Title and code of the project
Advancements in the DESIGN, conduct and analysis of randomised trials
on drug effects
Principle People/(co)promotores
Prof. D.E. Grobbee, MD, PhD, Clinical Epidemiology, Julius Center, UMC
Utrecht (chair)
C.B. Roes, PhD, Clinical Information & Biometrics, Organon, Oss (co-chair)
Other team members
Prof. A. de Boer , MD, PhD, Pharmaco Epidemiology, UU Utrecht
Prof. A.W. Hoes, MD, PhD, Clinical Epidemiology, Julius Center, UMC Utrecht
M.J. Knol, Clinical Epidemiology, Julius Center, UMC Utrecht
D. Dobre, MD, MPH, PhD, Department of Clinical Pharmacology, UMC Groningen
Statistician TBD
Location of PhD fellow
Julius Center of the University Medical Center Utrecht
Qualifications
The candidate should have an MD, PharmD or degree in biomedical
sciences or related field. Experience in research and training in
epidemiology are appreciated. Motivated to work in cutting edge drug
development research is a prerequisite
Application
Candidates can apply by sending their CV and application letter to
Mirjam Knol (m.j.knol@umcutrecht.nl).
Please indicate in your application letter how you heard of this vacancy.
Employment terms
The candidate will have an appointment at the Julius Center of the
University Medical Center Utrecht (www.juliuscenter.nl) and will
closely collaborate with people from other institutions. We offer a
temporary full time appointment as a PhD student for one year with the
perspective of prolongation with another three years.
Contact People for information on project/application
M.J. Knol, University Medical Center Utrecht,
+31 (0)88 755 9380,
m.j.knol@umcutrecht.nl
P.A. van Meurs, Project leader Escher programme
+31 (0)88 755 5196 or mobile +31 (0)621 512631, p.a.vanmeurs@umcutrecht.nl
Introduction of the Research topic/ background
(300 words)
In the past decades the RCT has been viewed as the paradigm study
design to determine the intended effects of drug interventions. In
addition RCTs are important to assess type A (i.e. more common,
predictable) unintended effects of drugs. Typically these RCTs are
executed in three phases during a period of 10 years prior to drug
registration.
Currently, trials are not designed, conducted and analysed in the most
efficient and expeditious manner and several improvements in the
design, conduct and analysis phase could lead to increased efficiency.
For example, prevention of losses to follow-up and incomplete data,
and sophisticated methods to impute missing values if they occur can
increase the effective sample size. Sophisticated methods to indicate
when there is enough information to stop the trial can shorten the
duration of the trial and decrease the number of patients to be
included. By using information of earlier trials when analysing a new
trial, evidence of efficacy of a drug might be available earlier and
less trials have to be performed.
Research Questions
(200 words)
How can the design, conduct and analysis of randomized controlled
trials on drug effects be improved?
Improvements of design phase:
selection of patient populations
sample size estimation
randomization and blinding
primary, secondary and composite outcomes
Improvements in conduct phase:
recruitment and compliance of study participants
follow-up of study population
stopping trials early
Improvements in analysis phase:
imputation methods for ‘lost-to-follow-up’ and incomplete data
pooling of studies
Methods
(300 words)
Improvements in design phase:
Review of the literature summarizing different strategies to select
patient populations, to perform sample size estimations and to conduct
randomisation and blinding, and analysing which of these different
strategies are most effective. This review can then be used to
formulate a recommendation on designing RCTs.
Comparison of existing and development of new statistical methods to
analyze composite endpoints using empirical data.
Improvements in conduct phase:
Review of the literature on different strategies to recruit and
follow-up study participants and summarizing different strategies to
improve and monitor compliance. This information is used to analyse
which strategies are most effective and to formulate a recommendation
on improving conduct of RCTs.
Comparison of different methods and strategies, for example
conventional and Bayesian analyses, to stop trials early, using
empirical data of already performed trials.
Improvements in analysis phase:
Comparison of different imputation methods of increasing complexity
for random and non-random missing values due to ‘lost-to-follow-up’
and incomplete collection of data. Empirical data of trials will be
used to compare these different methods.
Comparison and application of different meta-analytical (Bayesian)
techniques to analyse data of a trial using data from previously
performed trials. Comparison and application of different
meta-analytical (Bayesian) techniques to pool phase III and IV
studies.
Deliverables
(300 words)
Recommendation to improve design phase of RCTs in terms of selection
of patient populations, sample size estimation, randomisation and
blinding, and composite outcomes.
Recommendation to improve conduct phase of RCTs in terms of
recruitment, compliance and follow-up of study participants, and
stopping trials early.
Recommendation to improve analysis phase of RCTs in terms of missing
data and pooling of studies.
5 Papers in international scientific journals
PhD Thesis
Presentations at (inter) national scientific meetings
Timelines and Milestones
(per 6 month episodes)
(200 words)
0-12 months: Reading relevant literature and research training in Epidemiology
12-18 months: Review and analysis of different strategies in design
phase and recommendation of improvements
18-24 months: Review and analysis of different strategies in conduct
phase and recommendation of improvements
24-30 months: Comparison of methods of stopping trials early
30-36 months: Comparison of imputation methods for missing data
36-42 months: Comparison of meta-analytical techniques to pool studies
42-48 months: Finalization of publications and PhD thesis. Most of the
aforementioned periods will be finalized by a manuscript
This entry was posted on September 9, 2008 at September 9, 2008 and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed.
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Things to Prepare Before Applying a Scholarship
Getting a scholarship for an overseas study is a competitive process. This is because many people like you want the scholarship, but not all can be awarded. The cholarship money is simply not enough to fund all at once. Also, the scholarship providers want to ensure that only the best, well prepared applicants are selected and so the money is spent rightly and efficiently to what it is intended for. So, you have to be a winner!
Lots of people have won scholarship. You hear this every time. But how have they done this good job? Are they luckier or more superior or intelligent than others? No, they are not! If you ask them about the winning secrets are, they may simply give you the following lists: things to prepare or consider before applying a scholarship.
Academic certificate and transcript
Soon after graduation, do not wait. Obtain your original academic certificate and transcript, and make some copies of them. You need to certify them and, remember, that people at university are some times going somewhere when you need their signatures. More importantly, you need to translate both your academic certificate and transcript. Check around, there maybe some people have done the same. This will ease the task. If not, they are yours anyway. When you are done, it is wise to get other people to see them. They may give you valuable inputs, even correcting misspelled course names. Again, you need signatures of dean and rector on the translated version of your academic certificate and record.
Research proposal
You need to decide earlier which study route you are going to undertake – course or research or both. If you prefer a course-based study, you do not need a proposal. But if you are going to do a research, you definitely need a research proposal.
Good research proposal require time and energy to construct. So it is always better to prepare it earlier. Basically, the proposal will not be much different to the one you have done previously in your research as part of your undergraduate study. This will include background, objective, problems or questions to answer, hypothesis, methodology, and references. These are the essences of a proposal. For more on research proposal, read here and here
When you are done with those basic requirements, ask suggestions from others. When the application is open, check if the scholarship provider requires a bit more to what you have prepared.
Letter from intended university and supervisors
Download application form from the university website and fill it before send it back to the university. The university will respond you and issue you with a letter of acceptance. You may indicate in the form that you will begin your study next year, waiting for a scholarship which you are now struggling for. Most likely they will issue you with a conditional acceptance. They will keep reissuing this until you succeed with your scholarship application.
While your are in the website, go to your targeted department or school to find your potential supervisor. Even, this needs to be done first before filling in a admission form. The reason you will not studying in this university unless you have got an academic staff willing to supervise you. So get their email address, and make contacts with them. In the first time, you just need to introduce yourself, mention your academic background and your research proposal, and ask if he/she is available to supervise you. If they are busy because there are many students already under their responsibilities, don’t panic. Ask him/her if they know people around there who are still able to take additional students.
The good with the letter from university and supervisor when you have them at hand is that you can attach them to your application form and present them to the interviewers. These letters will increase your chances of winning the scholarship because the interviewers will so impressed that you are better prepared and have taken more advanced steps compared to other candidates. Read more..
Scholarship Applications that Win!
by Bill Reynolds at FreSch!
Tip #1. ATTENTION TO DEADLINES
Try and have your application arrive EARLY as possible, absolutely not after the deadline date! I like to send applications with a “return receipt requested” or “registered” to make sure they get there. I think that this also conveys a positive characteristic about the sender.
Tip #2 START YOUR APPLICATION WITH A “THANK YOU” COVER LETTER
Sample Packet Cover Letter
1111 WinOne Street
Pensacola, Fl 32503
9 September 1999
Mary Smith, President
Whatever Scholarship Committee
Orlando Central Parkway
Orlando, Florida (zip code)
Dear Ms. Smith,
This letter is an introduction of myself, (your name), and my desire to participate in the (whatever it is called) Scholarship Program. I have been accepted to (Name of your College) for the 1999 fall term.
I would like to thank you and the (whatever) Scholarship Committee for supporting college bound students with an opportunity for financial assistance through your scholarship program. Enclosed you will find my application form, high school transcript, ACT results, letters of recommendation, and other pertinent information. Again, thank you for your interest on my behalf and for the youth of our state.
Respectfully,
(your name)
Tip #3 ANSWER THE “MAIL”
While this seems obvious, you must construct your application to make it EASY for the committee to see that you have provided every thing that was required. I like to provide items in the order that they are listed in the application. If possible, do not mix items on the same page. In another tip I am going to tell you to add extra items that were not requested to give your application that something extra. However, DO NOT add extra items if you are specifically told not to add anything extra. This means that you can not follow directions if you add items when your are forbidden to do so.
Tip #4 ADD EXTRA ITEMS TO YOUR APPLICATION (if not forbidden).
This is where you get to be creative to find ways and things that present you in a positive light to the selection committee. Here are a few ideas to get you started:
1. Write a short essay on MY EDUCATION/CAREER GOALS. Try to keep to one page but no more than two.
2. Write a paragraph or two on how this scholarship award will help you reach your education/career goals.
3. My son’s guidance counselor gave him a paper that congratulated him on being in the top 10% of his class and acknowledged his hard work to get there. We included this because it put him in a “positive light” and his hard work at his academics was recognized.
4. Before my son reached his 18th birthday, he registered for the Military Draft as required for all males when they reach the age of 18. He received a letter from the draft board congratulating him for doing his civic duty prior to his 18th birthday. You guessed it, this was also one of our “extra items”. A lot of scholarship committee members have military backgrounds or see this as good citizenship for this applicant.
5. One of the best extra items is a letter of acceptance for admission to “any” college. If the scholarship application is not for a specific college, you will be able to use the award at “any” college. You do not have to use it at the college you used in your application. Later you can get more college acceptance letters and when your make your selection you can notify the scholarship award committee of where to send the award. Therefore, any letter of acceptance shows that your are serious but it does not “lock” you into using the award at that college.
These are just a few examples to get you thinking. I would limit my extras to three or four at the most. Too many and you “sour” your application. Again, MAKE SURE you are not forbidden to add extra items before you do so.
Be creative to find things that make you look good and share them with the committee.
Tip #5 PERSONALIZE LETTERS OF RECOMMENDATION
This is a tip that conveys you took the time to make this application special. When you have a letter of recommendation addressed to the specific organization or person that is administering the application process it says that you took the time and effort to make this letter “Special” for them. If all you have is a letter that starts “To Whom It May Concern”, it is better than nothing. But if you can personalize the letter it says you cared to send the very best.
SUB TIP #5a Offer to do the work for the writer of your letter of recommendation. For example, you want to apply to twenty scholarship programs. When you ask someone to write you “1″ letter of recommendation they say sure. When you say you need twenty letters they say “sorry” I don’t have the time. Once they write you one letter, ask if you can put it on the computer so the TO ADDRESSEE can be personalized for each application and your writer only has to “sign their name twenty times”. Now your writer is happy to help you because you have done the work and make it easy for them to help you. If they have nice letter head, ask for blank copies to be used in this process.
SUB TIP #5b This is an “ADD EXTRA ITEM/s” when the application does not require a letter of recommendation.
SUB TIP #5c Try and get three to five letters of recommendation in your files. This will let you pick and choose which one or ones to send in for a specific application. I would never send more than three for an application unless the directions ask for more. I will cover some tips to give your recommendation writer in a later TIP.
TIP #6 – PROOF READ ALL MATERIALS and NEATNESS IS A MUST
When you write anything you must use correct grammar and spelling. If you have a problem in this area ask your English teacher to help you with proofreading your essay, cover letter, extra items you have included, and even letters of recommendation prepared by others. When there are hundreds or thousands of applications to review, correctness and neatness become the first screen out factor. Only when the “pile” is smaller does the content of your application start to become a factor in the selection process.
TIP # 7 – SUBMIT YOUR APPLICATION IN A CLEAR PLASTIC FOLDER
Now that your application is complete, the final “presentation” tip is to place all of your items in a clear plastic folder, with a slide locking binder. I like the cheap clear ones so that your “Thank You Cover Letter” (Tip #2) is on top. For that final “touch” I also like to include a wallet size picture of the student in the lower left side of your packet. The next item/s in you application packet are those required in the application (Tip #3 Answer the mail). Next I add any extra items (if not forbidden) and finally I place any letter(s) of recommendations.
If “extras” are forbidden, you should consider NOT using a plastic folder, however, this can be a judgement call on your part. Read the application carefully again regarding extras. Some judges feel the plastic folders “give them more work” (to remove the applications from the plastic folder) while others have no problem with it, even though they may forbid extras. I know, this can be confusing!
Your application packet is a great looking presentation of YOU, don’t mess it up by folding it to fit a small envelope. Use an 8X10 type envelope so your application arrives looking great. Consider sending it “Return Receipt Requested” so you know it arrived!