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Guidelines for Clinical Research in Complementary Medicine

David Aldridge

|Abstract| |Introduction| |Purpose of the Enquiry| |Aims of the Study | |Pilot studies| |Background
to the Study
| |Design of the study||Administration of the Study| |Conclusion|

Abstract

There are several stages to preparing a research application. Careful thinking about clinical practice and the allocation of time for research is essential. Statistical decisions are best made before data is collected. This paper gives some guidelines for new researchers, focussing upon these themes:

Aims of the Study: Have a good idea, decide to research, negotiate possible changes. Derive hypotheses. Try the ideas out on friends and colleagues. Identify target audience. Identify sponsors.

Pilot Study?: Gain statistical and methodological advice. Ask about ethical committee guidelines. Try out techniques and method of data collection. Look at the literature for examples of good practice or influential study

Review Literature: Make a careful study of the relevant literature.

Design Study: Sample size, choice of patients, what type of clinical trial, identify the dependent and treatment variables. Gain statistical and methodological advice.

Administration of the Study: Who will collect the data, say how the data will be collected and stored. Timetable of the research. Ask colleagues for help and advice.

Ethical Committee: Submit research plan early. Revise.

Submit Proposal: Arrange for the payment of costs and access to a research budget.

In summary: Do trial, analyse results. Gain statistical and methodological advice. Write up: Get advice from colleagues. Ask the statistician. Consult editors and be prepared to revise your paper.

Introduction

There is a wide range of considerations which need to be made before we begin clinical research. Perhaps the most important question to ask is what are the specific guidelines for clinical research within your own institution or the institution where the research is to take place. Hopefully clinicians intending to do research will find sufficient advice to plan
a research proposal from the institution where they are working. This will also mean that sufficient advice is given concerning the scientific ethics committee of the institution. One of the keys to successful planning is to ask crucial questions early in the research process. Here then are some considerations which a research methodologist would ask of you.

Why are you doing this anyway?

I shall assume that the researcher has already gone through the preliminary stages of having a good idea which appears to be completely original and potentially world shattering when written on the back of an envelope. The next stages of writing the ideas down for colleagues to criticise and making overtures to funding agencies are far more gruelling.

If you wish to do research then it is a continuing struggle to maintain that first flush of excitement against what may seem unreasonable odds and what at times seem to be tiresome practical details. These challenges are the ones which curb our worst excesses and in the end facilitate our research. Research takes a great deal of personal motivation. It is important to find some form of personal and professional support which is supportive
but critical. In addition, it is possible to work as a group to support each other, share varying skills and to teach each other about research methods.

How are you going to pay for this research?

It is important to bear in mind that research is greedy for resources. First there is money, which is presumably why you are considering some form of grant funding. At the end of this paper you will find a section about costing.

Do you have the time to do this?

It is essential to plan your own time very carefully as a researcher. Before the research and during the progress of the work, even in preparation, it is important to have time to think about what you are doing. It is also vital to read research literature thoroughly and perhaps with a different approach to the one which is used to scan journals for articles of interest. If you are a clinician who wishes to research concurrent with practice then you may have to consider drastically reducing your clinical practice or consider working with a restricted range of patients. The activity of research thinking and planned reading, while appearing as a luxury to colleagues, may mean a change in attitude to working for the clinician who constantly has to be seen to ‘do’. At this stage it is useful to consider how long a period you want to spend on your research project, and then set a target date for the end of that period.

Finally, your immediate family and friends may not quite share your single-minded commitment to advancing the cause of modern scientific endeavour. Apart from research eating into recreation time, those sudden flashes of inspiration of extended thoughts concerning methodological conundrums can occur at weekends or in the evening when you begin to relax. Sometimes spouses do not appreciate the riddle of formulating an algorithm for multiple variables measured over a time series, especially if this occurs over dinner.

Research is a serious activity and cannot be tacked on to other activities. If possible find some specialist advice either from a colleague who has researched in the field you are considering, from a known expert in the field, or from the funding agency you intend to approach. It is at this stage that statistical or methodological advice must be sought, not after data is collected.

Another question to be dealt with is: For whom are you doing this study?

Purpose of the Enquiry

It is important to state research questions precisely. The questions must be clear and simple. This process of clarifying your own emerging questions so that they can be understood by others is a vital stage for your work, and for finding funds. To a certain extent the purpose of the study will help define the target audience for your work. This will in turn influence the research methods you use.

If the purpose of you work is to satisfy your own curiosity as an individual or group of practitioners then that methodology may be developed in a way which is totally idiosyncratic to your clinical practice. Your work may be seen as the development of a research methodology appropriate for your particular way of working. This could be extended to the arena of your clinical peers to whom you wish to validate a set of hypotheses about your common practice. They may demand that certain restraints are imposed. For example; in working as a research consultant with music therapists their demand of me was to find research methods appropriate to their clinical practice, not to adapt practice to research restrictions.

Those of us who have been through the academic research mill have often been fortunate enough to satisfy our own questions within the guidelines of a particular research discipline. What we may need to develop within complementary medicine is an agency which can offer such impartial supervision and guidance.

Most clinicians when they do research are attempting to convince someone of the validity of their approach. Either they are trying to convince other practitioners, licensing authorities, journal editors, consumer or patient. It is important then to be able to see the purpose of what your are doing and why. In the field of complementary practice it is important to state where such practice could be used within a current health care framework, and how such a practice fits in with orthodox practice. In addition it is important to show where the proposed work will improve research expertise, current clinical practice or have an educational component.

Once these broad understandings have been considered then it is time to provide more details of the intended study.

Aims of the Study

The aims of clinical studies are multi-various. The exploration and generation of hypotheses, the refinement of those hypotheses; the discovery of the optimal use of a therapeutic regimen, the safety of that regimen or the active ingredient in a composite therapy are common aims. Similarly complementary practitioners often want to make a definitive demonstration of their therapeutic regime in comparison with another regimen or to demonstrate feasibility or efficacy in a particular setting.

Such clinical trials usually pose two radically different types of problem which demand differing types of solution and different methodological considerations.

The first is an explanatory trial. In this approach we seek information which will give us answers to scientific questions often at the biological level. Such trials are closer to laboratory conditions and may have no pragmatic consequences. The questions asked in these trials are more concerned with causality and the natural history of disease, the development of medicines and the refinement and application of techniques.

The second type of trial is a comparison of treatments as applied in practice. This is a pragmatic trial. In such a trial treatment conditions would be optimised and our purpose would be to make a decision about which treatment modality to use. In these trials we can incorporate factors other than the biological or psychological. These factors might be concerned with cost, efficacy, ease of use, acceptability by the patient, possibility for inclusion in general practice. Such trials are related to the context of the treatment approach and provide answers concerned with feasibility, but not necessarily answers which are explanatory; i.e. the treatment works but nobody knows why.

Both can be combined, but with extreme caution. In the interest of simplicity it is better to understand what you are attempting and then ask yourself if you are taking on too much. Rather than attempt an overly complex study it may be possible to work as a research group of practitioners satisfying interdependent aims. In this way of working practitioners can work co-operatively with colleagues developing differing sets of answers which answer a common question.

For example; in the music therapy research mentioned earlier some therapists
concentrated on developing methodologies which showed physiological changes during and after the process of therapy (explanatory trials), others where concerned with clinical outcomes (pragmatic trials), and all were concerned in the theoretical debate, based on experimental observation and clinical expertise about how clinical improvement was effected.

It is in the aims section where you will state your hypotheses to be tested.

Pilot studies

It really is important to make exploratory or pilot studies, not as an easy option. By attempting to try out our ideas in practice then we can see the pitfalls and the possibilities of what we are attempting. Some of these pitfalls can he avoided by asking expert opinion beforehand.

Unfortunately the pressure of research sponsors can be for precocious results and evidence that something is being done for their money. Exploratory trials and critical developmental thinking are often sacrificed to such impatience.

Pilot studies are not any easier to construct methodologically than later trials. Definitive studies cannot be generated from poorly thought out exploratory studies. As much statistical and methodological thinking must go into the pilot studies as the larger study. Data must be carefully evaluated in a series of sequential experiments. These are the platform for the future work.

The question always remains of when to stop piloting and when to begin a definitive study. The main objective in any clinical trial is to find a feasible, effective and tolerable regime which is easy to understand, is easily administered, has an evaluative index which demonstrates the identified clinical change and co-operative clinical partners. Once you have such an approach then it is time to try it out. In an application for research funding it is important to link any pilot work to an overall developmental strategy with some clear indication of a future definitive study.

Background to the Study

In your preliminary thinking you will have begun to understand the gap in present knowledge. You will then need to say how your study will begin to fill these gaps and contribute to that knowledge. This understanding is based on your own clinical knowledge, that of current expertise from other practitioners but is based predominantly on reviewing the clinical literature.

Reviewing literature can be a research study in itself. It demands a great deal of application to search, collect and read the relevant material. However it can bring much satisfaction. By reading of other research endeavours over the years we can gain a sense of the community of research practitioners in medicine who too have been excited by ideas and attempted to those ideas in practice.

There are numerous databases available for searching the literature. These searches are made easier and cheaper by your being clear about what categories you wish to search under, in what range of publications, published in which languages and over what period of time. For example; by disease: inflammatory bowel disease; with the following factors: family factors, immunological, historical, epidemiological, psychological; published in English, German and French during the last five years.

A good medical librarian is of invaluable help. These searches usually cost money. A search facility nay be available through your professional organisation. Once you have the list of papers it is then important to gather those papers together. Some of these papers may be in a local medical or University library. More often than not the papers must be secured through inter library loans. To do this you will need to make some arrangement with a library. Again, papers cost money and it is important to budget for this. Your professional organisation may have a paper ordering service which gathers papers at a reduced cost. These facilities are often slower than doing it yourself, and there is usually a limit to the number of papers you can order. It is then possible to make an extended search from the reference sections and bibliographies at those collected papers.

Then you have to read the papers critically, make notes and write up the conclusions. This is where you find that your writing skills may have become a little rusty.

Literature too can also act as a pilot study of ideas where your work builds upon previous studies. It is always an advantage to contact the authors of studies to ask how they would further their work. In journal papers not everything is revealed about the trial in terms of practical details; i.e. it may be an elegant study when reported but difficult to carry out in practice. By looking through the literature with a critical eye it is possible to see exactly what is needed as a next step in your own therapeutic discipline in terms of clinical practice or research methodology. It is also possible to see the mistakes of others and construct a trial which builds upon what has gone before.

Clinical literature is not solely confined to journal articles and books. Some articles quote eminent authors and they are worth contacting particularly for unpublished material which they may be willing to show you. If your work is based upon a literature review then it will have an influence upon the statistical methods that you use.

Design of the Study

In this section you will say what research strategy is to be used. Will you use a laboratory style explanatory approach or embark upon a survey? Are you using a controlled trial with randomised or matched controls, or are you carrying out a series or related single case designs? Are you attempting to describe a service within a hospital setting or is this a formal trial of a therapeutic procedure? This is where your methodological musings and debate must leave the heady heights of discussion and appear on paper.

It is important to give a detailed account of the research design you intend to use, and some indication of why you are using that design.

It is possible to be innovative in clinical trials design. The Research Council for Complementary Medicine application form (page 3) emphasises that Studies should not conflict with the best practices in the complementary discipline involved; they should be planned so that the major sources of error and bias are avoided; provided that this rigour is sought, they need not conform to the traditional patterns of clinical trials methodology. What then are the major considerations for avoiding error and bias, and how do we show that rigour is being sought?

Selection of subjects for the study

It is important to describe the class of patients who are to be included in the study. If you are studying a particular disease then it is important to define a sub-class of patients who are suitable for that trial. This will mean giving discrete criteria for patient inclusion and exclusion (e.g. by age, gender, chronicity, previous treatment). Beware of defining this group too narrowly such that they become unrepresentative. The study which accepts a broad spectrum of patients has a generalisability and persuasiveness that is essential to influencing a target audience of practitioners. Although hand-picking patients may be desirable in statistical terms there is a trade off between efficiency and generalisability. If your purpose is to demonstrate the efficacy of your approach with the aim of influencing applicability in general practice then choose carefully over a broad range of patients.

If you are conducting a controlled trial you will have to say what criteria are being used for control selection.

There is also a further sub-class of patients; those who complete the trial, i.e. those you actually gather data about. Withdrawals give rise to serious difficulties, especially if they occur during the treatment regime. People leave trials because they are frightened of what is going on, they may believe that they are not receiving an important life saving medication, the regime or data collection may be tedious, the medicine may taste nasty or the procedure is painful. Some patients don’t see the paint of the study after a while and somehow their commitment to research doesn’t match that of the researcher. Some patients at follow up are found to have left the area. Some patients die. Some researchers call this process one of ‘patient attrition’.

While withdrawals may throw important light on a particular practice and provide useful information it is always better to structure such a possibility into the trial if you believe this is going to happen. A careful pilot study should give some ideas about whether a treatment regime can be sustained or not.

Another important consideration is that of sample size. This is why it is emphasised that statistical thinking is vital at this stage of the study. Not after data has been collected.

If groups are to be compared then decisions will have to be made about randomisation of subjects to groups, how many patients are needed in those groups to achieve statistical significance, and more importantly, what is the power of those statistics. It is vital that appropriately sized groups are chosen in clinical trials designs so that clinically meaningful differences are not missed.

For example; if comparing two treatments (X and Y) in a pragmatic approach the researcher will want to know by what margin does one treatment regime surpass the other. This pragmatic approach is concerned with reducing the probability of preferring the inferior treatment (an error of the third kind). Whereas, in an explanatory approach it is important to avoid concluding that treatments X and Y differ when they are the same (an error of the first kind), or that treatments X and Y are equal when they are not (an error of the second kind).

Choice of data

Perhaps the greatest challenge is to sift out what data to collect. There is a temptation to collect masses and masses of data in some mistaken belief that more data is somehow representative of the whole person. It is important to collect multiple data sets which are indicators of therapeutic influence, but these data have to be analysed at the end of the trial. The challenge then is to define how the criteria which are used for evaluation are related to the treatment intervention, and one with another. The variables measured by the experimenter in this way are the dependent variables.

The panel which assesses your application will want to know why you have chosen particular measures or indices.

In assessing the effects of a treatment regimen we may use several diverse criteria; regression of a tumour, decrease in pain, return to work or mean survival time compared with a given prognosis. Return to work may be an important variable as identified by the patient but it offers no biological information. Regression of tumour size may be biologically important but this may have no effect upon survival.

It is therefore important to develop an instrument for measuring clinical change appropriate to the study. Explanatory studies will seek to find separate criteria. A pragmatic approach will look for a single index which can be used to indicate therapeutic efficacy.

It may be that the aim of the research design itself will concentrate on developing an index. This may be in the form of a questionnaire, or a battery of measures. In constructing such an increment you will be able to use your own expert knowledge, the clinical experience of colleagues, the clinical literature you have reviewed and the experience of patients. It is essential to bear in mind how patient status will change in relationship to the therapeutic application, and that your instrument measures all clinically important treatment effects. (If you take this route beware! Questionnaire design and validation is a project within itself).

What most of us seek is some sort of gold-standard measure which is both reliable and valid. Reliable in this sense refers to the consistency of a research instrument when applied to a stable population. Valid refers to whether those measures are genuine, i.e. do they measure what you say they are measuring? In addition the measure must be responsive enough to measure a small, but real, difference when one is present.

There are three main types of index which can be developed:

  1. The discriminative index which helps to distinguish between individuals or groups where no gold-standard exists.
  2. The predictive index which is used to classify individuals into predefined categories. This is evident in screening measures which identify specific individuals who will have a target condition or outcome. We see this in prognostic indicators or predictors of mortality.
  3. The evaluative index which is used to measure longitudinal change in an individual or group on the given criteria of interest. Such an index can utilise both quantitative and qualitative data and is often used to evaluate functional change.

My aim when giving advise is to find and use at least one index which is well validated in orthodox clinical practice. This helps build a bridge to other research traditions. There are also a number of well validated and reliable self report questionnaires. These are very useful if you do not have the resources to interview the subjects of your research yourself.

Data collection

It is necessary to say when the measures will be implemented, who will implement them and design a form for data collection. In planning the collection of data allow time for questionnaires to be filled in. If postal questionnaires are used make an allowance for the follow up of un-returned questionnaires, and be prepared to visit if necessary.

Ideally if data is collected by more than one person then one person must be placed in a position to collate that data. Research is an obsessive activity. Data collection is tedious. Missing data is a calamity.

With the advent of modern computing methods then it is easy to store and manipulate data. Putting data into a database or spreadsheet is relatively straightforward, getting it out again in a meaningful way is not. The statistical decisions which you made earlier, and your understanding of the relationships between sets of data, will be invaluable at this stage. If data is to be stored on a computer remember that someone has to enter that data and it will be necessary to say who will handle the data, and when they will enter the data. Entering large sets of data at the end of a project leads to error. Data sheets can be lost. Human errors from fatigue are common. It may be possible to consider direct entry of data to a computer with some form of data checking routine built in.

It is important to describe how any specialist laboratory tests will be carried out, the nature of those tests and who will carry them out. Specialist testing is expensive and another potential source of error so it is important to be clear about how valid or necessary such measures are. Some specialist tests can be. Therapeutic interventions in themselves and it is important to bear this in mind when designing the study and perhaps consider them as control variables. (A control variable is a potential independent variable which is held constant).

Treatment variables

Treatment variables are the independent variables. They refer to the techniques or the programme of treatment you will use as a clinician. This will probably be the easiest part for you to organise. It is important that you say clearly what you will do, when you will do it and why you are doing it. For complementary practitioners working together it is vital that they achieve some standardisation of practice while remaining true to their therapeutic discipline thereby maintaining their own therapeutic integrity and validity. If your therapeutic discipline contains its own idiosyncratic terms it may be necessary to provide a glossary of terms within the application document.

When a control group is used then it is essential to define how, when and where they will be treated, even if they receive no treatment.

If you are carrying out a clinical trial it will be necessary to incorporate some time when baseline data can be collected before treatment begins. The time when treatment periods begin and end must be planned and recorded. Criteria must be made for when the trial period of treatment is to end, and when a follow up assessment is to be made.

It is also important to say what will happen to patients discovered to have new needs during the process of the study.

Administration of the Study

Analysis of the results

If the data is stored on a computer, and the researchers understand their data then a statistical package can be used to analyse that data. If statistical advice is sought at the beginning of the trial, and the trial designed according to certain principles then the appropriate routines will be clear. With the implementation of statistical analysis packages on microcomputers then it is possible to view and analyse the data in a variety of ways. Such retrospective data analysis, sometimes called post hoc hypothesising, is dangerous. While it may suggest new hypotheses and correlations between data those relationships may be completely spurious. Analyses of data are only spurs to critical thinking, they cannot replace it.

When considering using a statistical package it may be necessary to enlist the help of a statistician to help interpret the results. Many packages also have a graphics capability which will enable the data to be displayed in forms which are easier to understand than tables of figures.

Timetable of the study

In the process of making the previous decision you will have some idea of how long the study will take. The most common mistake that novice researchers make is to underestimate the amount of time necessary to complete a study. I shall assume that you have contacted the practitioners and referrers to be involved and gained their co-operation.

First you will need to assess how long it will take to recruit the requisite number of patients. If you are recruiting patients with special characteristics through a seemingly co-operative referrer check the time it will take to recruit a starting sample, assess them and gain their consent. This information will also influence how many patients can be treated in a given period of time. If you are collecting data as well as treating patients then the time you allow for your usual treatment session may be extended.

Second, plot the time it will take for all the subjects of the research to be treated and make a definite date for the trial to end. Ensure that any specialist testing will have been carried out by that date and the results received. Allow for any missing questionnaire data to be followed up.

Third, allow time to analyse the results. Initial data is raw data; it can do nothing by itself, you as researcher must process it. Unlike patients, data is not self-actualising.

For example; a client group of ‘Heilpraktiker’ in West Germany while willing to collect data over a period of eighteen months were astounded by the suggestion that the analysis of the data and the writing up the report would take at least another six months (in my opinion a conservative estimate). Originally they heard this suggestion as six weeks, and thought this too was too long.

Fourth, consider that the results must be thought about and then written up in some form for publication or as a presentation to your target audience. Because we are practitioners does not always mean that we are writers. If you are writing a joint report then allow time for arguing. A useful tip is to present your work at regular intervals to colleagues, and to the collaborators in your study at the end of the trial. This thinking for a presentation can help your writing, particularly if you record the presentation on audio-tape.

Finally, if you are writing and working with colleagues make sure that you have made a decision about who is to be senior author, or at least to have final say on the finished report and who is to be accredited in the list of authors.

Ethical considerations

If your professional group has a code of ethical consideration for research then it will be necessary to consider them. Mention such a code of practice in your research application. If you are working with an institution then there will be an ethical committee which will need to see your research submission. Your sponsors will want to satisfy themselves that you have obtained approval for your intended research from an ethical committee. While your sponsors may be flexible in their approach, local ethical committees may not be quite as well educated. The onus is on the clinician/ researcher to consult with them and explain what he or she intends to do.

As soon as data is collected, and particularly if it is stored on a computer, then that data must be protected and made confidential. Similarly, if the research is to be written as a report which can potentially be published then arrangements must be made to maintain confidentiality and this must be stated in the application.

The consent of patients and co-operating practitioners must also be obtained. Be clear how you are to obtain this consent, and what information you will give to the patient in the trial. The rights of the patient to refuse to participate in, or withdraw from, the trial must be observed.

It is essential that any possible risks to the patient are made clear and harmful consequences removed. If an unorthodox practice is to be used then be prepared for what seem to be obstructive and awkward questions. As practitioners we take for granted what we do. Cur normal decisions and practices can sometimes be misunderstood or misinterpreted.

For example: A news programme which juxtaposes concern about the spread of AIDS, and highlights the use of needles by addicts coupled with the debate about complementary medical practice, notably acupuncture, can indirectly raise issues about risks to the patient from the use of needles. If you are about to embark on an acupuncture trial, and are attempting to recruit patients from referrers who are only marginally convinced about co-operating, then such news can have negative consequences. Any statements about insurance for professional indemnity and the limit of that indemnity can be included here.

Costing of the project

As mentioned earlier, research is greedy for resources and particularly for money. In a research submission you will need to justify your needs and also satisfy your potential sponsors that the request is valid. Ask for enough. Do not underestimate your requirements. Find out what is the minimum or maximum trial budget that they will consider. Some research councils will not consider small-scale trials as the administration costsalone are too expensive.

The principle considerations are:

  • Staffing costs;
    1. a) the salary of the investigator(s) and the hidden pension and N.I.
      costs over a given period of time. Allow for annual increments.
    2. secretarial costs,
    3. specialist consultancy services for data handling, statistical advice
      and analysis and research supervision,
    4. specialist consultancy services for patient assessment.
  • Treatment costs; any tests will need to be costed, particularly when carried out by an external agency, and the cost of treatments or medicines will need to be considered.
  • Handling charges; most sponsors will support an institution rather than an individual. Such institutions will often charge a handling cost as a percentage of the funds received.
  • Administrative costs; there will be accommodation charges, telephone bills, stationery needs, printing requirements, postage and overheads.
  • Travel costs; visits to expert informants, visits to follow up patients.
  • Hardware costs; any specialist equipment which must be rented or bought.
  • Computing costs; it may be necessary to purchase software for computing or to have that software adapted or written for your trial. If you have access to a computer centre then that centre may charge for such support. Library services; searching for references in the literature, collecting literature and photocopying literature is costly.

Sometimes it is necessary to break these costs down into yearly requirements.

Personnel

For the main personnel working on the project it is important to include curricula vitae, and their appropriate clinical and academic qualifications. Some sponsors require you to nominate a key person to oversee the work. If you are using an external supervisor then his or her qualifications will need to be included.

Research experience can be included in this section. Hopefully lack of experience should not preclude the clinician from a research grant providing the sponsor is satisfied that there is adequate research supervision. Otherwise it would be impossible to gain research experience. With the dwindling resources available for research through academic institutions we are in danger of seriously damaging our research tradition in England. However by taking research out of the academic environment we have a chance to promote research training for clinicians within the context of their own practice. This approach is not bound by traditional thinking and should enliven our scientific medical culture.

Submitting the research

Send the completed design with a covering letter. It may be that you can submit your design for a preliminary review before a formal submission to a full committee. Be prepared to revise and negotiate a little. Most big committees meet only once or twice a year so it is important to find the final date for submission.

Conclusion

If you can incorporate all these considerations then the research itself should be easy. Applying for funds is the worst part. It takes a lot of work and organisation with no guarantee of results. Remember that research takes time; personal time, reading time, thinking time, and time away from your routine practice. It is prudent to negotiate such changes with your friends, colleagues and family.

Be clear about the intended audience for your research.

Research is expensive. It may be worthwhile investing in preliminary research planning which would include a brief review of the literature and statistical or methodological advice.

For future research in complementary medicine we need a research agency which can offer;

  • methodological and statistical advice,
  • computer support, with a provision for extended data analysis,
  • research supervision,
  • library and literature support
  • brokerage with potential sponsors.

A set of ethical guidelines for complementary medical research applications
would also be timely.

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