Dr Vipul Gandhi
Homoeopathic Clinical Research is the task ahead in Homoeopathy. I have made efforts in compiling the guidelines for preparing Homoeopathic Clinical trial Protocol/ Clinical Technical document( CTD)
1. Protocol title, protocol identifying number and date. Any amendments should also bear the amendment numbers and dates.
2. Name and address of the Sponsor and monitor.
3. Name and title of the investigator who is responsible for conducting the trial and address and telephone numbers of the trial site
4. Names and addresses of the clinical laboratory and other medical and/ or technical departments and/ or institutions involved in the trial.
1. Background information:
1.1 Name and description of the investigational products
1.2 A Summary of findings from non clinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial
1.3 Summary of the known and potential risks and benefits , if any, to human subjects
1.4 Description of , and justification for, the route of administration , dosage, dosage regimen and treatment period
1.5 A statement that the trial will be conducted in compliance with the protocol , Good Clinical practices and the requirements of Central council of research in Homoeopathy.
1.6 References to literature and data that are relevant to the trial and that provide background for the trial
2. Trial objectives and purpose:
2.1 A detailed description of the objectives and purpose of the trial.
3.1 A description of the type /design of the trial to be conducted ( e.g. double blind, placebo controlled, parallel design) and a schematic diagram of trial design , procedure and stages.
3.2 A description of the trial treatments and the dosage regimen of the investigational products
3.3 the expected duration of subject participation and a description of the sequence and duration of all trial periods including follow up , if any
3.4 A description of the Drop[ out criteria for individual subjects ,parts of the trial and the entire trial
3.5 Accountability procedures for the investigational products , including the placebos
3.6 maintenance of trial treatment codes and procedures for breaking codes
4.Selection and withdrawal of subjects:
4.1 Subject inclusion criteria
4.2 Subject exclusion criteria
4.3 Subject withdrawal criteria( i.e. terminating investigational product treatment/ trial treatment) and procedures specifying:
a) when and how to withdraw subjects from the trial/ investigational product treatment
b) The type and timing of the data o be collected from withdrawn subjects
c) Whether and how subjects are to be replaced
d) The follow up for subjects withdrawn from investigational product treatment / trial treatment
5. Treatment of Subjects:
5.1 The treatment to be administered including the names of all the products , the doses , the dosing schedules , the route/modes of administration and the treatment periods including the follow up period for subjects for each investigational product treatment/ trial treatment.
5.2 Medication / treatment permitted and not permitted before and or during the trial.
5.3 Procedures for monitoring subject compliance
6. Assessment of efficacy and safety
6.1 Specification of efficacy parameters
6.2 Methods and timing for assessing , recording and analyzing of efficacy parameters
6.3 specifications of safety parameters
6.4 Procedures for eliciting report of and for recording and reporting adverse event and intercurrent illnesses
6.5 The type and duration for follow up of subjects after adverse events .
7.1 a description of the statistical methods to be employed , including timing of any planned interim analysis
7.2 the number of subjects planned to be enrolled , In multicentric trials , the numbers of enrolled subjects projected for each trial site should be specified . reason for choice of sample size , including reflections on the power of the trial and clinical justification
7.3 significance tests to be used
7.4 criteria for termination of trial
7.5 procedure for accounting for missing , unused and spurious data.
7.6 Procedures for reporting any deviation s from the original statistical plan which should be justified in the final report
7.7 The selection of subjects to be included in the analysis ( e.g. all randomized subjects , all dosed subjects, all eligible subjects, invaluable subjects)
8. Direct access to source data / document
8.1 The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator/ institution will permit trial related monitoring , audits , institutional review board / independent ethics committee review and regulatory inspections , providing direct access to source data / documents .
8.2 Data handling and record keeping
9.1 Description of ethical considerations relating to the trial
10. Quality control and quality assurance
10.1.1 The medicine used in the study shall comply with the pharmacopial and quality standards
10.2 financing and insurance
10.3 publication policy
Dr Vipul Gandhi
Reader , Department of Medicine
D, Y . Patil Homoeopathic College. Pimpri, Pune
Email : [email protected]v