suggestions.
  • The topics covered may have warranted a 1-day event. Some of the speakers where a little rushed. On the other hand, I think all the key messages came across very clearly.
  • Very difficult to improve on this level of quality
  • Uniformly excellent. Several of our staff will be joining the AHPPI.
  • Have a slightly bigger room for food and drinks if possible. Got quite claustrophobic
  • Excellent
  • Would it be possible to have access to the presentations? Since some had reference to very interesting publications
  • The event was good but i think there needs to be a focus on where the industry is going i.e. future innovation in clinical trials. Also more transparency with list of attendees and opportunity to interact/make new connections
  • Giving a certificate to attendees are not a bad idea.
  • None
  • Longer notice of the date/programme would help, I think this was just 7 weeks.
  • First one I have been to in a few years, very good and well organized, would be nice to have access to a list of attendees at the event on the day but don’t know if this is for confidentiality reasons this is not shared.
  • Get it more widely advertised & make it inclusive to all colleagues working in different areas of the drug development process in Academia and Pharmaceutical Industry.

10. How likely is it that you would recommend the AHPPI to a friend or colleague?

Twenty-one (63.64%) respondents are promoters of the AHPPI, 11 (33.33%) are passives and one (3.03% )is a detractor. This compares favourably with Global Benchmarks – 52.68, 25.12 and 22.20% respectively.

SurveyMonkey_Analyze_-_AHPPI_Annual_Meeting__29-Oct-2015

Conclusion

The survey respondents reported that the meeting was well organised, but could have been longer in order to do justice to the content. They provided feedback that the venue was good but the facilities the committee had selected were not sufficient for the breaks. There is a sentiment that a longer meeting with larger facilities would enhance networking opportunities. The meeting was regarded by the majority as either excellent or very good value for money. Most attendees (63.64%) asserted they were net promoters of the AHPPI.

Conflicts of Interest

The author was on the organising committee for the meeting described in this article.

Acknowledgements

The author would like to thank Kerry Broomfield, Tim Hardman and Nathan McCavery for their support in organising and conducting the meeting. The AHPPI Committee would like to thank Niche Science & Technology and BioKinetic Europe for sponsoring the meeting.

References

  1. https://www.surveymonkey.com
  2. https://www.eventbrite.co.uk
  3. https://en.wikipedia.org/wiki/Net_Promoter
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Sponsors have up to 30 months after the end of a trial to publish results of Category 1 trials under EU CTR

EMA_LogoOn 05 October 2015, the EMA signed the Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”. In this document, the EMA introduces a new categorisation of clinical trials.  Trials that are not intended to treat, prevent or diagnose a condition (including Phase 1, bioequivalence, bioavailability and biosimilarity trials) are defined as “Category 1” trials.

The Appendix provides sponsors with the unique opportunity to combine compliance with recognised transparency measures with an assured protection of their IP and patent rights. The Appendix achieves this by setting straight-forward and universally acceptable rules that allow up to 30 months after the end of a trial for publication of Category 1 trials’ information and summary results.

A copy of the Appendix on disclosure rules can be found here.

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Update on the implementation of the new EU Clinical Trial Regulation’s transparency rules for early phase trials

ulrikeb&wDr Ulrike Lorch, AHPPI Chair-elect

Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).

 

 


The new EU Clinical Trials Regulation (EU CTR) is intended to stimulate innovation, research and development in Europe. One of its key aims is to reverse the decrease in the number of clinical trials performed in Europe, by simplifying clinical trial application and authorisation processes. The second key aim is to increase transparency and availability of information on clinical trials and their results.

Phase 1 clinical trials are usually conducted early during a new medicine’s development. At this stage, particular care needs to be taken to find the right balance between protecting commercially confidential information and making relevant information about the trial available to the public.

The presentation described how the AHPPI, as a member of the European Federation for Exploratory Medicines Development (EUFEMED), participated in stakeholder discussions led by the European Medicines Agency (EMA) over the last year. We made proposals on how the transparency requirements of the EU CTR could be suitably implemented for Phase 1 trials, within the framework of the functional specifications of the EU portal and database.

The presentation goes on to describe the outcomes of the stakeholder discussions. In early October 2015 the EMA published the finalised disclosure rules. These rules give a clear definition of what types of trials are defined as “Category 1”, i.e. trials – including Phase 1 – that do not intend to treat, prevent or diagnose a condition. For Category 1 trials the disclosure rules allow adequate time windows for publication of trial information and results that are of sufficient length to protect commercially confidential information and patent rights. Equally, the time windows are appropriate for publication at a time when the information becomes relevant for the public.

07. Ulrike Lorch_AHPPI


Written by Dr Ulrike Lorch Richmond Pharmacology Limited. Ulrike trained as an anaesthetist in London and has more than 15 years’ experience in conducting early phase clinical research as a principal investigator. She is an appraiser for physicians revalidating with the UK’s General Medical Council and a member of the Faculty of Pharmaceutical Medicine’s Board of Examiners and an Educational Supervisor for specialist trainees in Pharmaceutical Medicine. Dr Lorch is the AHPPI Chair-elect.

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Cardiac Safety – the regulatory perspective

KrishnaB&WDr Krishna Prasad, MHRA

Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).

 

 


Krishna reviewed the status quo pointing out that the regulations were a success in that no drugs having undergone E14 testing had to be withdrawn subsequent to receiving marketing approval. However, over 400 TQT studies have been conducted over the 10 years costing well in excess of £1bn whilst having a negative impact on drug development due to the premature discontinuation of promising drugs due to hERG effect or a QT signal.  He suggested that many potentially good compounds might not have been evaluated in humans due to a hERG effect, a view that is shared by many.

He gave an example of an iQT study which was deemed adequate to assess the pro‑arrhythmic risk by both the FDA and EMA, but he also pointed out that this one precedent did not create a universally applicable standard a drug developer could rely on. He discussed whether CE analysis in early phase studies would provide adequate confidence in risk evaluation and labelling.  In the absence of a TQT study, careful assessments of the limitations of the proposed alternatives are needed: are sufficient exposures achieved in SAD/MAD studies; have period and sequence effects in ascending dose studies been adequately considered; was there clear exposition of PK of parent and metabolites? He also flagged the operator dependency of modelling approaches which still needs to be addressed, raising the question “Would CE analysis in early phase provide confidence in risk evaluation and appropriately guide B:R evaluation and labelling?”
04. Krishna Prasad_MHRA

He suggested that CIPA will standardize in vitro and in silico assays and establish best practices. He expressed hope that this would prevent early attrition solely caused by a positive hERG test. CIPA will provide a more complete assessment of pro‑arrhythmic risk and may help to re‑label drugs with risk warnings. He cautioned that it will not replace phase 1 ECG safety studies or in-vivo studies with fully integrated systems, pointing out that at this point in time, for some cases, a TQT study might still be the most cost effective option! Early phase studies are still binary (yes or no) but will benefit from a more comprehensive non‑clinical background making the two approaches complementary.


Written by Dr Jörg Täubel, Richmond Pharmacology Limited. Jörg trained in clinical jorgb&wpharmacology and has been a principal investigator since 1995, conducting studies in patients and healthy volunteers ranging from first time in man (FTIM) to later phase studies particularly in cardiology, neurology, and gastroenterology. He provides expert advice in cardiac safety assessments and ethnic comparison studies. Jörg is an honorary fellow at St George’s University and his academic research is focussed on the role of hyperglycaemia in relation to sudden cardiac death in Type I diabetic patients. He is a member of AHPPI and AGAH and the EUFEMED scientific committee. 

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Cardiac Safety – the industry perspective

Dr Boaz Mendzelevski, BioClinica

Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).

 

 


This year marks the 10th anniversary of the introduction of the ICH E14 guideline which was introduced to provide a global standard in the clinical evaluation of QT/QTc interval prolongation and pro‑arrhythmic potential for non‑antiarrhythmic drugs.  Following an initiative by the FDA discussions of the possibility of replacing the thorough QT (TQT) study with nonclinical proarrhythmia assays and QT assessment in early phase clinical studies are ongoing. The anticipation of revised ICH S7B and E14 guidelines created uncertainty amongst sponsors planning their exploratory medicine studies in man.

As the first speaker in this Cardiac Safety Session, Boaz briefly introduced the new cardiac safety paradigm including the proposed Comprehensive In vitro Proarrhythmia Assay (CIPA), multiple ion channel evaluation (MICE), in silico predictive modeling, cell-based assays and Phase 1 Intensive QT (IQT) studies.
The proposal is for IQT assessments to be added to routine Phase 1 SAD/MAD studies using exposure‑response modelling, i.e. the analysis of the relationship between drug plasma concentrations and QTc in place of the ICH‑E14 time-course analysis. The ER modelling has shown to be more effective and meet current statistical requirements with significantly fewer subjects.

Boaz reported on a recent IQ/CSRC Study and pointed out that this IQT validation study had several limitations – it investigated medicines with a marked effect on the QTc interval, but did not answer the question of how well the proposed model will perform in drugs with borderline QTc effects and drugs with known autonomic effects (QT:RR hysteresis). Moreover, drugs with long half‑life, delayed effects (PK:PD hysteresis), active metabolites, and drugs requiring up‑titration do not fit into this crossover study model, as they may require a parallel group design.

03. Boaz Mendzelevski_BioClinica
Amongst the issues to be resolved and/or agreed, he listed the confirmation of assay sensitivity without using a pharmacological positive control and how to otherwise exhibit sensitivity and specificity to identify both false positive and false negative effects. It is also not yet clear whether the E14 threshold of concern (upper 90% CI of 10 msec) will be retained in the new paradigm, and how will this affect the power required to clear the current or future regulatory end-point in IQT studies.

In concluding, Boaz reiterated that drug developers need to rule out QT prolongation or accept a QTc prolongation label, based on robust evidence.  He advocated the conduct of intensive (SAD/MAD) IQT studies where appropriate and to consider a TQT study where an IQT design is not a good option.


 

jorgb&wWritten by Dr Jörg Täubel, Richmond Pharmacology Limited. Jörg trained in clinical pharmacology and has been a principal investigator since 1995, conducting studies in patients and healthy volunteers ranging from first time in man (FTIM) to later phase studies particularly in cardiology, neurology, and gastroenterology. He provides expert advice in cardiac safety assessments and ethnic comparison studies. Jörg is an honorary fellow at St George’s University and his academic research is focussed on the role of hyperglycaemia in relation to sudden cardiac death in Type I diabetic patients. He is a member of AHPPI and AGAH and the EUFEMED scientific committee. 

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Introduction to EUFEMED & European Training Course in Human Pharmacology

jorgb&wDr Jörg Täubel, EUFEMED

Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).

 

 


Jörg explained that the AHPPI is a founder member of EUFEMED, which was born after a long gestation on 20 May 2015 in Brussels, on the occasion of the third joint meeting of the four European early phase clinical drug development associations – namely from Belgium (BAPU), from France (Club Phase 1), Germany (AGAH) and from the United Kingdom (AHPPI). The godparents were Prof Dr Jan de Hoon (BAPU), Dr Y Donazzolo (Club Phase 1), Prof Dr H Sourgens (AGAH) and Dr P Dewland (AHPPI). The aims of the Federation are to promote European Clinical Pharmacology by international meetings, gaining recognition as a European stakeholder in international and national regulatory discussions and to establish an international post-graduate training programme in this area of study.

Over the past four years there have been three scientific meetings involving contributions from all participating associations (Berlin in 2011, Nice in 2013 and Brussels in 2015) with the next being planned for 2017 in the UK. Successful contributions have included revisions to the Clinical Trial Regulation coordinated by the EMA. As a recognised EU stakeholder meetings were attended by EUFEMED committee members.

06. Hammond_Taubel_EUFEMED
The first modules for EUFEMED’s Diploma in Clinical Pharmacology are scheduled for the fourth quarter of 2016. This is truly international in the content of its syllabus and national delivery by all EUFEMED member associations.


 

Written by Dr Mike Hammond, Principal of Clinical Quality Management Solutions. Mike graduated in Pharmacology and has a PhD from the University of London. He has held various career positions in drug discovery with US, European and Japanese pharmaceutical companies. He currently works on the Quality and Regulatory aspects of development and commercial exploitation of novel therapies. He is a committee member of the AHPPI Committee.

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Use of a Novel Risk Rating System in Early Clinical Trials

Dr Brian Leaker, Respiratory Clinical Trials.

Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).

 

 


Brian outlined the structure of his unit and, in particular, the research side of the operation. The unit has a “Medical Advisory Committee” one of whose functions is to minimise risk. Reporting to the MAC is the Research Governance Committee which has an independent Chair who is a clinical pharmacologist and independent members in the form of a toxicologist and QP and non-voting members from the unit itself. The committee’s remit is to review protocols and related IBs and other relevant information and to quantify risk. It does this on an ongoing basis and requires a majority verdict.

05. Brian Leaker_RCT

The committee uses a scoring system which forms a matrix with risk score (graded 1-4) down the side and factors including IMP, methods to be used and intended population across the top.  This means that by positioning risk categories using the main protocol events such as IMP nature and formulation, potentially invasive methods etc a Risk score can be read off the matrix.

Brian went on to give several specific examples of studies which they had performed in the Respiratory field and how they had scored them along with the results of each study which supported the categorization method which they had used.

This was an interesting and very practically based talk describing a model which might well be adapted for general Phase I (and maybe later phase) studies.


Written by Dr Peter Dewland, Peter Dewland Consulting. Peter is an independent peterconsultant in pharmaceutical medicine and has a Master’s degree in Medical Ethics together with degrees in Biochemistry and Medicine along with 30 years experience of developing new drugs. He is a founder member of the Faculty of Pharmaceutical Medicine and now both teaches and examines students of this specialty. He is a past Chairman and current Treasurer of the AHPPI.

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